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Study of Safety and Immunogenicity of HIV Vaccines in Healthy Volunteers

Status
Ongoing
Phase
I
Principal Investigator(s)
Mark Connors, M.D
Objective

This study tests experimental human immunodeficiency virus (HIV) vaccines that use an adenovirus as a transporter. 

Prevention Option(s)
HIV Vaccine
Study Design
Randomized
Double-blind
Arms and Assigned Interventions
Description
The vaccine candidates Ad4-mgag and Ad4-EnvC150 will be formulated as enteric-coated capsules to be delivered orally, and as an aqueous formulation for intranasal administration. Determining the optimal regimen and route will greatly accelerate investigations of these vectors as HIV vaccine platforms. Participants volunteering to receive the vaccine orally will be randomized to 1 of 4 treatment arms, and those volunteering to receive the vaccine via the intranasal route will be randomized to 1 of 3 treatment arms. Participants will receive either 1 or both vaccines or placebo, depending on group assignment.
Products
Ad4
ARMs
Experimental
Clade
C
Trial Sponsors
NIAID, PaxVax
October 2013
February 2020
Enrollment
440
18
Years
49
Years
Population
Women
Men
Sites

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland
United States of America