HealthyPhase 3MOSAICONCT03964415
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
A Phase 3 study testing Ad26.Mos4.HIV and Clade C and Mosaic gp140 HIV bivalent vaccine in people with Healthy, run by Janssen Vaccines & Prevention B.V. at 53 sites in 9 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ad26.Mos4.HIV and Clade C and Mosaic gp140 HIV bivalent vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,900 participants
- Where
- 53 sitesin 9 countries
- Study dates
- 31 Oct 2019to 10 Aug 2023
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
53 sites in 9 countries.
53 sites in 9 countries
United States20 sites
Emory University Rollins School of Public Health - Ponce De Leon CRS
Atlanta, Georgia, 30322
University of Alabama at Birmingham
Birmingham, Alabama, 35222
Dana-Farber/Brigham and Women's Hospital
Boston, Massachusetts, 02115
Fenway Health
Boston, Massachusetts, 02215
University Of Illinois
Chicago, Illinois, 60612
The Hope Clinic at Emory University
Decatur, Georgia, 30030
Gordon E. Crofoot MD
Houston, Texas, 77098
University of Miami
Miami, Florida, 33136
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
New Orleans Adolescent Trials Unit CRS
New Orleans, Louisiana, 70112
Harlem Prevention Center CRS
New York, New York, 10027
Columbia University Medical Center
New York, New York, 10032
New York Blood Center
New York, New York, 10065
Rutgers, The State University of New Jersey - The University Hospital/ACTG Network
Newark, New Jersey, 07103
Orlando Immunology Center
Orlando, Florida, 32803
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Strong Memorial Infectious Disease
Rochester, New York, 14642
Bridge HIV
San Francisco, California, 94102
Seattle Vaccine Trials Unit
Seattle, Washington, 98104
Whitman Walker Health
Washington D.C., District of Columbia, 20816
Brazil8 sites
Universidade Federal De Minas Gerais - Hospital das Clínicas
Belo Horizonte, 30130-100
Centro Medico Sao Francisco
Curitiba, 80810-050
Fundacao de Medicina Tropical Doutor Heitor Vieira Dourado - FMT
Manaus, 69040-000
Fundacao Oswaldo Cruz
Rio de Janeiro, 21040-900
Municipio de Nova Iguacu - Hospital Geral de Nova Iguacu
Rio de Janeiro, 26030-380
Instituto de infectologia Emilio Ribas
São Paulo, 01246-900
Hospital Das Clinicas Da Faculdade De Medicina Da USP
São Paulo, 01246-903
Centro de Referencia E Treinamento Dst/Aids
São Paulo, 02141-000
Spain6 sites
Hosp. Univ. Germans Trias I Pujol
Badalona, 08916
Hosp. Univ. Vall D Hebron
Barcelona, 08001
Hosp Reina Sofia
Córdoba, 14004
Hosp Univ Fund Jimenez Diaz
Madrid, 28015
Hosp. Clinico San Carlos
Madrid, 28040
Hosp. Gral. Univ. Valencia
Valencia, 46014
Peru5 sites
Centro de Investigaciones Tecnologicas, Biomedica y medio ambientales (CITBM)
Callao, 07066
Asociacion Civil Selva Amazonica (ACSA)
Iquitos, 16001
Asociacion Civil Via Libre
Lima, 15001
Asociacion Civil Impacta Salud y Educacion - Barranco
Lima - Barranco, Barranco 15063
Asociacion Civil Impacta Salud y Educacion- San Miguel CRS
Lima - San Miguel, 15088
Argentina4 sites
Helios Salud Sa
Buenos Aires, C1141ACG
Fundacion Huesped
Ciudad Autonoma de Buenos Aire, C1202ABB
Hospital J. M. Ramos Mejía
Ciudad de Buenos Aires, C1221Adc
Instituto Caici Srl.
Rosario, S2000PBJ
Italy3 sites
Ospedale San Raffaele
Milan, 20127
Azienda Ospedaliero-Universitaria Policlinico di Modena
Modena, 41124
Istituto nazionale malattie infettive 'L. Spallanzani'
Roma, 00149
Mexico3 sites
Hospital Civil Fray Antonio Alcalde
Guadalajara, 44280
Unidad de Atención Medica e Investigacion en Salud (UNAMIS)
Mérida, 97000
Inst. Nal. de Ciencias Med. Y Nutricion Salvador Zubiran
Mexico City, 14000
Poland2 sites
Neutrum Lekarze M.Hlebowicz i Partnerzy spolka partnerska
Gdansk, 80-462
Wroclawskie Centrum Zdrowia SPZOZ, Poradnia Profilaktyczno-Lecznicza
Wroclaw, 50-136
Puerto Rico2 sites
Clinical Research Puerto Rico Inc
San Juan, 00909
University of Puerto Rico
San Juan, 00936-5067
About this study
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
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Ad26.Mos4.HIV, Clade C and Mosaic gp140 HIV bivalent vaccine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ad26.Mos4.HIVBiological
Participants will receive Ad26.Mos4.HIV via IM injection into the deltoid muscle at months 0 (Day 1), 3, 6 and 12.
Clade C and Mosaic gp140 HIV bivalent vaccineBiological
Participants will receive Clade C and Mosaic gp140 HIV bivalent vaccine as IM injection into the deltoid muscle at Months 6 and 12.
PlaceboBiological
Participants will receive matching placebo.
| Study group | Role | What they receive |
|---|---|---|
| Group1:Ad26.Mos4.HIV,Clade C and Mosaic gp140 bivalent vaccine | Experimental | 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). Receives: Biological: Ad26.Mos4.HIV; Biological: Clade C and Mosaic gp140 HIV bivalent vaccine |
| Group 2: Placebo | Placebo comparator | Participants will receive placebo into the deltoid muscle on Months 0 (Day 1), 3 (1 injection), 6 and 12 (2 injections). Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Between the Month 7 and Month 24 Visits (Per-protocol [PP] Set)
Number of participants with a confirmed HIV-1 infections diagnosed between the Month 7 and Month 24 visits (PP set) was reported. The data represents the cumulative incidence of HIV-1 infections.
Measured: From Month 7 up to Month 24
Number of Participants With a Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Between the Month 7 and Month 30 Visits (PP Set)
Number of participants with a confirmed HIV-1 infections diagnosed between the Month 7 and Month 30 visits (PP set) was reported. The data represents the cumulative incidence of HIV-1 infections.
Measured: From Month 7 up to Month 30
Secondary outcomes (16)
Number of Participants With Solicited Local Adverse Events (AEs)
Number of participants with solicited local AEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site) and which were noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Measured: Up to 7 days post each vaccination (dose) on Days 1 (up to Day 8), 84 (up to Day 91), 168 (up to Day 175), and 364 (up to 371)
Number of Participants With Solicited Systemic Adverse Events (AEs)
Number of participants with solicited systemic AEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which were noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Measured: Up to 7 days after each vaccination (dose) on Days 1 (up to Day 8), 84 (up to Day 91), 168 (up to Day 175), and 364 (up to 371)
Number of Participants With Unsolicited Adverse Events (AEs)
Number of participants with unsolicited AEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participants were not specifically questioned in the participant's diary.
Measured: Up to 28 days after each vaccination (dose) on Days 1 (up to Day 29), 84 (up to Day 112), 168 (up to Day 196), and 364 (up to 392)
Number of Participants With Adverse Events of Special Interest (AESIs)
Number of participants with AESIs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Thrombotic events and/or thrombocytopenia (defined as platelet count below the lower limit of normal [LLN] range for the testing lab) were considered to be potential AESIs.
Measured: Up to 6 months after the last vaccination (up to Month 18)
Number of Participants With Medically-attended Adverse Events (MAAEs)
Number of participants with MAAEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. MAAEs are defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason.
Measured: From Day 1 up to Month 40
Number of Participants With Serious Adverse Events (SAEs)
Number of participants with SAEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
Measured: From Day 1 up to Month 40
Number of Participants Who Discontinued the Study or Study Intervention Due to Adverse Events (AEs)
Number of participants who discontinued the study or study intervention due to AEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Measured: From Day 1 up to Month 40
Number of Participants With a Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Modified Intent-to-Treat [mITT] Set)
Number of participants with a confirmed HIV-1 infections diagnosed over time (mITT set) were reported. The data represents the cumulative incidence of HIV-1 infections at specified intervals.
Measured: Month 0 to 24, Month 0 to 30, Month 0 to 40
Number of Participants With a Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Modified Intent-to-Treat-2 [mITT-2] Set)
Number of participants with a confirmed HIV-1 infections diagnosed over time (mITT-2 set) were reported. The data represents the cumulative incidence of HIV-1 infections at specified intervals.
Measured: Month 7 to 24, Month 7 to 30, Month 7 to 40
Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Modified Intent-to-Treat-3 [mITT-3] Set)
Number of participants with confirmed HIV-1 infection diagnosed over time (mITT-3 set) were reported. The data represents the cumulative incidence of HIV-1 infections at specified intervals.
Measured: Month 7 to 24, Month 7 to 30, Month 7 to 40
Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections Diagnosed Over Time (Full Immunization Analysis Set [FIS])
Number of participants with confirmed HIV-1 infection diagnosed over time (FIS set) were reported. The data represents the cumulative incidence of HIV-1 infections at specified intervals.
Measured: Month 13 to 24, Month 13 to 30, Month 13 to 40
Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Age Groups
Number of participants with confirmed HIV-1 infection as assessed by demographic characteristics: age groups was reported. Age groups included 18-20, 21-24, 25-29, 30-34, 35-44, and greater than or equal to (>=) 45 years. The data represents the cumulative incidence of HIV-1 infections at specified intervals.
Measured: Month 7 to 24, Month 7 to 30, Month 7 to 40
Number of Participants With Confirmed Human Immunodeficiency Virus (HIV)-1 Infections as Assessed by Demographic Characteristics: Region-Wise Enrollment
Number of participants with confirmed HIV-1 infections as assessed by demographic characteristics: region-wise enrollment was reported. Regions were Latin-America (Argentina, Brazil, Mexico, and Peru), North America (Puerto Rico and United States of America), and Europe (Italy, Poland, and Spain). The data represents the cumulative incidence of HIV-1 infections at specified intervals.
Measured: Month 7 to 24, Month 7 to 30, Month 7 to 40
Number of Participants With an HIV-1 Infection by Adenovirus Serotype 26 (Ad26) at Baseline
Number of participants with an HIV-1 infection by Ad26 at baseline were reported.
Measured: Baseline (Day 1)
Geometric Mean Antibody Titers For Adenovirus Serotype 26 (Ad26) as Determined by Vector Neutralization Assay (VNA)
Geometric mean antibody titers for Ad26 as determined by VNA were reported.
Measured: From Day 1 up to Month 40
Number of Participants With HIV-1 Infection by Pre/Post-exposure Prophylaxis (P[r]EP) Use
Number of participants with HIV-1 infection by P(r)EP use were reported. P(r)EP was assessed with a 4 item survey. Each item was measured on a scale ranging from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicating higher levels of self-efficacy. If participant showed any evidence of P(r)EP use during the period based on questionnaire responses, concomitant medications or dried blood spot analysis, the response was "yes". The data represents the cumulative incidence of HIV-1 infections at specified intervals.
Measured: Month 7 to 24, Month 7 to 30, Month 7 to 40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start31 Oct 2019
- Primary completion10 Aug 2023
- Study completion10 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 3,900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Vaccines & Prevention B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Vaccines & Prevention B.V. Clinical Trial, Study director, Janssen Vaccines & Prevention B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03964415
- Sponsor's protocol ID
- CR108604
- Other IDs
- 2018-003666-13, VAC89220HPX3002, HVTN 706, 2018
- Acronym
- MOSAICO
- Status last verified
- Jun 2024
- First submitted
- 24 May 2019
- Last updated
- 31 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
Buchbinder SP, Spinosa Guzman S, Sanchez J, Willems W, Stieh DJ, van Duijn J, van Rosmalen MGM, Hendriks J, Nijs S, Lavreys L, Paez CA, Grinzstejn B, Hutter J, Mann P, Sierra Madero JG, Cahn P, Castagna A, Truyers C, Roels S, Gilbert PB, Carone M, Luedtke A, Corey L, Pau MG, Tomaka F; HVTN 706/HPX3002/Mosaico Study Team. Efficacy and safety of a mosaic HIV-1 vaccine regimen in men who have sex with men and transgender individuals (HVTN 706/HPX3002/Mosaico): a global, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet HIV. 2025 Dec;12(12):e823-e835. doi: 10.1016/S2352-3018(25)00195-X.
PubMed 41314741