HIV Infections
Conditions
Brief summary
The purpose of this study is to evaluate the safety and immunogenicity of an HIV-1 gp41 MPER-656 liposome vaccine in healthy, HIV-uninfected adults.
Detailed description
This study will evaluate the safety and immunogenicity of an HIV-1 gp41 MPER-656 liposome vaccine in healthy, HIV-uninfected adults. Participants will be randomly assigned to four groups. Participants in Group 1 (Treatment 1) will receive 500 mcg of MPER-656 liposome vaccine at Months 0, 2, and 6. Participants in Group 1 (Control 1) will receive placebo at Months 0, 2, and 6. Participants in Group 2 (Treatment 2) will receive 2000 mcg of MPER-656 liposome vaccine at Months 0, 2, and 6. Participants in Group 2 (Control 2) will receive placebo at Months 0, 2, and 6. Study staff will review safety data from Group 1 before deciding whether to enroll Group 2. Participants will attend several study visits through Month 12. Visits may include physical examinations, blood and urine collection, HIV testing, risk reduction counseling, and questionnaires. Study staff will contact participants at Month 18 for follow-up health monitoring. As of May 2020, vaccinations were discontinued for all participants.
Interventions
BIOLOGICALMPER-656 Liposome Vaccine
Administered by intramuscular injection
BIOLOGICALPlacebo for MPER-656 Liposome Vaccine
Administered by intramuscular injection
Sponsors
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 50 Years
Healthy volunteers
Yes
Inclusion criteria
General and Demographic Criteria * Age of 18 to 50 years * Access to a participating HIV Vaccine Trials Network (HVTN) clinical research site (CRS) and willingness to be followed for the planned duration of the study * Ability and willingness to provide informed consent * Assessment of understanding: volunteer demonstrates understanding of this study; completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly * Agrees not to enroll in another study of an investigational research agent while in this study * 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 study protocol for more information) 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 2,500 to 12,000 cells/mm\^3 with normal differential, or differential approved by Investigator of Record (IoR) as not clinically significant * Total lymphocyte count greater than or equal to 650 cells/mm\^3 with normal differential, or differential approved by IoR as not clinically significant * Remaining differential either within institutional normal range or with site physician approval * Platelets equal to 125,000 to 550,000 cells/mm\^3 Chemistry * Chemistry panel: alanine aminotransferase (ALT) less than 1.25 times the institutional upper limit of normal; creatinine less than or equal to 1.1 times the institutional upper limit of normal Clotting and autoantibodies * Anticardiolipin IgG antibodies below the upper limit of normal * Negative antinuclear antibodies Virology * Negative HIV-1 and -2 blood test: US volunteers must have a negative FDA-approved enzyme immunoassay (EIA) * 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 or trace urine protein, and * Negative, trace, or 1+ blood urine hemoglobin (if +1 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 (β-HCG) pregnancy test at screening (ie, prior to randomization) and prior to study product administration on the day of study product administration. Persons who are NOT of reproductive potential due to having undergone hysterectomy or bilateral oophorectomy (verified by medical records), are not required to undergo pregnancy testing. * Reproductive status: A volunteer who was assigned female sex at birth: * Must agree to use effective contraception 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 is defined as using the following methods: * Condoms (male or female) with or without a spermicide, * Diaphragm or cervical cap with spermicide, * Intrauterine device (IUD), * Hormonal contraception, * Tubal ligation, or * Any other contraceptive method approved by the HVTN 133 Protocol Safety Review Team (PSRT), * Successful vasectomy in any partner assigned male sex 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 postvasectomy); * Or not be of reproductive potential, such as having reached menopause (no menses for 1 year) or having undergone hysterectomy, or bilateral oophorectomy, * Or 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
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: age greater than 45, 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 133 study * Pregnant or breastfeeding * Active duty and reserve US military personnel Vaccines and other Injections * HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received control/placebo in an HIV vaccine trial, the HVTN 133 PSRT will determine eligibility on a case-by-case basis. * Previous receipt of monoclonal antibodies (mAbs), whether licensed or investigational; the HVTN 133 PSRT will determine eligibility on a case-by-case basis. * Non-HIV experimental vaccine(s) received within the last 1 year in a prior vaccine trial. Exceptions may be made by the HVTN 133 PSRT for vaccines that have subsequently undergone licensure by the FDA. For volunteers who have received control/placebo in an experimental vaccine trial, the HVTN 133 PSRT will determine eligibility on a case-by-case basis. For volunteers who have received an experimental vaccine(s) greater than 1 year ago, eligibility for enrollment will be determined by the HVTN 133 PSRT on a case-by-case basis. * Live attenuated vaccines received within 30 days before first vaccination or scheduled within 14 days after injection (eg, measles, mumps, and rubella \[MMR\]; oral polio vaccine \[OPV\]; varicella; yellow fever; live attenuated influenza vaccine) * Any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination (eg, tetanus, pneumococcal, Hepatitis A or B) * Allergy treatment with antigen injections within 30 days before first vaccination or that are scheduled within 14 days after first vaccination Immune System * Immunosuppressive medications received within 168 days before first vaccination (Not exclusionary: \[1\] corticosteroid nasal spray; \[2\] inhaled corticosteroids; \[3\] topical corticosteroids for mild, uncomplicated dermatologic condition; 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 including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain. (Not excluded from participation: a volunteer who had a nonanaphylactic adverse reaction to pertussis vaccine as a child.) * Immunoglobulin received within 60 days before first vaccination (for mAb see criterion above) * Autoimmune disease, current or history, (Not exclusionary: mild, wellcontrolled psoriasis) * Adverse event of special interest (AESIs): Volunteers who currently have, or have a history of any condition that could be considered an AESI for the products administered in this protocol (representative examples are listed in the study protocol) * 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 |
|---|---|---|
| Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Magnitudes | Measured at Month 2.5(V5) and Month 6.5(V7) | Serum HIV-1-specific IgG responses against antigens listed below were on a Bio-Plex instrument (Bio-Rad) using a standardized custom HIV-1 Luminex assay, run at 1:50 dilution. The readout was background-subtracted mean fluorescence intensity (MFI), where background referred to a plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen minus reference antigen MFI. Net MFI below 1 is set to 1, and Net MFI above 22,000 is set to 22,000. Samples from post-baseline visits have positive responses if they meet three criteria: (1) net MFI \>= antigen-specific threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI \> 3 times baseline net MFI, and (3) experimental antigen MFI \> 3 times baseline MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 6500 MFI. |
| Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm | Measured during screening, Days 14, 70, 182 | For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population. |
| Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | Measured during screening, Days 14, 70, 182 | For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population. |
| The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Measured during screening, Days 14, 70, 182 | The number (percentage) of participants with lab grade \> 1 for alanine aminotransferase (ALT), creatinine, hemoglobin, lymphocyte count, neutrophil count, platelets, white blood cells (WBC) was summarized by arm. |
| Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Response Rates | Measured at Month 2.5(V5) and Month 6.5(V7) | Serum HIV-1-specific IgG responses against antigens listed below were on a Bio-Plex instrument (Bio-Rad) using a standardized custom HIV-1 Luminex assay, run at 1:50 dilution. The readout was background-subtracted mean fluorescence intensity (MFI), where background referred to a plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen minus reference antigen MFI. Net MFI below 1 is set to 1, and Net MFI above 22,000 is set to 22,000. Samples from post-baseline visits have positive responses if they meet three criteria: (1) net MFI \>= antigen-specific threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI \> 3 times baseline net MFI, and (3) experimental antigen MFI \> 3 times baseline MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 6500 MFI. |
| Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Measured through 7 days after each vaccine dose at Months (0,2,6,12) | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented |
| Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Measured through 7 days after each vaccine dose at Months (0,2,6,12) | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, 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 | Measured through 7 days after each vaccine dose at Months (0,2,6,12) | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: malaise and/or fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and body temperature. The item Max. Systemic Symptoms is the maximum of the individual systemic reactogenicities excluding body temperature for a participant. |
| Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L | Measured during screening, Days 14, 70, 182 | For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population. |
| Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Measured during screening, Days 14, 70, 182 | For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population. |
| Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Measured during screening, Days 14, 70, 182 | For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes | Measured at Month 2.5(V5) and Month 6.5(V7) | Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl and TZM-bl/Fcg RI cells . Assays in both cell lines measured neutralization titers as a function of a reduction in Tat-induced luciferase reporter gene expression after a single round of infection with Env-pseudotyped viruses. Test samples were assayed against a panel of HIV-1 strains that exhibit heightened susceptible to neutralization by MPER bnAbs in TZM-bl/Fcg RI cells. |
| Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response | Measured at Month 2.5(V5) and Month 6.5(V7) | Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl and TZM-bl/Fcg RI cells . Assays in both cell lines measured neutralization titers as a function of a reduction in Tat-induced luciferase reporter gene expression after a single round of infection with Env-pseudotyped viruses. Test samples were assayed against a panel of HIV-1 strains that exhibit heightened susceptible to neutralization by MPER bnAbs in TZM-bl/Fcg RI cells. |
| Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes | Measured at Month 2.5(V5) and Month 6.5(V7) | Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl and TZM-bl/Fcg RI cells . Assays in both cell lines measured neutralization titers as a function of a reduction in Tat-induced luciferase reporter gene expression after a single round of infection with Env-pseudotyped viruses. Test samples were assayed against a panel of HIV-1 strains that exhibit heightened susceptible to neutralization by MPER bnAbs in TZM-bl/Fcg RI cells. |
| Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates | Measured at Month 2.5(V5) and Month 6.5(V7) | Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl and TZM-bl/Fcg RI cells . Assays in both cell lines measured neutralization titers as a function of a reduction in Tat-induced luciferase reporter gene expression after a single round of infection with Env-pseudotyped viruses. Test samples were assayed against a panel of HIV-1 strains that exhibit heightened susceptible to neutralization by MPER bnAbs in TZM-bl/Fcg RI cells. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) MPER-656 liposomes, 500 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses intramuscularly (IM) at months 0, 2, 6, and 12. | 5 |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) MPER-656 liposomes, 2000 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12. | 15 |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12. | 1 |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12. | 3 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Study Terminated by Sponsor | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Control 1: Placebo for MPER-656 mo(0,2,6,12) | Control 2: Placebo for MPER-656 mo(0,2,6,12) |
|---|---|---|---|---|---|
| Age, Continuous | 27 years | 24 years | 29 years | 30 years | 23 years |
| Age, Customized 18 - 20 years | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Age, Customized 21 - 30 years | 13 Participants | 3 Participants | 7 Participants | 1 Participants | 2 Participants |
| Age, Customized 31 - 40 years | 10 Participants | 2 Participants | 7 Participants | 0 Participants | 1 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 | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants | 5 Participants | 15 Participants | 1 Participants | 2 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 | 3 Participants | 0 Participants | 3 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 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 | 18 Participants | 4 Participants | 11 Participants | 1 Participants | 2 Participants |
| Region of Enrollment United States | 24 Participants | 5 Participants | 15 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Female | 16 Participants | 2 Participants | 12 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Male | 8 Participants | 3 Participants | 3 Participants | 1 Participants | 1 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 / 5 | 0 / 15 | 0 / 1 | 0 / 3 |
| other Total, other adverse events | 4 / 5 | 10 / 15 | 0 / 1 | 2 / 3 |
| serious Total, serious adverse events | 0 / 5 | 1 / 15 | 0 / 1 | 0 / 3 |
Outcome results
Primary
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Time frame: Measured during screening, Days 14, 70, 182
Population: 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, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L | Alanine Aminotransferase (U/L)-Baseline | 14 U/L |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L | Alanine Aminotransferase (U/L)-Day 14 | 21 U/L |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L | Alanine Aminotransferase (U/L)-Day 70 | 14 U/L |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L | Alanine Aminotransferase (U/L)-Day 182 | 19 U/L |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L | Alanine Aminotransferase (U/L)-Day 14 | 11 U/L |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L | Alanine Aminotransferase (U/L)-Day 70 | 14 U/L |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L | Alanine Aminotransferase (U/L)-Day 182 | 16 U/L |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L | Alanine Aminotransferase (U/L)-Baseline | 15 U/L |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L | Alanine Aminotransferase (U/L)-Day 70 | 15 U/L |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L | Alanine Aminotransferase (U/L)-Day 14 | 15 U/L |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L | Alanine Aminotransferase (U/L)-Day 182 | 16 U/L |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L | Alanine Aminotransferase (U/L)-Baseline | 17 U/L |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L | Alanine Aminotransferase (U/L)-Day 182 | 13 U/L |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L | Alanine Aminotransferase (U/L)-Day 14 | 12 U/L |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L | Alanine Aminotransferase (U/L)-Baseline | 14 U/L |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L | Alanine Aminotransferase (U/L)-Day 70 | 9 U/L |
Primary
Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Time frame: Measured during screening, Days 14, 70, 182
Population: 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, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine (mg/dL)-Baseline | 0.97 mg/dL |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine (mg/dL)-Day 14 | 1 mg/dL |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine (mg/dL)-Day 70 | 0.92 mg/dL |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine (mg/dL)-Day 182 | 0.88 mg/dL |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine (mg/dL)-Day 14 | 0.7 mg/dL |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine (mg/dL)-Day 70 | 0.72 mg/dL |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine (mg/dL)-Day 182 | 0.78 mg/dL |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine (mg/dL)-Baseline | 0.73 mg/dL |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine (mg/dL)-Day 70 | 0.76 mg/dL |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine (mg/dL)-Day 14 | 0.74 mg/dL |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine (mg/dL)-Day 182 | 0.82 mg/dL |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine (mg/dL)-Baseline | 0.68 mg/dL |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine (mg/dL)-Day 182 | 0.71 mg/dL |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine (mg/dL)-Day 14 | 0.82 mg/dL |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine (mg/dL)-Baseline | 0.7 mg/dL |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL | Creatinine (mg/dL)-Day 70 | 0.83 mg/dL |
Primary
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Time frame: Measured during screening, Days 14, 70, 182
Population: 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, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL)-Baseline | 14 g/dL |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL)-Day 14 | 13 g/dL |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL)-Day 182 | 14 g/dL |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL)-Day 70 | 13 g/dL |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL)-Day 14 | 13 g/dL |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL)-Day 182 | 12 g/dL |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL)-Baseline | 14 g/dL |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL)-Day 70 | 13 g/dL |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL)-Day 70 | 15 g/dL |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL)-Baseline | 14 g/dL |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL)-Day 182 | 14 g/dL |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL)-Day 14 | 13 g/dL |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL)-Day 182 | 14 g/dL |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL)-Baseline | 14 g/dL |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL)-Day 14 | 13 g/dL |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | Hemoglobin (g/dL)-Day 70 | 12 g/dL |
Primary
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Time frame: Measured during screening, Days 14, 70, 182
Population: 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, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm | Lymphocytes (1000 cells/cubic mm)-Baseline | 2.44 1000 cells/cubic mm |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm | Lymphocytes (1000 cells/cubic mm)-Day 14 | 2.25 1000 cells/cubic mm |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm | Lymphocytes (1000 cells/cubic mm)-Day 182 | 2.53 1000 cells/cubic mm |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm | Lymphocytes (1000 cells/cubic mm)-Day 70 | 2.27 1000 cells/cubic mm |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm | Neutrophils (1000 cells/cubic mm)-Baseline | 4.42 1000 cells/cubic mm |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm | Neutrophils (1000 cells/cubic mm)-Day 14 | 3.99 1000 cells/cubic mm |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm | Neutrophils (1000 cells/cubic mm)-Day 70 | 3.8 1000 cells/cubic mm |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm | Neutrophils (1000 cells/cubic mm)-Day 182 | 4.135 1000 cells/cubic mm |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm | Neutrophils (1000 cells/cubic mm)-Day 14 | 3.76 1000 cells/cubic mm |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm | Neutrophils (1000 cells/cubic mm)-Baseline | 3.79 1000 cells/cubic mm |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm | Lymphocytes (1000 cells/cubic mm)-Day 14 | 2.027 1000 cells/cubic mm |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm | Neutrophils (1000 cells/cubic mm)-Day 182 | 3.93 1000 cells/cubic mm |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm | Neutrophils (1000 cells/cubic mm)-Day 70 | 3.47 1000 cells/cubic mm |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm | Lymphocytes (1000 cells/cubic mm)-Day 182 | 2.335 1000 cells/cubic mm |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm | Lymphocytes (1000 cells/cubic mm)-Day 70 | 2.017 1000 cells/cubic mm |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm | Lymphocytes (1000 cells/cubic mm)-Baseline | 2.09 1000 cells/cubic mm |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm | Lymphocytes (1000 cells/cubic mm)-Day 14 | 1.87 1000 cells/cubic mm |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm | Lymphocytes (1000 cells/cubic mm)-Day 70 | 1.88 1000 cells/cubic mm |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm | Lymphocytes (1000 cells/cubic mm)-Day 182 | 1.77 1000 cells/cubic mm |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm | Neutrophils (1000 cells/cubic mm)-Baseline | 4.48 1000 cells/cubic mm |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm | Neutrophils (1000 cells/cubic mm)-Day 14 | 1.99 1000 cells/cubic mm |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm | Neutrophils (1000 cells/cubic mm)-Day 182 | 1.91 1000 cells/cubic mm |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm | Lymphocytes (1000 cells/cubic mm)-Baseline | 2.39 1000 cells/cubic mm |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm | Neutrophils (1000 cells/cubic mm)-Day 70 | 1.55 1000 cells/cubic mm |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm | Lymphocytes (1000 cells/cubic mm)-Day 14 | 1.876 1000 cells/cubic mm |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm | Lymphocytes (1000 cells/cubic mm)-Day 182 | 2.67 1000 cells/cubic mm |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm | Neutrophils (1000 cells/cubic mm)-Day 70 | 5.412 1000 cells/cubic mm |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm | Lymphocytes (1000 cells/cubic mm)-Baseline | 2.587 1000 cells/cubic mm |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm | Neutrophils (1000 cells/cubic mm)-Baseline | 5.216 1000 cells/cubic mm |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm | Neutrophils (1000 cells/cubic mm)-Day 182 | 5.78 1000 cells/cubic mm |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm | Lymphocytes (1000 cells/cubic mm)-Day 70 | 1.811 1000 cells/cubic mm |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm | Neutrophils (1000 cells/cubic mm)-Day 14 | 5.7 1000 cells/cubic mm |
Primary
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Time frame: Measured during screening, Days 14, 70, 182
Population: 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, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | WBC (1000 cells/cubic mm)-Baseline | 7.61 1000 cells/cubic mm |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | WBC (1000 cells/cubic mm)-Day 14 | 7.28 1000 cells/cubic mm |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | WBC (1000 cells/cubic mm)-Day 70 | 6.93 1000 cells/cubic mm |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | WBC (1000 cells/cubic mm)-Day 182 | 7.91 1000 cells/cubic mm |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | Platelets (1000 cells/cubic mm)-Baseline | 229 1000 cells/cubic mm |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | Platelets (1000 cells/cubic mm)-Day 14 | 218 1000 cells/cubic mm |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | Platelets (1000 cells/cubic mm)-Day 70 | 237 1000 cells/cubic mm |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | Platelets (1000 cells/cubic mm)-Day 182 | 235.8 1000 cells/cubic mm |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | Platelets (1000 cells/cubic mm)-Day 14 | 277 1000 cells/cubic mm |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | Platelets (1000 cells/cubic mm)-Baseline | 250 1000 cells/cubic mm |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | WBC (1000 cells/cubic mm)-Day 14 | 6.54 1000 cells/cubic mm |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | Platelets (1000 cells/cubic mm)-Day 182 | 285.5 1000 cells/cubic mm |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | Platelets (1000 cells/cubic mm)-Day 70 | 278 1000 cells/cubic mm |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | WBC (1000 cells/cubic mm)-Day 182 | 7.12 1000 cells/cubic mm |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | WBC (1000 cells/cubic mm)-Day 70 | 6.38 1000 cells/cubic mm |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | WBC (1000 cells/cubic mm)-Baseline | 6.51 1000 cells/cubic mm |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | Platelets (1000 cells/cubic mm)-Day 70 | 260 1000 cells/cubic mm |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | WBC (1000 cells/cubic mm)-Day 70 | 4.04 1000 cells/cubic mm |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | WBC (1000 cells/cubic mm)-Day 182 | 4.32 1000 cells/cubic mm |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | Platelets (1000 cells/cubic mm)-Baseline | 242 1000 cells/cubic mm |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | Platelets (1000 cells/cubic mm)-Day 14 | 227 1000 cells/cubic mm |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | Platelets (1000 cells/cubic mm)-Day 182 | 231 1000 cells/cubic mm |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | WBC (1000 cells/cubic mm)-Baseline | 7.6 1000 cells/cubic mm |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | WBC (1000 cells/cubic mm)-Day 14 | 4.53 1000 cells/cubic mm |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | WBC (1000 cells/cubic mm)-Day 70 | 8.3 1000 cells/cubic mm |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | WBC (1000 cells/cubic mm)-Day 182 | 9.19 1000 cells/cubic mm |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | WBC (1000 cells/cubic mm)-Day 14 | 9.83 1000 cells/cubic mm |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | WBC (1000 cells/cubic mm)-Baseline | 8.4 1000 cells/cubic mm |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | Platelets (1000 cells/cubic mm)-Baseline | 290 1000 cells/cubic mm |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | Platelets (1000 cells/cubic mm)-Day 182 | 317 1000 cells/cubic mm |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | Platelets (1000 cells/cubic mm)-Day 70 | 298 1000 cells/cubic mm |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm | Platelets (1000 cells/cubic mm)-Day 14 | 306 1000 cells/cubic mm |
Primary
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented
Time frame: Measured through 7 days after each vaccine dose at Months (0,2,6,12)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | Gr 4: Complications AE | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | Gr 3: >=10 cm dim. | 1 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | Gr 3: Complications AE | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Not Gradable | 2 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | Gr 3: Complications AE | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | None | 3 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | Gr 2: 5 to less than 10 cm dim. | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 2 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 3: Complications AE | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | Gr 3: >=10 cm dim. | 1 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | Not Gradable | 1 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 3: >=10 cm dim. | 1 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | Gr 4: Complications AE | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | None | 3 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 4: Complications AE | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 2: 5 to less than 10 cm dim. | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | Not Gradable | 1 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | Gr 1: 2.5 to less than 5 cm dim. | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | Gr 1: 2.5 to less than 5 cm dim. | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 1: 2.5 to less than 5 cm dim. | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | Gr 2: 5 to less than 10 cm dim. | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | Gr 3: Complications AE | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Not Gradable | 1 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | Not Gradable | 1 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | Gr 3: >=10 cm dim. | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | Gr 1: 2.5 to less than 5 cm dim. | 2 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | Not Gradable | 1 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | Gr 4: Complications AE | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | Gr 3: Complications AE | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 3: Complications AE | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 12 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | None | 14 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | Gr 4: Complications AE | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 2: 5 to less than 10 cm dim. | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | Gr 1: 2.5 to less than 5 cm dim. | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | Gr 2: 5 to less than 10 cm dim. | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 4: Complications AE | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | None | 12 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 1: 2.5 to less than 5 cm dim. | 2 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | Gr 3: >=10 cm dim. | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | Gr 2: 5 to less than 10 cm dim. | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 3: >=10 cm dim. | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | Gr 1: 2.5 to less than 5 cm dim. | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | None | 1 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | Not Gradable | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | Gr 2: 5 to less than 10 cm dim. | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | Gr 3: >=10 cm dim. | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | Gr 3: Complications AE | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | Gr 4: Complications AE | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | None | 1 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | Not Gradable | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | Gr 1: 2.5 to less than 5 cm dim. | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | Gr 2: 5 to less than 10 cm dim. | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | Gr 3: >=10 cm dim. | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | Gr 3: Complications AE | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | Gr 4: Complications AE | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 1 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Not Gradable | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 1: 2.5 to less than 5 cm dim. | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 2: 5 to less than 10 cm dim. | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 3: >=10 cm dim. | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 3: Complications AE | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 4: Complications AE | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Not Gradable | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | Gr 1: 2.5 to less than 5 cm dim. | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | Not Gradable | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 3: Complications AE | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 1: 2.5 to less than 5 cm dim. | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | None | 3 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | Gr 4: Complications AE | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | Not Gradable | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 2: 5 to less than 10 cm dim. | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | Gr 3: Complications AE | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | Gr 3: >=10 cm dim. | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | None | 3 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 3: >=10 cm dim. | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | Gr 2: 5 to less than 10 cm dim. | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | Gr 4: Complications AE | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | Gr 3: Complications AE | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/redness | Gr 1: 2.5 to less than 5 cm dim. | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 3 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | Gr 3: >=10 cm dim. | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/swelling | Gr 2: 5 to less than 10 cm dim. | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 4: Complications AE | 0 Participants |
Primary
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented
Time frame: Measured through 7 days after each vaccine dose at Months (0,2,6,12)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Severe | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Mild | 2 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Potentially life-threatening | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Moderate | 2 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | None | 1 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Moderate | 4 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Severe | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Potentially life-threatening | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Mild | 11 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | None | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Moderate | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | None | 1 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Mild | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Severe | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Potentially life-threatening | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Severe | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Mild | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | None | 3 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Moderate | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Potentially life-threatening | 0 Participants |
Primary
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: malaise and/or fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and body temperature. The item Max. Systemic Symptoms is the maximum of the individual systemic reactogenicities excluding body temperature for a participant.
Time frame: Measured through 7 days after each vaccine dose at Months (0,2,6,12)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 3 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 3 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 2 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially life-threatening | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 4 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 1 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially life-threatening | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 2 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially life-threatening | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 1 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 4 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially life-threatening | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 3 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 2 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially life-threatening | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 4 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 1 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially life-threatening | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 1 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 4 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially life-threatening | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature (C) | None | 5 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature (C) | Mild | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature (C) | Moderate | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature (C) | Severe | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature (C) | Potentially life-threatening | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 14 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 10 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 13 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 5 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature (C) | None | 15 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 4 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 2 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 1 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 1 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 3 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially life-threatening | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 2 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 9 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially life-threatening | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 9 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 8 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature (C) | Mild | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 10 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially life-threatening | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 3 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 5 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially life-threatening | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature (C) | Severe | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 5 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature (C) | Potentially life-threatening | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially life-threatening | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially life-threatening | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature (C) | Moderate | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially life-threatening | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 1 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 1 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 1 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially life-threatening | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially life-threatening | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 1 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 1 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature (C) | Potentially life-threatening | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially life-threatening | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially life-threatening | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 1 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature (C) | None | 1 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature (C) | Moderate | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially life-threatening | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially life-threatening | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 1 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 1 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature (C) | Mild | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature (C) | Severe | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially life-threatening | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially life-threatening | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 1 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 2 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially life-threatening | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 2 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 1 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially life-threatening | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially life-threatening | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature (C) | Severe | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 3 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature (C) | None | 3 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature (C) | Potentially life-threatening | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially life-threatening | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 2 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 1 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature (C) | Mild | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially life-threatening | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 3 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 1 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature (C) | Moderate | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially life-threatening | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 2 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 2 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 1 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 0 Participants |
Primary
Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Magnitudes
Serum HIV-1-specific IgG responses against antigens listed below were on a Bio-Plex instrument (Bio-Rad) using a standardized custom HIV-1 Luminex assay, run at 1:50 dilution. The readout was background-subtracted mean fluorescence intensity (MFI), where background referred to a plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen minus reference antigen MFI. Net MFI below 1 is set to 1, and Net MFI above 22,000 is set to 22,000. Samples from post-baseline visits have positive responses if they meet three criteria: (1) net MFI \>= antigen-specific threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI \> 3 times baseline net MFI, and (3) experimental antigen MFI \> 3 times baseline MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 6500 MFI.
Time frame: Measured at Month 2.5(V5) and Month 6.5(V7)
Population: Avaiable Data at V5 and V7
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Magnitudes | IgG - Clade C MPER - Month 2.5(V5) | 6.25 Relative luminescence units (RLU) |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Magnitudes | IgG - Clade C MPER - Month 6.5(V7) | 5.38 Relative luminescence units (RLU) |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Magnitudes | IgG - NA/MPER656-GTH1-biotin - Month 2.5(V5) | 8714.25 Relative luminescence units (RLU) |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Magnitudes | IgG - NA/MPER656-GTH1-biotin - Month 6.5(V7) | 17438.62 Relative luminescence units (RLU) |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Magnitudes | IgG - SP62 - Month 2.5(V5) | 1057.5 Relative luminescence units (RLU) |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Magnitudes | IgG - SP62 - Month 6.5(V7) | 6435.5 Relative luminescence units (RLU) |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Magnitudes | IgG - gp41 - Month 2.5(V5) | 765.5 Relative luminescence units (RLU) |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Magnitudes | IgG - gp41 - Month 6.5(V7) | 5806.5 Relative luminescence units (RLU) |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Magnitudes | IgG - SP62 - Month 6.5(V7) | 3753.5 Relative luminescence units (RLU) |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Magnitudes | IgG - SP62 - Month 2.5(V5) | 2593 Relative luminescence units (RLU) |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Magnitudes | IgG - Clade C MPER - Month 6.5(V7) | 1 Relative luminescence units (RLU) |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Magnitudes | IgG - gp41 - Month 6.5(V7) | 2974.25 Relative luminescence units (RLU) |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Magnitudes | IgG - gp41 - Month 2.5(V5) | 1879.75 Relative luminescence units (RLU) |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Magnitudes | IgG - NA/MPER656-GTH1-biotin - Month 6.5(V7) | 22000 Relative luminescence units (RLU) |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Magnitudes | IgG - NA/MPER656-GTH1-biotin - Month 2.5(V5) | 21821.75 Relative luminescence units (RLU) |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Magnitudes | IgG - Clade C MPER - Month 2.5(V5) | 4.75 Relative luminescence units (RLU) |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Magnitudes | IgG - gp41 - Month 2.5(V5) | 678 Relative luminescence units (RLU) |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Magnitudes | IgG - NA/MPER656-GTH1-biotin - Month 2.5(V5) | 11 Relative luminescence units (RLU) |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Magnitudes | IgG - NA/MPER656-GTH1-biotin - Month 6.5(V7) | 11.75 Relative luminescence units (RLU) |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Magnitudes | IgG - SP62 - Month 2.5(V5) | 12 Relative luminescence units (RLU) |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Magnitudes | IgG - SP62 - Month 6.5(V7) | 8.25 Relative luminescence units (RLU) |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Magnitudes | IgG - gp41 - Month 6.5(V7) | 565 Relative luminescence units (RLU) |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Magnitudes | IgG - Clade C MPER - Month 2.5(V5) | 7.75 Relative luminescence units (RLU) |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Magnitudes | IgG - Clade C MPER - Month 6.5(V7) | 1 Relative luminescence units (RLU) |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Magnitudes | IgG - NA/MPER656-GTH1-biotin - Month 2.5(V5) | 20.5 Relative luminescence units (RLU) |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Magnitudes | IgG - NA/MPER656-GTH1-biotin - Month 6.5(V7) | 660.5 Relative luminescence units (RLU) |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Magnitudes | IgG - Clade C MPER - Month 6.5(V7) | 1 Relative luminescence units (RLU) |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Magnitudes | IgG - Clade C MPER - Month 2.5(V5) | 1 Relative luminescence units (RLU) |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Magnitudes | IgG - SP62 - Month 2.5(V5) | 1.75 Relative luminescence units (RLU) |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Magnitudes | IgG - gp41 - Month 6.5(V7) | 139 Relative luminescence units (RLU) |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Magnitudes | IgG - gp41 - Month 2.5(V5) | 384.25 Relative luminescence units (RLU) |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Magnitudes | IgG - SP62 - Month 6.5(V7) | 1 Relative luminescence units (RLU) |
Primary
Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Response Rates
Serum HIV-1-specific IgG responses against antigens listed below were on a Bio-Plex instrument (Bio-Rad) using a standardized custom HIV-1 Luminex assay, run at 1:50 dilution. The readout was background-subtracted mean fluorescence intensity (MFI), where background referred to a plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen minus reference antigen MFI. Net MFI below 1 is set to 1, and Net MFI above 22,000 is set to 22,000. Samples from post-baseline visits have positive responses if they meet three criteria: (1) net MFI \>= antigen-specific threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI \> 3 times baseline net MFI, and (3) experimental antigen MFI \> 3 times baseline MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 6500 MFI.
Time frame: Measured at Month 2.5(V5) and Month 6.5(V7)
Population: Avaiable Data at V5 and V7
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Response Rates | IgG - Clade C MPER - Month 2.5(V5) | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Response Rates | IgG - Clade C MPER - Month 6.5(V7) | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Response Rates | IgG - NA/MPER656-GTH1-biotin - Month 2.5(V5) | 5 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Response Rates | IgG - NA/MPER656-GTH1-biotin - Month 6.5(V7) | 3 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Response Rates | IgG - SP62 - Month 2.5(V5) | 5 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Response Rates | IgG - SP62 - Month 6.5(V7) | 3 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Response Rates | IgG - gp41 - Month 2.5(V5) | 2 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Response Rates | IgG - gp41 - Month 6.5(V7) | 2 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Response Rates | IgG - SP62 - Month 6.5(V7) | 1 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Response Rates | IgG - SP62 - Month 2.5(V5) | 15 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Response Rates | IgG - Clade C MPER - Month 6.5(V7) | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Response Rates | IgG - gp41 - Month 6.5(V7) | 1 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Response Rates | IgG - gp41 - Month 2.5(V5) | 12 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Response Rates | IgG - NA/MPER656-GTH1-biotin - Month 6.5(V7) | 1 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Response Rates | IgG - NA/MPER656-GTH1-biotin - Month 2.5(V5) | 14 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Response Rates | IgG - Clade C MPER - Month 2.5(V5) | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Response Rates | IgG - gp41 - Month 2.5(V5) | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Response Rates | IgG - NA/MPER656-GTH1-biotin - Month 2.5(V5) | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Response Rates | IgG - NA/MPER656-GTH1-biotin - Month 6.5(V7) | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Response Rates | IgG - SP62 - Month 2.5(V5) | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Response Rates | IgG - SP62 - Month 6.5(V7) | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Response Rates | IgG - gp41 - Month 6.5(V7) | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Response Rates | IgG - Clade C MPER - Month 2.5(V5) | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Response Rates | IgG - Clade C MPER - Month 6.5(V7) | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Response Rates | IgG - NA/MPER656-GTH1-biotin - Month 2.5(V5) | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Response Rates | IgG - NA/MPER656-GTH1-biotin - Month 6.5(V7) | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Response Rates | IgG - Clade C MPER - Month 6.5(V7) | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Response Rates | IgG - Clade C MPER - Month 2.5(V5) | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Response Rates | IgG - SP62 - Month 2.5(V5) | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Response Rates | IgG - gp41 - Month 6.5(V7) | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Response Rates | IgG - gp41 - Month 2.5(V5) | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Response Rates | IgG - SP62 - Month 6.5(V7) | 0 Participants |
Primary
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
The number (percentage) of participants with lab grade \> 1 for alanine aminotransferase (ALT), creatinine, hemoglobin, lymphocyte count, neutrophil count, platelets, white blood cells (WBC) was summarized by arm.
Time frame: Measured during screening, Days 14, 70, 182
Population: Overall Number of Participants Analyzed represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Alanine Aminotransferase (U/L)-Baseline | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Neutrophils (1000 cells/cubic mm)-Day 70 | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | WBC (1000 cells/cubic mm)-Day 182 | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Hemoglobin (g/dL)-Baseline | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Lymphocytes (1000 cells/cubic mm)-Baseline | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Platelets (1000 cells/cubic mm)-Baseline | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Platelets (1000 cells/cubic mm)-Day 14 | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | WBC (1000 cells/cubic mm)-Day 70 | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Platelets (1000 cells/cubic mm)-Day 182 | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Platelets (1000 cells/cubic mm)-Day 70 | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Hemoglobin (g/dL)-Day 14 | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Neutrophils (1000 cells/cubic mm)-Day 14 | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Hemoglobin (g/dL)-Day 70 | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Neutrophils (1000 cells/cubic mm)-Day 182 | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Hemoglobin (g/dL)-Day 182 | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Alanine Aminotransferase (U/L)-Day 70 | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Neutrophils (1000 cells/cubic mm)-Baseline | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Creatinine (mg/dL)-Baseline | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Creatinine (mg/dL)-Day 14 | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Lymphocytes (1000 cells/cubic mm)-Day 182 | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Creatinine (mg/dL)-Day 70 | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Creatinine (mg/dL)-Day 182 | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Alanine Aminotransferase (U/L)-Day 182 | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Lymphocytes (1000 cells/cubic mm)-Day 70 | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | WBC (1000 cells/cubic mm)-Baseline | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | WBC (1000 cells/cubic mm)-Day 14 | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Alanine Aminotransferase (U/L)-Day 14 | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Lymphocytes (1000 cells/cubic mm)-Day 14 | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Neutrophils (1000 cells/cubic mm)-Day 70 | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | WBC (1000 cells/cubic mm)-Day 70 | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Hemoglobin (g/dL)-Day 182 | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Lymphocytes (1000 cells/cubic mm)-Baseline | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Lymphocytes (1000 cells/cubic mm)-Day 70 | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | WBC (1000 cells/cubic mm)-Day 182 | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | WBC (1000 cells/cubic mm)-Baseline | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Creatinine (mg/dL)-Day 182 | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Creatinine (mg/dL)-Baseline | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Platelets (1000 cells/cubic mm)-Baseline | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Hemoglobin (g/dL)-Baseline | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Platelets (1000 cells/cubic mm)-Day 182 | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Alanine Aminotransferase (U/L)-Day 70 | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Platelets (1000 cells/cubic mm)-Day 14 | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Lymphocytes (1000 cells/cubic mm)-Day 182 | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Alanine Aminotransferase (U/L)-Day 182 | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Creatinine (mg/dL)-Day 14 | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Platelets (1000 cells/cubic mm)-Day 70 | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Alanine Aminotransferase (U/L)-Day 14 | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Neutrophils (1000 cells/cubic mm)-Day 14 | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Neutrophils (1000 cells/cubic mm)-Day 182 | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Hemoglobin (g/dL)-Day 14 | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Alanine Aminotransferase (U/L)-Baseline | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Lymphocytes (1000 cells/cubic mm)-Day 14 | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | WBC (1000 cells/cubic mm)-Day 14 | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Hemoglobin (g/dL)-Day 70 | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Creatinine (mg/dL)-Day 70 | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Neutrophils (1000 cells/cubic mm)-Baseline | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Platelets (1000 cells/cubic mm)-Day 14 | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Alanine Aminotransferase (U/L)-Baseline | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Alanine Aminotransferase (U/L)-Day 14 | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Alanine Aminotransferase (U/L)-Day 70 | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Alanine Aminotransferase (U/L)-Day 182 | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Hemoglobin (g/dL)-Baseline | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Hemoglobin (g/dL)-Day 14 | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Hemoglobin (g/dL)-Day 70 | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Hemoglobin (g/dL)-Day 182 | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Creatinine (mg/dL)-Baseline | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Creatinine (mg/dL)-Day 14 | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Creatinine (mg/dL)-Day 70 | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Creatinine (mg/dL)-Day 182 | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | WBC (1000 cells/cubic mm)-Baseline | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | WBC (1000 cells/cubic mm)-Day 14 | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | WBC (1000 cells/cubic mm)-Day 70 | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | WBC (1000 cells/cubic mm)-Day 182 | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Platelets (1000 cells/cubic mm)-Baseline | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Platelets (1000 cells/cubic mm)-Day 70 | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Platelets (1000 cells/cubic mm)-Day 182 | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Lymphocytes (1000 cells/cubic mm)-Baseline | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Lymphocytes (1000 cells/cubic mm)-Day 14 | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Lymphocytes (1000 cells/cubic mm)-Day 70 | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Lymphocytes (1000 cells/cubic mm)-Day 182 | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Neutrophils (1000 cells/cubic mm)-Baseline | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Neutrophils (1000 cells/cubic mm)-Day 14 | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Neutrophils (1000 cells/cubic mm)-Day 70 | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Neutrophils (1000 cells/cubic mm)-Day 182 | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | WBC (1000 cells/cubic mm)-Day 14 | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | WBC (1000 cells/cubic mm)-Baseline | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Alanine Aminotransferase (U/L)-Day 70 | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Lymphocytes (1000 cells/cubic mm)-Day 14 | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Creatinine (mg/dL)-Day 182 | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Creatinine (mg/dL)-Day 70 | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Neutrophils (1000 cells/cubic mm)-Day 182 | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Lymphocytes (1000 cells/cubic mm)-Day 70 | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Creatinine (mg/dL)-Day 14 | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Creatinine (mg/dL)-Baseline | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Neutrophils (1000 cells/cubic mm)-Day 70 | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Lymphocytes (1000 cells/cubic mm)-Day 182 | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Hemoglobin (g/dL)-Day 182 | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Hemoglobin (g/dL)-Day 70 | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Alanine Aminotransferase (U/L)-Day 14 | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Neutrophils (1000 cells/cubic mm)-Baseline | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Hemoglobin (g/dL)-Day 14 | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Hemoglobin (g/dL)-Baseline | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Alanine Aminotransferase (U/L)-Baseline | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Platelets (1000 cells/cubic mm)-Day 70 | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Platelets (1000 cells/cubic mm)-Day 14 | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Platelets (1000 cells/cubic mm)-Baseline | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Neutrophils (1000 cells/cubic mm)-Day 14 | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Platelets (1000 cells/cubic mm)-Day 182 | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | WBC (1000 cells/cubic mm)-Day 182 | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | WBC (1000 cells/cubic mm)-Day 70 | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Alanine Aminotransferase (U/L)-Day 182 | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm | Lymphocytes (1000 cells/cubic mm)-Baseline | 0 Participants |
Secondary
Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes
Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl and TZM-bl/Fcg RI cells . Assays in both cell lines measured neutralization titers as a function of a reduction in Tat-induced luciferase reporter gene expression after a single round of infection with Env-pseudotyped viruses. Test samples were assayed against a panel of HIV-1 strains that exhibit heightened susceptible to neutralization by MPER bnAbs in TZM-bl/Fcg RI cells.
Time frame: Measured at Month 2.5(V5) and Month 6.5(V7)
Population: Avaiable Data at V5 and V7
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-80 - SC422661.8 - Month 6.5(V7) | NA Relative luminescence units (RLU) |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-80 - W61D(TCLA).71 - Month 6.5(V7) | NA Relative luminescence units (RLU) |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-80 - HXB2 - Month 6.5(V7) | NA Relative luminescence units (RLU) |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-50 - HXB2 - Month 2.5(V5) | NA Relative luminescence units (RLU) |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-80 - SC422661.8 - Month 2.5(V5) | NA Relative luminescence units (RLU) |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-50 - SC422661.8 - Month 2.5(V5) | NA Relative luminescence units (RLU) |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-50 - SC422661.8 - Month 6.5(V7) | NA Relative luminescence units (RLU) |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-50 - HXB2 - Month 6.5(V7) | NA Relative luminescence units (RLU) |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-80 - W61D(TCLA).71 - Month 2.5(V5) | NA Relative luminescence units (RLU) |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-50 - W61D(TCLA).71 - Month 2.5(V5) | NA Relative luminescence units (RLU) |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-50 - W61D(TCLA).71 - Month 6.5(V7) | NA Relative luminescence units (RLU) |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-80 - HXB2 - Month 2.5(V5) | NA Relative luminescence units (RLU) |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-50 - HXB2 - Month 6.5(V7) | NA Relative luminescence units (RLU) |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-80 - HXB2 - Month 2.5(V5) | NA Relative luminescence units (RLU) |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-50 - SC422661.8 - Month 6.5(V7) | NA Relative luminescence units (RLU) |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-80 - SC422661.8 - Month 2.5(V5) | NA Relative luminescence units (RLU) |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-80 - SC422661.8 - Month 6.5(V7) | NA Relative luminescence units (RLU) |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-80 - HXB2 - Month 6.5(V7) | NA Relative luminescence units (RLU) |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-50 - HXB2 - Month 2.5(V5) | NA Relative luminescence units (RLU) |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-50 - W61D(TCLA).71 - Month 6.5(V7) | NA Relative luminescence units (RLU) |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-50 - W61D(TCLA).71 - Month 2.5(V5) | NA Relative luminescence units (RLU) |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-50 - SC422661.8 - Month 2.5(V5) | NA Relative luminescence units (RLU) |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-80 - W61D(TCLA).71 - Month 6.5(V7) | NA Relative luminescence units (RLU) |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-80 - W61D(TCLA).71 - Month 2.5(V5) | NA Relative luminescence units (RLU) |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-80 - HXB2 - Month 6.5(V7) | NA Relative luminescence units (RLU) |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-50 - HXB2 - Month 2.5(V5) | NA Relative luminescence units (RLU) |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-50 - HXB2 - Month 6.5(V7) | NA Relative luminescence units (RLU) |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-50 - SC422661.8 - Month 2.5(V5) | NA Relative luminescence units (RLU) |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-50 - SC422661.8 - Month 6.5(V7) | NA Relative luminescence units (RLU) |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-50 - W61D(TCLA).71 - Month 2.5(V5) | NA Relative luminescence units (RLU) |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-50 - W61D(TCLA).71 - Month 6.5(V7) | NA Relative luminescence units (RLU) |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-80 - HXB2 - Month 2.5(V5) | NA Relative luminescence units (RLU) |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-80 - SC422661.8 - Month 2.5(V5) | NA Relative luminescence units (RLU) |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-80 - SC422661.8 - Month 6.5(V7) | NA Relative luminescence units (RLU) |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-80 - W61D(TCLA).71 - Month 2.5(V5) | NA Relative luminescence units (RLU) |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-80 - W61D(TCLA).71 - Month 6.5(V7) | NA Relative luminescence units (RLU) |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-50 - W61D(TCLA).71 - Month 6.5(V7) | NA Relative luminescence units (RLU) |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-50 - W61D(TCLA).71 - Month 2.5(V5) | NA Relative luminescence units (RLU) |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-50 - HXB2 - Month 2.5(V5) | NA Relative luminescence units (RLU) |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-80 - SC422661.8 - Month 6.5(V7) | NA Relative luminescence units (RLU) |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-50 - SC422661.8 - Month 6.5(V7) | NA Relative luminescence units (RLU) |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-50 - SC422661.8 - Month 2.5(V5) | NA Relative luminescence units (RLU) |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-80 - W61D(TCLA).71 - Month 6.5(V7) | NA Relative luminescence units (RLU) |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-80 - W61D(TCLA).71 - Month 2.5(V5) | NA Relative luminescence units (RLU) |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-80 - HXB2 - Month 6.5(V7) | NA Relative luminescence units (RLU) |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-80 - HXB2 - Month 2.5(V5) | NA Relative luminescence units (RLU) |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-50 - HXB2 - Month 6.5(V7) | NA Relative luminescence units (RLU) |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-80 - SC422661.8 - Month 2.5(V5) | NA Relative luminescence units (RLU) |
Secondary
Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates
Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl and TZM-bl/Fcg RI cells . Assays in both cell lines measured neutralization titers as a function of a reduction in Tat-induced luciferase reporter gene expression after a single round of infection with Env-pseudotyped viruses. Test samples were assayed against a panel of HIV-1 strains that exhibit heightened susceptible to neutralization by MPER bnAbs in TZM-bl/Fcg RI cells.
Time frame: Measured at Month 2.5(V5) and Month 6.5(V7)
Population: Avaiable Data at V5 and V7
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates | ID-80 - SC422661.8 - Month 6.5(V7) | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates | ID-80 - W61D(TCLA).71 - Month 6.5(V7) | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates | ID-80 - HXB2 - Month 6.5(V7) | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates | ID-50 - HXB2 - Month 2.5(V5) | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates | ID-80 - SC422661.8 - Month 2.5(V5) | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates | ID-50 - SC422661.8 - Month 2.5(V5) | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates | ID-50 - SC422661.8 - Month 6.5(V7) | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates | ID-50 - HXB2 - Month 6.5(V7) | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates | ID-80 - W61D(TCLA).71 - Month 2.5(V5) | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates | ID-50 - W61D(TCLA).71 - Month 2.5(V5) | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates | ID-50 - W61D(TCLA).71 - Month 6.5(V7) | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates | ID-80 - HXB2 - Month 2.5(V5) | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates | ID-50 - HXB2 - Month 6.5(V7) | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates | ID-80 - HXB2 - Month 2.5(V5) | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates | ID-50 - SC422661.8 - Month 6.5(V7) | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates | ID-80 - SC422661.8 - Month 2.5(V5) | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates | ID-80 - SC422661.8 - Month 6.5(V7) | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates | ID-80 - HXB2 - Month 6.5(V7) | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates | ID-50 - HXB2 - Month 2.5(V5) | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates | ID-50 - W61D(TCLA).71 - Month 6.5(V7) | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates | ID-50 - W61D(TCLA).71 - Month 2.5(V5) | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates | ID-50 - SC422661.8 - Month 2.5(V5) | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates | ID-80 - W61D(TCLA).71 - Month 6.5(V7) | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates | ID-80 - W61D(TCLA).71 - Month 2.5(V5) | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates | ID-80 - HXB2 - Month 6.5(V7) | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates | ID-50 - HXB2 - Month 2.5(V5) | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates | ID-50 - HXB2 - Month 6.5(V7) | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates | ID-50 - SC422661.8 - Month 2.5(V5) | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates | ID-50 - SC422661.8 - Month 6.5(V7) | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates | ID-50 - W61D(TCLA).71 - Month 2.5(V5) | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates | ID-50 - W61D(TCLA).71 - Month 6.5(V7) | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates | ID-80 - HXB2 - Month 2.5(V5) | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates | ID-80 - SC422661.8 - Month 2.5(V5) | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates | ID-80 - SC422661.8 - Month 6.5(V7) | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates | ID-80 - W61D(TCLA).71 - Month 2.5(V5) | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates | ID-80 - W61D(TCLA).71 - Month 6.5(V7) | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates | ID-50 - W61D(TCLA).71 - Month 6.5(V7) | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates | ID-50 - W61D(TCLA).71 - Month 2.5(V5) | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates | ID-50 - HXB2 - Month 2.5(V5) | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates | ID-80 - SC422661.8 - Month 6.5(V7) | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates | ID-50 - SC422661.8 - Month 6.5(V7) | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates | ID-50 - SC422661.8 - Month 2.5(V5) | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates | ID-80 - W61D(TCLA).71 - Month 6.5(V7) | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates | ID-80 - W61D(TCLA).71 - Month 2.5(V5) | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates | ID-80 - HXB2 - Month 6.5(V7) | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates | ID-80 - HXB2 - Month 2.5(V5) | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates | ID-50 - HXB2 - Month 6.5(V7) | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates | ID-80 - SC422661.8 - Month 2.5(V5) | 0 Participants |
Secondary
Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes
Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl and TZM-bl/Fcg RI cells . Assays in both cell lines measured neutralization titers as a function of a reduction in Tat-induced luciferase reporter gene expression after a single round of infection with Env-pseudotyped viruses. Test samples were assayed against a panel of HIV-1 strains that exhibit heightened susceptible to neutralization by MPER bnAbs in TZM-bl/Fcg RI cells.
Time frame: Measured at Month 2.5(V5) and Month 6.5(V7)
Population: Avaiable Data at V5 and V7
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-80 - HXB2 - Month 6.5(V7) | NA Relative luminescence units (RLU) |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-80 - HXB2 - Month 2.5(V5) | NA Relative luminescence units (RLU) |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-50 - W61D(TCLA).71 - Month 2.5(V5) | NA Relative luminescence units (RLU) |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-80 - W61D(TCLA).71 - Month 6.5(V7) | NA Relative luminescence units (RLU) |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-50 - W61D(TCLA).71 - Month 6.5(V7) | NA Relative luminescence units (RLU) |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-80 - W61D(TCLA).71 - Month 2.5(V5) | NA Relative luminescence units (RLU) |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-50 - SC422661.8 - Month 2.5(V5) | NA Relative luminescence units (RLU) |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-50 - HXB2 - Month 6.5(V7) | NA Relative luminescence units (RLU) |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-80 - SC422661.8 - Month 6.5(V7) | NA Relative luminescence units (RLU) |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-80 - SC422661.8 - Month 2.5(V5) | NA Relative luminescence units (RLU) |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-50 - SC422661.8 - Month 6.5(V7) | NA Relative luminescence units (RLU) |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-50 - HXB2 - Month 2.5(V5) | NA Relative luminescence units (RLU) |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-80 - SC422661.8 - Month 6.5(V7) | NA Relative luminescence units (RLU) |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-50 - HXB2 - Month 6.5(V7) | NA Relative luminescence units (RLU) |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-50 - SC422661.8 - Month 2.5(V5) | NA Relative luminescence units (RLU) |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-50 - SC422661.8 - Month 6.5(V7) | NA Relative luminescence units (RLU) |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-50 - W61D(TCLA).71 - Month 2.5(V5) | NA Relative luminescence units (RLU) |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-50 - W61D(TCLA).71 - Month 6.5(V7) | NA Relative luminescence units (RLU) |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-80 - HXB2 - Month 2.5(V5) | NA Relative luminescence units (RLU) |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-80 - HXB2 - Month 6.5(V7) | NA Relative luminescence units (RLU) |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-80 - SC422661.8 - Month 2.5(V5) | NA Relative luminescence units (RLU) |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-80 - W61D(TCLA).71 - Month 2.5(V5) | NA Relative luminescence units (RLU) |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-80 - W61D(TCLA).71 - Month 6.5(V7) | NA Relative luminescence units (RLU) |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-50 - HXB2 - Month 2.5(V5) | NA Relative luminescence units (RLU) |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-50 - HXB2 - Month 6.5(V7) | NA Relative luminescence units (RLU) |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-50 - SC422661.8 - Month 6.5(V7) | NA Relative luminescence units (RLU) |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-80 - HXB2 - Month 6.5(V7) | NA Relative luminescence units (RLU) |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-80 - W61D(TCLA).71 - Month 6.5(V7) | NA Relative luminescence units (RLU) |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-80 - SC422661.8 - Month 2.5(V5) | NA Relative luminescence units (RLU) |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-50 - SC422661.8 - Month 2.5(V5) | NA Relative luminescence units (RLU) |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-50 - HXB2 - Month 2.5(V5) | NA Relative luminescence units (RLU) |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-80 - SC422661.8 - Month 6.5(V7) | NA Relative luminescence units (RLU) |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-80 - W61D(TCLA).71 - Month 2.5(V5) | NA Relative luminescence units (RLU) |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-50 - W61D(TCLA).71 - Month 2.5(V5) | NA Relative luminescence units (RLU) |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-50 - W61D(TCLA).71 - Month 6.5(V7) | NA Relative luminescence units (RLU) |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-80 - HXB2 - Month 2.5(V5) | NA Relative luminescence units (RLU) |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-80 - W61D(TCLA).71 - Month 2.5(V5) | NA Relative luminescence units (RLU) |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-80 - HXB2 - Month 2.5(V5) | NA Relative luminescence units (RLU) |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-80 - SC422661.8 - Month 6.5(V7) | NA Relative luminescence units (RLU) |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-50 - HXB2 - Month 2.5(V5) | NA Relative luminescence units (RLU) |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-50 - HXB2 - Month 6.5(V7) | NA Relative luminescence units (RLU) |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-80 - HXB2 - Month 6.5(V7) | NA Relative luminescence units (RLU) |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-50 - SC422661.8 - Month 2.5(V5) | NA Relative luminescence units (RLU) |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-80 - W61D(TCLA).71 - Month 6.5(V7) | NA Relative luminescence units (RLU) |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-50 - SC422661.8 - Month 6.5(V7) | NA Relative luminescence units (RLU) |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-80 - SC422661.8 - Month 2.5(V5) | NA Relative luminescence units (RLU) |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-50 - W61D(TCLA).71 - Month 2.5(V5) | NA Relative luminescence units (RLU) |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes | ID-50 - W61D(TCLA).71 - Month 6.5(V7) | NA Relative luminescence units (RLU) |
Secondary
Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response
Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl and TZM-bl/Fcg RI cells . Assays in both cell lines measured neutralization titers as a function of a reduction in Tat-induced luciferase reporter gene expression after a single round of infection with Env-pseudotyped viruses. Test samples were assayed against a panel of HIV-1 strains that exhibit heightened susceptible to neutralization by MPER bnAbs in TZM-bl/Fcg RI cells.
Time frame: Measured at Month 2.5(V5) and Month 6.5(V7)
Population: Avaiable Data at V5 and V7
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response | ID-80 - SC422661.8 - Month 6.5(V7) | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response | ID-80 - W61D(TCLA).71 - Month 6.5(V7) | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response | ID-80 - HXB2 - Month 6.5(V7) | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response | ID-50 - HXB2 - Month 2.5(V5) | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response | ID-80 - SC422661.8 - Month 2.5(V5) | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response | ID-50 - SC422661.8 - Month 2.5(V5) | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response | ID-50 - SC422661.8 - Month 6.5(V7) | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response | ID-50 - HXB2 - Month 6.5(V7) | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response | ID-80 - W61D(TCLA).71 - Month 2.5(V5) | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response | ID-50 - W61D(TCLA).71 - Month 2.5(V5) | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response | ID-50 - W61D(TCLA).71 - Month 6.5(V7) | 0 Participants |
| Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response | ID-80 - HXB2 - Month 2.5(V5) | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response | ID-50 - HXB2 - Month 6.5(V7) | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response | ID-80 - HXB2 - Month 2.5(V5) | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response | ID-50 - SC422661.8 - Month 6.5(V7) | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response | ID-80 - SC422661.8 - Month 2.5(V5) | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response | ID-80 - SC422661.8 - Month 6.5(V7) | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response | ID-80 - HXB2 - Month 6.5(V7) | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response | ID-50 - HXB2 - Month 2.5(V5) | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response | ID-50 - W61D(TCLA).71 - Month 6.5(V7) | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response | ID-50 - W61D(TCLA).71 - Month 2.5(V5) | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response | ID-50 - SC422661.8 - Month 2.5(V5) | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response | ID-80 - W61D(TCLA).71 - Month 6.5(V7) | 0 Participants |
| Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response | ID-80 - W61D(TCLA).71 - Month 2.5(V5) | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response | ID-80 - HXB2 - Month 6.5(V7) | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response | ID-50 - HXB2 - Month 2.5(V5) | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response | ID-50 - HXB2 - Month 6.5(V7) | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response | ID-50 - SC422661.8 - Month 2.5(V5) | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response | ID-50 - SC422661.8 - Month 6.5(V7) | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response | ID-50 - W61D(TCLA).71 - Month 2.5(V5) | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response | ID-50 - W61D(TCLA).71 - Month 6.5(V7) | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response | ID-80 - HXB2 - Month 2.5(V5) | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response | ID-80 - SC422661.8 - Month 2.5(V5) | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response | ID-80 - SC422661.8 - Month 6.5(V7) | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response | ID-80 - W61D(TCLA).71 - Month 2.5(V5) | 0 Participants |
| Control 1: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response | ID-80 - W61D(TCLA).71 - Month 6.5(V7) | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response | ID-50 - W61D(TCLA).71 - Month 6.5(V7) | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response | ID-50 - W61D(TCLA).71 - Month 2.5(V5) | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response | ID-50 - HXB2 - Month 2.5(V5) | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response | ID-80 - SC422661.8 - Month 6.5(V7) | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response | ID-50 - SC422661.8 - Month 6.5(V7) | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response | ID-50 - SC422661.8 - Month 2.5(V5) | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response | ID-80 - W61D(TCLA).71 - Month 6.5(V7) | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response | ID-80 - W61D(TCLA).71 - Month 2.5(V5) | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response | ID-80 - HXB2 - Month 6.5(V7) | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response | ID-80 - HXB2 - Month 2.5(V5) | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response | ID-50 - HXB2 - Month 6.5(V7) | 0 Participants |
| Control 2: Placebo for MPER-656 mo(0,2,6,12) | Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response | ID-80 - SC422661.8 - Month 2.5(V5) | 0 Participants |