Study of Safety and Immunogenicity of HIV Vaccines in Healthy Volunteers

Status:Completed
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.    Last updated February 26, 2021
Prevention Option(s):HIV Vaccine
Study Design:Double-blind, Randomized
Arms and Assigned Interventions
DescriptionThe 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.
Mode of Delivery
ARMsExperimental
Official Code: NCT01989533
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Trial Sponsors: NIAID, PaxVax
Start Date
End Date
November 19, 2013
April 8, 2019
Enrollment:62
Age range: 18 Years ↔ 49 Years
Population:Cisgender Men, Cisgender Women