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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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Antibodies
An antibody is a protein produced by the body's immune system when it detects harmful substances, called antigens. Examples of antigens include microorganisms (such as bacteria, fungi, parasites, and viruses) and chemicals. Antibodies may be produc...


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