search
Back to results

A Study to Assess the Efficacy of a Heterologous Prime/Boost Vaccine Regimen of Ad26.Mos4.HIV and Aluminum Phosphate-Adjuvanted Clade C gp140 in Preventing Human Immunodeficiency Virus (HIV) -1 Infection in Women in Sub-Saharan Africa

Primary Purpose

HIV-1

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ad26.Mos4.HIV
Clade C gp140
Placebo
Sponsored by
Janssen Vaccines & Prevention B.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV-1

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Sexually active, defined as having had sexual intercourse with a male partner at least twice in the past 30 days prior to screening, and is considered by the site staff to be at risk for Human Immunodeficiency Virus (HIV) infection
  • Access to a participating HIV Vaccine Trials Network (HVTN) Clinical Research Sites (CRS) and willingness to be followed for the planned duration of the study
  • Willingness to discuss HIV infection risks and willing to receive HIV risk reduction counseling and appropriate referrals to minimize HIV acquisition, as applicable
  • Negative beta human chorionic gonadotropin (beta-HCG) pregnancy test performed prior to vaccination on the day of initial vaccination. Persons who are NOT of reproductive potential due to having undergone total hysterectomy or bilateral oophorectomy (verified by medical records), are not required to undergo pregnancy testing
  • Participants must also agree not to seek pregnancy through alternative methods, such as artificial insemination or in vitro fertilization until 3 months after the last vaccination

Exclusion Criteria:

  • Investigational research agents received within 30 days before first vaccination
  • HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received control/placebo in an HIV vaccine trial, the HVTN 705/HPX2008 (Protocol Safety Review Team) PSRT will determine eligibility on a case-by-case basis
  • Live attenuated vaccines received within 30 days before first vaccination or scheduled within 14 days after injection (example: measles, mumps, and rubella [MMR]; oral polio vaccine [OPV]; varicella; yellow fever)
  • Any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination (example, tetanus, pneumococcal, Hepatitis A or B)
  • Immunosuppressive medications received within 6 months before first vaccination

Sites / Locations

  • UNC Lilongwe Project
  • Polana Caniço Health Research and Training Center (CISPOC)
  • Josha Research
  • Masiphumelele Research Centre
  • Ndlovu Elandsdoorn Site
  • Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital
  • Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital
  • The Aurum Institute Klerksdorp Clinical Research Centre
  • Qhakaza Mbokodo Research Centre
  • South African Medical Research Council Chatsworth Clinical Research Site
  • Centre for the AIDS Programme of Research in South Africa
  • South African Medical Research Council Tongaat Clinical Research Site
  • Stanza Clinical Research Centre : Mamelodi
  • Nelson Mandela Academic Clinical Research Unit 'NeMACRU'
  • MeCRU Clinical Research Unit
  • The Aurum Institute Rustenburg Clinical Research Site
  • Setshaba Research Centre
  • The Aurum Institute: Tembisa - Clinic 4
  • Centre for Infectious Disease Research in Zambia (CIDRZ)
  • Center for Family Health Research in Zambia (CFHRZ)
  • Center for Family Health Research in Zambia (CFHRZ)
  • St Mary's Clinic
  • University of Zimbabwe-UCSF

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group 1

Group 2

Arm Description

Participants will receive Ad26.Mos4.HIV 5*10^10 virus particles (vp) as 0.5 milliliter (mL) via Intramuscular (IM) injection into the left deltoid on Months 0, 3, 6, and 12 and Clade C gp140 (250 [microgram] mcg) mixed with Aluminum phosphate adjuvant as 0.5 mL IM into the right deltoid on Months 6 and 12.

Participants will receive Placebo for Ad26.Mos4.HIV as 0.5 mL into the left deltoid on Months 0, 3, 6, and 12 and Placebo for Clade C gp140 / Aluminum phosphate adjuvant as 0.5 mL IM into the right deltoid on Months 6 and 12.

Outcomes

Primary Outcome Measures

Number of Participants With Human Immuno Deficiency Virus-1 (HIV-1) Infection Diagnosed Between Month 7 to Month 24 Post Enrollment
Number of participants with HIV-1 infection diagnosed between Month 7 to Month 24 post enrollment was reported. The data represents the cumulative incidence of HIV-1 infections.
Percentage of Participants With Local Reactogenicity Signs and Symptoms After First Vaccination
Percentage of participants with local reactogenicity signs and symptoms after first vaccination were reported. Local reactogenicity events (solicited local adverse events) were defined as events at the injection site. Local reactogenicity signs and symptoms included pain and/or tenderness proximal to the injection site.
Percentage of Participants With Local Reactogenicity Signs and Symptoms After Second Vaccination
Percentage of participants with local reactogenicity signs and symptoms after second vaccination was reported. Local reactogenicity events (solicited local adverse events) were defined as events at the injection site. Local reactogenicity signs and symptoms included pain and/or tenderness proximal to the injection site.
Percentage of Participants With Local Reactogenicity Signs and Symptoms After Third Vaccination
Percentage of participants with local reactogenicity signs and symptoms after third vaccination was reported. Local reactogenicity events (solicited local adverse events) were defined as events at the injection site. Local reactogenicity signs and symptoms included pain and/or tenderness proximal to the injection site.
Percentage of Participants With Local Reactogenicity Signs and Symptoms After Fourth Vaccination
Percentage of participants with local reactogenicity signs and symptoms after fourth vaccination was reported. Local reactogenicity events (solicited local adverse events) were defined as events at the injection site. Local reactogenicity signs and symptoms included pain and/or tenderness proximal to the injection site.
Percentage of Participants With Systematic Reactogenicity Signs and Symptoms After First Vaccination
Percentage of participants with systematic reactogenicity signs and symptoms after first vaccination was reported. Systemic reactogenicity events (solicited systemic adverse events) defined as events occurred in a predefined post-vaccination period for which the subject was specifically questioned. Systemic reactogenicity signs and symptoms included increased body temperature, malaise and/or fatigue, myalgia, headache, chills, arthralgia, nausea, and vomiting.
Percentage of Participants With Systematic Reactogenicity Signs and Symptoms After Second Vaccination
Percentage of participants with systematic reactogenicity signs and symptoms after second vaccination was reported. Systemic reactogenicity events (solicited systemic adverse events) defined as events occurred in a predefined post-vaccination period for which the subject was specifically questioned. Systemic reactogenicity signs and symptoms included increased body temperature, malaise and/or fatigue, myalgia, headache, chills, arthralgia, nausea, and vomiting.
Percentage of Participants With Systematic Reactogenicity Signs and Symptoms After Third Vaccination
Percentage of participants with systematic reactogenicity signs and symptoms after third vaccination was reported. Systemic reactogenicity events (solicited systemic adverse events) defined as events occurred in a predefined post-vaccination period for which the subject was specifically questioned. Systemic reactogenicity signs and symptoms included increased body temperature, malaise and/or fatigue, myalgia, headache, chills, arthralgia, nausea, and vomiting.
Percentage of Participants With Systematic Reactogenicity Signs and Symptoms After Fourth Vaccination
Percentage of participants with systematic reactogenicity signs and symptoms after fourth vaccination was reported. Systemic reactogenicity events (solicited systemic adverse events) defined as events occurred in a predefined post-vaccination period for which the subject was specifically questioned. Systemic reactogenicity signs and symptoms included increased body temperature, malaise and/or fatigue, myalgia, headache, chills, arthralgia, nausea, and vomiting.
Percentage of Participants With Unsolicited Adverse Events (AEs) for 30 Days After First Vaccination
An AE is any untoward medical occurrence in a clinical investigation participant administered a study product and which does not necessarily have a causal relationship with the study treatment. The most frequent unsolicited AEs were upper respiratory tract infection, back pain, cough, and hypertension.
Percentage of Participants With Unsolicited AEs for 30 Days After Second Vaccination
An AE is any untoward medical occurrence in a clinical investigation participant administered a study product and which does not necessarily have a causal relationship with the study treatment. The most frequent unsolicited AEs were upper respiratory tract infection, back pain, cough, and hypertension.
Percentage of Participants With Unsolicited AEs for 30 Days After Third Vaccination
An AE is any untoward medical occurrence in a clinical investigation participant administered a study product and which does not necessarily have a causal relationship with the study treatment. The most frequent unsolicited AEs were upper respiratory tract infection, back pain, cough, and hypertension.
Percentage of Participants With Unsolicited AEs for 30 Days After Fourth Vaccination
An AE is any untoward medical occurrence in a clinical investigation participant administered a study product and which does not necessarily have a causal relationship with the study treatment. The most frequent unsolicited AEs were upper respiratory tract infection, back pain, cough, and hypertension.
Percentage of Participants With Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical investigation participant administered a study product and which does not necessarily have a causal relationship with the study treatment. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
Percentage of Participants With Adverse Events of Special Interest (AESIs)
Percentage of participants with AESIs was reported. Immune-mediated diseases were considered as AESIs in this study.
Percentage of Participants With AEs Leading to Early Participant Withdrawal or Early Discontinuation of Study Product
Percentage of participants with AEs leading to early participant withdrawal or early discontinuation of study product were reported. An AE is any untoward medical occurrence in a clinical investigation participant administered a study product and which does not necessarily have a causal relationship with this treatment.

Secondary Outcome Measures

Number of Participants With HIV-1 Infection Diagnosed From Enrollment (Baseline) Through Month 24 Post Enrollment
Number of participants with HIV-1 infection diagnosed from enrollment (baseline) through month 24 post enrollment was reported. The data represents the cumulative incidence of HIV-1 infections.
Number of Participants With HIV-1 Infection Diagnosed From Enrollment (Baseline) Through Month 36 (End of Study) Post Enrollment
Number of participants with HIV-1 infection diagnosed from enrollment (baseline) through Month 36 post enrollment was reported. The data represents the cumulative incidence of HIV-1 infections.
Number of Participants With HIV-1 Infection Diagnosed From Month 13 Through Month 24 Post Enrollment
Number of participants with HIV-1 infection diagnosed from Month 13 through Month 24 post enrollment was reported. The data represents the cumulative incidence of HIV-1 infections.
Number of Participants With HIV-1 Infection Diagnosed From Month 13 Through Month 36 (End of Study) Post Enrollment
Number of participants with HIV-1 infection diagnosed from Month 13 through Month 36 (end of study) post enrollment was reported. The data represents the cumulative incidence of HIV-1 infections.
Geometric Mean of Binding Antibody Responses to HIV Envelop (ENV) Clade (gp140) C (ZA) Analyzed by Enzyme-linked Immunosorbent Assay (ELISA)
A weighted geometric mean of the binding antibody responses to HIV envelope (ENV) gp140 Clade C 97ZA protein analyzed by ELISA was reported.
Geometric Mean of Interferon-gamma (IFN-gamma) T-Cells Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot)
Geometric mean of IFN-gamma T-cells responses analyzed by ELISpot were reported. A weighted geometric mean of the number of spot-forming cells (SFC) per million peripheral blood mononuclear cells (PBMCs) producing Interferon-gamma upon stimulation with potential T-cell epitope (PTE) ENV peptide pools analyzed by ELISpot was reported. Reported responses are the sum of the number of SFCs/10^6 PBMCS for PTE Env1, Env2 and Env3 sub-pools.
Number of Participants With Viral Sequences
Number of participants with viral sequences were reported. Viral sequencing was conducted on the earliest available plasma specimens with positive HIV-1 ribose nucleic acid polymerase chain reaction (RNA PCR) tests from study participants who were diagnosed with HIV-1 infection.

Full Information

First Posted
February 17, 2017
Last Updated
March 24, 2023
Sponsor
Janssen Vaccines & Prevention B.V.
search

1. Study Identification

Unique Protocol Identification Number
NCT03060629
Brief Title
A Study to Assess the Efficacy of a Heterologous Prime/Boost Vaccine Regimen of Ad26.Mos4.HIV and Aluminum Phosphate-Adjuvanted Clade C gp140 in Preventing Human Immunodeficiency Virus (HIV) -1 Infection in Women in Sub-Saharan Africa
Official Title
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2b Efficacy Study of a Heterologous Prime/Boost Vaccine Regimen of Ad26.Mos4.HIV and Aluminum Phosphate-adjuvanted Clade C gp140 in Preventing HIV-1 Infection in Adult Women in Sub-Saharan Africa
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Study was terminated by the sponsor after the last participant completed the Month 24 visit as the pre-specified criteria to continue the study were not met.
Study Start Date
November 3, 2017 (Actual)
Primary Completion Date
February 2, 2022 (Actual)
Study Completion Date
February 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Vaccines & Prevention B.V.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary purpose of this study is to assess the preventive vaccine efficacy (VE), safety and tolerability of a heterologous prime/boost regimen utilizing Ad26.Mos4.HIV and aluminum-phosphate adjuvanted Clade C gp 140 for the prevention of Human Immuno Virus (HIV) infection in HIV-seronegative women residing in sub-Saharan Africa from confirmed HIV-1 infections diagnosed between the Month 7 and Month 24 visits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV-1

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Sponsor will be also blinded
Allocation
Randomized
Enrollment
2636 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Participants will receive Ad26.Mos4.HIV 5*10^10 virus particles (vp) as 0.5 milliliter (mL) via Intramuscular (IM) injection into the left deltoid on Months 0, 3, 6, and 12 and Clade C gp140 (250 [microgram] mcg) mixed with Aluminum phosphate adjuvant as 0.5 mL IM into the right deltoid on Months 6 and 12.
Arm Title
Group 2
Arm Type
Placebo Comparator
Arm Description
Participants will receive Placebo for Ad26.Mos4.HIV as 0.5 mL into the left deltoid on Months 0, 3, 6, and 12 and Placebo for Clade C gp140 / Aluminum phosphate adjuvant as 0.5 mL IM into the right deltoid on Months 6 and 12.
Intervention Type
Biological
Intervention Name(s)
Ad26.Mos4.HIV
Intervention Description
Participants will receive Ad26.Mos4.HIV 5x10^10 virus particles (vp) as 0.5 milliliter (mL) via Intramuscular (IM) into the left deltoid on Months 0, 3, 6, and 12.
Intervention Type
Biological
Intervention Name(s)
Clade C gp140
Intervention Description
Participants will receive Clade C gp140 (250 mcg) mixed with Aluminum phosphate adjuvant as 0.5 mL IM into the right deltoid on Months 6 and 12.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Participants will receive matching placebo.
Primary Outcome Measure Information:
Title
Number of Participants With Human Immuno Deficiency Virus-1 (HIV-1) Infection Diagnosed Between Month 7 to Month 24 Post Enrollment
Description
Number of participants with HIV-1 infection diagnosed between Month 7 to Month 24 post enrollment was reported. The data represents the cumulative incidence of HIV-1 infections.
Time Frame
Month 7 up to Month 24
Title
Percentage of Participants With Local Reactogenicity Signs and Symptoms After First Vaccination
Description
Percentage of participants with local reactogenicity signs and symptoms after first vaccination were reported. Local reactogenicity events (solicited local adverse events) were defined as events at the injection site. Local reactogenicity signs and symptoms included pain and/or tenderness proximal to the injection site.
Time Frame
Up to 7 days after first vaccination on Day 0 (Day 7)
Title
Percentage of Participants With Local Reactogenicity Signs and Symptoms After Second Vaccination
Description
Percentage of participants with local reactogenicity signs and symptoms after second vaccination was reported. Local reactogenicity events (solicited local adverse events) were defined as events at the injection site. Local reactogenicity signs and symptoms included pain and/or tenderness proximal to the injection site.
Time Frame
Up to 7 days after second vaccination on Day 84 (Day 91)
Title
Percentage of Participants With Local Reactogenicity Signs and Symptoms After Third Vaccination
Description
Percentage of participants with local reactogenicity signs and symptoms after third vaccination was reported. Local reactogenicity events (solicited local adverse events) were defined as events at the injection site. Local reactogenicity signs and symptoms included pain and/or tenderness proximal to the injection site.
Time Frame
Up to 7 days after third vaccination on Day 168 (Up to Day 175)
Title
Percentage of Participants With Local Reactogenicity Signs and Symptoms After Fourth Vaccination
Description
Percentage of participants with local reactogenicity signs and symptoms after fourth vaccination was reported. Local reactogenicity events (solicited local adverse events) were defined as events at the injection site. Local reactogenicity signs and symptoms included pain and/or tenderness proximal to the injection site.
Time Frame
Up to 7 days after fourth vaccination on Day 364 (Up to Day 371)
Title
Percentage of Participants With Systematic Reactogenicity Signs and Symptoms After First Vaccination
Description
Percentage of participants with systematic reactogenicity signs and symptoms after first vaccination was reported. Systemic reactogenicity events (solicited systemic adverse events) defined as events occurred in a predefined post-vaccination period for which the subject was specifically questioned. Systemic reactogenicity signs and symptoms included increased body temperature, malaise and/or fatigue, myalgia, headache, chills, arthralgia, nausea, and vomiting.
Time Frame
Up to 7 days after first vaccination on Day 0 (Day 7)
Title
Percentage of Participants With Systematic Reactogenicity Signs and Symptoms After Second Vaccination
Description
Percentage of participants with systematic reactogenicity signs and symptoms after second vaccination was reported. Systemic reactogenicity events (solicited systemic adverse events) defined as events occurred in a predefined post-vaccination period for which the subject was specifically questioned. Systemic reactogenicity signs and symptoms included increased body temperature, malaise and/or fatigue, myalgia, headache, chills, arthralgia, nausea, and vomiting.
Time Frame
Up to 7 days after second vaccination on Day 84 (Day 91)
Title
Percentage of Participants With Systematic Reactogenicity Signs and Symptoms After Third Vaccination
Description
Percentage of participants with systematic reactogenicity signs and symptoms after third vaccination was reported. Systemic reactogenicity events (solicited systemic adverse events) defined as events occurred in a predefined post-vaccination period for which the subject was specifically questioned. Systemic reactogenicity signs and symptoms included increased body temperature, malaise and/or fatigue, myalgia, headache, chills, arthralgia, nausea, and vomiting.
Time Frame
Up to 7 days after third vaccination on Day 168 (Up to Day 175)
Title
Percentage of Participants With Systematic Reactogenicity Signs and Symptoms After Fourth Vaccination
Description
Percentage of participants with systematic reactogenicity signs and symptoms after fourth vaccination was reported. Systemic reactogenicity events (solicited systemic adverse events) defined as events occurred in a predefined post-vaccination period for which the subject was specifically questioned. Systemic reactogenicity signs and symptoms included increased body temperature, malaise and/or fatigue, myalgia, headache, chills, arthralgia, nausea, and vomiting.
Time Frame
Up to 7 days after fourth vaccination on Day 364 (Up to Day 371)
Title
Percentage of Participants With Unsolicited Adverse Events (AEs) for 30 Days After First Vaccination
Description
An AE is any untoward medical occurrence in a clinical investigation participant administered a study product and which does not necessarily have a causal relationship with the study treatment. The most frequent unsolicited AEs were upper respiratory tract infection, back pain, cough, and hypertension.
Time Frame
30 days after first vaccination on Day 0 (Up to Day 30)
Title
Percentage of Participants With Unsolicited AEs for 30 Days After Second Vaccination
Description
An AE is any untoward medical occurrence in a clinical investigation participant administered a study product and which does not necessarily have a causal relationship with the study treatment. The most frequent unsolicited AEs were upper respiratory tract infection, back pain, cough, and hypertension.
Time Frame
30 days after second vaccination on Day 84 (Up to Day 114)
Title
Percentage of Participants With Unsolicited AEs for 30 Days After Third Vaccination
Description
An AE is any untoward medical occurrence in a clinical investigation participant administered a study product and which does not necessarily have a causal relationship with the study treatment. The most frequent unsolicited AEs were upper respiratory tract infection, back pain, cough, and hypertension.
Time Frame
30 days after third vaccination on Day 168 (Up to Day 198)
Title
Percentage of Participants With Unsolicited AEs for 30 Days After Fourth Vaccination
Description
An AE is any untoward medical occurrence in a clinical investigation participant administered a study product and which does not necessarily have a causal relationship with the study treatment. The most frequent unsolicited AEs were upper respiratory tract infection, back pain, cough, and hypertension.
Time Frame
30 days after fourth vaccination on Day 364 (Up to Day 394)
Title
Percentage of Participants With Serious Adverse Events (SAEs)
Description
An AE is any untoward medical occurrence in a clinical investigation participant administered a study product and which does not necessarily have a causal relationship with the study treatment. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
Time Frame
Up to Month 36 (up to end of the study)
Title
Percentage of Participants With Adverse Events of Special Interest (AESIs)
Description
Percentage of participants with AESIs was reported. Immune-mediated diseases were considered as AESIs in this study.
Time Frame
Up to Month 36 (up to end of the study)
Title
Percentage of Participants With AEs Leading to Early Participant Withdrawal or Early Discontinuation of Study Product
Description
Percentage of participants with AEs leading to early participant withdrawal or early discontinuation of study product were reported. An AE is any untoward medical occurrence in a clinical investigation participant administered a study product and which does not necessarily have a causal relationship with this treatment.
Time Frame
Up to Month 36 (up to end of the study)
Secondary Outcome Measure Information:
Title
Number of Participants With HIV-1 Infection Diagnosed From Enrollment (Baseline) Through Month 24 Post Enrollment
Description
Number of participants with HIV-1 infection diagnosed from enrollment (baseline) through month 24 post enrollment was reported. The data represents the cumulative incidence of HIV-1 infections.
Time Frame
Baseline up to Month 24
Title
Number of Participants With HIV-1 Infection Diagnosed From Enrollment (Baseline) Through Month 36 (End of Study) Post Enrollment
Description
Number of participants with HIV-1 infection diagnosed from enrollment (baseline) through Month 36 post enrollment was reported. The data represents the cumulative incidence of HIV-1 infections.
Time Frame
Baseline up to Month 36 (End of study)
Title
Number of Participants With HIV-1 Infection Diagnosed From Month 13 Through Month 24 Post Enrollment
Description
Number of participants with HIV-1 infection diagnosed from Month 13 through Month 24 post enrollment was reported. The data represents the cumulative incidence of HIV-1 infections.
Time Frame
Month 13 up to Month 24
Title
Number of Participants With HIV-1 Infection Diagnosed From Month 13 Through Month 36 (End of Study) Post Enrollment
Description
Number of participants with HIV-1 infection diagnosed from Month 13 through Month 36 (end of study) post enrollment was reported. The data represents the cumulative incidence of HIV-1 infections.
Time Frame
Month 13 up to Month 36 (End of study)
Title
Geometric Mean of Binding Antibody Responses to HIV Envelop (ENV) Clade (gp140) C (ZA) Analyzed by Enzyme-linked Immunosorbent Assay (ELISA)
Description
A weighted geometric mean of the binding antibody responses to HIV envelope (ENV) gp140 Clade C 97ZA protein analyzed by ELISA was reported.
Time Frame
Months 0, 7, 13 and 24
Title
Geometric Mean of Interferon-gamma (IFN-gamma) T-Cells Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot)
Description
Geometric mean of IFN-gamma T-cells responses analyzed by ELISpot were reported. A weighted geometric mean of the number of spot-forming cells (SFC) per million peripheral blood mononuclear cells (PBMCs) producing Interferon-gamma upon stimulation with potential T-cell epitope (PTE) ENV peptide pools analyzed by ELISpot was reported. Reported responses are the sum of the number of SFCs/10^6 PBMCS for PTE Env1, Env2 and Env3 sub-pools.
Time Frame
Months 0, 7, 13 and 24
Title
Number of Participants With Viral Sequences
Description
Number of participants with viral sequences were reported. Viral sequencing was conducted on the earliest available plasma specimens with positive HIV-1 ribose nucleic acid polymerase chain reaction (RNA PCR) tests from study participants who were diagnosed with HIV-1 infection.
Time Frame
Month 7 up to Month 24

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Sexually active, defined as having had sexual intercourse with a male partner at least twice in the past 30 days prior to screening, and is considered by the site staff to be at risk for Human Immunodeficiency Virus (HIV) infection Access to a participating HIV Vaccine Trials Network (HVTN) Clinical Research Sites (CRS) and willingness to be followed for the planned duration of the study Willingness to discuss HIV infection risks and willing to receive HIV risk reduction counseling and appropriate referrals to minimize HIV acquisition, as applicable Negative beta human chorionic gonadotropin (beta-HCG) pregnancy test performed prior to vaccination on the day of initial vaccination. Persons who are NOT of reproductive potential due to having undergone total hysterectomy or bilateral oophorectomy (verified by medical records), are not required to undergo pregnancy testing Participants must also agree not to seek pregnancy through alternative methods, such as artificial insemination or in vitro fertilization until 3 months after the last vaccination Exclusion Criteria: Investigational research agents received within 30 days before first vaccination HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received control/placebo in an HIV vaccine trial, the HVTN 705/HPX2008 (Protocol Safety Review Team) PSRT will determine eligibility on a case-by-case basis Live attenuated vaccines received within 30 days before first vaccination or scheduled within 14 days after injection (example: measles, mumps, and rubella [MMR]; oral polio vaccine [OPV]; varicella; yellow fever) Any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination (example, tetanus, pneumococcal, Hepatitis A or B) Immunosuppressive medications received within 6 months before first vaccination
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Vaccines & Prevention B.V. Clinical Trial
Organizational Affiliation
Janssen Vaccines & Prevention B.V.
Official's Role
Study Director
Facility Information:
Facility Name
UNC Lilongwe Project
City
Lilongwe
Country
Malawi
Facility Name
Polana Caniço Health Research and Training Center (CISPOC)
City
Maputo
Country
Mozambique
Facility Name
Josha Research
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Masiphumelele Research Centre
City
Cape Town
ZIP/Postal Code
7975
Country
South Africa
Facility Name
Ndlovu Elandsdoorn Site
City
Dennilton
ZIP/Postal Code
0485
Country
South Africa
Facility Name
Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital
City
Diepkloof
ZIP/Postal Code
1862
Country
South Africa
Facility Name
Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital
City
Johannesburg
ZIP/Postal Code
1862
Country
South Africa
Facility Name
The Aurum Institute Klerksdorp Clinical Research Centre
City
Klerksdorp
ZIP/Postal Code
2571
Country
South Africa
Facility Name
Qhakaza Mbokodo Research Centre
City
KwaZulu-Natal
ZIP/Postal Code
4030
Country
South Africa
Facility Name
South African Medical Research Council Chatsworth Clinical Research Site
City
KwaZulu-Natal
ZIP/Postal Code
4030
Country
South Africa
Facility Name
Centre for the AIDS Programme of Research in South Africa
City
KwaZulu-Natal
ZIP/Postal Code
4110
Country
South Africa
Facility Name
South African Medical Research Council Tongaat Clinical Research Site
City
KwaZulu-Natal
ZIP/Postal Code
4399
Country
South Africa
Facility Name
Stanza Clinical Research Centre : Mamelodi
City
Mamelodi East
ZIP/Postal Code
122
Country
South Africa
Facility Name
Nelson Mandela Academic Clinical Research Unit 'NeMACRU'
City
Mthatha
ZIP/Postal Code
5099
Country
South Africa
Facility Name
MeCRU Clinical Research Unit
City
Pretoria
ZIP/Postal Code
204
Country
South Africa
Facility Name
The Aurum Institute Rustenburg Clinical Research Site
City
Rustenburg
ZIP/Postal Code
300
Country
South Africa
Facility Name
Setshaba Research Centre
City
Soshanguve
ZIP/Postal Code
152
Country
South Africa
Facility Name
The Aurum Institute: Tembisa - Clinic 4
City
Tembisa
ZIP/Postal Code
1632
Country
South Africa
Facility Name
Centre for Infectious Disease Research in Zambia (CIDRZ)
City
Lusaka
ZIP/Postal Code
10101
Country
Zambia
Facility Name
Center for Family Health Research in Zambia (CFHRZ)
City
Lusaka
ZIP/Postal Code
P/BagE891
Country
Zambia
Facility Name
Center for Family Health Research in Zambia (CFHRZ)
City
Ndola
ZIP/Postal Code
240262
Country
Zambia
Facility Name
St Mary's Clinic
City
Chitungwiza
Country
Zimbabwe
Facility Name
University of Zimbabwe-UCSF
City
Harare - Seke South
Country
Zimbabwe

12. IPD Sharing Statement

Citations:
PubMed Identifier
30047376
Citation
Barouch DH, Tomaka FL, Wegmann F, Stieh DJ, Alter G, Robb ML, Michael NL, Peter L, Nkolola JP, Borducchi EN, Chandrashekar A, Jetton D, Stephenson KE, Li W, Korber B, Tomaras GD, Montefiori DC, Gray G, Frahm N, McElrath MJ, Baden L, Johnson J, Hutter J, Swann E, Karita E, Kibuuka H, Mpendo J, Garrett N, Mngadi K, Chinyenze K, Priddy F, Lazarus E, Laher F, Nitayapan S, Pitisuttithum P, Bart S, Campbell T, Feldman R, Lucksinger G, Borremans C, Callewaert K, Roten R, Sadoff J, Scheppler L, Weijtens M, Feddes-de Boer K, van Manen D, Vreugdenhil J, Zahn R, Lavreys L, Nijs S, Tolboom J, Hendriks J, Euler Z, Pau MG, Schuitemaker H. Evaluation of a mosaic HIV-1 vaccine in a multicentre, randomised, double-blind, placebo-controlled, phase 1/2a clinical trial (APPROACH) and in rhesus monkeys (NHP 13-19). Lancet. 2018 Jul 21;392(10143):232-243. doi: 10.1016/S0140-6736(18)31364-3. Epub 2018 Jul 6.
Results Reference
derived

Learn more about this trial

A Study to Assess the Efficacy of a Heterologous Prime/Boost Vaccine Regimen of Ad26.Mos4.HIV and Aluminum Phosphate-Adjuvanted Clade C gp140 in Preventing Human Immunodeficiency Virus (HIV) -1 Infection in Women in Sub-Saharan Africa

We'll reach out to this number within 24 hrs