HIV Infections
Conditions
Keywords
HIV
Brief summary
A phase 1/2a clinical trial to evaluate the safety and immunogenicity of ALVAC-HIV (vCP2438) and of MF59®- or AS01B-adjuvanted clade C Env protein, in healthy, HIV-uninfected adult participants
Detailed description
The primary objective of this study is to evaluate the safety and tolerability of ALVAC-HIV and bivalent gp120 protein/MF59 or bivalent gp120 protein/AS01(B). This study will also compare HIV-specific CD4+ T-cell response rates at the Month 6.5 timepoint (2 weeks after the fourth vaccination) of ALVAC-HIV and bivalent gp120 protein/MF59 to each of the bivalent gp120 protein/AS01(B) vaccine regimens. Additionally, this study will compare HIV-specific Env-gp120 binding antibody response magnitudes at the Month 12 timepoint (6 months after the fourth vaccination) of ALVAC-HIV and bivalent gp120 protein/MF59 to each of the bivalent gp120 protein/AS01(B) vaccine regimens. The study will enroll 160 healthy, HIV-uninfected volunteers aged 18 to 40 years. Groups 1 to 3 will consist of a total of 150 participants who will receive the vaccines at Months 0, 1, 3, and 6, while 10 participants in Group 4 will receive placebos at Months 0, 1, 3, 6. 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 rectal fluid, cervical fluid, semen, and/or stool samples.
Interventions
BIOLOGICALALVAC-HIV (vCP2438)
expresses the gene products 96ZM651 gp120 (clade C strain) linked to the sequences encoding the HIV-1 transmembrane anchor (TM) sequence of gp41 (28 amino acids clade B LAI strain) and Gag and Pro (clade B LAI strain). It is formulated as a lyophilized vaccine for injection at a viral titer greater than or equal to 1 × 10\^6 cell culture infectious dose (CCID)50 and less than 1 × 10\^8 CCID50 (nominal dose of 10\^7 CCID50) and is reconstituted with 1 mL of sterile sodium chloride solution (NaCl 0.4%), administered IM as a single 1 mL dose.
BIOLOGICALBivalent subtype C gp120/MF59
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 IM as a single 0.5 mL dose.
BIOLOGICALBivalent subtype C gp120/AS01(B)
clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 20 mcg or 100 mcg, mixed with AS01B adjuvant, administered IM as a single 0.75 mL dose.
BIOLOGICALPlacebo
Sodium Chloride for Injection, 0.9%, administered IM.
Sponsors
GlaxoSmithKline
Sanofi Pasteur, a Sanofi Company
National Institute of Allergy and Infectious Diseases (NIAID)
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; provides answers to 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 clinic visit * 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 (see the study protocol for more information about low risk guidelines). Laboratory Inclusion Values: Hemogram/Complete Blood Count (CBC): * Hemoglobin greater than or equal to 11.0 g/dL for volunteers who were assigned female sex at birth, greater than or equal to 13.0 g/dL for volunteers who were assigned male sex at birth. For transgender participants who have been on hormone therapy for more than 6 consecutive months, determine hemoglobin eligibility based on the gender with which they identify (ie, a transgender female who has been on hormone therapy for more than 6 consecutive months should be assessed for eligibility using the hemoglobin parameters for persons assigned female sex at birth). * 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 ALP 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 assigned female sex at birth: negative serum or urine beta human chorionic gonadotropin 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: Africa - A volunteer who was assigned female sex at birth must: * Agree to consistently use effective contraception (see the study 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 Africa is defined as using 2 methods of birth control. These include 1 of the following methods: * Condoms (male or female), or * Diaphragm or cervical cap, PLUS 1 of the following methods: * Intrauterine device (IUD), * Hormonal contraception (in accordance with applicable national contraception guidelines), * Successful vasectomy in any partner assigned male at birth (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 after vasectomy); or * Any other contraceptive method approved by the HVTN 120 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. * Reproductive status: United States - A volunteer who was assigned female sex at birth must: * Agree to consistently use effective contraception (see the study 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 of birth control: * Condoms (male or female) with or without spermicide, * Diaphragm or cervical cap with spermicide, * Intrauterine device (IUD), * Hormonal contraception, or * Successful vasectomy in any partner assigned male at birth (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 after vasectomy); or * Any other contraceptive method approved by the HVTN 120 PSRT * Or must 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 must be sexually abstinent. * Volunteers who were assigned female sex at birth 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 assigned female sex at birth consenting to provide cervical samples: * Pap smear within: * the 3 years prior to enrollment with the latest result reported as normal or ASCUS (atypical squamous cells of undetermined significance), OR * the 5 years prior to enrollment, with the latest result reported as normal, or ASCUS with no evidence of high risk HPV. * If no pap smear was done within the last 3 years prior to enrollment (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 120 study * Pregnant or breastfeeding * Active duty and reserve U.S. 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 120 PSRT will determine eligibility on a case-by-case basis. * Previous receipt of monoclonal antibodies (mAbs), whether licensed or investigational; the HVTN 120 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 120 PSRT will determine eligibility on a case-by-case basis. For volunteers who have received an experimental vaccine(s) more than 5 years ago, eligibility for enrollment will be determined by the HVTN 120 PSRT on a case-by-case basis. * Live attenuated vaccines received within 30 days before first study vaccination or scheduled within 14 days after first study vaccination (eg, measles, mumps, and rubella \[MMR\]; oral polio vaccine \[OPV\]; varicella; yellow fever; live attenuated influenza vaccine) * Any vaccines that are not live attenuated vaccines and were received within 14 days prior to first study vaccination (eg, tetanus, pneumococcal, Hepatitis A or B) * Allergy treatment with antigen injections within 30 days before first study vaccination or that are scheduled within 14 days after first study vaccination Immune System: * Immunosuppressive medications received within 168 days before first study 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 prednisone or equivalent at doses less than or equal to 60 mg/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 such as eggs, egg products, or neomycin, 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 study vaccination (for mAb see criterion above) * Autoimmune disease * Immunodeficiency Clinically Significant Medical Conditions: * 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
| Measure | Time frame | Description |
|---|---|---|
| Level of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 12.] | Measured at Month 12 | Serum IgG responses were measured on a Bio-Plex instrument using a standardized 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 MFI minus reference antigen MFI. Values outside the linear range of the assay are not meaningful and are truncated: net MFI less than 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. |
| Frequency of Adverse Events by Relationship to the Study Product | Measured through 30 days after each vaccination at Month 0, 1, 3 and 6. | For participants reporting multiple AEs over the time frame, the maximum relationship is counted. |
| Frequency of SAEs, AESIs, and New Chronic Conditions | Measured through Month 18. | No SAEs, AESIs, or new chronic conditions were reported over the course of the study |
| Alkaline Phosphatase, AST, ALT in U/L | Measured at Month 0 (Screening) ,0.5(Day 14), 1.5 (Day 42) , 3.5 (Day 98) and 6.5 (Day 182) | Laboratory results are summarized by analyte and timepoint. |
| Hemoglobin, Creatinine in g/dL | Measured at Month 0 (Screening) ,0.5(Day 14), 1.5 (Day 42) , 3.5 (Day 98) and 6.5 (Day 182) | Laboratory results are summarized by analyte and timepoint. |
| WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Measured at Month 0 (Screening) ,0.5(Day 14), 1.5 (Day 42) , 3.5 (Day 98) and 6.5 (Day 182) | Laboratory results are summarized by analyte and timepoint. |
| AEs or Reactro Leading to Early Participant Withdrawal or Early Discontinuation of Study Products Administration Throughout the Study. | Measured through month 12 | From the study product discontinuation form, study product administration reasons are tabulated by treatment arm |
| Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | Measured at Month 6.5 | 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 IL-2/IFNy 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. A response is positive if p\<=0.00001.The number and percentage of participants with positive responses are summarized by peptide pool. |
| Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | Measured at Month 6.5 | Measured by flow cytometry ICS assay: refer to earlier description for assay methods and analysis variable derivation. The percentage of T-cells expressing IL-1/IFNy are summarized for positive responders only. |
| Number of Participants With HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 12.] | Measured at Month 12 | Serum IgG responses were measured on a Bio-Plex instrument using a standardized 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 MFI minus reference antigen MFI. Values outside the linear range of the assay are not meaningful and are truncated: net MFI less than 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Samples from post-enrollment visits have positive responses if: (1) net MFI \>= an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), and (2) net MFI \> 3 times baseline net MFI, and (3) experimental antigen MFI \> 3 times baseline MFI. |
| Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Measured through 7 days after participants' last vaccination at Month 0,1,3, and 6 | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017. The maximum grade observed for each symptom over the time frame is presented; |
| Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Measured through 7 days after each vaccination at Month 0, 1, 3, and 6 | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1,July 2017. The maximum grade observed for each symptom over the time frame is presented; |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | Measured at Month 12 | Measured by flow cytometry ICS assay: refer to earlier description for assay methods and analysis variable derivation. The percentage of T-cells expressing IL-1/IFNy are summarized for positive responders only. |
| Number of Participants With HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5.] | Measured at Month 6.5 | Serum IgG responses were measured on a Bio-Plex instrument using a standardized 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 MFI minus reference antigen MFI. Values outside the linear range of the assay are not meaningful and are truncated: net MFI less than 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Samples from post-enrollment visits have positive responses if: (1) net MFI \>= an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), and (2) net MFI \> 3 times baseline net MFI, and (3) experimental antigen MFI \> 3 times baseline MFI. |
| Level of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5] | Measured at Month 6.5 | Serum IgG responses were measured on a Bio-Plex instrument using a standardized 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 MFI minus reference antigen MFI. Values outside the linear range of the assay are not meaningful and are truncated: net MFI less than 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. |
| Area Under Titration Curve of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Breadth as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5.] | Measured at Month 6.5 | Area under titration curve from serial dilution (AUTC) is calculated using the trapezoidal rule based on the raw MFI values truncated at zero across the log base 10 dilution factors, i.e., the summation of products of raw MFI values and log10(dilution factor). The dilution factor refers to the ratio of the volume of the initial (concentrated) solution (V1) to the volume of the final (dilute) solution (V2), and therefore it is unitless. For example, for a dilution of V1:V2=1:50 of a solution, the corresponding dilution factor is V2/V1=50/1=50. |
| Number of Participants With Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 6.5.] | Measured at Month 6.5 | Serum IgG responses were measured on a Bio-Plex instrument using a standardized 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 MFI minus reference antigen MFI. Values outside the linear range of the assay are not meaningful and are truncated: net MFI less than 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Samples from post-enrollment visits have positive responses if: (1) net MFI \>= an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), and (2) net MFI \> 3 times baseline net MFI, and (3) experimental antigen MFI \> 3 times baseline MFI. |
| Level of Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 6.5.] | Measured at Month 6.5 | Serum IgG responses were measured on a Bio-Plex instrument using a standardized 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 MFI minus reference antigen MFI. Values outside the linear range of the assay are not meaningful and are truncated: net MFI less than 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. |
| Number of Participants With Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 10.] | Measured at Month Month 12 | Serum IgG responses were measured on a Bio-Plex instrument using a standardized 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 MFI minus reference antigen MFI. Values outside the linear range of the assay are not meaningful and are truncated: net MFI less than 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Samples from post-enrollment visits have positive responses if: (1) net MFI \>= an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), and (2) net MFI \> 3 times baseline net MFI, and (3) experimental antigen MFI \> 3 times baseline MFI. |
| Level of Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 12.] | Measured at Month 12 | Serum IgG responses were measured on a Bio-Plex instrument using a standardized 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 MFI minus reference antigen MFI. Values outside the linear range of the assay are not meaningful and are truncated: net MFI less than 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. |
| Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | Measured at Month 12 | 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 IL-2/IFNy 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. A response is positive if p\<=0.00001.The number and percentage of participants with positive responses are summarized by peptide pool. |
Countries
Tanzania, United States, Zambia, Zimbabwe
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vaccine w/ MF59 ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/MF59 at Months 3 and 6 | 50 |
| Vaccine w/ AS01B - High Dose ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 100mcg Protein/AS01B at Months 3 and 6 | 50 |
| Vaccine w/ AS01B - Low Dose ALVAC-HIV at Months 0 and 1, ALVAC-HIV + 20mcg Protein/AS01B at Months 3 and 6 | 50 |
| Placebo Placebo at Months 0, 1, 3, and 6 | 10 |
| Total | 160 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 2 | 2 | 0 |
| Overall Study | Participant unable to adhere | 1 | 1 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 2 | 1 | 0 |
Baseline characteristics
| Characteristic | Vaccine w/ AS01B - High Dose | Vaccine w/ AS01B - Low Dose | Vaccine w/ MF59 | Placebo | Total |
|---|---|---|---|---|---|
| Age, Continuous | 23.5 years | 25.5 years | 24 years | 24 years | 24 years |
| Age, Customized 18 - 20 years | 9 Participants | 6 Participants | 9 Participants | 2 Participants | 26 Participants |
| Age, Customized 21 - 30 years | 32 Participants | 32 Participants | 30 Participants | 6 Participants | 100 Participants |
| Age, Customized 31 - 40 years | 9 Participants | 12 Participants | 11 Participants | 2 Participants | 34 Participants |
| Age, Customized 41 - 50 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Above 50 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Less than 18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 49 Participants | 49 Participants | 48 Participants | 9 Participants | 155 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 31 Participants | 31 Participants | 30 Participants | 7 Participants | 99 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 1 Participants | 2 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 17 Participants | 17 Participants | 3 Participants | 53 Participants |
| Region of Enrollment Tanzania | 15 Participants | 15 Participants | 15 Participants | 3 Participants | 48 Participants |
| Region of Enrollment USA | 20 Participants | 20 Participants | 20 Participants | 4 Participants | 64 Participants |
| Region of Enrollment Zambia | 5 Participants | 5 Participants | 5 Participants | 1 Participants | 16 Participants |
| Region of Enrollment Zimbabwe | 10 Participants | 10 Participants | 10 Participants | 2 Participants | 32 Participants |
| Sex: Female, Male Female | 30 Participants | 25 Participants | 31 Participants | 2 Participants | 88 Participants |
| Sex: Female, Male Male | 20 Participants | 25 Participants | 19 Participants | 8 Participants | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 | 0 / 50 | 0 / 10 |
| other Total, other adverse events | 32 / 50 | 28 / 50 | 26 / 50 | 6 / 10 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 | 0 / 50 | 0 / 10 |
Outcome results
Primary
AEs or Reactro Leading to Early Participant Withdrawal or Early Discontinuation of Study Products Administration Throughout the Study.
From the study product discontinuation form, study product administration reasons are tabulated by treatment arm
Time frame: Measured through month 12
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccine w/ MF59 | AEs or Reactro Leading to Early Participant Withdrawal or Early Discontinuation of Study Products Administration Throughout the Study. | Clinical Event | 0 Participants |
| Vaccine w/ MF59 | AEs or Reactro Leading to Early Participant Withdrawal or Early Discontinuation of Study Products Administration Throughout the Study. | Reactogenicity | 0 Participants |
| Vaccine w/ MF59 | AEs or Reactro Leading to Early Participant Withdrawal or Early Discontinuation of Study Products Administration Throughout the Study. | Other reason | 1 Participants |
| Vaccine w/ MF59 | AEs or Reactro Leading to Early Participant Withdrawal or Early Discontinuation of Study Products Administration Throughout the Study. | No discontinuation | 49 Participants |
| Vaccine w/ AS01B - High Dose | AEs or Reactro Leading to Early Participant Withdrawal or Early Discontinuation of Study Products Administration Throughout the Study. | Reactogenicity | 0 Participants |
| Vaccine w/ AS01B - High Dose | AEs or Reactro Leading to Early Participant Withdrawal or Early Discontinuation of Study Products Administration Throughout the Study. | Other reason | 2 Participants |
| Vaccine w/ AS01B - High Dose | AEs or Reactro Leading to Early Participant Withdrawal or Early Discontinuation of Study Products Administration Throughout the Study. | No discontinuation | 48 Participants |
| Vaccine w/ AS01B - High Dose | AEs or Reactro Leading to Early Participant Withdrawal or Early Discontinuation of Study Products Administration Throughout the Study. | Clinical Event | 0 Participants |
| Vaccine w/ AS01B - Low Dose | AEs or Reactro Leading to Early Participant Withdrawal or Early Discontinuation of Study Products Administration Throughout the Study. | Other reason | 1 Participants |
| Vaccine w/ AS01B - Low Dose | AEs or Reactro Leading to Early Participant Withdrawal or Early Discontinuation of Study Products Administration Throughout the Study. | Reactogenicity | 1 Participants |
| Vaccine w/ AS01B - Low Dose | AEs or Reactro Leading to Early Participant Withdrawal or Early Discontinuation of Study Products Administration Throughout the Study. | No discontinuation | 48 Participants |
| Vaccine w/ AS01B - Low Dose | AEs or Reactro Leading to Early Participant Withdrawal or Early Discontinuation of Study Products Administration Throughout the Study. | Clinical Event | 0 Participants |
| Placebo | AEs or Reactro Leading to Early Participant Withdrawal or Early Discontinuation of Study Products Administration Throughout the Study. | No discontinuation | 10 Participants |
| Placebo | AEs or Reactro Leading to Early Participant Withdrawal or Early Discontinuation of Study Products Administration Throughout the Study. | Reactogenicity | 0 Participants |
| Placebo | AEs or Reactro Leading to Early Participant Withdrawal or Early Discontinuation of Study Products Administration Throughout the Study. | Clinical Event | 0 Participants |
| Placebo | AEs or Reactro Leading to Early Participant Withdrawal or Early Discontinuation of Study Products Administration Throughout the Study. | Other reason | 0 Participants |
Primary
Alkaline Phosphatase, AST, ALT in U/L
Laboratory results are summarized by analyte and timepoint.
Time frame: Measured at Month 0 (Screening) ,0.5(Day 14), 1.5 (Day 42) , 3.5 (Day 98) and 6.5 (Day 182)
Population: The overall number of participants analyzed represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Vaccine w/ MF59 | Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Screening | 75 U/L |
| Vaccine w/ MF59 | Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day14 | 17 U/L |
| Vaccine w/ MF59 | Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day98 | 21 U/L |
| Vaccine w/ MF59 | Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day42 | 70 U/L |
| Vaccine w/ MF59 | Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day182 | 22 U/L |
| Vaccine w/ MF59 | Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Screening | 17.5 U/L |
| Vaccine w/ MF59 | Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day98 | 70.5 U/L |
| Vaccine w/ MF59 | Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day14 | 74.5 U/L |
| Vaccine w/ MF59 | Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day98 | 16.5 U/L |
| Vaccine w/ MF59 | Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day182 | 72 U/L |
| Vaccine w/ MF59 | Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Screening | 20.5 U/L |
| Vaccine w/ MF59 | Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day42 | 17 U/L |
| Vaccine w/ MF59 | Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day14 | 20 U/L |
| Vaccine w/ MF59 | Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day182 | 16 U/L |
| Vaccine w/ MF59 | Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day42 | 22 U/L |
| Vaccine w/ AS01B - High Dose | Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day42 | 21 U/L |
| Vaccine w/ AS01B - High Dose | Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day14 | 16 U/L |
| Vaccine w/ AS01B - High Dose | Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day182 | 66.5 U/L |
| Vaccine w/ AS01B - High Dose | Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day98 | 20 U/L |
| Vaccine w/ AS01B - High Dose | Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day14 | 67 U/L |
| Vaccine w/ AS01B - High Dose | Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Screening | 16.5 U/L |
| Vaccine w/ AS01B - High Dose | Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day42 | 18 U/L |
| Vaccine w/ AS01B - High Dose | Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day182 | 19 U/L |
| Vaccine w/ AS01B - High Dose | Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day42 | 65 U/L |
| Vaccine w/ AS01B - High Dose | Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day14 | 20 U/L |
| Vaccine w/ AS01B - High Dose | Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day182 | 17.5 U/L |
| Vaccine w/ AS01B - High Dose | Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day98 | 18 U/L |
| Vaccine w/ AS01B - High Dose | Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Screening | 20 U/L |
| Vaccine w/ AS01B - High Dose | Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day98 | 67 U/L |
| Vaccine w/ AS01B - High Dose | Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Screening | 69 U/L |
| Vaccine w/ AS01B - Low Dose | Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day42 | 20 U/L |
| Vaccine w/ AS01B - Low Dose | Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Screening | 72 U/L |
| Vaccine w/ AS01B - Low Dose | Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day14 | 70 U/L |
| Vaccine w/ AS01B - Low Dose | Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day42 | 67 U/L |
| Vaccine w/ AS01B - Low Dose | Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day98 | 69.5 U/L |
| Vaccine w/ AS01B - Low Dose | Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day182 | 68 U/L |
| Vaccine w/ AS01B - Low Dose | Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Screening | 22 U/L |
| Vaccine w/ AS01B - Low Dose | Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day14 | 21 U/L |
| Vaccine w/ AS01B - Low Dose | Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day98 | 20 U/L |
| Vaccine w/ AS01B - Low Dose | Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day182 | 20 U/L |
| Vaccine w/ AS01B - Low Dose | Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Screening | 16.5 U/L |
| Vaccine w/ AS01B - Low Dose | Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day14 | 16.5 U/L |
| Vaccine w/ AS01B - Low Dose | Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day42 | 16 U/L |
| Vaccine w/ AS01B - Low Dose | Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day98 | 16.5 U/L |
| Vaccine w/ AS01B - Low Dose | Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day182 | 17 U/L |
| Placebo | Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day14 | 21.5 U/L |
| Placebo | Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day14 | 78 U/L |
| Placebo | Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day14 | 20.5 U/L |
| Placebo | Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Screening | 22.5 U/L |
| Placebo | Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day182 | 74.5 U/L |
| Placebo | Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Screening | 78 U/L |
| Placebo | Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day42 | 19 U/L |
| Placebo | Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day98 | 81.5 U/L |
| Placebo | Alkaline Phosphatase, AST, ALT in U/L | Alkaline Phosphatase (U/L)- Day42 | 77 U/L |
| Placebo | Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day182 | 22.5 U/L |
| Placebo | Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day182 | 25.5 U/L |
| Placebo | Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day98 | 25.5 U/L |
| Placebo | Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Day98 | 24 U/L |
| Placebo | Alkaline Phosphatase, AST, ALT in U/L | ALT (SGPT) (U/L)- Screening | 18.5 U/L |
| Placebo | Alkaline Phosphatase, AST, ALT in U/L | AST (U/L)- Day42 | 21 U/L |
Primary
Frequency of Adverse Events by Relationship to the 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccine w/ MF59 | Frequency of Adverse Events by Relationship to the Study Product | Related | 2 Participants |
| Vaccine w/ MF59 | Frequency of Adverse Events by Relationship to the Study Product | No AE Reported | 18 Participants |
| Vaccine w/ MF59 | Frequency of Adverse Events by Relationship to the Study Product | Not Related | 30 Participants |
| Vaccine w/ AS01B - High Dose | Frequency of Adverse Events by Relationship to the Study Product | Related | 7 Participants |
| Vaccine w/ AS01B - High Dose | Frequency of Adverse Events by Relationship to the Study Product | Not Related | 21 Participants |
| Vaccine w/ AS01B - High Dose | Frequency of Adverse Events by Relationship to the Study Product | No AE Reported | 22 Participants |
| Vaccine w/ AS01B - Low Dose | Frequency of Adverse Events by Relationship to the Study Product | Not Related | 24 Participants |
| Vaccine w/ AS01B - Low Dose | Frequency of Adverse Events by Relationship to the Study Product | Related | 2 Participants |
| Vaccine w/ AS01B - Low Dose | Frequency of Adverse Events by Relationship to the Study Product | No AE Reported | 24 Participants |
| Placebo | Frequency of Adverse Events by Relationship to the Study Product | No AE Reported | 4 Participants |
| Placebo | Frequency of Adverse Events by Relationship to the Study Product | Not Related | 6 Participants |
| Placebo | Frequency of Adverse Events by Relationship to the Study Product | Related | 0 Participants |
Primary
Frequency of SAEs, AESIs, and New Chronic Conditions
No SAEs, AESIs, or new chronic conditions were reported over the course of the study
Time frame: Measured through Month 18.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccine w/ MF59 | Frequency of SAEs, AESIs, and New Chronic Conditions | SAE | 0 Participants |
| Vaccine w/ MF59 | Frequency of SAEs, AESIs, and New Chronic Conditions | No SAE or AESI or New Chronic condition | 50 Participants |
| Vaccine w/ MF59 | Frequency of SAEs, AESIs, and New Chronic Conditions | AESI or new Chronic Condiiton | 0 Participants |
| Vaccine w/ AS01B - High Dose | Frequency of SAEs, AESIs, and New Chronic Conditions | SAE | 0 Participants |
| Vaccine w/ AS01B - High Dose | Frequency of SAEs, AESIs, and New Chronic Conditions | No SAE or AESI or New Chronic condition | 50 Participants |
| Vaccine w/ AS01B - High Dose | Frequency of SAEs, AESIs, and New Chronic Conditions | AESI or new Chronic Condiiton | 0 Participants |
| Vaccine w/ AS01B - Low Dose | Frequency of SAEs, AESIs, and New Chronic Conditions | AESI or new Chronic Condiiton | 0 Participants |
| Vaccine w/ AS01B - Low Dose | Frequency of SAEs, AESIs, and New Chronic Conditions | SAE | 0 Participants |
| Vaccine w/ AS01B - Low Dose | Frequency of SAEs, AESIs, and New Chronic Conditions | No SAE or AESI or New Chronic condition | 50 Participants |
| Placebo | Frequency of SAEs, AESIs, and New Chronic Conditions | SAE | 0 Participants |
| Placebo | Frequency of SAEs, AESIs, and New Chronic Conditions | No SAE or AESI or New Chronic condition | 10 Participants |
| Placebo | Frequency of SAEs, AESIs, and New Chronic Conditions | AESI or new Chronic Condiiton | 0 Participants |
Primary
Hemoglobin, Creatinine in g/dL
Laboratory results are summarized by analyte and timepoint.
Time frame: Measured at Month 0 (Screening) ,0.5(Day 14), 1.5 (Day 42) , 3.5 (Day 98) and 6.5 (Day 182)
Population: The overall number of participants analyzed represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Vaccine w/ MF59 | Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Screening | 14.45 g/dL |
| Vaccine w/ MF59 | Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day14 | 14.1 g/dL |
| Vaccine w/ MF59 | Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day42 | 14.45 g/dL |
| Vaccine w/ MF59 | Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day98 | 14.5 g/dL |
| Vaccine w/ MF59 | Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day182 | 14 g/dL |
| Vaccine w/ MF59 | Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Screening | 0.00073 g/dL |
| Vaccine w/ MF59 | Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day14 | 0.00076 g/dL |
| Vaccine w/ MF59 | Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day42 | 0.00075 g/dL |
| Vaccine w/ MF59 | Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day98 | 0.000775 g/dL |
| Vaccine w/ MF59 | Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day182 | 0.00071 g/dL |
| Vaccine w/ AS01B - High Dose | Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day42 | 14.6 g/dL |
| Vaccine w/ AS01B - High Dose | Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day98 | 0.000775 g/dL |
| Vaccine w/ AS01B - High Dose | Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day98 | 14.8 g/dL |
| Vaccine w/ AS01B - High Dose | Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day182 | 14.25 g/dL |
| Vaccine w/ AS01B - High Dose | Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Screening | 0.00079 g/dL |
| Vaccine w/ AS01B - High Dose | Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day14 | 0.0008 g/dL |
| Vaccine w/ AS01B - High Dose | Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day182 | 0.0008 g/dL |
| Vaccine w/ AS01B - High Dose | Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day42 | 0.00075 g/dL |
| Vaccine w/ AS01B - High Dose | Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Screening | 15.05 g/dL |
| Vaccine w/ AS01B - High Dose | Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day14 | 14.5 g/dL |
| Vaccine w/ AS01B - Low Dose | Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day42 | 0.0008 g/dL |
| Vaccine w/ AS01B - Low Dose | Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day14 | 0.00076 g/dL |
| Vaccine w/ AS01B - Low Dose | Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day182 | 0.0008 g/dL |
| Vaccine w/ AS01B - Low Dose | Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Screening | 14.7 g/dL |
| Vaccine w/ AS01B - Low Dose | Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day98 | 14.1 g/dL |
| Vaccine w/ AS01B - Low Dose | Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Screening | 0.000785 g/dL |
| Vaccine w/ AS01B - Low Dose | Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day98 | 0.0008 g/dL |
| Vaccine w/ AS01B - Low Dose | Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day14 | 14 g/dL |
| Vaccine w/ AS01B - Low Dose | Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day182 | 14 g/dL |
| Vaccine w/ AS01B - Low Dose | Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day42 | 14.05 g/dL |
| Placebo | Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day182 | 14.45 g/dL |
| Placebo | Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day42 | 0.00081 g/dL |
| Placebo | Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Screening | 0.00086 g/dL |
| Placebo | Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day182 | 0.000895 g/dL |
| Placebo | Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day14 | 0.000765 g/dL |
| Placebo | Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day14 | 14.9 g/dL |
| Placebo | Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day42 | 14.8 g/dL |
| Placebo | Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Day98 | 14.45 g/dL |
| Placebo | Hemoglobin, Creatinine in g/dL | Hemoglobin (g/dL)- Screening | 14.9 g/dL |
| Placebo | Hemoglobin, Creatinine in g/dL | Creatinine (g/dL)- Day98 | 0.000885 g/dL |
Primary
Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry.
Measured by flow cytometry ICS assay: refer to earlier description for assay methods and analysis variable derivation. The percentage of T-cells expressing IL-1/IFNy are summarized for positive responders only.
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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Vaccine w/ MF59 | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | LAI gp41TM | -0.006455715 % CD4+ T-cells |
| Vaccine w/ MF59 | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | Env-1-ZM96 | 0.045957505 % CD4+ T-cells |
| Vaccine w/ MF59 | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | TV1 gp120 | 0.064060235 % CD4+ T-cells |
| Vaccine w/ MF59 | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | Env-2-ZM96 | 0.00239069 % CD4+ T-cells |
| Vaccine w/ MF59 | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | LAI Gag | 0.00479596 % CD4+ T-cells |
| Vaccine w/ MF59 | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | 1086 gp120 | 0.043625715 % CD4+ T-cells |
| Vaccine w/ AS01B - High Dose | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | Env-2-ZM96 | 0.03477023 % CD4+ T-cells |
| Vaccine w/ AS01B - High Dose | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | LAI gp41TM | -0.00486893 % CD4+ T-cells |
| Vaccine w/ AS01B - High Dose | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | LAI Gag | 0.00389424 % CD4+ T-cells |
| Vaccine w/ AS01B - High Dose | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | TV1 gp120 | 0.217194305 % CD4+ T-cells |
| Vaccine w/ AS01B - High Dose | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | 1086 gp120 | 0.21257737 % CD4+ T-cells |
| Vaccine w/ AS01B - High Dose | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | Env-1-ZM96 | 0.17245457 % CD4+ T-cells |
| Vaccine w/ AS01B - Low Dose | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | LAI gp41TM | -0.00631803 % CD4+ T-cells |
| Vaccine w/ AS01B - Low Dose | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | Env-1-ZM96 | 0.204674615 % CD4+ T-cells |
| Vaccine w/ AS01B - Low Dose | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | LAI Gag | 0.0069258 % CD4+ T-cells |
| Vaccine w/ AS01B - Low Dose | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | Env-2-ZM96 | 0.034977865 % CD4+ T-cells |
| Vaccine w/ AS01B - Low Dose | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | 1086 gp120 | 0.236469065 % CD4+ T-cells |
| Vaccine w/ AS01B - Low Dose | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | TV1 gp120 | 0.333606595 % CD4+ T-cells |
| Placebo | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | TV1 gp120 | -0.00195339 % CD4+ T-cells |
| Placebo | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | 1086 gp120 | -0.00430092 % CD4+ T-cells |
| Placebo | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | Env-1-ZM96 | 0.00005561 % CD4+ T-cells |
| Placebo | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | Env-2-ZM96 | -0.00905211 % CD4+ T-cells |
| Placebo | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | LAI Gag | 0.00050871 % CD4+ T-cells |
| Placebo | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | LAI gp41TM | -0.00614691 % CD4+ T-cells |
Primary
Level of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 12.]
Serum IgG responses were measured on a Bio-Plex instrument using a standardized 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 MFI minus reference antigen MFI. Values outside the linear range of the assay are not meaningful and are truncated: net MFI less than 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500.
Time frame: Measured at Month 12
Population: Overall number of participants analyzed represents the HIV uninfected participants with specimens at Month 12. Number Analyzed shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Vaccine w/ MF59 | Level of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 12.] | 1086C_D7gp120.avi/293F at Month 12 | 7686.25 relative fluorescence units |
| Vaccine w/ MF59 | Level of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 12.] | TV1c8_D11gp120.avi/293F at Month 12 | 1342.75 relative fluorescence units |
| Vaccine w/ MF59 | Level of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 12.] | 96ZM651.D11gp120.avi at Month 12 | 938 relative fluorescence units |
| Vaccine w/ AS01B - High Dose | Level of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 12.] | 1086C_D7gp120.avi/293F at Month 12 | 19787.75 relative fluorescence units |
| Vaccine w/ AS01B - High Dose | Level of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 12.] | TV1c8_D11gp120.avi/293F at Month 12 | 6409.5 relative fluorescence units |
| Vaccine w/ AS01B - High Dose | Level of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 12.] | 96ZM651.D11gp120.avi at Month 12 | 2202.5 relative fluorescence units |
| Vaccine w/ AS01B - Low Dose | Level of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 12.] | 96ZM651.D11gp120.avi at Month 12 | 2580.5 relative fluorescence units |
| Vaccine w/ AS01B - Low Dose | Level of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 12.] | 1086C_D7gp120.avi/293F at Month 12 | 22000 relative fluorescence units |
| Vaccine w/ AS01B - Low Dose | Level of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 12.] | TV1c8_D11gp120.avi/293F at Month 12 | 8421 relative fluorescence units |
| Placebo | Level of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 12.] | 1086C_D7gp120.avi/293F at Month 12 | 1 relative fluorescence units |
| Placebo | Level of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 12.] | TV1c8_D11gp120.avi/293F at Month 12 | 1 relative fluorescence units |
| Placebo | Level of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 12.] | 96ZM651.D11gp120.avi at Month 12 | 7.875 relative fluorescence units |
Primary
Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017. The maximum grade observed for each symptom over the time frame is presented;
Time frame: Measured through 7 days after participants' last vaccination at Month 0,1,3, and 6
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Vaccine w/ MF59 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Erythema | Mild | 2 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Erythema | None | 46 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Tenderness | Severe | 1 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Erythema and/or Induration | Severe | 0 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Pain and/or Tenderness | Severe | 1 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Tenderness | Potentially Life-threatening | 0 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Erythema and/or Induration | None | 45 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Pain and/or Tenderness | Moderate | 8 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Pain and/or Tenderness | Mild | 26 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Pain and/or Tenderness | None | 15 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Induration | Potentially Life-threatening | 0 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Pain | Severe | 1 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Pain | Mild | 27 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Induration | Severe | 0 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Pain | None | 16 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Pain | Potentially Life-threatening | 0 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Induration | Moderate | 1 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Induration | Mild | 0 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Tenderness | None | 21 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Erythema and/or Induration | Moderate | 3 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Induration | None | 49 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Erythema | Potentially Life-threatening | 0 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Tenderness | Mild | 22 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Erythema and/or Induration | Mild | 2 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Erythema | Severe | 0 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Erythema | Moderate | 2 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Tenderness | Moderate | 6 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Pain | Moderate | 6 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Induration | Moderate | 1 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Pain | None | 18 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Pain | Mild | 17 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Pain | Moderate | 13 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Pain | Severe | 2 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Pain | Potentially Life-threatening | 0 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Tenderness | None | 20 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Tenderness | Mild | 12 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Tenderness | Moderate | 17 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Tenderness | Severe | 1 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Tenderness | Potentially Life-threatening | 0 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Pain and/or Tenderness | None | 15 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Pain and/or Tenderness | Mild | 17 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Pain and/or Tenderness | Moderate | 16 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Pain and/or Tenderness | Severe | 2 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Erythema | None | 42 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Erythema | Mild | 2 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Erythema | Moderate | 2 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Erythema | Severe | 4 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Erythema | Potentially Life-threatening | 0 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Induration | None | 45 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Induration | Mild | 1 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Induration | Severe | 3 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Induration | Potentially Life-threatening | 0 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Erythema and/or Induration | None | 42 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Erythema and/or Induration | Mild | 2 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Erythema and/or Induration | Moderate | 2 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Erythema and/or Induration | Severe | 4 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Induration | Moderate | 4 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Tenderness | Moderate | 17 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Pain | Severe | 0 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Induration | Severe | 0 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Erythema and/or Induration | Moderate | 8 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Erythema | Potentially Life-threatening | 0 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Erythema and/or Induration | Severe | 1 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Induration | Potentially Life-threatening | 0 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Pain | Mild | 20 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Pain | Moderate | 14 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Tenderness | None | 15 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Pain and/or Tenderness | None | 12 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Erythema | Moderate | 6 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Induration | None | 43 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Erythema and/or Induration | None | 39 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Pain and/or Tenderness | Mild | 19 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Erythema | None | 43 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Tenderness | Potentially Life-threatening | 0 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Tenderness | Mild | 18 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Pain and/or Tenderness | Moderate | 19 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Erythema | Mild | 0 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Induration | Mild | 3 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Erythema | Severe | 1 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Pain and/or Tenderness | Severe | 0 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Pain | Potentially Life-threatening | 0 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Tenderness | Severe | 0 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Pain | None | 16 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Erythema and/or Induration | Mild | 2 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Erythema | None | 9 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Erythema and/or Induration | Mild | 1 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Erythema | Mild | 1 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Tenderness | Mild | 2 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Erythema | Moderate | 0 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Erythema | Severe | 0 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Tenderness | None | 8 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Erythema | Potentially Life-threatening | 0 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Erythema and/or Induration | Moderate | 0 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Induration | None | 10 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Pain | Potentially Life-threatening | 0 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Pain | None | 7 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Induration | Mild | 0 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Pain | Severe | 0 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Induration | Moderate | 0 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Induration | Severe | 0 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Pain | Moderate | 0 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Induration | Potentially Life-threatening | 0 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Erythema and/or Induration | Severe | 0 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Pain and/or Tenderness | None | 7 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Tenderness | Potentially Life-threatening | 0 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Pain and/or Tenderness | Mild | 3 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Erythema and/or Induration | None | 9 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Pain and/or Tenderness | Moderate | 0 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Tenderness | Severe | 0 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Pain | Mild | 3 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Pain and/or Tenderness | Severe | 0 Participants |
| Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen | Tenderness | Moderate | 0 Participants |
Primary
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1,July 2017. The maximum grade observed for each symptom over the time frame is presented;
Time frame: Measured through 7 days after each vaccination at Month 0, 1, 3, and 6
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Vaccine w/ MF59 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Vomiting | Mild | 1 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Vomiting | None | 48 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Myalgia | Potentially Life-threatening | 0 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Temperature | Severe | 0 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Nausea | Potentially Life-threatening | 0 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Nausea | Moderate | 2 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Headache | None | 30 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Nausea | Mild | 6 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Nausea | None | 42 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Headache | Mild | 15 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Max. Systemic Symptoms | Severe | 1 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Headache | Potentially Life-threatening | 0 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Headache | Severe | 0 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Headache | Moderate | 5 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Malaise and/or fatigue | Mild | 17 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Chills | None | 42 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Max. Systemic Symptoms | Moderate | 11 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Max. Systemic Symptoms | Mild | 18 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Malaise and/or fatigue | Moderate | 6 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Arthralgia | Severe | 0 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Max. Systemic Symptoms | None | 20 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Arthralgia | Potentially Life-threatening | 0 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Malaise and/or fatigue | Severe | 1 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Temperature | Moderate | 1 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Arthralgia | Moderate | 3 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Arthralgia | Mild | 7 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Temperature | Mild | 2 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Arthralgia | None | 40 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Chills | Potentially Life-threatening | 0 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Myalgia | None | 38 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Temperature | None | 47 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Chills | Severe | 0 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Chills | Moderate | 1 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Myalgia | Mild | 11 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Temperature | Potentially Life-threatening | 0 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Chills | Mild | 7 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Vomiting | Potentially Life-threatening | 0 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Myalgia | Moderate | 1 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Malaise and/or fatigue | None | 26 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Vomiting | Severe | 0 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Vomiting | Moderate | 1 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Myalgia | Severe | 0 Participants |
| Vaccine w/ MF59 | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Nausea | Severe | 0 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Myalgia | Severe | 2 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Nausea | Severe | 0 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Arthralgia | Moderate | 7 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Temperature | Mild | 2 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Malaise and/or fatigue | None | 27 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Malaise and/or fatigue | Mild | 7 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Malaise and/or fatigue | Moderate | 13 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Malaise and/or fatigue | Severe | 3 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Myalgia | None | 32 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Myalgia | Mild | 7 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Myalgia | Moderate | 9 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Myalgia | Potentially Life-threatening | 0 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Headache | None | 26 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Headache | Mild | 13 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Headache | Moderate | 11 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Headache | Severe | 0 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Headache | Potentially Life-threatening | 0 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Nausea | None | 39 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Nausea | Mild | 10 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Nausea | Moderate | 1 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Nausea | Potentially Life-threatening | 0 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Vomiting | None | 48 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Vomiting | Mild | 2 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Vomiting | Moderate | 0 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Vomiting | Severe | 0 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Vomiting | Potentially Life-threatening | 0 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Chills | None | 33 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Chills | Mild | 10 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Chills | Moderate | 6 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Chills | Severe | 1 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Chills | Potentially Life-threatening | 0 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Arthralgia | None | 39 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Arthralgia | Mild | 3 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Arthralgia | Severe | 1 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Arthralgia | Potentially Life-threatening | 0 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Max. Systemic Symptoms | None | 21 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Max. Systemic Symptoms | Mild | 10 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Max. Systemic Symptoms | Moderate | 16 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Max. Systemic Symptoms | Severe | 3 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Temperature | None | 46 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Temperature | Moderate | 2 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Temperature | Severe | 0 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Temperature | Potentially Life-threatening | 0 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Myalgia | Mild | 9 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Vomiting | None | 49 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Myalgia | Severe | 4 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Malaise and/or fatigue | None | 22 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Vomiting | Mild | 0 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Vomiting | Moderate | 1 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Myalgia | Moderate | 8 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Vomiting | Severe | 0 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Vomiting | Potentially Life-threatening | 0 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Chills | Mild | 8 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Chills | None | 30 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Temperature | None | 45 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Chills | Moderate | 10 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Myalgia | None | 29 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Max. Systemic Symptoms | Mild | 13 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Chills | Severe | 2 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Temperature | Mild | 5 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Chills | Potentially Life-threatening | 0 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Arthralgia | None | 35 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Arthralgia | Mild | 5 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Malaise and/or fatigue | Severe | 4 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Arthralgia | Moderate | 10 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Arthralgia | Severe | 0 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Temperature | Moderate | 0 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Arthralgia | Potentially Life-threatening | 0 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Malaise and/or fatigue | Moderate | 12 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Max. Systemic Symptoms | None | 18 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Malaise and/or fatigue | Mild | 12 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Headache | Moderate | 7 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Temperature | Potentially Life-threatening | 0 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Headache | Severe | 3 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Headache | Mild | 15 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Max. Systemic Symptoms | Moderate | 14 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Headache | Potentially Life-threatening | 0 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Nausea | None | 38 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Headache | None | 25 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Nausea | Mild | 7 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Temperature | Severe | 0 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Nausea | Moderate | 5 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Nausea | Severe | 0 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Myalgia | Potentially Life-threatening | 0 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Max. Systemic Symptoms | Severe | 5 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Nausea | Potentially Life-threatening | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Myalgia | Potentially Life-threatening | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Arthralgia | Moderate | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Vomiting | None | 9 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Temperature | Potentially Life-threatening | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Nausea | Severe | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Arthralgia | Severe | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Vomiting | Mild | 1 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Myalgia | Moderate | 1 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Temperature | Severe | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Malaise and/or fatigue | Moderate | 1 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Vomiting | Moderate | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Headache | Potentially Life-threatening | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Headache | None | 7 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Vomiting | Severe | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Myalgia | Mild | 2 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Max. Systemic Symptoms | Moderate | 2 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Temperature | Moderate | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Vomiting | Potentially Life-threatening | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Myalgia | Severe | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Max. Systemic Symptoms | None | 4 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Chills | None | 10 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Max. Systemic Symptoms | Severe | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Malaise and/or fatigue | Mild | 3 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Myalgia | None | 7 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Temperature | None | 10 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Chills | Mild | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Chills | Moderate | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Max. Systemic Symptoms | Mild | 4 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Nausea | None | 7 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Nausea | Moderate | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Chills | Severe | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Headache | Moderate | 2 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Headache | Mild | 1 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Chills | Potentially Life-threatening | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Malaise and/or fatigue | None | 6 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Temperature | Mild | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Nausea | Potentially Life-threatening | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Arthralgia | None | 7 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Malaise and/or fatigue | Severe | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Arthralgia | Potentially Life-threatening | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Headache | Severe | 0 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Arthralgia | Mild | 3 Participants |
| Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Nausea | Mild | 3 Participants |
Primary
Number of Participants With HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 12.]
Serum IgG responses were measured on a Bio-Plex instrument using a standardized 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 MFI minus reference antigen MFI. Values outside the linear range of the assay are not meaningful and are truncated: net MFI less than 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Samples from post-enrollment visits have positive responses if: (1) net MFI \>= an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), and (2) net MFI \> 3 times baseline net MFI, and (3) experimental antigen MFI \> 3 times baseline MFI.
Time frame: Measured at Month 12
Population: Overall number of participants analyzed represents the HIV uninfected participants with specimens at Month 12. Number Analyzed shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccine w/ MF59 | Number of Participants With HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 12.] | 1086C_D7gp120.avi/293F at Month 12 | 46 Participants |
| Vaccine w/ MF59 | Number of Participants With HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 12.] | TV1c8_D11gp120.avi/293F at Month 12 | 38 Participants |
| Vaccine w/ MF59 | Number of Participants With HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 12.] | 96ZM651.D11gp120.avi at Month 12 | 14 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants With HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 12.] | 1086C_D7gp120.avi/293F at Month 12 | 43 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants With HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 12.] | TV1c8_D11gp120.avi/293F at Month 12 | 43 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants With HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 12.] | 96ZM651.D11gp120.avi at Month 12 | 22 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants With HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 12.] | 96ZM651.D11gp120.avi at Month 12 | 20 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants With HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 12.] | 1086C_D7gp120.avi/293F at Month 12 | 42 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants With HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 12.] | TV1c8_D11gp120.avi/293F at Month 12 | 40 Participants |
| Placebo | Number of Participants With HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 12.] | 1086C_D7gp120.avi/293F at Month 12 | 0 Participants |
| Placebo | Number of Participants With HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 12.] | TV1c8_D11gp120.avi/293F at Month 12 | 0 Participants |
| Placebo | Number of Participants With HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 12.] | 96ZM651.D11gp120.avi at Month 12 | 0 Participants |
Primary
Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry.
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 IL-2/IFNy 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. A response is positive if p\<=0.00001.The number and percentage of participants with positive responses are summarized by peptide pool.
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccine w/ MF59 | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | 1086 gp120 | 18 Participants |
| Vaccine w/ MF59 | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | Env-1-ZM96 | 19 Participants |
| Vaccine w/ MF59 | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | Env-2-ZM96 | 6 Participants |
| Vaccine w/ MF59 | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | LAI Gag | 0 Participants |
| Vaccine w/ MF59 | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | LAI gp41TM | 1 Participants |
| Vaccine w/ MF59 | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | TV1 gp120 | 23 Participants |
| Vaccine w/ AS01B - High Dose | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | TV1 gp120 | 39 Participants |
| Vaccine w/ AS01B - High Dose | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | LAI Gag | 4 Participants |
| Vaccine w/ AS01B - High Dose | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | 1086 gp120 | 38 Participants |
| Vaccine w/ AS01B - High Dose | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | Env-2-ZM96 | 17 Participants |
| Vaccine w/ AS01B - High Dose | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | Env-1-ZM96 | 34 Participants |
| Vaccine w/ AS01B - High Dose | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | LAI gp41TM | 0 Participants |
| Vaccine w/ AS01B - Low Dose | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | Env-1-ZM96 | 37 Participants |
| Vaccine w/ AS01B - Low Dose | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | Env-2-ZM96 | 16 Participants |
| Vaccine w/ AS01B - Low Dose | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | LAI Gag | 1 Participants |
| Vaccine w/ AS01B - Low Dose | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | TV1 gp120 | 37 Participants |
| Vaccine w/ AS01B - Low Dose | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | LAI gp41TM | 1 Participants |
| Vaccine w/ AS01B - Low Dose | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | 1086 gp120 | 35 Participants |
| Placebo | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | LAI gp41TM | 0 Participants |
| Placebo | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | TV1 gp120 | 0 Participants |
| Placebo | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | Env-1-ZM96 | 0 Participants |
| Placebo | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | LAI Gag | 0 Participants |
| Placebo | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | 1086 gp120 | 0 Participants |
| Placebo | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | Env-2-ZM96 | 0 Participants |
Primary
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
Laboratory results are summarized by analyte and timepoint.
Time frame: Measured at Month 0 (Screening) ,0.5(Day 14), 1.5 (Day 42) , 3.5 (Day 98) and 6.5 (Day 182)
Population: The overall number of participants analyzed represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Vaccine w/ MF59 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Neutrophils (1000/cubic mm)- Screening | 2.6835 thousand cells/cubic mm |
| Vaccine w/ MF59 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Lymphocytes (1000/cubic mm)- Day14 | 1.825 thousand cells/cubic mm |
| Vaccine w/ MF59 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | WBC (1000/cubic mm)- Day98 | 4.805 thousand cells/cubic mm |
| Vaccine w/ MF59 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Lymphocytes (1000/cubic mm)- Day182 | 1.913 thousand cells/cubic mm |
| Vaccine w/ MF59 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Lymphocytes (1000/cubic mm)- Day42 | 1.9135 thousand cells/cubic mm |
| Vaccine w/ MF59 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | WBC (1000/cubic mm)- Screening | 5.29 thousand cells/cubic mm |
| Vaccine w/ MF59 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Lymphocytes (1000/cubic mm)- Day98 | 1.86 thousand cells/cubic mm |
| Vaccine w/ MF59 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | WBC (1000/cubic mm)- Day14 | 5.3 thousand cells/cubic mm |
| Vaccine w/ MF59 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Neutrophils (1000/cubic mm)- Day98 | 2.37 thousand cells/cubic mm |
| Vaccine w/ MF59 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | WBC (1000/cubic mm)- Day182 | 4.93 thousand cells/cubic mm |
| Vaccine w/ MF59 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Platelets (1000/cubic mm)- Screening | 263.5 thousand cells/cubic mm |
| Vaccine w/ MF59 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Neutrophils (1000/cubic mm)- Day42 | 2.577 thousand cells/cubic mm |
| Vaccine w/ MF59 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Platelets (1000/cubic mm)- Day14 | 264 thousand cells/cubic mm |
| Vaccine w/ MF59 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Neutrophils (1000/cubic mm)- Day182 | 2.66 thousand cells/cubic mm |
| Vaccine w/ MF59 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Platelets (1000/cubic mm)- Day42 | 254 thousand cells/cubic mm |
| Vaccine w/ MF59 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | WBC (1000/cubic mm)- Day42 | 5.065 thousand cells/cubic mm |
| Vaccine w/ MF59 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Neutrophils (1000/cubic mm)- Day14 | 2.8755 thousand cells/cubic mm |
| Vaccine w/ MF59 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Platelets (1000/cubic mm)- Day98 | 264.5 thousand cells/cubic mm |
| Vaccine w/ MF59 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Platelets (1000/cubic mm)- Day182 | 264 thousand cells/cubic mm |
| Vaccine w/ MF59 | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Lymphocytes (1000/cubic mm)- Screening | 1.935 thousand cells/cubic mm |
| Vaccine w/ AS01B - High Dose | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Neutrophils (1000/cubic mm)- Screening | 2.9995 thousand cells/cubic mm |
| Vaccine w/ AS01B - High Dose | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Lymphocytes (1000/cubic mm)- Screening | 2.014 thousand cells/cubic mm |
| Vaccine w/ AS01B - High Dose | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Neutrophils (1000/cubic mm)- Day98 | 2.605 thousand cells/cubic mm |
| Vaccine w/ AS01B - High Dose | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Lymphocytes (1000/cubic mm)- Day182 | 1.91 thousand cells/cubic mm |
| Vaccine w/ AS01B - High Dose | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Platelets (1000/cubic mm)- Screening | 263.5 thousand cells/cubic mm |
| Vaccine w/ AS01B - High Dose | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Lymphocytes (1000/cubic mm)- Day14 | 1.98 thousand cells/cubic mm |
| Vaccine w/ AS01B - High Dose | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | WBC (1000/cubic mm)- Screening | 5.92 thousand cells/cubic mm |
| Vaccine w/ AS01B - High Dose | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Neutrophils (1000/cubic mm)- Day182 | 2.776 thousand cells/cubic mm |
| Vaccine w/ AS01B - High Dose | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Platelets (1000/cubic mm)- Day182 | 260 thousand cells/cubic mm |
| Vaccine w/ AS01B - High Dose | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Lymphocytes (1000/cubic mm)- Day42 | 1.88 thousand cells/cubic mm |
| Vaccine w/ AS01B - High Dose | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Platelets (1000/cubic mm)- Day14 | 248 thousand cells/cubic mm |
| Vaccine w/ AS01B - High Dose | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Lymphocytes (1000/cubic mm)- Day98 | 1.99 thousand cells/cubic mm |
| Vaccine w/ AS01B - High Dose | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Platelets (1000/cubic mm)- Day98 | 267 thousand cells/cubic mm |
| Vaccine w/ AS01B - High Dose | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | WBC (1000/cubic mm)- Day98 | 5.33 thousand cells/cubic mm |
| Vaccine w/ AS01B - High Dose | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Neutrophils (1000/cubic mm)- Day14 | 3.07 thousand cells/cubic mm |
| Vaccine w/ AS01B - High Dose | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | WBC (1000/cubic mm)- Day42 | 5.28 thousand cells/cubic mm |
| Vaccine w/ AS01B - High Dose | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Platelets (1000/cubic mm)- Day42 | 266 thousand cells/cubic mm |
| Vaccine w/ AS01B - High Dose | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | WBC (1000/cubic mm)- Day182 | 5.36 thousand cells/cubic mm |
| Vaccine w/ AS01B - High Dose | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | WBC (1000/cubic mm)- Day14 | 5.8 thousand cells/cubic mm |
| Vaccine w/ AS01B - High Dose | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Neutrophils (1000/cubic mm)- Day42 | 2.82 thousand cells/cubic mm |
| Vaccine w/ AS01B - Low Dose | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Lymphocytes (1000/cubic mm)- Day42 | 1.7995 thousand cells/cubic mm |
| Vaccine w/ AS01B - Low Dose | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | WBC (1000/cubic mm)- Screening | 5.4 thousand cells/cubic mm |
| Vaccine w/ AS01B - Low Dose | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | WBC (1000/cubic mm)- Day14 | 5.535 thousand cells/cubic mm |
| Vaccine w/ AS01B - Low Dose | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | WBC (1000/cubic mm)- Day42 | 5.025 thousand cells/cubic mm |
| Vaccine w/ AS01B - Low Dose | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | WBC (1000/cubic mm)- Day98 | 5.15 thousand cells/cubic mm |
| Vaccine w/ AS01B - Low Dose | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | WBC (1000/cubic mm)- Day182 | 5.28 thousand cells/cubic mm |
| Vaccine w/ AS01B - Low Dose | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Platelets (1000/cubic mm)- Screening | 233 thousand cells/cubic mm |
| Vaccine w/ AS01B - Low Dose | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Platelets (1000/cubic mm)- Day14 | 238 thousand cells/cubic mm |
| Vaccine w/ AS01B - Low Dose | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Platelets (1000/cubic mm)- Day42 | 242.5 thousand cells/cubic mm |
| Vaccine w/ AS01B - Low Dose | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Platelets (1000/cubic mm)- Day98 | 246.5 thousand cells/cubic mm |
| Vaccine w/ AS01B - Low Dose | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Platelets (1000/cubic mm)- Day182 | 251.1 thousand cells/cubic mm |
| Vaccine w/ AS01B - Low Dose | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Lymphocytes (1000/cubic mm)- Screening | 1.84 thousand cells/cubic mm |
| Vaccine w/ AS01B - Low Dose | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Lymphocytes (1000/cubic mm)- Day14 | 1.7945 thousand cells/cubic mm |
| Vaccine w/ AS01B - Low Dose | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Lymphocytes (1000/cubic mm)- Day98 | 1.812 thousand cells/cubic mm |
| Vaccine w/ AS01B - Low Dose | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Lymphocytes (1000/cubic mm)- Day182 | 1.767 thousand cells/cubic mm |
| Vaccine w/ AS01B - Low Dose | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Neutrophils (1000/cubic mm)- Screening | 2.8925 thousand cells/cubic mm |
| Vaccine w/ AS01B - Low Dose | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Neutrophils (1000/cubic mm)- Day14 | 2.896 thousand cells/cubic mm |
| Vaccine w/ AS01B - Low Dose | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Neutrophils (1000/cubic mm)- Day42 | 2.662 thousand cells/cubic mm |
| Vaccine w/ AS01B - Low Dose | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Neutrophils (1000/cubic mm)- Day98 | 2.66 thousand cells/cubic mm |
| Vaccine w/ AS01B - Low Dose | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Neutrophils (1000/cubic mm)- Day182 | 2.98 thousand cells/cubic mm |
| Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Platelets (1000/cubic mm)- Day182 | 245.5 thousand cells/cubic mm |
| Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Platelets (1000/cubic mm)- Day98 | 221 thousand cells/cubic mm |
| Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Neutrophils (1000/cubic mm)- Day98 | 2.105 thousand cells/cubic mm |
| Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Neutrophils (1000/cubic mm)- Screening | 2.415 thousand cells/cubic mm |
| Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Platelets (1000/cubic mm)- Day42 | 234 thousand cells/cubic mm |
| Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Platelets (1000/cubic mm)- Day14 | 236.5 thousand cells/cubic mm |
| Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | WBC (1000/cubic mm)- Day14 | 4.94 thousand cells/cubic mm |
| Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Neutrophils (1000/cubic mm)- Day14 | 2.529 thousand cells/cubic mm |
| Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Platelets (1000/cubic mm)- Screening | 223.5 thousand cells/cubic mm |
| Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | WBC (1000/cubic mm)- Day182 | 5.28 thousand cells/cubic mm |
| Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | WBC (1000/cubic mm)- Screening | 5.125 thousand cells/cubic mm |
| Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Neutrophils (1000/cubic mm)- Day42 | 2.55 thousand cells/cubic mm |
| Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | WBC (1000/cubic mm)- Day98 | 4.79 thousand cells/cubic mm |
| Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Lymphocytes (1000/cubic mm)- Day42 | 1.668 thousand cells/cubic mm |
| Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | WBC (1000/cubic mm)- Day42 | 4.58 thousand cells/cubic mm |
| Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Lymphocytes (1000/cubic mm)- Day98 | 1.7145 thousand cells/cubic mm |
| Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Lymphocytes (1000/cubic mm)- Day14 | 1.705 thousand cells/cubic mm |
| Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Lymphocytes (1000/cubic mm)- Screening | 1.9455 thousand cells/cubic mm |
| Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Neutrophils (1000/cubic mm)- Day182 | 2.45 thousand cells/cubic mm |
| Placebo | WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm | Lymphocytes (1000/cubic mm)- Day182 | 1.7905 thousand cells/cubic mm |
Secondary
Area Under Titration Curve of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Breadth as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5.]
Area under titration curve from serial dilution (AUTC) is calculated using the trapezoidal rule based on the raw MFI values truncated at zero across the log base 10 dilution factors, i.e., the summation of products of raw MFI values and log10(dilution factor). The dilution factor refers to the ratio of the volume of the initial (concentrated) solution (V1) to the volume of the final (dilute) solution (V2), and therefore it is unitless. For example, for a dilution of V1:V2=1:50 of a solution, the corresponding dilution factor is V2/V1=50/1=50.
Time frame: Measured at Month 6.5
Population: Overall number of participants analyzed represents the HIV uninfected participants with specimens at Month 6.5. Number Analyzed shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Vaccine w/ MF59 | Area Under Titration Curve of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Breadth as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5.] | 1086C_D7gp120.avi/293F at Month 6.5 | 40433.144898 RFU*log10(dilution factor) |
| Vaccine w/ MF59 | Area Under Titration Curve of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Breadth as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5.] | TV1c8_D11gp120.avi/293F at Month 6.5 | 29381.844583 RFU*log10(dilution factor) |
| Vaccine w/ MF59 | Area Under Titration Curve of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Breadth as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5.] | 96ZM651.D11gp120.avi at Month 6.5 | 19137.530429 RFU*log10(dilution factor) |
| Vaccine w/ AS01B - High Dose | Area Under Titration Curve of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Breadth as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5.] | 1086C_D7gp120.avi/293F at Month 6.5 | 42528.614697 RFU*log10(dilution factor) |
| Vaccine w/ AS01B - High Dose | Area Under Titration Curve of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Breadth as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5.] | TV1c8_D11gp120.avi/293F at Month 6.5 | 36046.799202 RFU*log10(dilution factor) |
| Vaccine w/ AS01B - High Dose | Area Under Titration Curve of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Breadth as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5.] | 96ZM651.D11gp120.avi at Month 6.5 | 26284.001341 RFU*log10(dilution factor) |
| Vaccine w/ AS01B - Low Dose | Area Under Titration Curve of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Breadth as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5.] | 96ZM651.D11gp120.avi at Month 6.5 | 19206.42867 RFU*log10(dilution factor) |
| Vaccine w/ AS01B - Low Dose | Area Under Titration Curve of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Breadth as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5.] | 1086C_D7gp120.avi/293F at Month 6.5 | 43564.082625 RFU*log10(dilution factor) |
| Vaccine w/ AS01B - Low Dose | Area Under Titration Curve of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Breadth as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5.] | TV1c8_D11gp120.avi/293F at Month 6.5 | 33717.692497 RFU*log10(dilution factor) |
| Placebo | Area Under Titration Curve of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Breadth as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5.] | 1086C_D7gp120.avi/293F at Month 6.5 | 0 RFU*log10(dilution factor) |
| Placebo | Area Under Titration Curve of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Breadth as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5.] | TV1c8_D11gp120.avi/293F at Month 6.5 | 0.0752574989 RFU*log10(dilution factor) |
| Placebo | Area Under Titration Curve of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Breadth as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5.] | 96ZM651.D11gp120.avi at Month 6.5 | 6.5850311551 RFU*log10(dilution factor) |
Secondary
Level of Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 12.]
Serum IgG responses were measured on a Bio-Plex instrument using a standardized 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 MFI minus reference antigen MFI. Values outside the linear range of the assay are not meaningful and are truncated: net MFI less than 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500.
Time frame: Measured at Month 12
Population: Overall number of participants analyzed represents the HIV uninfected participants with specimens at Month 12. Number Analyzed shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Vaccine w/ MF59 | Level of Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 12.] | C.1086C_V1_V2 Tags at Month 12 | 90 relative fluorescence units |
| Vaccine w/ MF59 | Level of Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 12.] | gp70-96ZM651.02 V1v2 at Month 12 | 1 relative fluorescence units |
| Vaccine w/ MF59 | Level of Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 12.] | gp70-TV1.21 V1V2 at Month 12 | 1 relative fluorescence units |
| Vaccine w/ MF59 | Level of Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 12.] | gp70-TV1.GSKvacV1V2/293F at Month 12 | 1 relative fluorescence units |
| Vaccine w/ AS01B - High Dose | Level of Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 12.] | gp70-96ZM651.02 V1v2 at Month 12 | 1.75 relative fluorescence units |
| Vaccine w/ AS01B - High Dose | Level of Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 12.] | gp70-TV1.21 V1V2 at Month 12 | 1 relative fluorescence units |
| Vaccine w/ AS01B - High Dose | Level of Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 12.] | gp70-TV1.GSKvacV1V2/293F at Month 12 | 1 relative fluorescence units |
| Vaccine w/ AS01B - High Dose | Level of Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 12.] | C.1086C_V1_V2 Tags at Month 12 | 235.875 relative fluorescence units |
| Vaccine w/ AS01B - Low Dose | Level of Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 12.] | gp70-TV1.21 V1V2 at Month 12 | 1 relative fluorescence units |
| Vaccine w/ AS01B - Low Dose | Level of Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 12.] | gp70-96ZM651.02 V1v2 at Month 12 | 1 relative fluorescence units |
| Vaccine w/ AS01B - Low Dose | Level of Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 12.] | gp70-TV1.GSKvacV1V2/293F at Month 12 | 1 relative fluorescence units |
| Vaccine w/ AS01B - Low Dose | Level of Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 12.] | C.1086C_V1_V2 Tags at Month 12 | 153 relative fluorescence units |
| Placebo | Level of Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 12.] | gp70-TV1.GSKvacV1V2/293F at Month 12 | 1 relative fluorescence units |
| Placebo | Level of Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 12.] | gp70-96ZM651.02 V1v2 at Month 12 | 1 relative fluorescence units |
| Placebo | Level of Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 12.] | C.1086C_V1_V2 Tags at Month 12 | 18.375 relative fluorescence units |
| Placebo | Level of Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 12.] | gp70-TV1.21 V1V2 at Month 12 | 1 relative fluorescence units |
Secondary
Level of Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 6.5.]
Serum IgG responses were measured on a Bio-Plex instrument using a standardized 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 MFI minus reference antigen MFI. Values outside the linear range of the assay are not meaningful and are truncated: net MFI less than 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500.
Time frame: Measured at Month 6.5
Population: Overall number of participants analyzed represents the HIV uninfected participants with specimens at Month 6.5. Number Analyzed shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Vaccine w/ MF59 | Level of Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 6.5.] | C.1086C_V1_V2 Tags at Month 6.5 | 1193.125 relative fluorescence units |
| Vaccine w/ MF59 | Level of Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 6.5.] | gp70-96ZM651.02 V1v2 at Month 6.5 | 429.5 relative fluorescence units |
| Vaccine w/ MF59 | Level of Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 6.5.] | gp70-TV1.21 V1V2 at Month 6.5 | 209.125 relative fluorescence units |
| Vaccine w/ MF59 | Level of Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 6.5.] | gp70-TV1.GSKvacV1V2/293F at Month 6.5 | 225 relative fluorescence units |
| Vaccine w/ AS01B - High Dose | Level of Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 6.5.] | gp70-96ZM651.02 V1v2 at Month 6.5 | 1327.75 relative fluorescence units |
| Vaccine w/ AS01B - High Dose | Level of Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 6.5.] | gp70-TV1.21 V1V2 at Month 6.5 | 442.25 relative fluorescence units |
| Vaccine w/ AS01B - High Dose | Level of Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 6.5.] | gp70-TV1.GSKvacV1V2/293F at Month 6.5 | 709.75 relative fluorescence units |
| Vaccine w/ AS01B - High Dose | Level of Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 6.5.] | C.1086C_V1_V2 Tags at Month 6.5 | 4296.5 relative fluorescence units |
| Vaccine w/ AS01B - Low Dose | Level of Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 6.5.] | gp70-TV1.21 V1V2 at Month 6.5 | 1 relative fluorescence units |
| Vaccine w/ AS01B - Low Dose | Level of Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 6.5.] | gp70-96ZM651.02 V1v2 at Month 6.5 | 455.375 relative fluorescence units |
| Vaccine w/ AS01B - Low Dose | Level of Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 6.5.] | gp70-TV1.GSKvacV1V2/293F at Month 6.5 | 80.875 relative fluorescence units |
| Vaccine w/ AS01B - Low Dose | Level of Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 6.5.] | C.1086C_V1_V2 Tags at Month 6.5 | 1555.5 relative fluorescence units |
| Placebo | Level of Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 6.5.] | gp70-TV1.GSKvacV1V2/293F at Month 6.5 | 1 relative fluorescence units |
| Placebo | Level of Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 6.5.] | gp70-96ZM651.02 V1v2 at Month 6.5 | 1 relative fluorescence units |
| Placebo | Level of Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 6.5.] | C.1086C_V1_V2 Tags at Month 6.5 | 66.375 relative fluorescence units |
| Placebo | Level of Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 6.5.] | gp70-TV1.21 V1V2 at Month 6.5 | 1 relative fluorescence units |
Secondary
Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry.
Measured by flow cytometry ICS assay: refer to earlier description for assay methods and analysis variable derivation. The percentage of T-cells expressing IL-1/IFNy are summarized for positive responders only.
Time frame: Measured at Month 12
Population: In this report, the overall number of participants analyzed represents the HIV uninfected participants with specimens at Month12. 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Vaccine w/ MF59 | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | LAI Gag | 0.003934455 % CD4+ T-cells |
| Vaccine w/ MF59 | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | Env-1-ZM96 | 0.060435485 % CD4+ T-cells |
| Vaccine w/ MF59 | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | TV1 gp120 | 0.04961613 % CD4+ T-cells |
| Vaccine w/ MF59 | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | Env-2-ZM96 | 0.004117915 % CD4+ T-cells |
| Vaccine w/ MF59 | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | 1086 gp120 | 0.044319625 % CD4+ T-cells |
| Vaccine w/ AS01B - High Dose | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | Env-2-ZM96 | 0.01003653 % CD4+ T-cells |
| Vaccine w/ AS01B - High Dose | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | LAI Gag | 0.00199785 % CD4+ T-cells |
| Vaccine w/ AS01B - High Dose | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | TV1 gp120 | 0.10101452 % CD4+ T-cells |
| Vaccine w/ AS01B - High Dose | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | Env-1-ZM96 | 0.09662109 % CD4+ T-cells |
| Vaccine w/ AS01B - High Dose | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | 1086 gp120 | 0.10802498 % CD4+ T-cells |
| Vaccine w/ AS01B - Low Dose | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | Env-2-ZM96 | 0.020232585 % CD4+ T-cells |
| Vaccine w/ AS01B - Low Dose | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | 1086 gp120 | 0.15160478 % CD4+ T-cells |
| Vaccine w/ AS01B - Low Dose | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | Env-1-ZM96 | 0.1209486 % CD4+ T-cells |
| Vaccine w/ AS01B - Low Dose | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | LAI Gag | 0.002998855 % CD4+ T-cells |
| Vaccine w/ AS01B - Low Dose | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | TV1 gp120 | 0.145474815 % CD4+ T-cells |
| Placebo | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | LAI Gag | 0.000049675 % CD4+ T-cells |
| Placebo | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | Env-1-ZM96 | 0.00009746 % CD4+ T-cells |
| Placebo | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | 1086 gp120 | 0.000078395 % CD4+ T-cells |
| Placebo | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | Env-2-ZM96 | -0.004564435 % CD4+ T-cells |
| Placebo | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | TV1 gp120 | -0.005495385 % CD4+ T-cells |
Secondary
Level of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5]
Serum IgG responses were measured on a Bio-Plex instrument using a standardized 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 MFI minus reference antigen MFI. Values outside the linear range of the assay are not meaningful and are truncated: net MFI less than 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500.
Time frame: Measured at Month 6.5
Population: Overall number of participants analyzed represents the HIV uninfected participants with specimens at Month 6.5. Number Analyzed shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Vaccine w/ MF59 | Level of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5] | 1086C_D7gp120.avi/293F at Month 6.5 | 22000 relative fluorescence units |
| Vaccine w/ MF59 | Level of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5] | TV1c8_D11gp120.avi/293F at Month 6.5 | 22000 relative fluorescence units |
| Vaccine w/ MF59 | Level of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5] | 96ZM651.D11gp120.avi at Month 6.5 | 22000 relative fluorescence units |
| Vaccine w/ AS01B - High Dose | Level of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5] | 1086C_D7gp120.avi/293F at Month 6.5 | 22000 relative fluorescence units |
| Vaccine w/ AS01B - High Dose | Level of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5] | TV1c8_D11gp120.avi/293F at Month 6.5 | 22000 relative fluorescence units |
| Vaccine w/ AS01B - High Dose | Level of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5] | 96ZM651.D11gp120.avi at Month 6.5 | 22000 relative fluorescence units |
| Vaccine w/ AS01B - Low Dose | Level of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5] | 96ZM651.D11gp120.avi at Month 6.5 | 22000 relative fluorescence units |
| Vaccine w/ AS01B - Low Dose | Level of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5] | 1086C_D7gp120.avi/293F at Month 6.5 | 22000 relative fluorescence units |
| Vaccine w/ AS01B - Low Dose | Level of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5] | TV1c8_D11gp120.avi/293F at Month 6.5 | 22000 relative fluorescence units |
| Placebo | Level of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5] | 1086C_D7gp120.avi/293F at Month 6.5 | 1 relative fluorescence units |
| Placebo | Level of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5] | TV1c8_D11gp120.avi/293F at Month 6.5 | 1 relative fluorescence units |
| Placebo | Level of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5] | 96ZM651.D11gp120.avi at Month 6.5 | 14.125 relative fluorescence units |
Secondary
Number of Participants With Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 10.]
Serum IgG responses were measured on a Bio-Plex instrument using a standardized 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 MFI minus reference antigen MFI. Values outside the linear range of the assay are not meaningful and are truncated: net MFI less than 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Samples from post-enrollment visits have positive responses if: (1) net MFI \>= an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), and (2) net MFI \> 3 times baseline net MFI, and (3) experimental antigen MFI \> 3 times baseline MFI.
Time frame: Measured at Month Month 12
Population: Overall number of participants analyzed represents the HIV uninfected participants with specimens at Month 12. Number Analyzed shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccine w/ MF59 | Number of Participants With Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 10.] | C.1086C_V1_V2 Tags at Month 12 | 2 Participants |
| Vaccine w/ MF59 | Number of Participants With Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 10.] | gp70-96ZM651.02 V1v2 at Month 12 | 3 Participants |
| Vaccine w/ MF59 | Number of Participants With Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 10.] | gp70-TV1.21 V1V2 at Month 12 | 5 Participants |
| Vaccine w/ MF59 | Number of Participants With Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 10.] | gp70-TV1.GSKvacV1V2/293F at Month 12 | 7 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants With Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 10.] | gp70-96ZM651.02 V1v2 at Month 12 | 4 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants With Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 10.] | gp70-TV1.21 V1V2 at Month 12 | 0 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants With Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 10.] | gp70-TV1.GSKvacV1V2/293F at Month 12 | 1 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants With Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 10.] | C.1086C_V1_V2 Tags at Month 12 | 3 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants With Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 10.] | gp70-TV1.21 V1V2 at Month 12 | 2 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants With Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 10.] | gp70-96ZM651.02 V1v2 at Month 12 | 1 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants With Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 10.] | gp70-TV1.GSKvacV1V2/293F at Month 12 | 2 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants With Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 10.] | C.1086C_V1_V2 Tags at Month 12 | 4 Participants |
| Placebo | Number of Participants With Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 10.] | gp70-TV1.GSKvacV1V2/293F at Month 12 | 0 Participants |
| Placebo | Number of Participants With Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 10.] | gp70-96ZM651.02 V1v2 at Month 12 | 0 Participants |
| Placebo | Number of Participants With Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 10.] | C.1086C_V1_V2 Tags at Month 12 | 0 Participants |
| Placebo | Number of Participants With Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 10.] | gp70-TV1.21 V1V2 at Month 12 | 0 Participants |
Secondary
Number of Participants With Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 6.5.]
Serum IgG responses were measured on a Bio-Plex instrument using a standardized 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 MFI minus reference antigen MFI. Values outside the linear range of the assay are not meaningful and are truncated: net MFI less than 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Samples from post-enrollment visits have positive responses if: (1) net MFI \>= an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), and (2) net MFI \> 3 times baseline net MFI, and (3) experimental antigen MFI \> 3 times baseline MFI.
Time frame: Measured at Month 6.5
Population: Overall number of participants analyzed represents the HIV uninfected participants with specimens at Month 6.5. Number Analyzed shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccine w/ MF59 | Number of Participants With Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 6.5.] | C.1086C_V1_V2 Tags at Month 6.5 | 20 Participants |
| Vaccine w/ MF59 | Number of Participants With Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 6.5.] | gp70-96ZM651.02 V1v2 at Month 6.5 | 17 Participants |
| Vaccine w/ MF59 | Number of Participants With Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 6.5.] | gp70-TV1.21 V1V2 at Month 6.5 | 24 Participants |
| Vaccine w/ MF59 | Number of Participants With Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 6.5.] | gp70-TV1.GSKvacV1V2/293F at Month 6.5 | 29 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants With Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 6.5.] | gp70-96ZM651.02 V1v2 at Month 6.5 | 24 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants With Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 6.5.] | gp70-TV1.21 V1V2 at Month 6.5 | 26 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants With Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 6.5.] | gp70-TV1.GSKvacV1V2/293F at Month 6.5 | 31 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants With Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 6.5.] | C.1086C_V1_V2 Tags at Month 6.5 | 27 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants With Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 6.5.] | gp70-TV1.21 V1V2 at Month 6.5 | 11 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants With Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 6.5.] | gp70-96ZM651.02 V1v2 at Month 6.5 | 17 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants With Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 6.5.] | gp70-TV1.GSKvacV1V2/293F at Month 6.5 | 16 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants With Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 6.5.] | C.1086C_V1_V2 Tags at Month 6.5 | 19 Participants |
| Placebo | Number of Participants With Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 6.5.] | gp70-TV1.GSKvacV1V2/293F at Month 6.5 | 0 Participants |
| Placebo | Number of Participants With Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 6.5.] | gp70-96ZM651.02 V1v2 at Month 6.5 | 0 Participants |
| Placebo | Number of Participants With Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 6.5.] | C.1086C_V1_V2 Tags at Month 6.5 | 0 Participants |
| Placebo | Number of Participants With Anti -V1/V2 Scaffold IgG Binding Antibody ( Vaccine V1V2 Panel) Responses. Measured by Binding Antibody Multiplex Assay (BAMA). [Time Frame: Measured at Month 6.5.] | gp70-TV1.21 V1V2 at Month 6.5 | 0 Participants |
Secondary
Number of Participants With HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5.]
Serum IgG responses were measured on a Bio-Plex instrument using a standardized 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 MFI minus reference antigen MFI. Values outside the linear range of the assay are not meaningful and are truncated: net MFI less than 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Samples from post-enrollment visits have positive responses if: (1) net MFI \>= an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), and (2) net MFI \> 3 times baseline net MFI, and (3) experimental antigen MFI \> 3 times baseline MFI.
Time frame: Measured at Month 6.5
Population: Overall number of participants analyzed represents the HIV uninfected participants with specimens at Month 6.5. Number Analyzed shows the number of HIV uninfected participants with available BAMA data after filtering for assay specific quality control criteria at each timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccine w/ MF59 | Number of Participants With HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5.] | 1086C_D7gp120.avi/293F at Month 6.5 | 49 Participants |
| Vaccine w/ MF59 | Number of Participants With HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5.] | TV1c8_D11gp120.avi/293F at Month 6.5 | 49 Participants |
| Vaccine w/ MF59 | Number of Participants With HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5.] | 96ZM651.D11gp120.avi at Month 6.5 | 47 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants With HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5.] | 1086C_D7gp120.avi/293F at Month 6.5 | 45 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants With HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5.] | TV1c8_D11gp120.avi/293F at Month 6.5 | 46 Participants |
| Vaccine w/ AS01B - High Dose | Number of Participants With HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5.] | 96ZM651.D11gp120.avi at Month 6.5 | 45 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants With HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5.] | 96ZM651.D11gp120.avi at Month 6.5 | 39 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants With HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5.] | 1086C_D7gp120.avi/293F at Month 6.5 | 41 Participants |
| Vaccine w/ AS01B - Low Dose | Number of Participants With HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5.] | TV1c8_D11gp120.avi/293F at Month 6.5 | 42 Participants |
| Placebo | Number of Participants With HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5.] | 1086C_D7gp120.avi/293F at Month 6.5 | 0 Participants |
| Placebo | Number of Participants With HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5.] | TV1c8_D11gp120.avi/293F at Month 6.5 | 0 Participants |
| Placebo | Number of Participants With HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 6.5.] | 96ZM651.D11gp120.avi at Month 6.5 | 0 Participants |
Secondary
Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry.
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 IL-2/IFNy 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. A response is positive if p\<=0.00001.The number and percentage of participants with positive responses are summarized by peptide pool.
Time frame: Measured at Month 12
Population: In this report, the overall number of participants analyzed represents the HIV uninfected participants with specimens at Month12. 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccine w/ MF59 | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | Env-2-ZM96 | 2 Participants |
| Vaccine w/ MF59 | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | LAI Gag | 0 Participants |
| Vaccine w/ MF59 | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | 1086 gp120 | 17 Participants |
| Vaccine w/ MF59 | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | Env-1-ZM96 | 24 Participants |
| Vaccine w/ MF59 | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | TV1 gp120 | 24 Participants |
| Vaccine w/ AS01B - High Dose | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | Env-2-ZM96 | 8 Participants |
| Vaccine w/ AS01B - High Dose | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | LAI Gag | 2 Participants |
| Vaccine w/ AS01B - High Dose | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | Env-1-ZM96 | 34 Participants |
| Vaccine w/ AS01B - High Dose | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | 1086 gp120 | 34 Participants |
| Vaccine w/ AS01B - High Dose | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | TV1 gp120 | 32 Participants |
| Vaccine w/ AS01B - Low Dose | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | Env-2-ZM96 | 10 Participants |
| Vaccine w/ AS01B - Low Dose | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | 1086 gp120 | 33 Participants |
| Vaccine w/ AS01B - Low Dose | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | Env-1-ZM96 | 33 Participants |
| Vaccine w/ AS01B - Low Dose | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | LAI Gag | 0 Participants |
| Vaccine w/ AS01B - Low Dose | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | TV1 gp120 | 32 Participants |
| Placebo | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | LAI Gag | 0 Participants |
| Placebo | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | Env-1-ZM96 | 1 Participants |
| Placebo | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | 1086 gp120 | 0 Participants |
| Placebo | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | Env-2-ZM96 | 0 Participants |
| Placebo | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry. | TV1 gp120 | 0 Participants |