Extended Follow-Up of Participants in Preventive HIV Vaccine Studies in Uganda

Completed

• Conditions: HIV Infections

• Registration Number: NCT01109342
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

Two previous studies of an HIV preventive vaccine, the STEP study and the Phambili study, were halted because people who received the vaccine were more likely to become infected with HIV. Why this vaccine failed is still being researched, but one reason may be related to the recombinant Adenovirus type 5 (rAd5) virus vector used in the vaccine. Two trials of another HIV preventive vaccine that used a rAd5 virus vector were conducted in Uganda. This study will obtain follow-up safety information on participants in those trials.

Detailed Description

Two previous trials of an HIV preventive vaccine, referred to as the MRK rAd5 vaccine, were halted because people receiving the vaccine were at greater risk of HIV infection. The MRK rAd5 vaccine delivered parts of HIV inside a recombinant Ad5 (rAd5) virus vector, which is a modified version of a common virus that does not usually cause serious disease. Analyses of these trials found that the increased risk of HIV infection was seen only in male participants who already had detectable antibodies to Adenovirus type 5 (Ad5).

A different HIV preventive vaccine developed by the Vaccine Research Center (VRC) at the U.S. National Institutes of Health (NIH) also uses a rAd5 virus vector. Although this vaccine, referred to as VRC Ad5, uses a rAd5 virus vector, it is structured and delivered differently than the MRK rAd5 vaccine. In two trials in Uganda it has shown no serious side effects. This study will perform safety follow-ups on participants in these two trials, RV 156A/WRAIR 1078A and RV 172/WRAIR 1218. Participants who received either the vaccine or the placebo will be recruited in order to compare health and HIV status.

Participants in this study will complete eight clinic visits over 1 year and 2 weeks. Four visits will be completed at baseline and after 4, 8, and 12 months. During these visits, participants will be checked for health changes and complete a blood draw. As part of the blood tests performed, participants will be tested for HIV. Every 2 weeks after the four visits mentioned (on Days 14, 134, 254, and 374), participants will return to the clinic to receive the results of their HIV tests. On all eight visits, participants will also receive HIV risk reduction counseling.

Study Timeline

• Study First Submitted: 2010-04-21
• Study First Submitted QC: 2010-04-21
• Study First Posted: 2010-04-23
• Study Start: 2010-07
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-28
• Last Update Posted: 2021-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Participated in either of the following studies: (1) RV 156A/WRAIR 1078A, or (2) RV 172/WRAIR 1218
• Able to provide informed consent

Exclusion Criteria

• Incapacitating illness precluding clinic visits

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Laboratory measures of safety, as defined in protocol	Measured at baseline and on Days 120, 240, and 360
Product-related adverse and serious adverse experiences	Measured over 1 year follow-up
HIV and rAdenovirus type 5 (rAd5) T-cell and antibody immune responses	Measured at baseline and on Days 120, 240, and 360
Risk behaviors	Measured at baseline and on Days 120, 240, and 360
HIV status	Measured on Days 14, 134, 154, and 374

Trial Locations

Locations (1)

Makerere University Walter Reed Project (MUWRP); 🇺🇬 Kampala, Uganda