Sign in

NCT02935686CompletedPhase 1/2

A Safety, Tolerability and Immunogenicity Study of 2 Different Regimens of Tetravalent Ad26.Mos4.HIV Prime Followed by Boost With Tetravalent Ad26.Mos4.HIV Along With Either Clade C gp140 Plus Adjuvant OR With a Combination of Mosaic and Clade C gp140 Plus Adjuvant in Healthy HIV Uninfected Adults

A Randomized, Parallel-group, Placebo-controlled, Double-blind Phase 1/2a Study in Healthy HIV Uninfected Adults to Assess Safety/Tolerability and Immunogenicity of 2 Different Prime/Boost Regimens: Priming With Tetravalent Ad26.Mos4.HIV and Boosting With Tetravalent Ad26.Mos4.HIV and Either Clade C gp140 Plus Adjuvant OR a Combination of Mosaic and Clade C gp140 Plus Adjuvant

Source: ClinicalTrials.gov · Last updated 25 May 2025

Brief summary (registry, in English)

The primary purpose of this study is to assess safety/tolerability of the different vaccine regimens and of a late boost vaccination; and to assess envelope (Env)-binding antibody (Ab) responses of the 2 different vaccine regimens.

Status (registry)
Completed
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
155 (actual)
First submitted
14 Oct 2016
Start date
31 Mar 2017
Primary completion date
22 Nov 2023
Lead sponsor
Janssen Vaccines & Prevention B.V.
Diseases
HIV
NCT number
NCT02935686

What you commit to

  • Study type: Interventional · Phase 1/2
  • Participants enrolled: 155
  • From 31 Mar 2017 to the primary completion date, 22 Nov 2023
  • 13 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • In the 12 months prior to randomization, participant has a history of newly acquired herpes simplex virus type 2 (HSV-2), syphilis, gonorrhea, non-gonococcal urethritis, chlamydia, pelvic inflammatory disease, trichomonas, mucopurulent cervicitis, epididymitis, proctitis, lymphogranulomavenereum, chancroid, or hepatitis B
  • Participant has had major surgery (eg, requiring general anesthesia) within the 4 weeks before screening, or will not have fully recovered from surgery, or has surgery planned through the course of the study
  • Current or past drug/alcohol use that investigator assesses poses any more than a remotely increased risk of the ability of the participant to comply with the protocol requirements
  • Has been in receipt of any licensed vaccine within 14 days prior to the first dose of study vaccine or placebo, plans to receive within 14 days after the first study vaccination, or plans to receive within 14 days before or after the second, third or fourth vaccination
  • Is a recipient of a prophylactic or therapeutic HIV vaccine candidate at any time, or a recipient of other experimental vaccine(s) within the last 12 months prior to the Day 1 visit (Vaccination 1). For participants who received an experimental vaccine (except HIV vaccine) more than 12 months prior to the Day 1 visit (Vaccination 1), documentation of the identity of the experimental vaccine must be provided to the sponsor, who will determine eligibility on a case-by-case basis

Other illness

  • Has chronic hepatitis B (measured by hepatitis B surface antigen test) or active hepatitis C (measured by hepatitis C virus \[HCV\] Ab test; if positive, HCV ribonucleic acid \[RNA\] polymerase chain reaction (PCR) test will be used to confirm active versus past HCV infection), active syphilis infection, chlamydia, gonorrhea, or trichomonas
  • Participant has had a thyroidectomy or active thyroid disease requiring medication during the last 12 months (not excluded: a stable thyroid supplementation)

Who the study is looking for

  • Participant must be healthy on the basis of medical history, physical examination, and vital signs measurement performed at screening
  • Participants are negative for human immunodeficiency virus (HIV) infection at screening
  • Participants are amenable to HIV-risk reduction counseling and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit
  • All female participants of childbearing potential must have a negative serum (beta-human chorionic gonadotropin \[beta-hCG\]) at the screening visit, and a negative urine pregnancy test pre-dose on Day 1
  • Participants are willing/able to adhere to the prohibitions and restrictions specified in the protocol and study procedures
  • Participant must be enrolled in the LTE phase to receive the late boost vaccination

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (13)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Walter Reed Project Clinical Research Center
Coordinator of this site? Confirm its status
KerichoKenyaUnknown status
Center for Family Health Research/Project San Francisco
Coordinator of this site? Confirm its status
KigaliRwandaUnknown status
Alabama Vaccine Research Clinic at UAB
Coordinator of this site? Confirm its status
BirminghamUnited StatesUnknown status
Fenway Health
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status
Brigham and Women's Hospital
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status
Beth Israel Deaconess Medical Center
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status
The Hope Clinic at Emory University
Coordinator of this site? Confirm its status
DecaturUnited StatesUnknown status
Columbia University HIV Vaccine Unit
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
New York Blood Center
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
University of Pennsylvania
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesUnknown status
Strong Memorial Infectious Disease
Coordinator of this site? Confirm its status
RochesterUnited StatesUnknown status
Bridge HIV
Coordinator of this site? Confirm its status
San FranciscoUnited StatesUnknown status
Seattle Vaccine Trials Unit
Coordinator of this site? Confirm its status
SeattleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.