Back to resultsA Study of Heterologous Vaccine Regimen of Adenovirus Serotype 26 Mosaic4 Human Immunodeficiency Virus(Ad26.Mos4.HIV), Adjuvanted Clade C gp140 and Mosaic gp140 to Prevent HIV-1 Infection Among Cis-gender Men and Transgender Individuals Who Have Sex With Cis-gender Men and/or Transgender Individuals (MOSAICO)
Primary Purpose
Healthy
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ad26.Mos4.HIV
Clade C and Mosaic gp140 HIV bivalent vaccine
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Healthy
Eligibility Criteria
Inclusion Criteria:
- Individual is either cis-gender man having sex with cis-gender men and/or transgender individuals or transgender woman having sex with cis-gender men and/or transgender individuals or transgender man having sex with cis-gender men and/or transgender women or gender non-conforming individual having receptive or insertive anal and/or vaginal condom-less intercourse and who is considered by the site staff to be at increased risk for HIV-1 infection. The potential participants must in the last 6 months have had any condom-less receptive anal or vaginal sex (not included is condom-less anal sex within a mutually monogamous relationship >=12 months if the partner is HIV negative or living with HIV and virally suppressed) or rectal or urethral gonorrhea or chlamydia or incident syphilis or any stimulant use or any other drug and/or substance which in the local context may be associated with increased HIV transmission (example, cocaine, amphetamine) or 5 or more sex partners
- Potential participant has a negative test result for HIV-1 and HIV-2 infection less than or equal to (<=) 28 days prior to first vaccination
- Potential participant must be healthy based on medical history, physical examination, and vital sign measurement performed at screening
- Contraceptive use by participants assigned female at birth and who have not had sexual reassignment surgery should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies
- All participants of childbearing potential must have a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening and have a negative urine beta-hCG pregnancy test immediately prior to each study vaccine administration
Exclusion Criteria:
- Potential participants choosing to use PrEP. However, once participants are enrolled and received their first vaccination, and they change their mind regarding PrEP usage, they will be allowed to take PrEP according to the site PrEP plan and will continue to receive further vaccinations. The use of long acting PrEP is disallowed from 24 months prior to Day 1
- Potential participant is a recipient of a HIV-vaccine candidate at any time, or a recipient of other experimental vaccine(s) within the last 12 months prior to Day 1. For participants who received an experimental vaccine (except HIV vaccine) more than 12 months prior to Day 1, documentation of the identity of the experimental vaccine must be provided to the HPX3002/HVTN 706 safety review team, who will determine eligibility on a case by-case basis. Exceptions: participants can be included if the vaccine received (except HIV vaccine) was subsequently licensed or authorized for emergency use (example, Emergency Use Authorization (EUA), Emergency Use Listing (EUL), or similar program). Participants with proof of having received only placebo can also be included. Participants who are currently still in an interventional study of such a licensed/emergency use-authorized vaccine are to be excluded from the current study
- Potential participant has received an HIV-related mAb, whether licensed or investigational, within the last 12 months prior to Day 1. For participants who received an HIV-related mAb more than 12 months prior to Day 1, documentation of the identity of the mAb must be provided to the HPX3002/HVTN 706 safety review team, who will determine eligibility on a case-by-case basis.
- Potential participant has known allergy or history of anaphylaxis or other serious adverse reactions to vaccines
- Pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 90 days after the last dose of study vaccination
Sites / Locations
- University of Alabama at Birmingham
- Bridge HIV
- Whitman Walker Health
- University of Miami
- Orlando Immunology Center
- Emory University Rollins School of Public Health - Ponce De Leon CRS
- The Hope Clinic at Emory University
- University Of Illinois
- New Orleans Adolescent Trials Unit CRS
- Dana-Farber/Brigham and Women's Hospital
- Fenway Health
- Rutgers, The State University of New Jersey - The University Hospital/ACTG Network
- Harlem Prevention Center CRS
- Columbia University Medical Center
- New York Blood Center
- Strong Memorial Infectious Disease
- University of Pennsylvania
- Vanderbilt University Medical Center
- Gordon E. Crofoot MD
- Seattle Vaccine Trials Unit
- Helios Salud Sa
- Fundacion Huesped
- Hospital J. M. Ramos Mejía
- Instituto Caici Srl.
- Universidade Federal De Minas Gerais - Hospital das Clínicas
- Centro Medico Sao Francisco
- Fundacao de Medicina Tropical Doutor Heitor Vieira Dourado - FMT
- Fundacao Oswaldo Cruz
- Municipio de Nova Iguacu - Hospital Geral de Nova Iguacu
- Instituto de infectologia Emilio Ribas
- Hospital Das Clinicas Da Faculdade De Medicina Da USP
- Centro de Referencia E Treinamento Dst/Aids
- Ospedale San Raffaele
- Azienda Ospedaliero-Universitaria Policlinico di Modena
- Istituto nazionale malattie infettive 'L. Spallanzani'
- Hospital Civil Fray Antonio Alcalde
- Unidad de Atención Medica e Investigacion en Salud (UNAMIS)
- Inst. Nal. de Ciencias Med. Y Nutricion Salvador Zubiran
- Centro de Investigaciones Tecnologicas, Biomedica y medio ambientales (CITBM)
- Asociacion Civil Selva Amazonica (ACSA)
- Asociacion Civil Impacta Salud y Educacion - Barranco
- Asociacion Civil Impacta Salud y Educacion- San Miguel CRS
- Asociacion Civil Via Libre
- Neutrum Lekarze M.Hlebowicz i Partnerzy spolka partnerska
- Wroclawskie Centrum Zdrowia SPZOZ, Poradnia Profilaktyczno-Lecznicza
- Clinical Research Puerto Rico Inc
- University of Puerto Rico
- Hosp. Univ. Germans Trias I Pujol
- Hosp. Univ. Vall D Hebron
- Hosp. Reina Sofia
- Hosp. Univ. Fund. Jimenez Diaz
- Hosp. Clinico San Carlos
- Hosp. Gral. Univ. Valencia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Group1:Ad26.Mos4.HIV,Clade C and Mosaic gp140 bivalent vaccine
Group 2: Placebo
Arm Description
Participants will receive adenovirus serotype 26.Mosaic 4.human immunodeficiency virus (Ad26.Mos4.HIV) via intramuscular (IM) injection into the deltoid muscle at months 0 (Day 1) and 3 (preferably the deltoid of the non-dominant upper arm) and, Ad26.Mos4.HIV together with Clade C and Mosaic gp140 HIV bivalent vaccine IM into the deltoid muscle at Months 6 and 12 (different deltoid for each injection).
Participants will receive placebo into the deltoid muscle on Months 0 (Day 1), 3 (1 injection), 6 and 12 (2 injections).
Outcomes
Primary Outcome Measures
Vaccine Efficacy (VE) as Derived From Confirmed HIV-1 Infections Diagnosed Between the Month 7 and Month X (with 24 Less Than or Equal to [<=] X <= 30) Visits
Vaccine efficacy is defined as 1-cumulative incidence ratio (vaccine versus placebo) between Month 7 and Month X after first vaccination and is estimated by the transformation of the Nelson-Aalen estimator for the cumulative hazard function after enrollment in the per-protocol (PP) population. Here, month X will be between month 24 and month 30.
Secondary Outcome Measures
Number of Participants with Solicited Local and Systemic Adverse Events (AEs)
Number of participants with local solicited adverse events will be evaluated. An adverse event is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product and does not necessarily have a causal relationship with the intervention, therefore it can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. Solicited local AEs include assessment of pain/tenderness, erythema and swelling. Solicited systemic AEs: fatigue, headache, nausea, myalgia, chills, arthralgia, and vomiting will be assessed.
Number of Participants with Unsolicited Adverse Events
Number of Participants with unsolicited AEs will be evaluated. Unsolicited adverse events are all adverse events for which the participant is specifically not questioned in the participant diary.
Number of Participants with Adverse Events of Special Interest (AESIs)
Number of participants with AESIs will be reported. Thrombosis with thrombocytopenia syndrome is considered to be an AESI.
Number of Participants with Medically-attended adverse events (MAAEs)
Number of participants with MAAEs will be evaluated. MAAEs are defined as adverse events with medically attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason.
Number of Participants with Serious Adverse Events (SAEs)
Number of participants with SAE will be evaluated. An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
Number of Participants who Discontinue from the Study or Vaccination due to Adverse Events
Number of participants who discontinue from the study or vaccination due to AEs will be evaluated. Participants will be withdrawn from study vaccine administration due to unblinding due to safety reasons, Pregnancy, Confirmed HIV-1 infection, Any related adverse event, Worsening of health status or intercurrent illnesses that in the opinion of the investigator, Required discontinuation from study vaccine, Anaphylactic reaction following vaccination, Serious adverse event or other potentially life-threatening (Grade 4) event that is determined to be related to study vaccine, Chronic or recurrent use of systemic immunomodulators/suppressants, example, cancer chemotherapeutic agents (after discussion with the sponsor), Use of HIV-related monoclonal antibodies (mAbs).
Vaccine Efficacy as Derived From Confirmed HIV-1 Infections Diagnosed at VE (0-X months) per Modified Intent-to-Treat (mITT) Population
Vaccine efficacy is defined as 1-cumulative incidence ratio (vaccine versus placebo) between Month 0 and Month X after first vaccination and is estimated by the transformation of the Nelson-Aalen estimator for the cumulative hazard function per mITT populations. Here, month X will be between month 24 and month 30.
Vaccine Efficacy as Derived From Confirmed HIV-1 Infections Diagnosed at VE (13-X months) per mITT Population
Vaccine efficacy is defined as 1-cumulative incidence ratio (vaccine versus placebo) between Month 13 and Month X after first vaccination and is estimated by the transformation of the Nelson-Aalen estimator for the cumulative hazard function per mITT populations. Here, month X will be between month 24 and month 30.
Vaccine Efficacy Assessed by Demographic Characteristics
The vaccine efficacy assessed by demographic characteristics diagnosed by HIV-1 infection will be reported.
Number of Participants who are Ad26 Seropositive
Number of participants who are Ad26 seropositive will be assessed by vector neutralization assay.
Antibody Titers for Ad26 as Determined by Vector Neutralization Assay
Antibody titers will be determined by vector neutralization assay.
Sexual Risk Behavior as Assessed by Sexual Activity Questionnaire
Sexual risk behavior collected through sexual activity questionnaire (composed with 36 questions) in which participants will be asked about specific sexual activities.
Pre-Exposure Prophylaxis (PrEP) Uptake as Measured by Self Report Questionnaire
For HIV-negative participants, participants will be asked whether they use HIV PrEP as part of a self-report questionnaire (composed of 5 questions).
Full Information
NCT ID
NCT03964415
First Posted
May 24, 2019
Last Updated
September 13, 2023
Sponsor
Janssen Vaccines & Prevention B.V.
1. Study Identification
Unique Protocol Identification Number
NCT03964415
Brief Title
A Study of Heterologous Vaccine Regimen of Adenovirus Serotype 26 Mosaic4 Human Immunodeficiency Virus(Ad26.Mos4.HIV), Adjuvanted Clade C gp140 and Mosaic gp140 to Prevent HIV-1 Infection Among Cis-gender Men and Transgender Individuals Who Have Sex With Cis-gender Men and/or Transgender Individuals
Acronym
MOSAICO
Official Title
A Multi-center, Randomized, Double-blind, Placebo-controlled Phase 3 Efficacy Study of a Heterologous Vaccine Regimen of Ad26.Mos4.HIV and Adjuvanted Clade C gp140 and Mosaic gp140 to Prevent HIV-1 Infection Among Cis-gender Men and Transgender Individuals Who Have Sex With Cis-gender Men and/or Transgender Individuals
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 31, 2019 (Actual)
Primary Completion Date
August 10, 2023 (Actual)
Study Completion Date
August 10, 2023 (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 purpose of this study is to evaluate the vaccine efficacy (VE) of a heterologous vaccine regimen utilizing Ad26.Mos4.HIV and aluminum phosphate-adjuvanted Clade C gp140 and Mosaic gp140 for the prevention of HIV-1 infection in HIV-1 seronegative cis-gender men and transgender individuals having sex with cis-gender men and/or transgender individuals.
Detailed Description
Human immunodeficiency virus type 1 (HIV-1) is a retrovirus that, if left untreated, can progress to acquired immunodeficiency syndrome (AIDS), a condition in which the immune system is severely compromised, leading to life-threatening conditions. Ad26.Mos4.HIV is a tetravalent vaccine composed of Ad26.Mos1.Gag-Pol, Ad26.Mos2.Gag-Pol, Ad26.Mos1.Env, and Ad26.Mos2S.Env. Clade C and Mosaic gp140 HIV bivalent vaccine contains: Clade C gp140, HIV-1 Env gp140 of Clade C, Mosaic gp140, HIV-1 Env gp140, and aluminum phosphate adjuvant. Evidences showed that a combination of vaccination with Ad26.Mos.HIV followed by Ad26.Mos.HIV together with Clade C gp140 protein in aluminum phosphate adjuvant led to highest level of protection observed so far with this vaccine concept. Study comprises of a screening period of 45 days, a 12-month vaccination period and a follow-up period of at least 18 months after fourth vaccination (until Month 30) in participants who remain HIV-1 negative or up to 6 months after diagnosis of HIV-1 infection in participants who become HIV-1 infected. Participants who completed their Month 30 visit will be followed for HIV infection, medically-attended adverse event (MAAEs) and serious adverse events until the end of study (Month 30). Primary analysis of vaccine efficacy will evaluate the number of HIV-1 infections in the vaccine group compared to number of HIV-1 infections in the placebo group between Month 7 and Month X (with 24<=X<=30) in per-protocol population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
3900 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group1:Ad26.Mos4.HIV,Clade C and Mosaic gp140 bivalent vaccine
Arm Type
Experimental
Arm Description
Participants will receive adenovirus serotype 26.Mosaic 4.human immunodeficiency virus (Ad26.Mos4.HIV) via intramuscular (IM) injection into the deltoid muscle at months 0 (Day 1) and 3 (preferably the deltoid of the non-dominant upper arm) and, Ad26.Mos4.HIV together with Clade C and Mosaic gp140 HIV bivalent vaccine IM into the deltoid muscle at Months 6 and 12 (different deltoid for each injection).
Arm Title
Group 2: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo into the deltoid muscle on Months 0 (Day 1), 3 (1 injection), 6 and 12 (2 injections).
Intervention Type
Biological
Intervention Name(s)
Ad26.Mos4.HIV
Intervention Description
Participants will receive Ad26.Mos4.HIV via IM injection into the deltoid muscle at months 0 (Day 1), 3, 6 and 12.
Intervention Type
Biological
Intervention Name(s)
Clade C and Mosaic gp140 HIV bivalent vaccine
Intervention Description
Participants will receive Clade C and Mosaic gp140 HIV bivalent vaccine as IM injection into the deltoid muscle at Months 6 and 12.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Participants will receive matching placebo.
Primary Outcome Measure Information:
Title
Vaccine Efficacy (VE) as Derived From Confirmed HIV-1 Infections Diagnosed Between the Month 7 and Month X (with 24 Less Than or Equal to [<=] X <= 30) Visits
Description
Vaccine efficacy is defined as 1-cumulative incidence ratio (vaccine versus placebo) between Month 7 and Month X after first vaccination and is estimated by the transformation of the Nelson-Aalen estimator for the cumulative hazard function after enrollment in the per-protocol (PP) population. Here, month X will be between month 24 and month 30.
Time Frame
From Month 7 up to Month 30
Secondary Outcome Measure Information:
Title
Number of Participants with Solicited Local and Systemic Adverse Events (AEs)
Description
Number of participants with local solicited adverse events will be evaluated. An adverse event is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product and does not necessarily have a causal relationship with the intervention, therefore it can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. Solicited local AEs include assessment of pain/tenderness, erythema and swelling. Solicited systemic AEs: fatigue, headache, nausea, myalgia, chills, arthralgia, and vomiting will be assessed.
Time Frame
7 days after each vaccination on Months 0, 3, 6, and 12
Title
Number of Participants with Unsolicited Adverse Events
Description
Number of Participants with unsolicited AEs will be evaluated. Unsolicited adverse events are all adverse events for which the participant is specifically not questioned in the participant diary.
Time Frame
28 days after each vaccination on Months 0, 3, 6, and 12
Title
Number of Participants with Adverse Events of Special Interest (AESIs)
Description
Number of participants with AESIs will be reported. Thrombosis with thrombocytopenia syndrome is considered to be an AESI.
Time Frame
Up to 6 months after the last vaccination (Month 18)
Title
Number of Participants with Medically-attended adverse events (MAAEs)
Description
Number of participants with MAAEs will be evaluated. MAAEs are defined as adverse events with medically attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason.
Time Frame
Up to 43 Months (participants will be followed until the last participant reaches Month 30)
Title
Number of Participants with Serious Adverse Events (SAEs)
Description
Number of participants with SAE will be evaluated. An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
Time Frame
Up to 43 Months (participants will be followed until the last participant reaches Month 30)
Title
Number of Participants who Discontinue from the Study or Vaccination due to Adverse Events
Description
Number of participants who discontinue from the study or vaccination due to AEs will be evaluated. Participants will be withdrawn from study vaccine administration due to unblinding due to safety reasons, Pregnancy, Confirmed HIV-1 infection, Any related adverse event, Worsening of health status or intercurrent illnesses that in the opinion of the investigator, Required discontinuation from study vaccine, Anaphylactic reaction following vaccination, Serious adverse event or other potentially life-threatening (Grade 4) event that is determined to be related to study vaccine, Chronic or recurrent use of systemic immunomodulators/suppressants, example, cancer chemotherapeutic agents (after discussion with the sponsor), Use of HIV-related monoclonal antibodies (mAbs).
Time Frame
Up to 43 Months (participants will be followed until the last participant reaches Month 30)
Title
Vaccine Efficacy as Derived From Confirmed HIV-1 Infections Diagnosed at VE (0-X months) per Modified Intent-to-Treat (mITT) Population
Description
Vaccine efficacy is defined as 1-cumulative incidence ratio (vaccine versus placebo) between Month 0 and Month X after first vaccination and is estimated by the transformation of the Nelson-Aalen estimator for the cumulative hazard function per mITT populations. Here, month X will be between month 24 and month 30.
Time Frame
Month 0 (Day 1) up to Month 30
Title
Vaccine Efficacy as Derived From Confirmed HIV-1 Infections Diagnosed at VE (13-X months) per mITT Population
Description
Vaccine efficacy is defined as 1-cumulative incidence ratio (vaccine versus placebo) between Month 13 and Month X after first vaccination and is estimated by the transformation of the Nelson-Aalen estimator for the cumulative hazard function per mITT populations. Here, month X will be between month 24 and month 30.
Time Frame
Month 13 up to Month 30
Title
Vaccine Efficacy Assessed by Demographic Characteristics
Description
The vaccine efficacy assessed by demographic characteristics diagnosed by HIV-1 infection will be reported.
Time Frame
Month 0 (Day 1) up to Month 30
Title
Number of Participants who are Ad26 Seropositive
Description
Number of participants who are Ad26 seropositive will be assessed by vector neutralization assay.
Time Frame
Month 0 (Day 1) up to Month 30
Title
Antibody Titers for Ad26 as Determined by Vector Neutralization Assay
Description
Antibody titers will be determined by vector neutralization assay.
Time Frame
Month 0 (Day 1) up to Month 30
Title
Sexual Risk Behavior as Assessed by Sexual Activity Questionnaire
Description
Sexual risk behavior collected through sexual activity questionnaire (composed with 36 questions) in which participants will be asked about specific sexual activities.
Time Frame
Month 0 (Day 1) up to Month 30
Title
Pre-Exposure Prophylaxis (PrEP) Uptake as Measured by Self Report Questionnaire
Description
For HIV-negative participants, participants will be asked whether they use HIV PrEP as part of a self-report questionnaire (composed of 5 questions).
Time Frame
Month 0 (Day 1), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30 and every 3 months post month 30 (up to 48 months)
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
Cis-gender men and transgender individuals who have sex with cis-gender men and/or transgender Individuals.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Individual is either cis-gender man having sex with cis-gender men and/or transgender individuals or transgender woman having sex with cis-gender men and/or transgender individuals or transgender man having sex with cis-gender men and/or transgender women or gender non-conforming individual having receptive or insertive anal and/or vaginal condom-less intercourse and who is considered by the site staff to be at increased risk for HIV-1 infection. The potential participants must in the last 6 months have had any condom-less receptive anal or vaginal sex (not included is condom-less anal sex within a mutually monogamous relationship >=12 months if the partner is HIV negative or living with HIV and virally suppressed) or rectal or urethral gonorrhea or chlamydia or incident syphilis or any stimulant use or any other drug and/or substance which in the local context may be associated with increased HIV transmission (example, cocaine, amphetamine) or 5 or more sex partners
Potential participant has a negative test result for HIV-1 and HIV-2 infection less than or equal to (<=) 28 days prior to first vaccination
Potential participant must be healthy based on medical history, physical examination, and vital sign measurement performed at screening
Contraceptive use by participants assigned female at birth and who have not had sexual reassignment surgery should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies
All participants of childbearing potential must have a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening and have a negative urine beta-hCG pregnancy test immediately prior to each study vaccine administration
Exclusion Criteria:
Potential participants choosing to use PrEP. However, once participants are enrolled and received their first vaccination, and they change their mind regarding PrEP usage, they will be allowed to take PrEP according to the site PrEP plan and will continue to receive further vaccinations. The use of long acting PrEP is disallowed from 24 months prior to Day 1
Potential participant is a recipient of a HIV-vaccine candidate at any time, or a recipient of other experimental vaccine(s) within the last 12 months prior to Day 1. For participants who received an experimental vaccine (except HIV vaccine) more than 12 months prior to Day 1, documentation of the identity of the experimental vaccine must be provided to the HPX3002/HVTN 706 safety review team, who will determine eligibility on a case by-case basis. Exceptions: participants can be included if the vaccine received (except HIV vaccine) was subsequently licensed or authorized for emergency use (example, Emergency Use Authorization (EUA), Emergency Use Listing (EUL), or similar program). Participants with proof of having received only placebo can also be included. Participants who are currently still in an interventional study of such a licensed/emergency use-authorized vaccine are to be excluded from the current study
Potential participant has received an HIV-related mAb, whether licensed or investigational, within the last 12 months prior to Day 1. For participants who received an HIV-related mAb more than 12 months prior to Day 1, documentation of the identity of the mAb must be provided to the HPX3002/HVTN 706 safety review team, who will determine eligibility on a case-by-case basis
Potential participant has known allergy or history of anaphylaxis or other serious adverse reactions to vaccines
Pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 90 days after the last dose of study 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
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35222
Country
United States
Facility Name
Bridge HIV
City
San Francisco
State/Province
California
ZIP/Postal Code
94102
Country
United States
Facility Name
Whitman Walker Health
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20816
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Orlando Immunology Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Emory University Rollins School of Public Health - Ponce De Leon CRS
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
The Hope Clinic at Emory University
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
University Of Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
New Orleans Adolescent Trials Unit CRS
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Dana-Farber/Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Fenway Health
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Rutgers, The State University of New Jersey - The University Hospital/ACTG Network
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Harlem Prevention Center CRS
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
New York Blood Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Strong Memorial Infectious Disease
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Gordon E. Crofoot MD
City
Houston
State/Province
Texas
ZIP/Postal Code
77098
Country
United States
Facility Name
Seattle Vaccine Trials Unit
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Helios Salud Sa
City
Buenos Aires
ZIP/Postal Code
C1141ACG
Country
Argentina
Facility Name
Fundacion Huesped
City
Ciudad Autonoma De Buenos Aire
ZIP/Postal Code
C1202ABB
Country
Argentina
Facility Name
Hospital J. M. Ramos Mejía
City
Ciudad de Buenos Aires
ZIP/Postal Code
C1221Adc
Country
Argentina
Facility Name
Instituto Caici Srl.
City
Rosario
ZIP/Postal Code
S2000PBJ
Country
Argentina
Facility Name
Universidade Federal De Minas Gerais - Hospital das Clínicas
City
Belo Horizonte
ZIP/Postal Code
30130-100
Country
Brazil
Facility Name
Centro Medico Sao Francisco
City
Curitiba
ZIP/Postal Code
80810-050
Country
Brazil
Facility Name
Fundacao de Medicina Tropical Doutor Heitor Vieira Dourado - FMT
City
Manaus
ZIP/Postal Code
69040-000
Country
Brazil
Facility Name
Fundacao Oswaldo Cruz
City
Rio de Janeiro
ZIP/Postal Code
21040-900
Country
Brazil
Facility Name
Municipio de Nova Iguacu - Hospital Geral de Nova Iguacu
City
Rio de Janeiro
ZIP/Postal Code
26030-380
Country
Brazil
Facility Name
Instituto de infectologia Emilio Ribas
City
Sao Paulo
ZIP/Postal Code
01246-900
Country
Brazil
Facility Name
Hospital Das Clinicas Da Faculdade De Medicina Da USP
City
Sao Paulo
ZIP/Postal Code
01246-903
Country
Brazil
Facility Name
Centro de Referencia E Treinamento Dst/Aids
City
Sao Paulo
ZIP/Postal Code
02141-000
Country
Brazil
Facility Name
Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20127
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Policlinico di Modena
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
Istituto nazionale malattie infettive 'L. Spallanzani'
City
Roma
ZIP/Postal Code
00149
Country
Italy
Facility Name
Hospital Civil Fray Antonio Alcalde
City
Guadalajara
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Unidad de Atención Medica e Investigacion en Salud (UNAMIS)
City
Merida
ZIP/Postal Code
97000
Country
Mexico
Facility Name
Inst. Nal. de Ciencias Med. Y Nutricion Salvador Zubiran
City
Mexico City
ZIP/Postal Code
14000
Country
Mexico
Facility Name
Centro de Investigaciones Tecnologicas, Biomedica y medio ambientales (CITBM)
City
Callao
ZIP/Postal Code
07066
Country
Peru
Facility Name
Asociacion Civil Selva Amazonica (ACSA)
City
Iquitos
ZIP/Postal Code
16001
Country
Peru
Facility Name
Asociacion Civil Impacta Salud y Educacion - Barranco
City
Lima - Barranco
ZIP/Postal Code
Barranco 15063
Country
Peru
Facility Name
Asociacion Civil Impacta Salud y Educacion- San Miguel CRS
City
Lima - San Miguel
ZIP/Postal Code
15088
Country
Peru
Facility Name
Asociacion Civil Via Libre
City
Lima
ZIP/Postal Code
15001
Country
Peru
Facility Name
Neutrum Lekarze M.Hlebowicz i Partnerzy spolka partnerska
City
Gdansk
ZIP/Postal Code
80-462
Country
Poland
Facility Name
Wroclawskie Centrum Zdrowia SPZOZ, Poradnia Profilaktyczno-Lecznicza
City
Wroclaw
ZIP/Postal Code
50-136
Country
Poland
Facility Name
Clinical Research Puerto Rico Inc
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
University of Puerto Rico
City
San Juan
ZIP/Postal Code
00936-5067
Country
Puerto Rico
Facility Name
Hosp. Univ. Germans Trias I Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hosp. Univ. Vall D Hebron
City
Barcelona
ZIP/Postal Code
08001
Country
Spain
Facility Name
Hosp. Reina Sofia
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hosp. Univ. Fund. Jimenez Diaz
City
Madrid
ZIP/Postal Code
28015
Country
Spain
Facility Name
Hosp. Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hosp. Gral. Univ. Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency
Learn more about this trial
A Study of Heterologous Vaccine Regimen of Adenovirus Serotype 26 Mosaic4 Human Immunodeficiency Virus(Ad26.Mos4.HIV), Adjuvanted Clade C gp140 and Mosaic gp140 to Prevent HIV-1 Infection Among Cis-gender Men and Transgender Individuals Who Have Sex With Cis-gender Men and/or Transgender Individuals
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