NCT02771730

Study to Evaluate the Safety and Immunogenicity of an Oral HIV Vaccine in Healthy, HIV-uninfected Adults

A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of Orally-administered Replication-competent Adenovirus Type-4 HIV Vaccine Regimens in Combination With an AIDSVAX® B/E Boost in Healthy, HIV-uninfected Adult Participants

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Emergent BioSolutions · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to test experimental human immunodeficiency virus (HIV) vaccines that use an adenovirus vector. The adenovirus vector may help the vaccines stimulate an immune response. Researchers want to see how the immune system will respond to these vaccines as well as if they are safe to give to people. Participants cannot get HIV from these vaccines. However, researchers also want to see if the vaccine's adenovirus is contagious. Adenoviruses cause cold symptoms or mild eye infections, therefore household and intimate contacts will be asked to participate as well.

Conditions

• Healthy Volunteer
• HIV Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	Ad4-mgag	A live replication-competent Adenovirus type-4 vector encoding a mosaic HIV Gag antigen, delivered orally by enteric-coated capsules.
BIOLOGICAL	Ad4-EnvC150	A live replication-competent Adenovirus type-4 vector encoding an HIV clade C Env protein (gp150 1086.C), delivered orally by enteric-coated capsules.
OTHER	Placebo Comparator	Oral sucrose capsules
BIOLOGICAL	AIDSVAX B/E	300 mcg of subtype B (MN) HIV gp120 glycoprotein and 300 mcg of subtype E (A244) HIV gp120 glycoprotein adsorbed onto 600 mcg of aluminum hydroxide gel adjuvant, administered intramuscularly (IM).

Timeline

• Start date: 2015-03-01
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2016-05-13
• Last updated: 2024-03-18

Locations

1 site across 1 country: United States