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Evaluating the Safety and Immunogenicity of HIV Clade C DNA Vaccine and MF59- or AS01B-Adjuvanted Clade C Env Protein Vaccines in Various Combinations in Healthy, HIV-Uninfected Adults

A Phase 1/2a Clinical Trial to Evaluate the Safety and Immunogenicity of HIV Clade C DNA, and of MF59®- or AS01B-Adjuvanted Clade C Env Protein in Various Combinations, in Healthy, HIV-Uninfected Adult Participants

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02915016
Enrollment
334
Registered
2016-09-26
Start date
2016-12-07
Completion date
2020-02-12
Last updated
2022-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Brief summary

This study will evaluate the safety and immune response to the DNA-HIV-PT123 vaccine used in combination with one of two protein vaccines (Bivalent Subtype C gp120/MF59 or Bivalent Subtype C gp120/AS01B) in healthy, HIV-uninfected adults.

Detailed description

The purpose of this study is to evaluate the safety, tolerability, and immune response of the DNA-HIV-PT123 vaccine when used in combination with one of two protein vaccines: Bivalent Subtype C gp120/MF59 (Protein/MF59) or Bivalent Subtype C gp120/AS01B (Protein/AS01B). These protein vaccines may boost the immune response to the DNA vaccine. The study will enroll healthy, HIV-uninfected adults. Participants will be randomly assigned to one of eight groups, and each group will receive a different sequence of vaccines during the study. Groups 1 and 4 will receive the DNA-HIV-PT123 vaccine, the Protein/MF59 vaccine, and placebo. Groups 2, 3, 5, 6, and 7 will receive the DNA-HIV-PT123 vaccine, the Protein/AS01B vaccine, and placebo. Group 8 will only receive placebo. All participants will receive their assigned vaccines at Months 0, 1, 3, and 6. Each of these visits will include three injections. Follow-up visits will occur at Week 2 and Months 1.5, 3.5, 6.25, 6.5, 9, and 12. Study visits will include a physical examination, an interview and/or questionnaire, HIV testing and HIV risk reduction counseling, and urine and blood collection. Participants may optionally choose to provide stool, rectal fluid, cervical fluid, or semen samples. Participants will be contacted 6 months after the last scheduled visit by phone, text message, or e-mail for information about their health.

Interventions

BIOLOGICALDNA-HIV-PT123 vaccine

Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.

BIOLOGICALBivalent Subtype C gp120/MF59 vaccine

Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.

BIOLOGICALBivalent Subtype C gp120/AS01B vaccine

Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.

BIOLOGICALPlacebo

Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

General and Demographic Criteria * Age of 18 to 40 years * Access to a participating HVTN clinical research site (CRS) and willingness to be followed for the planned duration of the study * Ability and willingness to provide informed consent * Assessment of understanding: volunteer demonstrates understanding of this study; completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly * Agrees not to enroll in another study of an investigational research agent before the last required protocol clinic visit * Willing to be contacted by phone, text message, or e-mail 6 months after completion of the scheduled clinic visits * Good general health as shown by medical history, physical exam, and screening laboratory tests HIV-Related Criteria: * Willingness to receive HIV test results * Willingness to discuss HIV infection risks and amenable to HIV risk reduction counseling. * Assessed by the clinic staff as being at low risk for HIV infection and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit. Laboratory Inclusion Values: Hemogram/Complete Blood Count (CBC) * Hemoglobin greater than or equal to 11.0 g/dL for volunteers who were born female, greater than or equal to 13.0 g/dL for volunteers who were born male * White blood cell count equal to 3,300 to 12,000 cells/mm\^3 * Total lymphocyte count greater than or equal to 800 cells/mm\^3 * Remaining differential either within institutional normal range or with site physician approval * Platelets equal to 125,000 to 550,000/mm\^3 Chemistry * Chemistry panel: ALT, AST, and alkaline phosphatase less than 1.25 times the institutional upper limit of normal; creatinine less than or equal to institutional upper limit of normal. Virology * Negative HIV-1 and -2 blood test: US volunteers must have a negative FDA-approved enzyme immunoassay (EIA). Non-US sites may use locally available assays that have been approved by HVTN Laboratory Operations. * Negative Hepatitis B surface antigen (HBsAg) * Negative anti-Hepatitis C virus antibodies (anti-HCV), or negative HCV polymerase chain reaction (PCR) if the anti-HCV is positive Urine * Normal urine: * Negative urine glucose, and * Negative or trace urine protein, and * Negative or trace urine hemoglobin (if trace hemoglobin is present on dipstick, a microscopic urinalysis with red blood cells levels within institutional normal range). Reproductive Status * Volunteers who were born female: negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test performed prior to vaccination on the day of initial vaccination. Persons who are NOT of reproductive potential due to having undergone total hysterectomy or bilateral oophorectomy (verified by medical records), are not required to undergo pregnancy testing. Reproductive status: United States A volunteer who was born female must: * Agree to consistently use effective contraception (see the protocol for more information) for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment through the last required protocol clinic visit. Effective contraception for participants in the United States is defined as using any 1 or more of the following methods: * Condoms (male or female) with or without a spermicide, * Diaphragm or cervical cap with spermicide, * Intrauterine device (IUD), * Hormonal contraception, or * Successful vasectomy in the male partner (considered successful if a volunteer reports that a male partner has \[1\] documentation of azoospermia by microscopy, or \[2\] a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity postvasectomy), or * Any other contraceptive method approved by the HVTN 108 protocol safety review team (PSRT) * Or not be of reproductive potential, such as having reached menopause (no menses for 1 year) or having undergone hysterectomy, bilateral oophorectomy, or tubal ligation; * Or be sexually abstinent. Southern Africa A volunteer who was born female must: * Agree to consistently use effective contraception (see the protocol for more information) for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment through the last required protocol clinic visit. Effective contraception for participants in Southern Africa is defined as using 2 methods of birth control. These include 1 of the following methods: * Condoms (male or female) * Diaphragm or cervical cap * PLUS 1 of the following methods: * IUD, * Hormonal contraception (in accordance with applicable national contraception guidelines), or * Successful vasectomy in the male partner (considered successful if a volunteer reports that a male partner has \[1\] documentation of azoospermia by microscopy, or \[2\] a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity postvasectomy), or * Any other contraceptive method approved by the HVTN 108 PSRT * Or not be of reproductive potential, such as having reached menopause (no menses for 1 year) or having undergone hysterectomy, bilateral oophorectomy, or tubal ligation; * Or be sexually abstinent. * Volunteers who were born female must also agree not to seek pregnancy through alternative methods, such as artificial insemination or in vitro fertilization until after the last required protocol clinic visit Other Volunteers 21 years of age and older who were born female consenting to provide cervical samples: * Pap smear within: * the 3 years prior to enrollment with the latest result reported as normal or atypical squamous cells of undetermined significance (ASCUS), or * the 5 years prior to enrollment, with the latest result reported as normal, or ASCUS with no evidence of high risk human papillomavirus (HPV). * If no pap smear was done within the last 3 years (or within the last 5 years, if high risk HPV testing was performed), the volunteer must be willing to undergo a pap smear with the result reported as normal or ASCUS prior to sample collection.

Exclusion criteria

General * Blood products received within 120 days before first vaccination * Investigational research agents received within 30 days before first vaccination * Body mass index (BMI) greater than or equal to 40; or BMI greater than or equal to 35 with 2 or more of the following: systolic blood pressure greater than 140 mm Hg, diastolic blood pressure greater than 90 mm Hg, current smoker, known hyperlipidemia * Intent to participate in another study of an investigational research agent or any other study that requires non-HVTN HIV antibody testing during the planned duration of the HVTN 108 study * Pregnant or breastfeeding * Active duty and reserve US military personnel Vaccines and Other Injections * HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received control/placebo in an HIV vaccine trial, the HVTN 108 PSRT will determine eligibility on a case-by-case basis. * Non-HIV experimental vaccine(s) received within the last 5 years in a prior vaccine trial. Exceptions may be made for vaccines that have subsequently undergone licensure. For volunteers who have received control/placebo in an experimental vaccine trial, the HVTN 108 PSRT will determine eligibility on a case-by-case basis. For volunteers who have received an experimental vaccine(s) greater than 5 years ago, eligibility for enrollment will be determined by the HVTN 108 PSRT on a case-by-case basis. * Live attenuated vaccines other than influenza vaccine received within 30 days before first vaccination or scheduled within 14 days after injection (eg, measles, mumps, and rubella \[MMR\]; oral polio vaccine \[OPV\]; varicella; yellow fever) * Influenza vaccine or any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination (eg, tetanus, pneumococcal, Hepatitis A or B) * Allergy treatment with antigen injections within 30 days before first vaccination or that are scheduled within 14 days after first vaccination Immune System * Immunosuppressive medications received within 168 days before first vaccination. (Not exclusionary: \[1\] corticosteroid nasal spray; \[2\] inhaled corticosteroids; \[3\] topical corticosteroids for mild, uncomplicated dermatitis; or \[4\] a single course of oral/parenteral corticosteroids at doses less than 2 mg/kg/day and length of therapy less than 11 days with completion at least 30 days prior to enrollment.) * Serious adverse reactions to vaccines or to vaccine components including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain. (Not excluded from participation: a volunteer who had a nonanaphylactic adverse reaction to pertussis vaccine as a child.) * Immunoglobulin received within 60 days before first vaccination * Autoimmune disease * Immunodeficiency Clinically significant medical conditions * Untreated or incompletely treated syphilis infection * Clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health. A clinically significant condition or process includes but is not limited to: * A process that would affect the immune response, * A process that would require medication that affects the immune response, * Any contraindication to repeated injections or blood draws, * A condition that requires active medical intervention or monitoring to avert grave danger to the volunteer's health or well-being during the study period, * A condition or process for which signs or symptoms could be confused with reactions to vaccine, or * Any condition specifically listed among the

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessMeasured through 7 days after each vaccine dose at Month 0, 1, 3, and 6Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\]. The maximum grade observed for each symptom over the time frame is presented.
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationMeasured through 7 days after each vaccine dose at Month 0, 1, 3, and 6Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\]. The maximum grade observed for each symptom over the time frame is presented.
Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsMeasured through 7 days after each vaccination at Month 0, 1, 3, and 6Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\]. The following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: malaise and/or fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and body temperature. The item Max. Systemic Reaction is the maximum of the individual systemic variables for a participant. It does not include temperature.
Number of Participants Reporting Adverse Events (AEs), by Relationship to Study ProductMeasured through 30 days after each vaccination at Month 0, 1, 3, and 6For participants reporting multiple AEs over the time frame, the maximum relationship is counted.
Number of Participants Reporting Adverse Events (AEs), by Severity GradeMeasured through 30 days after each vaccination at Month 0, 1, 3, and 6For participants reporting multiple AEs over the time frame, the maximum severity grade is counted.
Number of Participants Reporting Serious Adverse Events (SAEs)Measured through Month 12Measured as outlined in Version 2.0 (January 2010) of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual)
Number of Participants Reporting Adverse Events of Special Interest (AESIs)Measured through Month 18There were no adverse events of special interest reported by any participant.
Number of Participants Reporting New Chronic Conditions (Requiring Medical Intervention for ≥ 30 Days)Measured through Month 12There were no new chronic conditions (requiring medical intervention for ≥ 30 days) reported by any participant.
Number of Participants With Early Study Termination Associated With an AE or ReactogenicityMeasured through Month 12There were no early study terminations associated with an AE or reactogenicity reported by any participant.
Number of Participants With Study Product Discontinuation Associated With an AE or ReactogenicityMeasured through Month 6.5From the study product discontinuation form, study product administration reasons are tabulated by treatment arm.
Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.Measured during screening, and 2 weeks after each vaccination at Month 0, 1, 3, and 6For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Chemistry and Hematology Laboratory Measures - Creatinine.Measured during screening, and 2 weeks after each vaccination at Month 0, 1, 3, and 6For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Chemistry and Hematology Laboratory Measures - Hemoglobin.Measured during screening, and 2 weeks after each vaccination at Month 0, 1, 3, and 6For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Measured during screening, and 2 weeks after each vaccination at Month 0, 1, 3, and 6For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Chemistry and Hematology Laboratory Measures - Platelets, WBC.Measured during screening, and 2 weeks after each vaccination at Month 0, 1, 3, and 6For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Numbers of Participants With Grade 1 or Higher Local Laboratory Results.Measured during screening, and 2 weeks after each vaccination at Month 0, 1, 3, and 6The numbers (percentages) of participants with local laboratory values recorded as meeting Grade 1 AE criteria or above as specified in the DAIDS AE Grading Table were tabulated by treatment group for each post vaccination timepoint.
Occurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.Measured at Month 6.5IgG binding antibody breadth assays were not run. Instead, IgG was assayed against a smaller panel of antigens. Serum IgG responses were measured on a Bio-Plex instrument using a custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen minus reference antigen MFI. Net MFI below 1 is set to 1, and Net MFI above 22,000 is set to 22,000. Samples from post-baseline visits have positive responses if they meet three criteria: (1) net MFI \>= antigen-specific threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI \> 3 times baseline net MFI, and (3) experimental antigen MFI \> 3 times baseline MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI.
Occurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.Measured at Month 6.5IgG binding antibody breadth assays were not run. Instead, IgG was assayed against a smaller panel of antigens.Serum IgG responses were measured on a Bio-Plex instrument using a custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen minus reference antigen MFI. Net MFI below 1 is set to 1, and Net MFI above 22,000 is set to 22,000. Samples from post-baseline visits have positive responses if they meet three criteria: (1) net MFI \>= antigen-specific threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI \> 3 times baseline net MFI, and (3) experimental antigen MFI \> 3 times baseline MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI.
Occurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Responses - Positive Response Rates.Measured at Month 6.5Serum IgG responses were measured on a Bio-Plex instrument using a custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen minus reference antigen MFI. Net MFI below 1 is set to 1, and Net MFI above 22,000 is set to 22,000. Samples from post-baseline visits have positive responses if they meet three criteria: (1) net MFI \>= antigen-specific threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI \> 3 times baseline net MFI, and (3) experimental antigen MFI \> 3 times baseline MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI.
Occurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Response - Magnitudes.Measured at Month 6.5Serum IgG responses were measured on a Bio-Plex instrument using a custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen minus reference antigen MFI. Net MFI below 1 is set to 1, and Net MFI above 22,000 is set to 22,000. Samples from post-baseline visits have positive responses if they meet three criteria: (1) net MFI \>= antigen-specific threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI \> 3 times baseline net MFI, and (3) experimental antigen MFI \> 3 times baseline MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI.
Occurrence and Level of Neutralizing Antibody Responses Against HIV-1 Isolates.Measured at Month 6.5The neutralizing antibody assay was not run. Therefore this dataset doesn't exist
Occurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.Measured at Month 6.5PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p\<=0.00001. Any Env magnitude is the maximum of gp120 and Env ZM96 magnitude; Any Pol is the sum of CN54 magnitude; and Any HIV is the sum of Gag ZM96, Nef CN54, Any Pol, and Any Env. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.
Occurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.Measured at Month 6.5PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p\<=0.00001. Any Env magnitude is the maximum of gp120 and Env ZM96 magnitude; Any Pol is the sum of CN54 magnitude; and Any HIV is the sum of Gag ZM96, Nef CN54, Any Pol, and Any Env. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.
Occurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.Measured at Month 6.5PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p\<=0.00001. Any Env magnitude is the maximum of gp120 and Env ZM96 magnitude; Any Pol is the sum of CN54 magnitude; and Any HIV is the sum of Gag ZM96, Nef CN54, Any Pol, and Any Env. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.
Occurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.Measured at Month 6.5PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p\<=0.00001. Any Env magnitude is the maximum of gp120 and Env ZM96 magnitude; Any Pol is the sum of CN54 magnitude; and Any HIV is the sum of Gag ZM96, Nef CN54, Any Pol, and Any Env. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.

Countries

South Africa, United States

Participant flow

Participants by arm

ArmCount
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/MF59 vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
30
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
50
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo in their right deltoid at Months 0 and 1, and placebo and the Protein/AS01B vaccine in their right deltoid at Months 3 and 6. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
50
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/MF59 vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/MF59 vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
30
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01B
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
50
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01B
Participants will receive the DNA-HIV-PT123 vaccine in their left deltoid at Months 0, 1, and 6 and placebo in their left deltoid at Month 3. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. DNA-HIV-PT123 vaccine: Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
50
Group 7: Placebo + Protein/AS01B
Participants will receive placebo in their left deltoid at Months 0, 1, 3, and 6. They will receive placebo and the Protein/AS01B vaccine in their right deltoid at Months 0, 1, and 6 and placebo in their right deltoid at Month 3. Bivalent Subtype C gp120/AS01B vaccine: Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose. Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
50
Group 8: Placebo
Participants will receive placebo in both their right and left deltoids at Months 0, 1, 3, and 6. Placebo: Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
24
Total334

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005FG006FG007
Overall StudyElected not to continue00010010
Overall StudyHIV infection11101000
Overall StudyLost to Follow-up42535282
Overall StudyParticipant unable to adhere00000001
Overall StudyPhysician Decision00100120
Overall StudyWithdrawal by Subject20101311

Baseline characteristics

CharacteristicGroup 2: DNA-HIV-PT123 + Placebo + Protein/AS01BTotalGroup 8: PlaceboGroup 7: Placebo + Protein/AS01BGroup 6: DNA-HIV-PT123 + Placebo + Protein/AS01BGroup 5: DNA-HIV-PT123 + Placebo + Protein/AS01BGroup 1: DNA-HIV-PT123 + Placebo + Protein/MF59Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01B
Age, Continuous25 years25 years26 years25 years25 years27 years24 years24 years25 years
Age, Customized
18 - 20 years
9 Participants49 Participants3 Participants7 Participants9 Participants6 Participants6 Participants4 Participants5 Participants
Age, Customized
21 - 30 years
35 Participants233 Participants16 Participants36 Participants33 Participants32 Participants20 Participants22 Participants39 Participants
Age, Customized
31 - 40 years
6 Participants52 Participants5 Participants7 Participants8 Participants12 Participants4 Participants4 Participants6 Participants
Age, Customized
41 - 50 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Customized
Less than 18 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Customized
Over 50 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants26 Participants0 Participants3 Participants6 Participants3 Participants6 Participants1 Participants4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
47 Participants308 Participants24 Participants47 Participants44 Participants47 Participants24 Participants29 Participants46 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants5 Participants0 Participants2 Participants1 Participants1 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
3 Participants25 Participants0 Participants2 Participants4 Participants5 Participants4 Participants4 Participants3 Participants
Race (NIH/OMB)
Black or African American
27 Participants161 Participants11 Participants27 Participants24 Participants26 Participants8 Participants9 Participants29 Participants
Race (NIH/OMB)
More than one race
0 Participants3 Participants0 Participants1 Participants1 Participants0 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants6 Participants0 Participants2 Participants3 Participants0 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
White
19 Participants134 Participants13 Participants16 Participants17 Participants18 Participants18 Participants17 Participants16 Participants
Region of Enrollment
Africa
23 Participants132 Participants9 Participants23 Participants23 Participants23 Participants4 Participants4 Participants23 Participants
Region of Enrollment
United States
27 Participants202 Participants15 Participants27 Participants27 Participants27 Participants26 Participants26 Participants27 Participants
Sex: Female, Male
Female
22 Participants173 Participants13 Participants22 Participants25 Participants30 Participants19 Participants18 Participants24 Participants
Sex: Female, Male
Male
28 Participants161 Participants11 Participants28 Participants25 Participants20 Participants11 Participants12 Participants26 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
deaths
Total, all-cause mortality
0 / 300 / 500 / 500 / 300 / 500 / 500 / 500 / 24
other
Total, other adverse events
24 / 3033 / 5034 / 5020 / 3039 / 5031 / 5027 / 5013 / 24
serious
Total, serious adverse events
0 / 301 / 500 / 501 / 301 / 501 / 500 / 500 / 24

Outcome results

Primary

Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.

For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.

Time frame: Measured during screening, and 2 weeks after each vaccination at Month 0, 1, 3, and 6

ArmMeasureGroupValue (MEDIAN)
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.Alkaline Phosphatase (U/L)-Day 9860 U/L
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.AST (U/L)-Day 9817.5 U/L
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.AST (U/L)-Day 18219 U/L
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.ALT (SGPT) (U/L)-Day 4214 U/L
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.AST (U/L)-Day 4219.5 U/L
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.ALT (SGPT) (U/L)-Day 9815 U/L
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.Alkaline Phosphatase (U/L)-Day 18262.5 U/L
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.Alkaline Phosphatase (U/L)-Day 4260 U/L
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.Alkaline Phosphatase (U/L)-Day 1460.5 U/L
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.ALT (SGPT) (U/L)-Day 18215 U/L
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.ALT (SGPT) (U/L)-Day 1414 U/L
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.AST (U/L)-Day 1418 U/L
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.Alkaline Phosphatase (U/L)-Screening60.5 U/L
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.ALT (SGPT) (U/L)-Screening15 U/L
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.AST (U/L)-Screening20 U/L
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.ALT (SGPT) (U/L)-Day 9815 U/L
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.AST (U/L)-Day 4219 U/L
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.AST (U/L)-Day 1418 U/L
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.Alkaline Phosphatase (U/L)-Day 18270 U/L
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.ALT (SGPT) (U/L)-Day 1416 U/L
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.Alkaline Phosphatase (U/L)-Day 9864 U/L
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.Alkaline Phosphatase (U/L)-Day 4267 U/L
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.ALT (SGPT) (U/L)-Day 4214 U/L
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.ALT (SGPT) (U/L)-Screening14.5 U/L
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.Alkaline Phosphatase (U/L)-Screening72.5 U/L
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.ALT (SGPT) (U/L)-Day 18217 U/L
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.Alkaline Phosphatase (U/L)-Day 1467 U/L
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.AST (U/L)-Day 18220 U/L
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.AST (U/L)-Day 9818 U/L
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.AST (U/L)-Screening18.5 U/L
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.AST (U/L)-Day 9818.5 U/L
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.ALT (SGPT) (U/L)-Day 1416 U/L
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.AST (U/L)-Day 18219 U/L
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.Alkaline Phosphatase (U/L)-Day 9865 U/L
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.AST (U/L)-Screening19 U/L
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.ALT (SGPT) (U/L)-Day 18214 U/L
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.AST (U/L)-Day 4218 U/L
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.Alkaline Phosphatase (U/L)-Day 18270 U/L
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.AST (U/L)-Day 1419 U/L
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.Alkaline Phosphatase (U/L)-Day 1462.5 U/L
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.Alkaline Phosphatase (U/L)-Screening70.5 U/L
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.ALT (SGPT) (U/L)-Day 4214 U/L
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.Alkaline Phosphatase (U/L)-Day 4267 U/L
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.ALT (SGPT) (U/L)-Day 9814.5 U/L
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.ALT (SGPT) (U/L)-Screening15 U/L
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.AST (U/L)-Day 4216.5 U/L
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.ALT (SGPT) (U/L)-Screening13.5 U/L
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.ALT (SGPT) (U/L)-Day 1413 U/L
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.ALT (SGPT) (U/L)-Day 4213 U/L
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.ALT (SGPT) (U/L)-Day 9814 U/L
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.ALT (SGPT) (U/L)-Day 18216 U/L
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.AST (U/L)-Screening19 U/L
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.AST (U/L)-Day 1418 U/L
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.AST (U/L)-Day 9818 U/L
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.AST (U/L)-Day 18218.5 U/L
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.Alkaline Phosphatase (U/L)-Screening70 U/L
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.Alkaline Phosphatase (U/L)-Day 1465.5 U/L
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.Alkaline Phosphatase (U/L)-Day 4264 U/L
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.Alkaline Phosphatase (U/L)-Day 9863 U/L
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.Alkaline Phosphatase (U/L)-Day 18269 U/L
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.Alkaline Phosphatase (U/L)-Day 1464 U/L
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.ALT (SGPT) (U/L)-Screening16.5 U/L
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.AST (U/L)-Day 18219.5 U/L
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.AST (U/L)-Screening20 U/L
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.Alkaline Phosphatase (U/L)-Day 18264.5 U/L
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.Alkaline Phosphatase (U/L)-Screening69.5 U/L
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.Alkaline Phosphatase (U/L)-Day 9862 U/L
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.ALT (SGPT) (U/L)-Day 1417.5 U/L
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.AST (U/L)-Day 4219 U/L
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.AST (U/L)-Day 9820 U/L
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.ALT (SGPT) (U/L)-Day 9818 U/L
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.Alkaline Phosphatase (U/L)-Day 4262 U/L
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.ALT (SGPT) (U/L)-Day 4216 U/L
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.AST (U/L)-Day 1419.5 U/L
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.ALT (SGPT) (U/L)-Day 18216 U/L
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.AST (U/L)-Screening19 U/L
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.AST (U/L)-Day 4219 U/L
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.ALT (SGPT) (U/L)-Screening16 U/L
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.AST (U/L)-Day 9820 U/L
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.ALT (SGPT) (U/L)-Day 18219.5 U/L
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.AST (U/L)-Day 18221 U/L
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.ALT (SGPT) (U/L)-Day 9817 U/L
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.Alkaline Phosphatase (U/L)-Screening70 U/L
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.ALT (SGPT) (U/L)-Day 4216 U/L
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.Alkaline Phosphatase (U/L)-Day 1468 U/L
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.Alkaline Phosphatase (U/L)-Day 18269.5 U/L
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.Alkaline Phosphatase (U/L)-Day 4268 U/L
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.ALT (SGPT) (U/L)-Day 1416 U/L
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.Alkaline Phosphatase (U/L)-Day 9868 U/L
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.AST (U/L)-Day 1419.5 U/L
Group 7: Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.ALT (SGPT) (U/L)-Day 4215 U/L
Group 7: Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.AST (U/L)-Day 18219 U/L
Group 7: Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.AST (U/L)-Day 4219 U/L
Group 7: Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.Alkaline Phosphatase (U/L)-Day 1463 U/L
Group 7: Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.ALT (SGPT) (U/L)-Day 1415.5 U/L
Group 7: Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.AST (U/L)-Day 1419 U/L
Group 7: Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.AST (U/L)-Day 9818 U/L
Group 7: Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.Alkaline Phosphatase (U/L)-Day 4265 U/L
Group 7: Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.ALT (SGPT) (U/L)-Day 18216 U/L
Group 7: Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.Alkaline Phosphatase (U/L)-Day 18265 U/L
Group 7: Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.AST (U/L)-Screening19.5 U/L
Group 7: Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.Alkaline Phosphatase (U/L)-Day 9862 U/L
Group 7: Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.ALT (SGPT) (U/L)-Day 9815 U/L
Group 7: Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.ALT (SGPT) (U/L)-Screening15 U/L
Group 7: Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.Alkaline Phosphatase (U/L)-Screening66 U/L
Group 8: PlaceboChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.ALT (SGPT) (U/L)-Day 4214 U/L
Group 8: PlaceboChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.ALT (SGPT) (U/L)-Screening17 U/L
Group 8: PlaceboChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.ALT (SGPT) (U/L)-Day 9816 U/L
Group 8: PlaceboChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.Alkaline Phosphatase (U/L)-Day 18268 U/L
Group 8: PlaceboChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.ALT (SGPT) (U/L)-Day 18220 U/L
Group 8: PlaceboChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.Alkaline Phosphatase (U/L)-Day 1465.5 U/L
Group 8: PlaceboChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.AST (U/L)-Day 9820 U/L
Group 8: PlaceboChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.ALT (SGPT) (U/L)-Day 1416 U/L
Group 8: PlaceboChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.AST (U/L)-Day 18223 U/L
Group 8: PlaceboChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.Alkaline Phosphatase (U/L)-Screening59.5 U/L
Group 8: PlaceboChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.AST (U/L)-Day 4219 U/L
Group 8: PlaceboChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.AST (U/L)-Day 1419 U/L
Group 8: PlaceboChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.Alkaline Phosphatase (U/L)-Day 9866.5 U/L
Group 8: PlaceboChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.Alkaline Phosphatase (U/L)-Day 4267 U/L
Group 8: PlaceboChemistry and Hematology Laboratory Measures - ALT(SGPT), AST, Alkaline Phosphatase.AST (U/L)-Screening20 U/L
Primary

Chemistry and Hematology Laboratory Measures - Creatinine.

For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.

Time frame: Measured during screening, and 2 weeks after each vaccination at Month 0, 1, 3, and 6

ArmMeasureGroupValue (MEDIAN)
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Creatinine.Creatinine (mg/dL)-Day 1820.81 mg/dL
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Creatinine.Creatinine (mg/dL)-Day 980.815 mg/dL
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Creatinine.Creatinine (mg/dL)-Day 420.83 mg/dL
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Creatinine.Creatinine (mg/dL)-Screening0.795 mg/dL
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Creatinine.Creatinine (mg/dL)-Day 140.785 mg/dL
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Creatinine.Creatinine (mg/dL)-Day 980.8 mg/dL
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Creatinine.Creatinine (mg/dL)-Day 140.84 mg/dL
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Creatinine.Creatinine (mg/dL)-Day 1820.855 mg/dL
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Creatinine.Creatinine (mg/dL)-Day 420.83 mg/dL
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Creatinine.Creatinine (mg/dL)-Screening0.8 mg/dL
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Creatinine.Creatinine (mg/dL)-Day 140.8 mg/dL
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Creatinine.Creatinine (mg/dL)-Day 980.8 mg/dL
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Creatinine.Creatinine (mg/dL)-Day 1820.8 mg/dL
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Creatinine.Creatinine (mg/dL)-Day 420.805 mg/dL
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Creatinine.Creatinine (mg/dL)-Screening0.8 mg/dL
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Creatinine.Creatinine (mg/dL)-Day 980.81 mg/dL
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Creatinine.Creatinine (mg/dL)-Screening0.79 mg/dL
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Creatinine.Creatinine (mg/dL)-Day 1820.84 mg/dL
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Creatinine.Creatinine (mg/dL)-Day 420.81 mg/dL
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Creatinine.Creatinine (mg/dL)-Day 140.88 mg/dL
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Creatinine.Creatinine (mg/dL)-Day 420.8 mg/dL
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Creatinine.Creatinine (mg/dL)-Screening0.77 mg/dL
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Creatinine.Creatinine (mg/dL)-Day 1820.8 mg/dL
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Creatinine.Creatinine (mg/dL)-Day 140.78 mg/dL
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Creatinine.Creatinine (mg/dL)-Day 980.78 mg/dL
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Creatinine.Creatinine (mg/dL)-Day 980.79 mg/dL
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Creatinine.Creatinine (mg/dL)-Screening0.715 mg/dL
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Creatinine.Creatinine (mg/dL)-Day 1820.785 mg/dL
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Creatinine.Creatinine (mg/dL)-Day 140.79 mg/dL
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Creatinine.Creatinine (mg/dL)-Day 420.79 mg/dL
Group 7: Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Creatinine.Creatinine (mg/dL)-Day 420.8 mg/dL
Group 7: Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Creatinine.Creatinine (mg/dL)-Screening0.8 mg/dL
Group 7: Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Creatinine.Creatinine (mg/dL)-Day 140.8 mg/dL
Group 7: Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Creatinine.Creatinine (mg/dL)-Day 980.83 mg/dL
Group 7: Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Creatinine.Creatinine (mg/dL)-Day 1820.84 mg/dL
Group 8: PlaceboChemistry and Hematology Laboratory Measures - Creatinine.Creatinine (mg/dL)-Day 420.84 mg/dL
Group 8: PlaceboChemistry and Hematology Laboratory Measures - Creatinine.Creatinine (mg/dL)-Day 140.805 mg/dL
Group 8: PlaceboChemistry and Hematology Laboratory Measures - Creatinine.Creatinine (mg/dL)-Screening0.8 mg/dL
Group 8: PlaceboChemistry and Hematology Laboratory Measures - Creatinine.Creatinine (mg/dL)-Day 1820.87 mg/dL
Group 8: PlaceboChemistry and Hematology Laboratory Measures - Creatinine.Creatinine (mg/dL)-Day 980.9 mg/dL
Primary

Chemistry and Hematology Laboratory Measures - Hemoglobin.

For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.

Time frame: Measured during screening, and 2 weeks after each vaccination at Month 0, 1, 3, and 6

ArmMeasureGroupValue (MEDIAN)
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Hemoglobin.Hemoglobin (g/dL)-Day 9813.5 g/dL
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Hemoglobin.Hemoglobin (g/dL)-Day 18213.75 g/dL
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Hemoglobin.Hemoglobin (g/dL)-Day 4213.6 g/dL
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Hemoglobin.Hemoglobin (g/dL)-Screening14.15 g/dL
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Hemoglobin.Hemoglobin (g/dL)-Day 1413.6 g/dL
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Hemoglobin.Hemoglobin (g/dL)-Day 9813.95 g/dL
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Hemoglobin.Hemoglobin (g/dL)-Day 18214 g/dL
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Hemoglobin.Hemoglobin (g/dL)-Screening14.3 g/dL
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Hemoglobin.Hemoglobin (g/dL)-Day 4213.8 g/dL
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Hemoglobin.Hemoglobin (g/dL)-Day 1413.8 g/dL
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Hemoglobin.Hemoglobin (g/dL)-Day 9813.9 g/dL
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Hemoglobin.Hemoglobin (g/dL)-Day 18214.1 g/dL
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Hemoglobin.Hemoglobin (g/dL)-Screening14.2 g/dL
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Hemoglobin.Hemoglobin (g/dL)-Day 1413.6 g/dL
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Hemoglobin.Hemoglobin (g/dL)-Day 4213.8 g/dL
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Hemoglobin.Hemoglobin (g/dL)-Day 1413.55 g/dL
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Hemoglobin.Hemoglobin (g/dL)-Screening14.2 g/dL
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Hemoglobin.Hemoglobin (g/dL)-Day 9813.7 g/dL
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Hemoglobin.Hemoglobin (g/dL)-Day 4213.75 g/dL
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Hemoglobin.Hemoglobin (g/dL)-Day 18214 g/dL
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Hemoglobin.Hemoglobin (g/dL)-Day 18214.03 g/dL
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Hemoglobin.Hemoglobin (g/dL)-Day 9814.1 g/dL
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Hemoglobin.Hemoglobin (g/dL)-Day 1413.9 g/dL
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Hemoglobin.Hemoglobin (g/dL)-Screening14.2 g/dL
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Hemoglobin.Hemoglobin (g/dL)-Day 4213.9 g/dL
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Hemoglobin.Hemoglobin (g/dL)-Day 1413.7 g/dL
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Hemoglobin.Hemoglobin (g/dL)-Day 9814.05 g/dL
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Hemoglobin.Hemoglobin (g/dL)-Screening14.5 g/dL
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Hemoglobin.Hemoglobin (g/dL)-Day 4214 g/dL
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Hemoglobin.Hemoglobin (g/dL)-Day 18214.05 g/dL
Group 7: Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Hemoglobin.Hemoglobin (g/dL)-Day 4213.9 g/dL
Group 7: Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Hemoglobin.Hemoglobin (g/dL)-Day 1413.4 g/dL
Group 7: Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Hemoglobin.Hemoglobin (g/dL)-Screening13.85 g/dL
Group 7: Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Hemoglobin.Hemoglobin (g/dL)-Day 18214.05 g/dL
Group 7: Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Hemoglobin.Hemoglobin (g/dL)-Day 9814 g/dL
Group 8: PlaceboChemistry and Hematology Laboratory Measures - Hemoglobin.Hemoglobin (g/dL)-Day 9814.35 g/dL
Group 8: PlaceboChemistry and Hematology Laboratory Measures - Hemoglobin.Hemoglobin (g/dL)-Day 18214.1 g/dL
Group 8: PlaceboChemistry and Hematology Laboratory Measures - Hemoglobin.Hemoglobin (g/dL)-Day 4214 g/dL
Group 8: PlaceboChemistry and Hematology Laboratory Measures - Hemoglobin.Hemoglobin (g/dL)-Screening14.6 g/dL
Group 8: PlaceboChemistry and Hematology Laboratory Measures - Hemoglobin.Hemoglobin (g/dL)-Day 1414.05 g/dL
Primary

Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.

For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.

Time frame: Measured during screening, and 2 weeks after each vaccination at Month 0, 1, 3, and 6

ArmMeasureGroupValue (MEDIAN)
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Lymphocytes (cells/cubic mm)-Day 981859 cells/cubic mm
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Neutrophils (cells/cubic mm)-Day 423149 cells/cubic mm
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Neutrophils (cells/cubic mm)-Day 143156.5 cells/cubic mm
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Neutrophils (cells/cubic mm)-Day 1823061 cells/cubic mm
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Lymphocytes (cells/cubic mm)-Day 421881.5 cells/cubic mm
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Neutrophils (cells/cubic mm)-Day 982980 cells/cubic mm
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Lymphocytes (cells/cubic mm)-Screening2033 cells/cubic mm
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Lymphocytes (cells/cubic mm)-Day 141963.5 cells/cubic mm
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Lymphocytes (cells/cubic mm)-Day 1821868 cells/cubic mm
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Neutrophils (cells/cubic mm)-Screening4060.5 cells/cubic mm
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Neutrophils (cells/cubic mm)-Day 982969 cells/cubic mm
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Neutrophils (cells/cubic mm)-Day 1823259 cells/cubic mm
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Neutrophils (cells/cubic mm)-Screening3540 cells/cubic mm
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Lymphocytes (cells/cubic mm)-Day 981920.5 cells/cubic mm
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Neutrophils (cells/cubic mm)-Day 143230 cells/cubic mm
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Lymphocytes (cells/cubic mm)-Day 1821887 cells/cubic mm
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Lymphocytes (cells/cubic mm)-Day 421794 cells/cubic mm
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Lymphocytes (cells/cubic mm)-Day 141953 cells/cubic mm
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Neutrophils (cells/cubic mm)-Day 422795 cells/cubic mm
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Lymphocytes (cells/cubic mm)-Screening1906 cells/cubic mm
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Lymphocytes (cells/cubic mm)-Day 421972 cells/cubic mm
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Neutrophils (cells/cubic mm)-Day 1823311 cells/cubic mm
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Neutrophils (cells/cubic mm)-Day 423300 cells/cubic mm
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Lymphocytes (cells/cubic mm)-Day 982010 cells/cubic mm
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Lymphocytes (cells/cubic mm)-Day 1821848.5 cells/cubic mm
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Lymphocytes (cells/cubic mm)-Screening2044.5 cells/cubic mm
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Neutrophils (cells/cubic mm)-Day 983602.5 cells/cubic mm
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Neutrophils (cells/cubic mm)-Day 143404 cells/cubic mm
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Lymphocytes (cells/cubic mm)-Day 141936 cells/cubic mm
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Neutrophils (cells/cubic mm)-Screening3108.5 cells/cubic mm
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Neutrophils (cells/cubic mm)-Day 1823508.5 cells/cubic mm
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Neutrophils (cells/cubic mm)-Screening3919 cells/cubic mm
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Neutrophils (cells/cubic mm)-Day 143108 cells/cubic mm
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Neutrophils (cells/cubic mm)-Day 423467.5 cells/cubic mm
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Neutrophils (cells/cubic mm)-Day 983805 cells/cubic mm
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Lymphocytes (cells/cubic mm)-Screening1993.5 cells/cubic mm
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Lymphocytes (cells/cubic mm)-Day 141965 cells/cubic mm
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Lymphocytes (cells/cubic mm)-Day 421944 cells/cubic mm
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Lymphocytes (cells/cubic mm)-Day 982035 cells/cubic mm
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Lymphocytes (cells/cubic mm)-Day 1822090.5 cells/cubic mm
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Neutrophils (cells/cubic mm)-Screening3616 cells/cubic mm
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Lymphocytes (cells/cubic mm)-Day 422060 cells/cubic mm
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Lymphocytes (cells/cubic mm)-Day 1821990 cells/cubic mm
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Lymphocytes (cells/cubic mm)-Day 141857 cells/cubic mm
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Lymphocytes (cells/cubic mm)-Screening2054.5 cells/cubic mm
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Neutrophils (cells/cubic mm)-Day 983519 cells/cubic mm
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Neutrophils (cells/cubic mm)-Day 1823616 cells/cubic mm
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Neutrophils (cells/cubic mm)-Day 423440 cells/cubic mm
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Neutrophils (cells/cubic mm)-Day 143910 cells/cubic mm
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Lymphocytes (cells/cubic mm)-Day 982003 cells/cubic mm
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Neutrophils (cells/cubic mm)-Day 1823395 cells/cubic mm
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Lymphocytes (cells/cubic mm)-Day 421990 cells/cubic mm
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Lymphocytes (cells/cubic mm)-Screening2002.5 cells/cubic mm
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Neutrophils (cells/cubic mm)-Screening3505 cells/cubic mm
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Lymphocytes (cells/cubic mm)-Day 1822066.5 cells/cubic mm
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Neutrophils (cells/cubic mm)-Day 423580 cells/cubic mm
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Lymphocytes (cells/cubic mm)-Day 142014.5 cells/cubic mm
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Neutrophils (cells/cubic mm)-Day 983331.5 cells/cubic mm
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Lymphocytes (cells/cubic mm)-Day 981907.5 cells/cubic mm
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Neutrophils (cells/cubic mm)-Day 143874 cells/cubic mm
Group 7: Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Neutrophils (cells/cubic mm)-Day 1823794.5 cells/cubic mm
Group 7: Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Neutrophils (cells/cubic mm)-Day 423630 cells/cubic mm
Group 7: Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Lymphocytes (cells/cubic mm)-Screening1942 cells/cubic mm
Group 7: Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Neutrophils (cells/cubic mm)-Day 143420 cells/cubic mm
Group 7: Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Lymphocytes (cells/cubic mm)-Day 141746.5 cells/cubic mm
Group 7: Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Lymphocytes (cells/cubic mm)-Day 421910 cells/cubic mm
Group 7: Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Neutrophils (cells/cubic mm)-Screening3389 cells/cubic mm
Group 7: Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Lymphocytes (cells/cubic mm)-Day 1821795 cells/cubic mm
Group 7: Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Lymphocytes (cells/cubic mm)-Day 981863 cells/cubic mm
Group 7: Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Neutrophils (cells/cubic mm)-Day 983345 cells/cubic mm
Group 8: PlaceboChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Lymphocytes (cells/cubic mm)-Day 142030.5 cells/cubic mm
Group 8: PlaceboChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Neutrophils (cells/cubic mm)-Day 423532 cells/cubic mm
Group 8: PlaceboChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Lymphocytes (cells/cubic mm)-Day 982198 cells/cubic mm
Group 8: PlaceboChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Neutrophils (cells/cubic mm)-Day 143366.5 cells/cubic mm
Group 8: PlaceboChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Lymphocytes (cells/cubic mm)-Screening2150 cells/cubic mm
Group 8: PlaceboChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Neutrophils (cells/cubic mm)-Day 983433 cells/cubic mm
Group 8: PlaceboChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Neutrophils (cells/cubic mm)-Day 1823370 cells/cubic mm
Group 8: PlaceboChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Lymphocytes (cells/cubic mm)-Day 422008 cells/cubic mm
Group 8: PlaceboChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Lymphocytes (cells/cubic mm)-Day 1821962 cells/cubic mm
Group 8: PlaceboChemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils.Neutrophils (cells/cubic mm)-Screening3861 cells/cubic mm
Primary

Chemistry and Hematology Laboratory Measures - Platelets, WBC.

For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.

Time frame: Measured during screening, and 2 weeks after each vaccination at Month 0, 1, 3, and 6

ArmMeasureGroupValue (MEDIAN)
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Platelets, WBC.Platelets (x1000/cubic mm)-Screening232.5 x1000/cubic mm
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Platelets, WBC.Platelets (x1000/cubic mm)-Day 14223.5 x1000/cubic mm
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Platelets, WBC.Platelets (x1000/cubic mm)-Day 182238.5 x1000/cubic mm
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Platelets, WBC.WBC (x1000/cubic mm)-Day 145.705 x1000/cubic mm
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Platelets, WBC.WBC (x1000/cubic mm)-Day 425.815 x1000/cubic mm
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Platelets, WBC.WBC (x1000/cubic mm)-Screening6.53 x1000/cubic mm
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Platelets, WBC.Platelets (x1000/cubic mm)-Day 98241 x1000/cubic mm
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Platelets, WBC.WBC (x1000/cubic mm)-Day 985.92 x1000/cubic mm
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Platelets, WBC.Platelets (x1000/cubic mm)-Day 42222.5 x1000/cubic mm
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Platelets, WBC.WBC (x1000/cubic mm)-Day 1825.6 x1000/cubic mm
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Platelets, WBC.Platelets (x1000/cubic mm)-Day 14236 x1000/cubic mm
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Platelets, WBC.WBC (x1000/cubic mm)-Day 146.04 x1000/cubic mm
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Platelets, WBC.WBC (x1000/cubic mm)-Day 425.55 x1000/cubic mm
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Platelets, WBC.Platelets (x1000/cubic mm)-Day 98250.5 x1000/cubic mm
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Platelets, WBC.WBC (x1000/cubic mm)-Day 985.69 x1000/cubic mm
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Platelets, WBC.WBC (x1000/cubic mm)-Screening6.45 x1000/cubic mm
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Platelets, WBC.Platelets (x1000/cubic mm)-Day 42241 x1000/cubic mm
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Platelets, WBC.Platelets (x1000/cubic mm)-Screening243 x1000/cubic mm
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Platelets, WBC.Platelets (x1000/cubic mm)-Day 182265.9 x1000/cubic mm
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Platelets, WBC.WBC (x1000/cubic mm)-Day 1826.29 x1000/cubic mm
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Platelets, WBC.WBC (x1000/cubic mm)-Day 985.985 x1000/cubic mm
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Platelets, WBC.Platelets (x1000/cubic mm)-Day 182269.5 x1000/cubic mm
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Platelets, WBC.WBC (x1000/cubic mm)-Day 145.795 x1000/cubic mm
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Platelets, WBC.WBC (x1000/cubic mm)-Screening5.94 x1000/cubic mm
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Platelets, WBC.Platelets (x1000/cubic mm)-Day 14264.5 x1000/cubic mm
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Platelets, WBC.Platelets (x1000/cubic mm)-Day 98271 x1000/cubic mm
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Platelets, WBC.WBC (x1000/cubic mm)-Day 1825.515 x1000/cubic mm
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Platelets, WBC.Platelets (x1000/cubic mm)-Screening269.5 x1000/cubic mm
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Platelets, WBC.WBC (x1000/cubic mm)-Day 426 x1000/cubic mm
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Platelets, WBC.Platelets (x1000/cubic mm)-Day 42264 x1000/cubic mm
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Platelets, WBC.WBC (x1000/cubic mm)-Day 426.04 x1000/cubic mm
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Platelets, WBC.Platelets (x1000/cubic mm)-Screening258 x1000/cubic mm
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Platelets, WBC.Platelets (x1000/cubic mm)-Day 42258.95 x1000/cubic mm
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Platelets, WBC.Platelets (x1000/cubic mm)-Day 14255.15 x1000/cubic mm
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Platelets, WBC.WBC (x1000/cubic mm)-Screening6.665 x1000/cubic mm
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Platelets, WBC.WBC (x1000/cubic mm)-Day 986.68 x1000/cubic mm
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Platelets, WBC.Platelets (x1000/cubic mm)-Day 182256.2 x1000/cubic mm
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Platelets, WBC.WBC (x1000/cubic mm)-Day 146.155 x1000/cubic mm
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Platelets, WBC.Platelets (x1000/cubic mm)-Day 98254 x1000/cubic mm
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Chemistry and Hematology Laboratory Measures - Platelets, WBC.WBC (x1000/cubic mm)-Day 1826.46 x1000/cubic mm
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Platelets, WBC.WBC (x1000/cubic mm)-Day 426.25 x1000/cubic mm
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Platelets, WBC.WBC (x1000/cubic mm)-Screening6.35 x1000/cubic mm
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Platelets, WBC.WBC (x1000/cubic mm)-Day 146.41 x1000/cubic mm
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Platelets, WBC.WBC (x1000/cubic mm)-Day 986.22 x1000/cubic mm
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Platelets, WBC.WBC (x1000/cubic mm)-Day 1826.39 x1000/cubic mm
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Platelets, WBC.Platelets (x1000/cubic mm)-Screening275 x1000/cubic mm
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Platelets, WBC.Platelets (x1000/cubic mm)-Day 14285 x1000/cubic mm
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Platelets, WBC.Platelets (x1000/cubic mm)-Day 42292 x1000/cubic mm
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Platelets, WBC.Platelets (x1000/cubic mm)-Day 98258 x1000/cubic mm
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Platelets, WBC.Platelets (x1000/cubic mm)-Day 182284 x1000/cubic mm
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Platelets, WBC.Platelets (x1000/cubic mm)-Day 182276 x1000/cubic mm
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Platelets, WBC.Platelets (x1000/cubic mm)-Day 42288 x1000/cubic mm
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Platelets, WBC.Platelets (x1000/cubic mm)-Day 14279.5 x1000/cubic mm
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Platelets, WBC.WBC (x1000/cubic mm)-Day 426.4 x1000/cubic mm
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Platelets, WBC.WBC (x1000/cubic mm)-Day 1825.9 x1000/cubic mm
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Platelets, WBC.WBC (x1000/cubic mm)-Day 146.25 x1000/cubic mm
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Platelets, WBC.WBC (x1000/cubic mm)-Screening5.94 x1000/cubic mm
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Platelets, WBC.Platelets (x1000/cubic mm)-Screening280 x1000/cubic mm
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Platelets, WBC.WBC (x1000/cubic mm)-Day 986.075 x1000/cubic mm
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Platelets, WBC.Platelets (x1000/cubic mm)-Day 98259 x1000/cubic mm
Group 7: Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Platelets, WBC.WBC (x1000/cubic mm)-Day 1826.585 x1000/cubic mm
Group 7: Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Platelets, WBC.Platelets (x1000/cubic mm)-Day 14284 x1000/cubic mm
Group 7: Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Platelets, WBC.WBC (x1000/cubic mm)-Day 985.8 x1000/cubic mm
Group 7: Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Platelets, WBC.Platelets (x1000/cubic mm)-Day 42286 x1000/cubic mm
Group 7: Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Platelets, WBC.WBC (x1000/cubic mm)-Day 426.09 x1000/cubic mm
Group 7: Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Platelets, WBC.WBC (x1000/cubic mm)-Day 146 x1000/cubic mm
Group 7: Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Platelets, WBC.Platelets (x1000/cubic mm)-Day 182279 x1000/cubic mm
Group 7: Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Platelets, WBC.Platelets (x1000/cubic mm)-Day 98260 x1000/cubic mm
Group 7: Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Platelets, WBC.WBC (x1000/cubic mm)-Screening6.17 x1000/cubic mm
Group 7: Placebo + Protein/AS01BChemistry and Hematology Laboratory Measures - Platelets, WBC.Platelets (x1000/cubic mm)-Screening264.5 x1000/cubic mm
Group 8: PlaceboChemistry and Hematology Laboratory Measures - Platelets, WBC.Platelets (x1000/cubic mm)-Screening252.5 x1000/cubic mm
Group 8: PlaceboChemistry and Hematology Laboratory Measures - Platelets, WBC.Platelets (x1000/cubic mm)-Day 98262.75 x1000/cubic mm
Group 8: PlaceboChemistry and Hematology Laboratory Measures - Platelets, WBC.WBC (x1000/cubic mm)-Screening7.135 x1000/cubic mm
Group 8: PlaceboChemistry and Hematology Laboratory Measures - Platelets, WBC.Platelets (x1000/cubic mm)-Day 182257.5 x1000/cubic mm
Group 8: PlaceboChemistry and Hematology Laboratory Measures - Platelets, WBC.WBC (x1000/cubic mm)-Day 986.41 x1000/cubic mm
Group 8: PlaceboChemistry and Hematology Laboratory Measures - Platelets, WBC.Platelets (x1000/cubic mm)-Day 42248 x1000/cubic mm
Group 8: PlaceboChemistry and Hematology Laboratory Measures - Platelets, WBC.WBC (x1000/cubic mm)-Day 146.36 x1000/cubic mm
Group 8: PlaceboChemistry and Hematology Laboratory Measures - Platelets, WBC.Platelets (x1000/cubic mm)-Day 14257.5 x1000/cubic mm
Group 8: PlaceboChemistry and Hematology Laboratory Measures - Platelets, WBC.WBC (x1000/cubic mm)-Day 1825.835 x1000/cubic mm
Group 8: PlaceboChemistry and Hematology Laboratory Measures - Platelets, WBC.WBC (x1000/cubic mm)-Day 426.9 x1000/cubic mm
Primary

Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product

For participants reporting multiple AEs over the time frame, the maximum relationship is counted.

Time frame: Measured through 30 days after each vaccination at Month 0, 1, 3, and 6

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Adverse Events (AEs), by Relationship to Study ProductNot Related21 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Adverse Events (AEs), by Relationship to Study ProductRelated3 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Adverse Events (AEs), by Relationship to Study ProductNo AE reported6 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Adverse Events (AEs), by Relationship to Study ProductRelated2 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Adverse Events (AEs), by Relationship to Study ProductNo AE reported16 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Adverse Events (AEs), by Relationship to Study ProductNot Related32 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Adverse Events (AEs), by Relationship to Study ProductRelated1 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Adverse Events (AEs), by Relationship to Study ProductNo AE reported16 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Adverse Events (AEs), by Relationship to Study ProductNot Related33 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Adverse Events (AEs), by Relationship to Study ProductNot Related15 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Adverse Events (AEs), by Relationship to Study ProductRelated5 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Adverse Events (AEs), by Relationship to Study ProductNo AE reported10 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Adverse Events (AEs), by Relationship to Study ProductNot Related35 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Adverse Events (AEs), by Relationship to Study ProductRelated4 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Adverse Events (AEs), by Relationship to Study ProductNo AE reported11 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Adverse Events (AEs), by Relationship to Study ProductNot Related27 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Adverse Events (AEs), by Relationship to Study ProductRelated4 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Adverse Events (AEs), by Relationship to Study ProductNo AE reported19 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Adverse Events (AEs), by Relationship to Study ProductNot Related25 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Adverse Events (AEs), by Relationship to Study ProductRelated2 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Adverse Events (AEs), by Relationship to Study ProductNo AE reported23 Participants
Group 8: PlaceboNumber of Participants Reporting Adverse Events (AEs), by Relationship to Study ProductRelated1 Participants
Group 8: PlaceboNumber of Participants Reporting Adverse Events (AEs), by Relationship to Study ProductNot Related12 Participants
Group 8: PlaceboNumber of Participants Reporting Adverse Events (AEs), by Relationship to Study ProductNo AE reported11 Participants
Primary

Number of Participants Reporting Adverse Events (AEs), by Severity Grade

For participants reporting multiple AEs over the time frame, the maximum severity grade is counted.

Time frame: Measured through 30 days after each vaccination at Month 0, 1, 3, and 6

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Adverse Events (AEs), by Severity GradeSevere1 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Adverse Events (AEs), by Severity GradeMild11 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Adverse Events (AEs), by Severity GradeNo AE reported6 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Adverse Events (AEs), by Severity GradeModerate12 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Adverse Events (AEs), by Severity GradePotentially life-threatening0 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Adverse Events (AEs), by Severity GradeModerate19 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Adverse Events (AEs), by Severity GradePotentially life-threatening0 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Adverse Events (AEs), by Severity GradeSevere2 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Adverse Events (AEs), by Severity GradeMild13 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Adverse Events (AEs), by Severity GradeNo AE reported16 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Adverse Events (AEs), by Severity GradeModerate22 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Adverse Events (AEs), by Severity GradeMild10 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Adverse Events (AEs), by Severity GradeNo AE reported16 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Adverse Events (AEs), by Severity GradePotentially life-threatening0 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Adverse Events (AEs), by Severity GradeSevere2 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Adverse Events (AEs), by Severity GradePotentially life-threatening0 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Adverse Events (AEs), by Severity GradeMild6 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Adverse Events (AEs), by Severity GradeNo AE reported10 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Adverse Events (AEs), by Severity GradeSevere4 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Adverse Events (AEs), by Severity GradeModerate10 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Adverse Events (AEs), by Severity GradeNo AE reported11 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Adverse Events (AEs), by Severity GradeMild19 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Adverse Events (AEs), by Severity GradeModerate16 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Adverse Events (AEs), by Severity GradeSevere3 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Adverse Events (AEs), by Severity GradePotentially life-threatening1 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Adverse Events (AEs), by Severity GradeNo AE reported19 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Adverse Events (AEs), by Severity GradeModerate22 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Adverse Events (AEs), by Severity GradeMild8 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Adverse Events (AEs), by Severity GradePotentially life-threatening0 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Adverse Events (AEs), by Severity GradeSevere1 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Adverse Events (AEs), by Severity GradeMild9 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Adverse Events (AEs), by Severity GradeModerate16 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Adverse Events (AEs), by Severity GradeSevere2 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Adverse Events (AEs), by Severity GradePotentially life-threatening0 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Adverse Events (AEs), by Severity GradeNo AE reported23 Participants
Group 8: PlaceboNumber of Participants Reporting Adverse Events (AEs), by Severity GradeSevere0 Participants
Group 8: PlaceboNumber of Participants Reporting Adverse Events (AEs), by Severity GradeModerate10 Participants
Group 8: PlaceboNumber of Participants Reporting Adverse Events (AEs), by Severity GradeMild3 Participants
Group 8: PlaceboNumber of Participants Reporting Adverse Events (AEs), by Severity GradeNo AE reported11 Participants
Group 8: PlaceboNumber of Participants Reporting Adverse Events (AEs), by Severity GradePotentially life-threatening0 Participants
Primary

Number of Participants Reporting Adverse Events of Special Interest (AESIs)

There were no adverse events of special interest reported by any participant.

Time frame: Measured through Month 18

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Adverse Events of Special Interest (AESIs)0 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Adverse Events of Special Interest (AESIs)0 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Adverse Events of Special Interest (AESIs)0 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Adverse Events of Special Interest (AESIs)0 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Adverse Events of Special Interest (AESIs)0 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Adverse Events of Special Interest (AESIs)0 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Adverse Events of Special Interest (AESIs)0 Participants
Group 8: PlaceboNumber of Participants Reporting Adverse Events of Special Interest (AESIs)0 Participants
Primary

Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration

Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\]. The maximum grade observed for each symptom over the time frame is presented.

Time frame: Measured through 7 days after each vaccine dose at Month 0, 1, 3, and 6

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationNot gradable3 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 3: Greater or equal to 100 cm sq0 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationNot gradable1 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 1: Between 6.25 to 25 cm sq area0 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 3: Greater or equal to 10 cm0 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 1: Between 6.25 to 25 cm sq area1 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 2: Between 25 to 100 cm sq area1 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 3: Greater or equal to 10 cm0 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 2: Between 5 to 10 cm diameter0 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 3: Greater or equal to 100 cm sq0 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 2: Between 5 to 10 cm diameter0 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 4: complications0 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 3: Greater or equal to 10 cm0 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationNone28 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 2: Between 25 to 100 cm sq area0 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 1: Less than 5 cm diameter0 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 3: complications0 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 3: complications0 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaNot gradable3 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 1: Less than 5 cm diameter0 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 2: Between 5 to 10 cm diameter0 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 3: Greater or equal to 100 cm sq0 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 2: Between 25 to 100 cm sq area1 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 4: complications0 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 4: complications0 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 1: Less than 5 cm diameter0 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationNone25 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 3: complications0 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 1: Between 6.25 to 25 cm sq area1 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaNone26 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 1: Less than 5 cm diameter0 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 3: Greater or equal to 10 cm2 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaNot gradable4 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 2: Between 25 to 100 cm sq area4 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaNone35 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 4: complications0 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 3: Greater or equal to 100 cm sq0 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationNone31 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 4: complications0 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationNot gradable7 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 3: complications0 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 1: Less than 5 cm diameter0 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationNot gradable6 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 3: complications0 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 2: Between 25 to 100 cm sq area5 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 3: Greater or equal to 100 cm sq2 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 1: Between 6.25 to 25 cm sq area2 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 1: Between 6.25 to 25 cm sq area3 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 3: Greater or equal to 10 cm2 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 3: Greater or equal to 100 cm sq2 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 2: Between 5 to 10 cm diameter0 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 2: Between 25 to 100 cm sq area4 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 2: Between 5 to 10 cm diameter1 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 2: Between 5 to 10 cm diameter1 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 3: complications0 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 3: Greater or equal to 10 cm2 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 1: Between 6.25 to 25 cm sq area2 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 4: complications0 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 1: Less than 5 cm diameter0 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationNone35 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 3: Greater or equal to 100 cm sq1 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 2: Between 25 to 100 cm sq area3 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 3: Greater or equal to 10 cm0 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 4: complications0 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 3: Greater or equal to 100 cm sq0 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 1: Less than 5 cm diameter1 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 3: Greater or equal to 100 cm sq1 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 2: Between 5 to 10 cm diameter0 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 3: complications0 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 3: Greater or equal to 10 cm1 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 1: Less than 5 cm diameter2 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 1: Between 6.25 to 25 cm sq area3 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 4: complications0 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 2: Between 25 to 100 cm sq area2 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaNone38 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaNot gradable4 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 1: Less than 5 cm diameter2 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 1: Between 6.25 to 25 cm sq area2 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 2: Between 5 to 10 cm diameter0 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 2: Between 5 to 10 cm diameter0 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 2: Between 25 to 100 cm sq area2 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 3: Greater or equal to 10 cm1 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 3: complications0 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 3: complications0 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationNot gradable7 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 4: complications0 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationNone37 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationNone34 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationNot gradable7 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 1: Between 6.25 to 25 cm sq area2 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 2: Between 25 to 100 cm sq area2 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 2: Between 5 to 10 cm diameter1 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 3: complications0 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 2: Between 5 to 10 cm diameter1 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationNone22 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 2: Between 5 to 10 cm diameter1 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 4: complications0 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 2: Between 25 to 100 cm sq area3 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 4: complications0 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 3: Greater or equal to 10 cm0 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 1: Between 6.25 to 25 cm sq area2 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 3: Greater or equal to 100 cm sq0 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 1: Less than 5 cm diameter0 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 3: Greater or equal to 100 cm sq0 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationNot gradable2 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 1: Less than 5 cm diameter0 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 3: complications0 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationNot gradable2 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationNone23 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 4: complications0 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 3: Greater or equal to 100 cm sq0 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 2: Between 25 to 100 cm sq area3 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaNone23 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 3: complications0 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 1: Between 6.25 to 25 cm sq area2 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaNot gradable3 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 3: Greater or equal to 10 cm0 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 1: Less than 5 cm diameter0 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 3: Greater or equal to 10 cm0 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 1: Between 6.25 to 25 cm sq area0 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationNone31 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 1: Between 6.25 to 25 cm sq area3 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 4: complications0 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 2: Between 5 to 10 cm diameter2 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 2: Between 25 to 100 cm sq area4 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 1: Less than 5 cm diameter1 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 3: Greater or equal to 10 cm1 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 3: Greater or equal to 10 cm1 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 3: complications0 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 2: Between 5 to 10 cm diameter3 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 3: Greater or equal to 100 cm sq1 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaNot gradable3 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 2: Between 5 to 10 cm diameter1 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaNone34 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationNone33 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 3: complications0 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 2: Between 25 to 100 cm sq area5 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 1: Less than 5 cm diameter0 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 3: Greater or equal to 100 cm sq1 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationNot gradable4 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 1: Between 6.25 to 25 cm sq area5 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 3: Greater or equal to 10 cm0 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 4: complications0 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 2: Between 25 to 100 cm sq area6 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 3: complications0 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 3: Greater or equal to 100 cm sq1 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 4: complications0 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationNot gradable4 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 1: Between 6.25 to 25 cm sq area4 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 1: Less than 5 cm diameter2 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 1: Less than 5 cm diameter2 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaNot gradable4 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 1: Less than 5 cm diameter2 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 2: Between 5 to 10 cm diameter0 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 2: Between 25 to 100 cm sq area3 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 3: Greater or equal to 10 cm3 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationNot gradable2 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 1: Less than 5 cm diameter1 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 1: Between 6.25 to 25 cm sq area3 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 2: Between 5 to 10 cm diameter1 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 1: Between 6.25 to 25 cm sq area3 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 3: complications0 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaNone36 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 1: Between 6.25 to 25 cm sq area2 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 3: Greater or equal to 100 cm sq0 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 3: complications0 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 4: complications0 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationNone38 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 2: Between 25 to 100 cm sq area3 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 3: Greater or equal to 10 cm2 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 3: Greater or equal to 100 cm sq0 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 3: complications0 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 4: complications0 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationNone35 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationNot gradable4 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 2: Between 5 to 10 cm diameter0 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 2: Between 25 to 100 cm sq area3 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 3: Greater or equal to 10 cm3 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 3: Greater or equal to 100 cm sq0 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 4: complications0 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 4: complications0 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaNot gradable5 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 2: Between 25 to 100 cm sq area6 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationNone36 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 1: Between 6.25 to 25 cm sq area5 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 1: Less than 5 cm diameter0 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 3: Greater or equal to 10 cm2 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 3: complications0 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 3: complications0 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 2: Between 5 to 10 cm diameter2 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 3: Greater or equal to 10 cm2 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationNone30 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 1: Between 6.25 to 25 cm sq area3 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 1: Between 6.25 to 25 cm sq area6 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 3: Greater or equal to 100 cm sq1 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 1: Less than 5 cm diameter0 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 2: Between 5 to 10 cm diameter2 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 4: complications0 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 3: Greater or equal to 100 cm sq1 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 1: Less than 5 cm diameter0 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationNot gradable4 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 3: Greater or equal to 100 cm sq1 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationNot gradable4 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaNone31 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 3: Greater or equal to 10 cm1 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 2: Between 5 to 10 cm diameter0 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 2: Between 25 to 100 cm sq area2 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 2: Between 25 to 100 cm sq area6 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 4: complications0 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 3: complications0 Participants
Group 8: PlaceboNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 4: complications0 Participants
Group 8: PlaceboNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationNone24 Participants
Group 8: PlaceboNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 4: complications0 Participants
Group 8: PlaceboNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 1: Less than 5 cm diameter0 Participants
Group 8: PlaceboNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationNone21 Participants
Group 8: PlaceboNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 3: complications0 Participants
Group 8: PlaceboNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 3: Greater or equal to 100 cm sq0 Participants
Group 8: PlaceboNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationNot gradable2 Participants
Group 8: PlaceboNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 1: Less than 5 cm diameter0 Participants
Group 8: PlaceboNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 3: Greater or equal to 10 cm0 Participants
Group 8: PlaceboNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 2: Between 5 to 10 cm diameter1 Participants
Group 8: PlaceboNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 1: Between 6.25 to 25 cm sq area0 Participants
Group 8: PlaceboNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaNot gradable2 Participants
Group 8: PlaceboNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 2: Between 5 to 10 cm diameter1 Participants
Group 8: PlaceboNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaNone21 Participants
Group 8: PlaceboNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 3: complications0 Participants
Group 8: PlaceboNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 1: Between 6.25 to 25 cm sq area0 Participants
Group 8: PlaceboNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 2: Between 25 to 100 cm sq area0 Participants
Group 8: PlaceboNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 3: complications0 Participants
Group 8: PlaceboNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 3: Greater or equal to 100 cm sq0 Participants
Group 8: PlaceboNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 4: complications0 Participants
Group 8: PlaceboNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 3: Greater or equal to 10 cm0 Participants
Group 8: PlaceboNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 1: Between 6.25 to 25 cm sq area0 Participants
Group 8: PlaceboNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 1: Less than 5 cm diameter0 Participants
Group 8: PlaceboNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationNot gradable0 Participants
Group 8: PlaceboNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythema and/or IndurationGrade 3: Greater or equal to 100 cm sq0 Participants
Group 8: PlaceboNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 3: Greater or equal to 10 cm0 Participants
Group 8: PlaceboNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationErythemaGrade 2: Between 25 to 100 cm sq area0 Participants
Group 8: PlaceboNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 2: Between 25 to 100 cm sq area0 Participants
Group 8: PlaceboNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or IndurationIndurationGrade 2: Between 5 to 10 cm diameter0 Participants
Primary

Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness

Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\]. The maximum grade observed for each symptom over the time frame is presented.

Time frame: Measured through 7 days after each vaccine dose at Month 0, 1, 3, and 6

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPainSevere0 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPainModerate4 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPainMild21 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPain and/or TendernessSevere0 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessTendernessNone4 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPain and/or TendernessModerate7 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessTendernessLife Threatening0 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessTendernessSevere0 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPain and/or TendernessNone2 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessTendernessModerate6 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPain and/or TendernessMild21 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessTendernessMild20 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPainLife Threatening0 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPain and/or TendernessLife Threatening0 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPainNone5 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPainSevere0 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPainModerate23 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPain and/or TendernessNone6 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPainMild20 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPainNone7 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPain and/or TendernessLife Threatening0 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPain and/or TendernessModerate28 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessTendernessMild16 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPain and/or TendernessMild16 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessTendernessNone8 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessTendernessLife Threatening0 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPain and/or TendernessSevere0 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessTendernessSevere0 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPainLife Threatening0 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessTendernessModerate26 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPainNone6 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessTendernessNone11 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessTendernessMild16 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPain and/or TendernessSevere0 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPain and/or TendernessLife Threatening0 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPainMild27 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPainModerate17 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPainSevere0 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPainLife Threatening0 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessTendernessModerate23 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessTendernessSevere0 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessTendernessLife Threatening0 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPain and/or TendernessNone5 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPain and/or TendernessMild22 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPain and/or TendernessModerate23 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPainMild19 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessTendernessNone5 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPainLife Threatening0 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPainSevere0 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPainModerate3 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPain and/or TendernessMild22 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessTendernessModerate4 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPainNone8 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPain and/or TendernessLife Threatening0 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPain and/or TendernessSevere0 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessTendernessMild21 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessTendernessLife Threatening0 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPain and/or TendernessModerate4 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPain and/or TendernessNone4 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessTendernessSevere0 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPain and/or TendernessLife Threatening0 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessTendernessSevere1 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPainMild24 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPainSevere0 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPainModerate16 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPain and/or TendernessModerate20 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessTendernessModerate18 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPain and/or TendernessSevere1 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPain and/or TendernessMild21 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPainLife Threatening0 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessTendernessNone8 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPain and/or TendernessNone8 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessTendernessMild23 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPainNone10 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessTendernessLife Threatening0 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPain and/or TendernessMild16 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPainModerate27 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPainSevere0 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPainLife Threatening0 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessTendernessNone9 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessTendernessMild20 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPain and/or TendernessSevere0 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessTendernessSevere0 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessTendernessModerate21 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessTendernessLife Threatening0 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPain and/or TendernessNone4 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPain and/or TendernessLife Threatening0 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPain and/or TendernessModerate30 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPainNone5 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPainMild18 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPain and/or TendernessNone4 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPain and/or TendernessLife Threatening0 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPainMild24 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPainSevere0 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPainLife Threatening0 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessTendernessLife Threatening0 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPainNone4 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPain and/or TendernessSevere0 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessTendernessSevere0 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessTendernessMild17 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPain and/or TendernessMild18 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessTendernessModerate27 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPain and/or TendernessModerate28 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessTendernessNone6 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPainModerate22 Participants
Group 8: PlaceboNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessTendernessLife Threatening0 Participants
Group 8: PlaceboNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPain and/or TendernessLife Threatening0 Participants
Group 8: PlaceboNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessTendernessMild16 Participants
Group 8: PlaceboNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPainLife Threatening0 Participants
Group 8: PlaceboNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPain and/or TendernessModerate1 Participants
Group 8: PlaceboNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPain and/or TendernessMild16 Participants
Group 8: PlaceboNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPain and/or TendernessSevere0 Participants
Group 8: PlaceboNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessTendernessNone8 Participants
Group 8: PlaceboNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPainSevere0 Participants
Group 8: PlaceboNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPainMild13 Participants
Group 8: PlaceboNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPainNone10 Participants
Group 8: PlaceboNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessTendernessSevere0 Participants
Group 8: PlaceboNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPainModerate1 Participants
Group 8: PlaceboNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessTendernessModerate0 Participants
Group 8: PlaceboNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or TendernessPain and/or TendernessNone7 Participants
Primary

Number of Participants Reporting New Chronic Conditions (Requiring Medical Intervention for ≥ 30 Days)

There were no new chronic conditions (requiring medical intervention for ≥ 30 days) reported by any participant.

Time frame: Measured through Month 12

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting New Chronic Conditions (Requiring Medical Intervention for ≥ 30 Days)0 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting New Chronic Conditions (Requiring Medical Intervention for ≥ 30 Days)0 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting New Chronic Conditions (Requiring Medical Intervention for ≥ 30 Days)0 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting New Chronic Conditions (Requiring Medical Intervention for ≥ 30 Days)0 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting New Chronic Conditions (Requiring Medical Intervention for ≥ 30 Days)0 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting New Chronic Conditions (Requiring Medical Intervention for ≥ 30 Days)0 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting New Chronic Conditions (Requiring Medical Intervention for ≥ 30 Days)0 Participants
Group 8: PlaceboNumber of Participants Reporting New Chronic Conditions (Requiring Medical Intervention for ≥ 30 Days)0 Participants
Primary

Number of Participants Reporting Serious Adverse Events (SAEs)

Measured as outlined in Version 2.0 (January 2010) of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual)

Time frame: Measured through Month 12

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Serious Adverse Events (SAEs)0 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Serious Adverse Events (SAEs)1 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Serious Adverse Events (SAEs)0 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Serious Adverse Events (SAEs)1 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Serious Adverse Events (SAEs)1 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Serious Adverse Events (SAEs)1 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Serious Adverse Events (SAEs)0 Participants
Group 8: PlaceboNumber of Participants Reporting Serious Adverse Events (SAEs)0 Participants
Primary

Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms

Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\]. The following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: malaise and/or fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and body temperature. The item Max. Systemic Reaction is the maximum of the individual systemic variables for a participant. It does not include temperature.

Time frame: Measured through 7 days after each vaccination at Month 0, 1, 3, and 6

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsTemperatureNone29 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsMax. Systemic SymptomsSevere1 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsChillsModerate0 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsMyalgiaPotentially Life-threatening0 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsMyalgiaMild9 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsMax. Systemic SymptomsModerate7 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsChillsMild3 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsHeadacheNone20 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsChillsNone27 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsTemperatureMild1 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsVomitingPotentially Life-threatening0 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsHeadacheMild7 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsTemperatureModerate0 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsVomitingSevere0 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsMalaise and/or fatigueNone14 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsHeadacheModerate3 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsMyalgiaSevere0 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsVomitingModerate0 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsVomitingNone29 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsHeadacheSevere0 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsVomitingMild1 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsMax. Systemic SymptomsMild10 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsHeadachePotentially Life-threatening0 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsMalaise and/or fatigueMild11 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsMalaise and/or fatigueModerate4 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsNauseaModerate2 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsArthralgiaPotentially Life-threatening0 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsMalaise and/or fatigueSevere1 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsArthralgiaSevere0 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsNauseaPotentially Life-threatening0 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsArthralgiaModerate0 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsMalaise and/or fatiguePotentially Life-threatening0 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsChillsSevere0 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsArthralgiaMild5 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsMyalgiaNone17 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsNauseaSevere0 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsMax. Systemic SymptomsNone12 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsTemperaturePotentially Life-threatening0 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsTemperatureSevere0 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsArthralgiaNone25 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsNauseaNone21 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsMyalgiaModerate4 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsMax. Systemic SymptomsPotentially Life-threatening0 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsChillsPotentially Life-threatening0 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsNauseaMild7 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsArthralgiaMild9 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsNauseaModerate1 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsChillsModerate6 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMax. Systemic SymptomsNone13 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsChillsSevere1 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMyalgiaPotentially Life-threatening0 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsNauseaMild12 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMalaise and/or fatigueModerate8 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsArthralgiaNone38 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsChillsMild9 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsTemperatureMild4 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsChillsNone34 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsArthralgiaPotentially Life-threatening0 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsHeadacheNone21 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMax. Systemic SymptomsModerate17 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMalaise and/or fatigueMild21 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMyalgiaNone24 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsNauseaPotentially Life-threatening0 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsVomitingPotentially Life-threatening0 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsArthralgiaSevere0 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMyalgiaModerate10 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsHeadacheMild21 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMalaise and/or fatigueSevere1 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsTemperatureModerate5 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsNauseaNone37 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsVomitingSevere0 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsTemperatureNone41 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsTemperatureSevere0 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsTemperaturePotentially Life-threatening0 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsHeadacheModerate7 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMalaise and/or fatigueNone20 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMax. Systemic SymptomsSevere1 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsVomitingModerate1 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsArthralgiaModerate3 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMax. Systemic SymptomsPotentially Life-threatening0 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMyalgiaMild16 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsHeadacheSevere1 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMax. Systemic SymptomsMild19 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMyalgiaSevere0 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsVomitingMild3 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMalaise and/or fatiguePotentially Life-threatening0 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsNauseaSevere0 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsVomitingNone46 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsChillsPotentially Life-threatening0 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsHeadachePotentially Life-threatening0 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsArthralgiaMild12 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMyalgiaSevere0 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsNauseaPotentially Life-threatening0 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsNauseaNone34 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsTemperatureMild9 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsNauseaSevere0 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsNauseaModerate5 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsNauseaMild11 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMalaise and/or fatigueMild15 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsTemperatureNone38 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsChillsNone32 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsTemperaturePotentially Life-threatening0 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMax. Systemic SymptomsPotentially Life-threatening0 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsArthralgiaPotentially Life-threatening0 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMax. Systemic SymptomsSevere4 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMax. Systemic SymptomsModerate19 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMax. Systemic SymptomsMild19 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMalaise and/or fatigueNone18 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMax. Systemic SymptomsNone8 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMalaise and/or fatigueModerate14 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsTemperatureSevere1 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsArthralgiaSevere0 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMalaise and/or fatigueSevere3 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsArthralgiaModerate5 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMalaise and/or fatiguePotentially Life-threatening0 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsHeadachePotentially Life-threatening0 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMyalgiaNone20 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsArthralgiaNone33 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMyalgiaMild15 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsChillsPotentially Life-threatening0 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMyalgiaModerate15 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsChillsSevere1 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsTemperatureModerate2 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsChillsModerate9 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMyalgiaPotentially Life-threatening0 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsChillsMild8 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsHeadacheNone15 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsVomitingPotentially Life-threatening0 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsHeadacheMild21 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsVomitingSevere0 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsVomitingModerate1 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsHeadacheModerate14 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsVomitingMild2 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsHeadacheSevere0 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsVomitingNone47 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsMalaise and/or fatigueNone18 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsMalaise and/or fatigueMild10 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsMalaise and/or fatiguePotentially Life-threatening0 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsMyalgiaModerate3 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsNauseaPotentially Life-threatening0 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsChillsNone25 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsArthralgiaSevere0 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsMalaise and/or fatigueModerate1 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsMalaise and/or fatigueSevere1 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsMyalgiaNone16 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsMyalgiaMild11 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsMyalgiaSevere0 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsMyalgiaPotentially Life-threatening0 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsHeadacheNone14 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsHeadacheMild11 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsHeadacheModerate4 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsHeadacheSevere1 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsHeadachePotentially Life-threatening0 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsNauseaNone22 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsNauseaMild6 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsNauseaModerate2 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsNauseaSevere0 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsVomitingNone29 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsVomitingMild1 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsVomitingModerate0 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsVomitingSevere0 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsVomitingPotentially Life-threatening0 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsChillsMild5 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsChillsModerate0 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsChillsSevere0 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsChillsPotentially Life-threatening0 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsArthralgiaNone26 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsArthralgiaMild4 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsArthralgiaModerate0 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsArthralgiaPotentially Life-threatening0 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsMax. Systemic SymptomsNone8 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsMax. Systemic SymptomsMild13 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsMax. Systemic SymptomsModerate7 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsMax. Systemic SymptomsSevere2 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsMax. Systemic SymptomsPotentially Life-threatening0 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsTemperatureNone26 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsTemperatureMild2 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsTemperatureModerate1 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsTemperatureSevere0 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants Reporting Systemic Reactogenicity Signs and SymptomsTemperaturePotentially Life-threatening1 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMyalgiaPotentially Life-threatening0 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMax. Systemic SymptomsNone11 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsChillsMild12 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsVomitingSevere0 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMalaise and/or fatigueModerate13 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsTemperatureMild8 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsTemperaturePotentially Life-threatening0 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsArthralgiaSevere1 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsArthralgiaPotentially Life-threatening0 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsVomitingNone45 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsChillsModerate11 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMax. Systemic SymptomsModerate19 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMax. Systemic SymptomsMild16 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMyalgiaSevere2 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsHeadacheModerate11 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsNauseaSevere0 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMalaise and/or fatiguePotentially Life-threatening0 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsChillsSevere2 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsNauseaNone38 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsNauseaPotentially Life-threatening0 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMalaise and/or fatigueMild18 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsTemperatureModerate3 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsVomitingModerate0 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsVomitingPotentially Life-threatening0 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsChillsPotentially Life-threatening0 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsTemperatureSevere2 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMalaise and/or fatigueSevere3 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsTemperatureNone37 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMax. Systemic SymptomsSevere4 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMyalgiaMild11 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsHeadacheNone18 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsNauseaMild8 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMyalgiaNone23 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsArthralgiaNone29 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsChillsNone25 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsNauseaModerate4 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMyalgiaModerate14 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMax. Systemic SymptomsPotentially Life-threatening0 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsHeadachePotentially Life-threatening0 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsArthralgiaModerate5 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsVomitingMild5 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsArthralgiaMild15 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsHeadacheSevere3 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsHeadacheMild18 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMalaise and/or fatigueNone16 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsChillsModerate19 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsChillsSevere1 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMalaise and/or fatigueSevere4 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsArthralgiaModerate12 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMax. Systemic SymptomsNone3 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsVomitingSevere0 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsArthralgiaSevere2 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsHeadacheSevere1 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMax. Systemic SymptomsSevere4 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMalaise and/or fatigueModerate21 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsTemperatureSevere1 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsArthralgiaPotentially Life-threatening0 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsNauseaModerate7 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMalaise and/or fatigueMild14 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMalaise and/or fatigueNone11 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMax. Systemic SymptomsMild12 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsHeadacheNone14 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMax. Systemic SymptomsModerate31 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsVomitingPotentially Life-threatening0 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsHeadachePotentially Life-threatening0 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsTemperatureMild6 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsChillsNone22 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsNauseaMild13 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMyalgiaPotentially Life-threatening0 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsTemperatureModerate4 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsChillsMild8 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsVomitingNone45 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsNauseaSevere0 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMyalgiaSevere2 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsTemperaturePotentially Life-threatening0 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsHeadacheModerate21 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMyalgiaModerate22 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsTemperatureNone39 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsVomitingModerate0 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsChillsPotentially Life-threatening0 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsVomitingMild5 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMyalgiaMild11 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMyalgiaNone15 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsNauseaPotentially Life-threatening0 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsArthralgiaNone26 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsNauseaNone30 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMax. Systemic SymptomsPotentially Life-threatening0 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMalaise and/or fatiguePotentially Life-threatening0 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsHeadacheMild14 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsArthralgiaMild10 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsHeadacheSevere0 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsVomitingNone42 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsVomitingMild4 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsHeadacheModerate20 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsVomitingModerate4 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsHeadacheMild17 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsVomitingSevere0 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsHeadacheNone13 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsVomitingPotentially Life-threatening0 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsChillsNone23 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMyalgiaPotentially Life-threatening0 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsChillsMild6 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMyalgiaSevere1 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsTemperatureModerate6 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsChillsModerate17 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMyalgiaModerate20 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsChillsSevere4 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMyalgiaMild12 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMalaise and/or fatigueSevere1 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsChillsPotentially Life-threatening0 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsArthralgiaNone24 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMalaise and/or fatiguePotentially Life-threatening0 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsTemperaturePotentially Life-threatening2 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsArthralgiaMild10 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMyalgiaNone17 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsArthralgiaModerate15 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMalaise and/or fatigueModerate23 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsArthralgiaSevere1 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsArthralgiaPotentially Life-threatening0 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMalaise and/or fatigueMild10 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsTemperatureSevere0 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMalaise and/or fatigueNone16 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMax. Systemic SymptomsModerate22 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMax. Systemic SymptomsMild15 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMax. Systemic SymptomsNone8 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMax. Systemic SymptomsSevere5 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMax. Systemic SymptomsPotentially Life-threatening0 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsNauseaPotentially Life-threatening0 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsTemperatureNone36 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsNauseaMild10 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsNauseaModerate10 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsNauseaNone30 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsTemperatureMild6 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsNauseaSevere0 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsHeadachePotentially Life-threatening0 Participants
Group 8: PlaceboNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMax. Systemic SymptomsSevere1 Participants
Group 8: PlaceboNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMalaise and/or fatigueModerate4 Participants
Group 8: PlaceboNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsArthralgiaModerate0 Participants
Group 8: PlaceboNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMalaise and/or fatigueSevere0 Participants
Group 8: PlaceboNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsArthralgiaMild4 Participants
Group 8: PlaceboNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMalaise and/or fatiguePotentially Life-threatening0 Participants
Group 8: PlaceboNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsArthralgiaNone20 Participants
Group 8: PlaceboNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsHeadacheSevere1 Participants
Group 8: PlaceboNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMax. Systemic SymptomsPotentially Life-threatening0 Participants
Group 8: PlaceboNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsChillsModerate0 Participants
Group 8: PlaceboNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsNauseaSevere0 Participants
Group 8: PlaceboNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMalaise and/or fatigueMild5 Participants
Group 8: PlaceboNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsTemperaturePotentially Life-threatening0 Participants
Group 8: PlaceboNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsChillsPotentially Life-threatening0 Participants
Group 8: PlaceboNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMyalgiaMild4 Participants
Group 8: PlaceboNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsHeadachePotentially Life-threatening0 Participants
Group 8: PlaceboNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsChillsSevere0 Participants
Group 8: PlaceboNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMyalgiaModerate2 Participants
Group 8: PlaceboNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMyalgiaSevere0 Participants
Group 8: PlaceboNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsChillsMild3 Participants
Group 8: PlaceboNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsTemperatureMild2 Participants
Group 8: PlaceboNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsNauseaMild3 Participants
Group 8: PlaceboNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsChillsNone21 Participants
Group 8: PlaceboNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMyalgiaPotentially Life-threatening0 Participants
Group 8: PlaceboNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsNauseaNone20 Participants
Group 8: PlaceboNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsVomitingPotentially Life-threatening0 Participants
Group 8: PlaceboNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsHeadacheNone13 Participants
Group 8: PlaceboNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsVomitingSevere0 Participants
Group 8: PlaceboNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsHeadacheModerate2 Participants
Group 8: PlaceboNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsNauseaModerate1 Participants
Group 8: PlaceboNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsNauseaPotentially Life-threatening0 Participants
Group 8: PlaceboNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsVomitingModerate1 Participants
Group 8: PlaceboNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMax. Systemic SymptomsMild10 Participants
Group 8: PlaceboNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsTemperatureNone22 Participants
Group 8: PlaceboNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsTemperatureSevere0 Participants
Group 8: PlaceboNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsTemperatureModerate0 Participants
Group 8: PlaceboNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMyalgiaNone18 Participants
Group 8: PlaceboNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMax. Systemic SymptomsModerate4 Participants
Group 8: PlaceboNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsVomitingNone20 Participants
Group 8: PlaceboNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMalaise and/or fatigueNone15 Participants
Group 8: PlaceboNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsHeadacheMild8 Participants
Group 8: PlaceboNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsMax. Systemic SymptomsNone9 Participants
Group 8: PlaceboNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsArthralgiaPotentially Life-threatening0 Participants
Group 8: PlaceboNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsArthralgiaSevere0 Participants
Group 8: PlaceboNumber of Participants Reporting Systemic Reactogenicity Signs and SymptomsVomitingMild3 Participants
Primary

Number of Participants With Early Study Termination Associated With an AE or Reactogenicity

There were no early study terminations associated with an AE or reactogenicity reported by any participant.

Time frame: Measured through Month 12

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants With Early Study Termination Associated With an AE or Reactogenicity0 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants With Early Study Termination Associated With an AE or Reactogenicity0 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants With Early Study Termination Associated With an AE or Reactogenicity0 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants With Early Study Termination Associated With an AE or Reactogenicity0 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants With Early Study Termination Associated With an AE or Reactogenicity0 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants With Early Study Termination Associated With an AE or Reactogenicity0 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants With Early Study Termination Associated With an AE or Reactogenicity0 Participants
Group 8: PlaceboNumber of Participants With Early Study Termination Associated With an AE or Reactogenicity0 Participants
Primary

Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity

From the study product discontinuation form, study product administration reasons are tabulated by treatment arm.

Time frame: Measured through Month 6.5

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants With Study Product Discontinuation Associated With an AE or ReactogenicityClinical event1 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants With Study Product Discontinuation Associated With an AE or ReactogenicityReactogenicity symptom0 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants With Study Product Discontinuation Associated With an AE or ReactogenicityOther reason3 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants With Study Product Discontinuation Associated With an AE or ReactogenicityNo Discontinuation26 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants With Study Product Discontinuation Associated With an AE or ReactogenicityNo Discontinuation48 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants With Study Product Discontinuation Associated With an AE or ReactogenicityReactogenicity symptom0 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants With Study Product Discontinuation Associated With an AE or ReactogenicityClinical event0 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants With Study Product Discontinuation Associated With an AE or ReactogenicityOther reason2 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants With Study Product Discontinuation Associated With an AE or ReactogenicityClinical event0 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants With Study Product Discontinuation Associated With an AE or ReactogenicityNo Discontinuation48 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants With Study Product Discontinuation Associated With an AE or ReactogenicityReactogenicity symptom0 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants With Study Product Discontinuation Associated With an AE or ReactogenicityOther reason2 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants With Study Product Discontinuation Associated With an AE or ReactogenicityClinical event0 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants With Study Product Discontinuation Associated With an AE or ReactogenicityReactogenicity symptom1 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants With Study Product Discontinuation Associated With an AE or ReactogenicityOther reason1 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Number of Participants With Study Product Discontinuation Associated With an AE or ReactogenicityNo Discontinuation28 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants With Study Product Discontinuation Associated With an AE or ReactogenicityNo Discontinuation47 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants With Study Product Discontinuation Associated With an AE or ReactogenicityOther reason1 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants With Study Product Discontinuation Associated With an AE or ReactogenicityReactogenicity symptom2 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants With Study Product Discontinuation Associated With an AE or ReactogenicityClinical event0 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants With Study Product Discontinuation Associated With an AE or ReactogenicityNo Discontinuation43 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants With Study Product Discontinuation Associated With an AE or ReactogenicityOther reason4 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants With Study Product Discontinuation Associated With an AE or ReactogenicityReactogenicity symptom3 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumber of Participants With Study Product Discontinuation Associated With an AE or ReactogenicityClinical event0 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants With Study Product Discontinuation Associated With an AE or ReactogenicityNo Discontinuation43 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants With Study Product Discontinuation Associated With an AE or ReactogenicityClinical event0 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants With Study Product Discontinuation Associated With an AE or ReactogenicityOther reason1 Participants
Group 7: Placebo + Protein/AS01BNumber of Participants With Study Product Discontinuation Associated With an AE or ReactogenicityReactogenicity symptom6 Participants
Group 8: PlaceboNumber of Participants With Study Product Discontinuation Associated With an AE or ReactogenicityReactogenicity symptom0 Participants
Group 8: PlaceboNumber of Participants With Study Product Discontinuation Associated With an AE or ReactogenicityOther reason3 Participants
Group 8: PlaceboNumber of Participants With Study Product Discontinuation Associated With an AE or ReactogenicityNo Discontinuation21 Participants
Group 8: PlaceboNumber of Participants With Study Product Discontinuation Associated With an AE or ReactogenicityClinical event0 Participants
Primary

Numbers of Participants With Grade 1 or Higher Local Laboratory Results.

The numbers (percentages) of participants with local laboratory values recorded as meeting Grade 1 AE criteria or above as specified in the DAIDS AE Grading Table were tabulated by treatment group for each post vaccination timepoint.

Time frame: Measured during screening, and 2 weeks after each vaccination at Month 0, 1, 3, and 6

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Numbers of Participants With Grade 1 or Higher Local Laboratory Results.Creatinine (mg/dL)-Day 420 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Numbers of Participants With Grade 1 or Higher Local Laboratory Results.Creatinine (mg/dL)-Day 140 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Numbers of Participants With Grade 1 or Higher Local Laboratory Results.Platelets (x1000/cubic mm)-Day 140 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Numbers of Participants With Grade 1 or Higher Local Laboratory Results.Creatinine (mg/dL)-Day 980 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Numbers of Participants With Grade 1 or Higher Local Laboratory Results.Creatinine (mg/dL)-Day 1820 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Numbers of Participants With Grade 1 or Higher Local Laboratory Results.AST (U/L)-Day 140 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Numbers of Participants With Grade 1 or Higher Local Laboratory Results.Lymphocytes (cells/cubic mm)-Day 980 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumbers of Participants With Grade 1 or Higher Local Laboratory Results.Creatinine (mg/dL)-Day 980 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumbers of Participants With Grade 1 or Higher Local Laboratory Results.Creatinine (mg/dL)-Day 140 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumbers of Participants With Grade 1 or Higher Local Laboratory Results.Creatinine (mg/dL)-Day 420 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumbers of Participants With Grade 1 or Higher Local Laboratory Results.Creatinine (mg/dL)-Day 1824 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumbers of Participants With Grade 1 or Higher Local Laboratory Results.Platelets (x1000/cubic mm)-Day 141 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumbers of Participants With Grade 1 or Higher Local Laboratory Results.Lymphocytes (cells/cubic mm)-Day 980 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BNumbers of Participants With Grade 1 or Higher Local Laboratory Results.AST (U/L)-Day 140 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumbers of Participants With Grade 1 or Higher Local Laboratory Results.Creatinine (mg/dL)-Day 1821 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumbers of Participants With Grade 1 or Higher Local Laboratory Results.Creatinine (mg/dL)-Day 982 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumbers of Participants With Grade 1 or Higher Local Laboratory Results.Creatinine (mg/dL)-Day 140 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumbers of Participants With Grade 1 or Higher Local Laboratory Results.Lymphocytes (cells/cubic mm)-Day 980 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumbers of Participants With Grade 1 or Higher Local Laboratory Results.AST (U/L)-Day 140 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumbers of Participants With Grade 1 or Higher Local Laboratory Results.Creatinine (mg/dL)-Day 420 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BNumbers of Participants With Grade 1 or Higher Local Laboratory Results.Platelets (x1000/cubic mm)-Day 140 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Numbers of Participants With Grade 1 or Higher Local Laboratory Results.Creatinine (mg/dL)-Day 141 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Numbers of Participants With Grade 1 or Higher Local Laboratory Results.Lymphocytes (cells/cubic mm)-Day 980 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Numbers of Participants With Grade 1 or Higher Local Laboratory Results.Creatinine (mg/dL)-Day 1822 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Numbers of Participants With Grade 1 or Higher Local Laboratory Results.Creatinine (mg/dL)-Day 980 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Numbers of Participants With Grade 1 or Higher Local Laboratory Results.AST (U/L)-Day 140 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Numbers of Participants With Grade 1 or Higher Local Laboratory Results.Creatinine (mg/dL)-Day 420 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Numbers of Participants With Grade 1 or Higher Local Laboratory Results.Platelets (x1000/cubic mm)-Day 140 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumbers of Participants With Grade 1 or Higher Local Laboratory Results.Creatinine (mg/dL)-Day 140 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumbers of Participants With Grade 1 or Higher Local Laboratory Results.Lymphocytes (cells/cubic mm)-Day 980 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumbers of Participants With Grade 1 or Higher Local Laboratory Results.Platelets (x1000/cubic mm)-Day 140 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumbers of Participants With Grade 1 or Higher Local Laboratory Results.AST (U/L)-Day 140 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumbers of Participants With Grade 1 or Higher Local Laboratory Results.Creatinine (mg/dL)-Day 421 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumbers of Participants With Grade 1 or Higher Local Laboratory Results.Creatinine (mg/dL)-Day 980 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BNumbers of Participants With Grade 1 or Higher Local Laboratory Results.Creatinine (mg/dL)-Day 1823 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumbers of Participants With Grade 1 or Higher Local Laboratory Results.Creatinine (mg/dL)-Day 141 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumbers of Participants With Grade 1 or Higher Local Laboratory Results.Creatinine (mg/dL)-Day 1821 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumbers of Participants With Grade 1 or Higher Local Laboratory Results.Creatinine (mg/dL)-Day 422 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumbers of Participants With Grade 1 or Higher Local Laboratory Results.AST (U/L)-Day 140 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumbers of Participants With Grade 1 or Higher Local Laboratory Results.Creatinine (mg/dL)-Day 981 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumbers of Participants With Grade 1 or Higher Local Laboratory Results.Platelets (x1000/cubic mm)-Day 140 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BNumbers of Participants With Grade 1 or Higher Local Laboratory Results.Lymphocytes (cells/cubic mm)-Day 981 Participants
Group 7: Placebo + Protein/AS01BNumbers of Participants With Grade 1 or Higher Local Laboratory Results.Platelets (x1000/cubic mm)-Day 140 Participants
Group 7: Placebo + Protein/AS01BNumbers of Participants With Grade 1 or Higher Local Laboratory Results.Lymphocytes (cells/cubic mm)-Day 980 Participants
Group 7: Placebo + Protein/AS01BNumbers of Participants With Grade 1 or Higher Local Laboratory Results.Creatinine (mg/dL)-Day 981 Participants
Group 7: Placebo + Protein/AS01BNumbers of Participants With Grade 1 or Higher Local Laboratory Results.Creatinine (mg/dL)-Day 420 Participants
Group 7: Placebo + Protein/AS01BNumbers of Participants With Grade 1 or Higher Local Laboratory Results.Creatinine (mg/dL)-Day 1822 Participants
Group 7: Placebo + Protein/AS01BNumbers of Participants With Grade 1 or Higher Local Laboratory Results.AST (U/L)-Day 141 Participants
Group 7: Placebo + Protein/AS01BNumbers of Participants With Grade 1 or Higher Local Laboratory Results.Creatinine (mg/dL)-Day 141 Participants
Group 8: PlaceboNumbers of Participants With Grade 1 or Higher Local Laboratory Results.Creatinine (mg/dL)-Day 1821 Participants
Group 8: PlaceboNumbers of Participants With Grade 1 or Higher Local Laboratory Results.Creatinine (mg/dL)-Day 140 Participants
Group 8: PlaceboNumbers of Participants With Grade 1 or Higher Local Laboratory Results.Creatinine (mg/dL)-Day 981 Participants
Group 8: PlaceboNumbers of Participants With Grade 1 or Higher Local Laboratory Results.Lymphocytes (cells/cubic mm)-Day 980 Participants
Group 8: PlaceboNumbers of Participants With Grade 1 or Higher Local Laboratory Results.AST (U/L)-Day 140 Participants
Group 8: PlaceboNumbers of Participants With Grade 1 or Higher Local Laboratory Results.Creatinine (mg/dL)-Day 420 Participants
Group 8: PlaceboNumbers of Participants With Grade 1 or Higher Local Laboratory Results.Platelets (x1000/cubic mm)-Day 140 Participants
Primary

Occurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Response - Magnitudes.

Serum IgG responses were measured on a Bio-Plex instrument using a custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen minus reference antigen MFI. Net MFI below 1 is set to 1, and Net MFI above 22,000 is set to 22,000. Samples from post-baseline visits have positive responses if they meet three criteria: (1) net MFI \>= antigen-specific threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI \> 3 times baseline net MFI, and (3) experimental antigen MFI \> 3 times baseline MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI.

Time frame: Measured at Month 6.5

Population: In this report, the overall number of participants analyzed represents the HIV uninfected participants with specimens at Month6.5. The Number Analyzed in the Outcome Measure Data Table shows the number of participants with available BAMA data after filtering for assay specific quality control criteria.

ArmMeasureGroupValue (MEDIAN)
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Response - Magnitudes.TV1c8_D11gp120.avi/293F22000 relative fluorescence units
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Response - Magnitudes.gp70_B.CaseA_V1_V2744.5 relative fluorescence units
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Response - Magnitudes.gp70-TV1.GSKvacV1V2/293F521.5 relative fluorescence units
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Response - Magnitudes.gp70_B.CaseA_V1_V21110.625 relative fluorescence units
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Response - Magnitudes.gp70-TV1.GSKvacV1V2/293F1656 relative fluorescence units
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Response - Magnitudes.TV1c8_D11gp120.avi/293F22000 relative fluorescence units
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Response - Magnitudes.gp70_B.CaseA_V1_V2184.5 relative fluorescence units
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Response - Magnitudes.TV1c8_D11gp120.avi/293F22000 relative fluorescence units
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Response - Magnitudes.gp70-TV1.GSKvacV1V2/293F330 relative fluorescence units
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Response - Magnitudes.TV1c8_D11gp120.avi/293F22000 relative fluorescence units
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Response - Magnitudes.gp70-TV1.GSKvacV1V2/293F4948.75 relative fluorescence units
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Response - Magnitudes.gp70_B.CaseA_V1_V21881 relative fluorescence units
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Response - Magnitudes.gp70-TV1.GSKvacV1V2/293F16511.5 relative fluorescence units
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Response - Magnitudes.TV1c8_D11gp120.avi/293F22000 relative fluorescence units
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Response - Magnitudes.gp70_B.CaseA_V1_V25559 relative fluorescence units
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Response - Magnitudes.gp70-TV1.GSKvacV1V2/293F10392.25 relative fluorescence units
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Response - Magnitudes.TV1c8_D11gp120.avi/293F22000 relative fluorescence units
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Response - Magnitudes.gp70_B.CaseA_V1_V25231.875 relative fluorescence units
Group 7: Placebo + Protein/AS01BOccurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Response - Magnitudes.gp70-TV1.GSKvacV1V2/293F2409 relative fluorescence units
Group 7: Placebo + Protein/AS01BOccurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Response - Magnitudes.TV1c8_D11gp120.avi/293F22000 relative fluorescence units
Group 7: Placebo + Protein/AS01BOccurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Response - Magnitudes.gp70_B.CaseA_V1_V21329.625 relative fluorescence units
Group 8: PlaceboOccurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Response - Magnitudes.TV1c8_D11gp120.avi/293F1 relative fluorescence units
Group 8: PlaceboOccurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Response - Magnitudes.gp70-TV1.GSKvacV1V2/293F1 relative fluorescence units
Group 8: PlaceboOccurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Response - Magnitudes.gp70_B.CaseA_V1_V21 relative fluorescence units
Primary

Occurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Responses - Positive Response Rates.

Serum IgG responses were measured on a Bio-Plex instrument using a custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen minus reference antigen MFI. Net MFI below 1 is set to 1, and Net MFI above 22,000 is set to 22,000. Samples from post-baseline visits have positive responses if they meet three criteria: (1) net MFI \>= antigen-specific threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI \> 3 times baseline net MFI, and (3) experimental antigen MFI \> 3 times baseline MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI.

Time frame: Measured at Month 6.5

Population: In this report, the overall number of participants analyzed represents the HIV uninfected participants with specimens at Month6.5. The Number Analyzed in the Outcome Measure Data Table shows the number of participants with available BAMA data after filtering for assay specific quality control criteria.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Responses - Positive Response Rates.TV1c8_D11gp120.avi/293F19 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Responses - Positive Response Rates.gp70_B.CaseA_V1_V216 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Responses - Positive Response Rates.gp70-TV1.GSKvacV1V2/293F16 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Responses - Positive Response Rates.gp70_B.CaseA_V1_V231 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Responses - Positive Response Rates.gp70-TV1.GSKvacV1V2/293F35 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Responses - Positive Response Rates.TV1c8_D11gp120.avi/293F42 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Responses - Positive Response Rates.gp70_B.CaseA_V1_V220 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Responses - Positive Response Rates.TV1c8_D11gp120.avi/293F43 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Responses - Positive Response Rates.gp70-TV1.GSKvacV1V2/293F24 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Responses - Positive Response Rates.TV1c8_D11gp120.avi/293F24 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Responses - Positive Response Rates.gp70-TV1.GSKvacV1V2/293F23 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Responses - Positive Response Rates.gp70_B.CaseA_V1_V222 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Responses - Positive Response Rates.gp70-TV1.GSKvacV1V2/293F35 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Responses - Positive Response Rates.TV1c8_D11gp120.avi/293F39 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Responses - Positive Response Rates.gp70_B.CaseA_V1_V233 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Responses - Positive Response Rates.gp70-TV1.GSKvacV1V2/293F31 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Responses - Positive Response Rates.TV1c8_D11gp120.avi/293F36 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Responses - Positive Response Rates.gp70_B.CaseA_V1_V230 Participants
Group 7: Placebo + Protein/AS01BOccurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Responses - Positive Response Rates.gp70-TV1.GSKvacV1V2/293F30 Participants
Group 7: Placebo + Protein/AS01BOccurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Responses - Positive Response Rates.TV1c8_D11gp120.avi/293F40 Participants
Group 7: Placebo + Protein/AS01BOccurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Responses - Positive Response Rates.gp70_B.CaseA_V1_V228 Participants
Group 8: PlaceboOccurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Responses - Positive Response Rates.TV1c8_D11gp120.avi/293F0 Participants
Group 8: PlaceboOccurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Responses - Positive Response Rates.gp70-TV1.GSKvacV1V2/293F0 Participants
Group 8: PlaceboOccurrence and Level of Anti -V1/V2 Scaffold IgG Binding Antibody Responses - Positive Response Rates.gp70_B.CaseA_V1_V20 Participants
Primary

Occurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.

PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p\<=0.00001. Any Env magnitude is the maximum of gp120 and Env ZM96 magnitude; Any Pol is the sum of CN54 magnitude; and Any HIV is the sum of Gag ZM96, Nef CN54, Any Pol, and Any Env. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.

Time frame: Measured at Month 6.5

Population: In this report, the overall number of participants analyzed represents the HIV uninfected participants with specimens at Month6.5. The Number Analyzed in the Outcome Measure Data Table shows the number of participants with available ICS data after filtering for assay specific quality control criteria.

ArmMeasureGroupValue (MEDIAN)
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.Nef-CN54-0.003 percent T-cells
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.Gag-ZM960.039 percent T-cells
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.1086 gp1200.123 percent T-cells
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.Env-2-ZM960.047 percent T-cells
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.ANY ENV0.189 percent T-cells
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.ANY HIV0.237 percent T-cells
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.TV1 gp1200.151 percent T-cells
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.ANY POL0.003 percent T-cells
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.Pol-2-CN54-0.001 percent T-cells
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.Pol-1-CN540.001 percent T-cells
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.Env-1-ZM960.076 percent T-cells
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.TV1 gp1200.349 percent T-cells
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.Nef-CN54-0.001 percent T-cells
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.Env-2-ZM960.052 percent T-cells
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.ANY ENV0.37 percent T-cells
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.Pol-2-CN54-0.002 percent T-cells
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.Gag-ZM960.027 percent T-cells
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.Env-1-ZM960.196 percent T-cells
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.1086 gp1200.308 percent T-cells
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.ANY POL-0.001 percent T-cells
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.ANY HIV0.388 percent T-cells
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.Pol-1-CN54-0.001 percent T-cells
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.TV1 gp1200.319 percent T-cells
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.ANY ENV0.451 percent T-cells
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.Nef-CN54-0.002 percent T-cells
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.Pol-2-CN54-0.001 percent T-cells
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.ANY POL0 percent T-cells
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.Gag-ZM960.03 percent T-cells
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.Env-2-ZM960.085 percent T-cells
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.1086 gp1200.448 percent T-cells
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.ANY HIV0.492 percent T-cells
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.Env-1-ZM960.272 percent T-cells
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.Pol-1-CN540 percent T-cells
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.TV1 gp1200.096 percent T-cells
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.Gag-ZM960.016 percent T-cells
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.ANY HIV0.156 percent T-cells
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.ANY ENV0.124 percent T-cells
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.Env-1-ZM960.038 percent T-cells
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.ANY POL0.003 percent T-cells
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.Env-2-ZM960.02 percent T-cells
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.Nef-CN540 percent T-cells
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.Pol-1-CN540.001 percent T-cells
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.Pol-2-CN540.001 percent T-cells
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.1086 gp1200.078 percent T-cells
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.ANY POL-0.001 percent T-cells
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.Env-1-ZM960.12 percent T-cells
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.Pol-2-CN54-0.002 percent T-cells
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.TV1 gp1200.271 percent T-cells
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.ANY ENV0.328 percent T-cells
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.Nef-CN54-0.004 percent T-cells
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.Gag-ZM960.011 percent T-cells
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.ANY HIV0.364 percent T-cells
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.Env-2-ZM960.04 percent T-cells
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.1086 gp1200.241 percent T-cells
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.Pol-1-CN540.001 percent T-cells
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.TV1 gp1200.376 percent T-cells
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.Env-1-ZM960.186 percent T-cells
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.1086 gp1200.412 percent T-cells
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.Pol-1-CN540 percent T-cells
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.Pol-2-CN54-0.003 percent T-cells
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.Gag-ZM960.013 percent T-cells
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.ANY POL-0.002 percent T-cells
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.ANY ENV0.456 percent T-cells
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.Env-2-ZM960.054 percent T-cells
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.ANY HIV0.48 percent T-cells
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.Nef-CN54-0.004 percent T-cells
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.Pol-2-CN54-0.001 percent T-cells
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.Gag-ZM96-0.002 percent T-cells
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.Env-1-ZM960.092 percent T-cells
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.Nef-CN54-0.001 percent T-cells
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.ANY POL-0.002 percent T-cells
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.Pol-1-CN54-0.001 percent T-cells
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.ANY ENV0.504 percent T-cells
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.1086 gp1200.42 percent T-cells
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.ANY HIV0.52 percent T-cells
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.TV1 gp1200.334 percent T-cells
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.Env-2-ZM960.045 percent T-cells
Group 8: PlaceboOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.Env-1-ZM960.008 percent T-cells
Group 8: PlaceboOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.ANY ENV0.015 percent T-cells
Group 8: PlaceboOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.1086 gp120-0.001 percent T-cells
Group 8: PlaceboOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.TV1 gp120-0.003 percent T-cells
Group 8: PlaceboOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.Pol-1-CN54-0.001 percent T-cells
Group 8: PlaceboOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.ANY POL0.001 percent T-cells
Group 8: PlaceboOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.Nef-CN54-0.002 percent T-cells
Group 8: PlaceboOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.Gag-ZM960.001 percent T-cells
Group 8: PlaceboOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.Pol-2-CN540.001 percent T-cells
Group 8: PlaceboOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.ANY HIV0.016 percent T-cells
Group 8: PlaceboOccurrence and Level of HIV-specific CD4+ T-cell Responses - Magnitudes.Env-2-ZM960 percent T-cells
Primary

Occurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.

PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p\<=0.00001. Any Env magnitude is the maximum of gp120 and Env ZM96 magnitude; Any Pol is the sum of CN54 magnitude; and Any HIV is the sum of Gag ZM96, Nef CN54, Any Pol, and Any Env. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.

Time frame: Measured at Month 6.5

Population: In this report, the overall number of participants analyzed represents the HIV uninfected participants with specimens at Month6.5. The Number Analyzed in the Outcome Measure Data Table shows the number of participants with available ICS data after filtering for assay specific quality control criteria.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.Gag-ZM969 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.Env-2-ZM9612 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.ANY HIV20 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.1086 gp12017 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.ANY POL0 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.Pol-1-CN540 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.TV1 gp12017 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.Pol-2-CN540 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.Env-1-ZM9616 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.ANY ENV20 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.Nef-CN540 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.Nef-CN541 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.Env-2-ZM9625 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.Gag-ZM9614 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.ANY ENV47 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.ANY HIV47 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.Pol-2-CN541 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.1086 gp12047 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.Env-1-ZM9641 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.TV1 gp12047 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.Pol-1-CN540 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.ANY POL1 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.ANY ENV42 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.ANY POL2 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.Env-1-ZM9640 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.Env-2-ZM9628 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.Gag-ZM9610 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.Nef-CN540 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.Pol-1-CN541 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.Pol-2-CN541 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.TV1 gp12042 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.1086 gp12042 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.ANY HIV43 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.Nef-CN540 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.Pol-2-CN540 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.Gag-ZM963 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.ANY ENV20 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.Env-2-ZM965 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.Env-1-ZM9612 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.Pol-1-CN540 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.TV1 gp12017 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.1086 gp12017 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.ANY POL0 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.ANY HIV21 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.ANY ENV42 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.1086 gp12038 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.Env-2-ZM9618 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.Nef-CN541 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.TV1 gp12041 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.ANY HIV42 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.Pol-1-CN541 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.Gag-ZM965 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.ANY POL2 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.Pol-2-CN541 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.Env-1-ZM9632 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.Gag-ZM968 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.ANY POL0 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.Env-1-ZM9634 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.ANY HIV40 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.Env-2-ZM9621 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.Nef-CN540 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.TV1 gp12039 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.ANY ENV40 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.Pol-2-CN540 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.Pol-1-CN540 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.1086 gp12040 Participants
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.Env-1-ZM9626 Participants
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.Gag-ZM964 Participants
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.Nef-CN540 Participants
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.ANY POL1 Participants
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.Pol-1-CN541 Participants
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.Pol-2-CN540 Participants
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.ANY HIV40 Participants
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.TV1 gp12038 Participants
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.ANY ENV40 Participants
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.1086 gp12039 Participants
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.Env-2-ZM9616 Participants
Group 8: PlaceboOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.Env-2-ZM961 Participants
Group 8: PlaceboOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.1086 gp1201 Participants
Group 8: PlaceboOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.ANY ENV1 Participants
Group 8: PlaceboOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.Env-1-ZM961 Participants
Group 8: PlaceboOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.Pol-2-CN541 Participants
Group 8: PlaceboOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.Pol-1-CN540 Participants
Group 8: PlaceboOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.Nef-CN540 Participants
Group 8: PlaceboOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.ANY POL1 Participants
Group 8: PlaceboOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.Gag-ZM961 Participants
Group 8: PlaceboOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.ANY HIV1 Participants
Group 8: PlaceboOccurrence and Level of HIV-specific CD4+ T-cell Responses - Positive Response Rates.TV1 gp1201 Participants
Primary

Occurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.

PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p\<=0.00001. Any Env magnitude is the maximum of gp120 and Env ZM96 magnitude; Any Pol is the sum of CN54 magnitude; and Any HIV is the sum of Gag ZM96, Nef CN54, Any Pol, and Any Env. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.

Time frame: Measured at Month 6.5

Population: In this report, the overall number of participants analyzed represents the HIV uninfected participants with specimens at Month6.5. The Number Analyzed in the Outcome Measure Data Table shows the number of participants with available ICS data after filtering for assay specific quality control criteria.

ArmMeasureGroupValue (MEDIAN)
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.Gag-ZM960.002 percent T-cells
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.Env-1-ZM96-0.001 percent T-cells
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.1086 gp1200.003 percent T-cells
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.ANY HIV0.007 percent T-cells
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.ANY ENV0.006 percent T-cells
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.ANY POL-0.002 percent T-cells
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.TV1 gp1200 percent T-cells
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.Nef-CN54-0.003 percent T-cells
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.Env-2-ZM960.001 percent T-cells
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.Pol-2-CN540 percent T-cells
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.Pol-1-CN54-0.003 percent T-cells
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.Nef-CN540 percent T-cells
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.ANY HIV0.019 percent T-cells
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.TV1 gp1200.002 percent T-cells
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.Env-1-ZM960.003 percent T-cells
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.Pol-1-CN540.001 percent T-cells
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.1086 gp1200.002 percent T-cells
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.ANY ENV0.011 percent T-cells
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.Gag-ZM960.001 percent T-cells
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.Env-2-ZM960.002 percent T-cells
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.ANY POL0.002 percent T-cells
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.Pol-2-CN540.001 percent T-cells
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.ANY ENV0.013 percent T-cells
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.Nef-CN540.001 percent T-cells
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.1086 gp1200.002 percent T-cells
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.ANY HIV0.026 percent T-cells
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.ANY POL0.002 percent T-cells
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.TV1 gp1200.002 percent T-cells
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.Env-1-ZM960.002 percent T-cells
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.Pol-2-CN540.001 percent T-cells
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.Env-2-ZM960 percent T-cells
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.Pol-1-CN540.002 percent T-cells
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.Gag-ZM960.003 percent T-cells
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.ANY POL-0.001 percent T-cells
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.ANY HIV0.012 percent T-cells
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.Env-2-ZM960.005 percent T-cells
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.TV1 gp1200.001 percent T-cells
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.Nef-CN540 percent T-cells
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.Pol-1-CN54-0.002 percent T-cells
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.Pol-2-CN540 percent T-cells
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.Gag-ZM960 percent T-cells
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.Env-1-ZM960.001 percent T-cells
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.1086 gp1200.005 percent T-cells
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.ANY ENV0.01 percent T-cells
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.TV1 gp1200.003 percent T-cells
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.ANY HIV0.019 percent T-cells
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.ANY ENV0.008 percent T-cells
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.Env-2-ZM960 percent T-cells
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.ANY POL-0.001 percent T-cells
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.Env-1-ZM960.005 percent T-cells
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.Gag-ZM960.002 percent T-cells
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.Nef-CN54-0.001 percent T-cells
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.Pol-1-CN540 percent T-cells
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.Pol-2-CN54-0.001 percent T-cells
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.1086 gp1200.001 percent T-cells
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.TV1 gp1200.003 percent T-cells
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.ANY ENV0.009 percent T-cells
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.Gag-ZM960.001 percent T-cells
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.ANY HIV0.006 percent T-cells
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.Nef-CN54-0.002 percent T-cells
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.Env-1-ZM960.005 percent T-cells
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.Pol-2-CN540 percent T-cells
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.1086 gp1200.001 percent T-cells
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.ANY POL0 percent T-cells
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.Env-2-ZM96-0.002 percent T-cells
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.Pol-1-CN540 percent T-cells
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.ANY ENV0.009 percent T-cells
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.TV1 gp1200.001 percent T-cells
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.Pol-1-CN540.001 percent T-cells
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.Env-2-ZM960 percent T-cells
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.1086 gp1200 percent T-cells
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.ANY HIV0.013 percent T-cells
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.ANY POL0 percent T-cells
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.Gag-ZM960.002 percent T-cells
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.Env-1-ZM960.006 percent T-cells
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.Pol-2-CN540 percent T-cells
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.Nef-CN54-0.001 percent T-cells
Group 8: PlaceboOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.Pol-2-CN54-0.003 percent T-cells
Group 8: PlaceboOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.Env-2-ZM96-0.002 percent T-cells
Group 8: PlaceboOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.Pol-1-CN540 percent T-cells
Group 8: PlaceboOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.Env-1-ZM96-0.003 percent T-cells
Group 8: PlaceboOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.ANY POL-0.005 percent T-cells
Group 8: PlaceboOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.Nef-CN54-0.003 percent T-cells
Group 8: PlaceboOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.ANY ENV0.004 percent T-cells
Group 8: PlaceboOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.TV1 gp1200 percent T-cells
Group 8: PlaceboOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.ANY HIV-0.004 percent T-cells
Group 8: PlaceboOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.Gag-ZM96-0.001 percent T-cells
Group 8: PlaceboOccurrence and Level of HIV-specific CD8+ T-cell Responses - Magnitudes.1086 gp120-0.001 percent T-cells
Primary

Occurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.

PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p\<=0.00001. Any Env magnitude is the maximum of gp120 and Env ZM96 magnitude; Any Pol is the sum of CN54 magnitude; and Any HIV is the sum of Gag ZM96, Nef CN54, Any Pol, and Any Env. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.

Time frame: Measured at Month 6.5

Population: In this report, the overall number of participants analyzed represents the HIV uninfected participants with specimens at Month6.5. The Number Analyzed in the Outcome Measure Data Table shows the number of participants with available ICS data after filtering for assay specific quality control criteria.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.ANY ENV2 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.Nef-CN540 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.ANY HIV2 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.Env-1-ZM961 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.Pol-2-CN540 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.1086 gp1201 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.Env-2-ZM960 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.Gag-ZM960 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.ANY POL0 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.Pol-1-CN540 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.TV1 gp1201 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.Env-1-ZM961 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.Env-2-ZM960 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.Gag-ZM961 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.Pol-2-CN540 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.ANY HIV2 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.TV1 gp1200 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.ANY ENV1 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.Pol-1-CN540 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.ANY POL0 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.Nef-CN541 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.1086 gp1200 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.Pol-2-CN542 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.ANY ENV9 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.TV1 gp1202 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.ANY POL3 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.1086 gp1202 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.Nef-CN540 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.Env-2-ZM964 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.Gag-ZM962 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.ANY HIV11 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.Pol-1-CN541 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.Env-1-ZM963 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.Env-2-ZM960 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.Nef-CN540 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.ANY ENV1 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.Pol-2-CN540 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.Env-1-ZM961 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.ANY HIV1 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.TV1 gp1200 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.1086 gp1200 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.Gag-ZM961 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.Pol-1-CN540 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.ANY POL0 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.Nef-CN540 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.TV1 gp1201 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.1086 gp1200 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.ANY HIV4 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.ANY ENV2 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.ANY POL2 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.Env-1-ZM960 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.Env-2-ZM961 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.Gag-ZM960 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.Pol-1-CN541 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.Pol-2-CN541 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.Gag-ZM960 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.1086 gp1202 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.TV1 gp1204 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.Pol-2-CN540 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.ANY POL1 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.Env-2-ZM960 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.Nef-CN540 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.ANY ENV5 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.Env-1-ZM963 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.Pol-1-CN541 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.ANY HIV6 Participants
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.ANY HIV4 Participants
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.ANY POL1 Participants
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.1086 gp1202 Participants
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.Nef-CN540 Participants
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.Env-1-ZM962 Participants
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.ANY ENV4 Participants
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.Pol-2-CN540 Participants
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.TV1 gp1202 Participants
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.Gag-ZM961 Participants
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.Env-2-ZM960 Participants
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.Pol-1-CN541 Participants
Group 8: PlaceboOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.ANY HIV1 Participants
Group 8: PlaceboOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.TV1 gp1201 Participants
Group 8: PlaceboOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.Gag-ZM960 Participants
Group 8: PlaceboOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.ANY POL1 Participants
Group 8: PlaceboOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.ANY ENV1 Participants
Group 8: PlaceboOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.Nef-CN540 Participants
Group 8: PlaceboOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.Env-1-ZM961 Participants
Group 8: PlaceboOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.Pol-1-CN540 Participants
Group 8: PlaceboOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.1086 gp1201 Participants
Group 8: PlaceboOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.Pol-2-CN541 Participants
Group 8: PlaceboOccurrence and Level of HIV-specific CD8+ T-cell Responses - Positive Response Rates.Env-2-ZM960 Participants
Primary

Occurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.

IgG binding antibody breadth assays were not run. Instead, IgG was assayed against a smaller panel of antigens.Serum IgG responses were measured on a Bio-Plex instrument using a custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen minus reference antigen MFI. Net MFI below 1 is set to 1, and Net MFI above 22,000 is set to 22,000. Samples from post-baseline visits have positive responses if they meet three criteria: (1) net MFI \>= antigen-specific threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI \> 3 times baseline net MFI, and (3) experimental antigen MFI \> 3 times baseline MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI.

Time frame: Measured at Month 6.5

Population: In this report, the overall number of participants analyzed represents the HIV uninfected participants with specimens at Month6.5. The Number Analyzed in the Outcome Measure Data Table shows the number of participants with available BAMA data after filtering for assay specific quality control criteria.

ArmMeasureGroupValue (MEDIAN)
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.96ZM651.gp140C.avi21251 relative fluorescence units
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.Con S gp140 CFI22000 relative fluorescence units
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.1086C_D7gp120.avi/293F22000 relative fluorescence units
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.00MSA 4076 gp14022000 relative fluorescence units
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.Con 6 gp120/B22000 relative fluorescence units
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.A1.con.env03 140 CF22000 relative fluorescence units
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.96ZM651.gp140C.avi22000 relative fluorescence units
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.Con 6 gp120/B22000 relative fluorescence units
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.1086C_D7gp120.avi/293F22000 relative fluorescence units
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.A1.con.env03 140 CF22000 relative fluorescence units
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.Con S gp140 CFI22000 relative fluorescence units
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.00MSA 4076 gp14022000 relative fluorescence units
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.00MSA 4076 gp14022000 relative fluorescence units
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.Con 6 gp120/B22000 relative fluorescence units
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.96ZM651.gp140C.avi22000 relative fluorescence units
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.A1.con.env03 140 CF22000 relative fluorescence units
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.Con S gp140 CFI22000 relative fluorescence units
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.1086C_D7gp120.avi/293F22000 relative fluorescence units
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.1086C_D7gp120.avi/293F22000 relative fluorescence units
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.00MSA 4076 gp14022000 relative fluorescence units
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.96ZM651.gp140C.avi22000 relative fluorescence units
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.A1.con.env03 140 CF22000 relative fluorescence units
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.Con 6 gp120/B22000 relative fluorescence units
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.Con S gp140 CFI22000 relative fluorescence units
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.A1.con.env03 140 CF22000 relative fluorescence units
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.00MSA 4076 gp14022000 relative fluorescence units
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.96ZM651.gp140C.avi22000 relative fluorescence units
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.1086C_D7gp120.avi/293F22000 relative fluorescence units
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.Con S gp140 CFI22000 relative fluorescence units
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.Con 6 gp120/B22000 relative fluorescence units
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.1086C_D7gp120.avi/293F22000 relative fluorescence units
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.Con 6 gp120/B22000 relative fluorescence units
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.00MSA 4076 gp14022000 relative fluorescence units
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.A1.con.env03 140 CF22000 relative fluorescence units
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.96ZM651.gp140C.avi22000 relative fluorescence units
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.Con S gp140 CFI22000 relative fluorescence units
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.96ZM651.gp140C.avi22000 relative fluorescence units
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.1086C_D7gp120.avi/293F22000 relative fluorescence units
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.A1.con.env03 140 CF22000 relative fluorescence units
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.00MSA 4076 gp14022000 relative fluorescence units
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.Con S gp140 CFI22000 relative fluorescence units
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.Con 6 gp120/B22000 relative fluorescence units
Group 8: PlaceboOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.Con 6 gp120/B9.75 relative fluorescence units
Group 8: PlaceboOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.Con S gp140 CFI1 relative fluorescence units
Group 8: PlaceboOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.00MSA 4076 gp1401 relative fluorescence units
Group 8: PlaceboOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.A1.con.env03 140 CF1 relative fluorescence units
Group 8: PlaceboOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.1086C_D7gp120.avi/293F1 relative fluorescence units
Group 8: PlaceboOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Magnitudes.96ZM651.gp140C.avi1 relative fluorescence units
Primary

Occurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.

IgG binding antibody breadth assays were not run. Instead, IgG was assayed against a smaller panel of antigens. Serum IgG responses were measured on a Bio-Plex instrument using a custom Luminex assay, run at 1:50 dilution. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen minus reference antigen MFI. Net MFI below 1 is set to 1, and Net MFI above 22,000 is set to 22,000. Samples from post-baseline visits have positive responses if they meet three criteria: (1) net MFI \>= antigen-specific threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI \> 3 times baseline net MFI, and (3) experimental antigen MFI \> 3 times baseline MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI.

Time frame: Measured at Month 6.5

Population: In this report, the overall number of participants analyzed represents the HIV uninfected participants with specimens at Month6.5. The Number Analyzed in the Outcome Measure Data Table shows the number of participants with available BAMA data after filtering for assay specific quality control criteria.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.A1.con.env03 140 CF19 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.96ZM651.gp140C.avi19 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.Con S gp140 CFI20 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.00MSA 4076 gp14019 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.Con 6 gp120/B19 Participants
Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.1086C_D7gp120.avi/293F19 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.Con 6 gp120/B41 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.1086C_D7gp120.avi/293F44 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.96ZM651.gp140C.avi42 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.A1.con.env03 140 CF41 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.Con S gp140 CFI42 Participants
Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.00MSA 4076 gp14041 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.Con S gp140 CFI42 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.Con 6 gp120/B42 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.00MSA 4076 gp14042 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.1086C_D7gp120.avi/293F44 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.A1.con.env03 140 CF42 Participants
Group 3: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.96ZM651.gp140C.avi42 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.Con 6 gp120/B24 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.00MSA 4076 gp14024 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.Con S gp140 CFI24 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.1086C_D7gp120.avi/293F24 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.96ZM651.gp140C.avi24 Participants
Group 4: DNA-HIV-PT123 + Placebo + Protein/MF59Occurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.A1.con.env03 140 CF24 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.96ZM651.gp140C.avi39 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.Con S gp140 CFI39 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.00MSA 4076 gp14039 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.1086C_D7gp120.avi/293F39 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.A1.con.env03 140 CF39 Participants
Group 5: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.Con 6 gp120/B36 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.Con 6 gp120/B33 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.00MSA 4076 gp14033 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.96ZM651.gp140C.avi34 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.Con S gp140 CFI35 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.1086C_D7gp120.avi/293F35 Participants
Group 6: DNA-HIV-PT123 + Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.A1.con.env03 140 CF34 Participants
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.1086C_D7gp120.avi/293F39 Participants
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.96ZM651.gp140C.avi38 Participants
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.00MSA 4076 gp14038 Participants
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.A1.con.env03 140 CF37 Participants
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.Con S gp140 CFI39 Participants
Group 7: Placebo + Protein/AS01BOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.Con 6 gp120/B36 Participants
Group 8: PlaceboOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.00MSA 4076 gp1400 Participants
Group 8: PlaceboOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.96ZM651.gp140C.avi0 Participants
Group 8: PlaceboOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.Con 6 gp120/B0 Participants
Group 8: PlaceboOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.Con S gp140 CFI0 Participants
Group 8: PlaceboOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.A1.con.env03 140 CF0 Participants
Group 8: PlaceboOccurrence and Level of HIV-specific Total IgG Binding Antibody Response Breadth and Magnitude - Positive Response Rates.1086C_D7gp120.avi/293F1 Participants
Primary

Occurrence and Level of Neutralizing Antibody Responses Against HIV-1 Isolates.

The neutralizing antibody assay was not run. Therefore this dataset doesn't exist

Time frame: Measured at Month 6.5

Population: Data were not collected

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026