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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 Plu

2016-10-18 02:08:21 | BioPortfolio

Summary

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.

Description

This is a randomized (study medication assigned by chance), double-blind (neither physician nor participant knows the treatment received), placebo-controlled (placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial), parallel-group (each treatment group will be treated at the same time), multicenter (more than one clinical site) study in healthy human immunodeficiency virus (HIV)-uninfected adults. The study will be conducted in 3 phases: a 6-week screening period; a 48-week vaccination period; and a follow-up period to the final visit at Week 72. The approximate duration of the study will be approximately 78 weeks. Participants safety will be monitored throughout the study.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Conditions

Healthy

Intervention

Ad26.Mos4.HIV, Clade C gp140 plus adjuvant, Clade C gp140/Mosaic gp140 plus adjuvant, Placebo

Location

Birmingham
Alabama
United States

Status

Not yet recruiting

Source

Janssen Vaccines & Prevention B.V.

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-10-18T02:08:21-0400

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Immunologic adjuvant and sensitizing agent.

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