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

Description

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

Study Start Date

March, 31 2017

Estimated Completion Date

March 2019

Interventions

  • Biological: Clade C gp140/Mosaic gp140 plus adjuvant
  • Biological: Ad26.Mos4.HIV
  • Biological: Clade C gp140 plus adjuvant
  • Other: Placebo

Study ID

Janssen Vaccines & Prevention B.V. -- CR108207

Status

Recruiting

Trial ID

NCT02935686

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

150

Sponsor

Janssen Vaccines & Prevention B.V.

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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
  • 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
  • Participant has had a thyroidectomy or active thyroid disease requiring medication during the last 12 months (not excluded: a stable thyroid supplementation)
  • 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. For participants who received an experimental vaccine (except HIV vaccine) more than 12 months ago, documentation of the identity of the experimental vaccine must be provided to the sponsor, who will determine eligibility on a case-by-case basis

Gender

All

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Study Locations and Contact Information (25)

Study Location Distance Name Phone Email
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.4 miles None None None
Fenway Health - Boston, Massachusetts 2.4 miles None None None
Brigham Womens Hospital - Boston, Massachusetts 2.6 miles None None None
Brigham Womens Hospital - Boston, Massachusetts 2.6 miles None None None
Brigham Womens Hospital - Boston, Massachusetts 2.6 miles None None None
Brigham Womens Hospital - Boston, Massachusetts 2.6 miles None None None
Brigham Womens Hospital - Boston, Massachusetts 2.6 miles None None None
Columbia University HIV Vaccine Unit - New York, New York 181.2 miles None None None
New York Blood Center - New York, New York 187.1 miles None None None
University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles None None None
University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles None None None
University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles None None None
Strong Memorial Infectious Disease - Rochester, New York 335.8 miles None None None
MHRPWalter Reed Army Institute of Research - Silver Spring, Maryland 388.9 miles None None None
MHRPWalter Reed Army Institute of Research - Silver Spring, Maryland 388.9 miles None None None
MHRPWalter Reed Army Institute of Research - Silver Spring, Maryland 388.9 miles None None None
MHRPWalter Reed Army Institute of Research - Silver Spring, Maryland 388.9 miles None None None
MHRPWalter Reed Army Institute of Research - Silver Spring, Maryland 388.9 miles None None None
Vanderbilt University Medical Center - Nashville, Tennessee 944.2 miles None None None
Vanderbilt University Medical Center - Nashville, Tennessee 944.2 miles None None None
Vanderbilt University Medical Center - Nashville, Tennessee 944.2 miles None None None
Alabama Vaccine Research Clinic at UAB - Birmingham, Alabama 1,052.1 miles None None None
Seattle Vaccine Trials Unit - Seattle, Washington 2,489.6 miles None None None
Seattle Vaccine Trials Unit - Seattle, Washington 2,489.6 miles None None None
Seattle Vaccine Trials Unit - Seattle, Washington 2,489.6 miles None None None

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