Immune Response to an HIV DNA Plasmid Vaccine Prime Followed by Adenovirus Boost in HIV-uninfected Individuals

HIV Infections Clinical Trial

Official title: A Phase 1b Clinical Trial to Evaluate Mucosal Immune Responses to a DNA Plasmid Vaccine Prime Followed by an HIV-1 Adenoviral Vector Boost in Healthy Adenovirus Type 5 Seronegative HIV-1-uninfected Adults

Status Completed

Clinical Trial Summary

The purpose of the study is to determine the safety of mucosal immune responses to a DNA HIV vaccine followed by an adenoviral vector HIV vaccine in HIV uninfected adults.

Clinical Trial Description

The worldwide HIV/AIDS epidemic may only be controlled through development of a safe and effective vaccine that will prevent HIV infection. DNA vaccines are inexpensive to construct, readily produced in large quantities, and stable for long periods of time. This study will evaluate the safety and immunogenicity of an experimental multiclade HIV vaccine, VRC-HIVDNA016-00-VP, followed by a similarly structured adenovirus-vectored vaccine boost, VRC-HIVADV014-00-VP, in HIV uninfected adults. The DNA plasmids in both the vaccines code for proteins from HIV subtypes A, B, and C, which together represent 90% of new HIV infections in the world. The study's primary objective is to investigate the ability of a 6-plasmid DNA prime followed by a rAd5 boost to elicit HIV-specific cellular immune responses at mucosal surfaces.

This study will last 12 months and participants will visit the clinic 15 times. Participants will receive three injections of the VRC-HIVDNA016-00-VP vaccine at Months 0, 1, and 2 followed by an injection of VRC-HIVADV014-00-VP at Month 6. All injections will be given in the upper arm. At study visits participants will have a physical, medical history taken, blood collection, and risk reduction counseling. At some visits, rectal biopsies (via anoscopy or, optionally, by flexible sigmoidoscopy), saliva, semen, cervical and/or vaginal fluid samples will also be collected. Pregnancy testing for women will be done prior to each vaccination and study procedure.

Participants will be contacted by study staff once a year for 5 years after the initial study visit for follow-up health and safety monitoring. ;

Related Conditions & MeSH terms

• Adenoviridae Infections
• HIV Infections

• NCT number: NCT00955006
• Study type: Interventional
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Status: Completed
• Phase: Phase 1
• Start date: May 2011
• Completion date: November 22, 2017