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

HIV Infections Clinical Trial

Official title:

Extended Follow-Up for Participants in VRC HIV-1 Recombinant Adenovirus-5 Vector Vaccine Studies in Uganda

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01109342
• Other study ID #: RV 283/WRAIR 1631
• Secondary ID: 11698RV 283
• Status: Completed
• Start date: July 2010
• Est. completion date: June 2012

Study information

• Verified date: October 2021
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Locations

Country	Name	City	State
Uganda	Makerere University Walter Reed Project (MUWRP)	Kampala

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

Uganda, 

References & Publications (3)

Buchbinder SP, Mehrotra DV, Duerr A, Fitzgerald DW, Mogg R, Li D, Gilbert PB, Lama JR, Marmor M, Del Rio C, McElrath MJ, Casimiro DR, Gottesdiener KM, Chodakewitz JA, Corey L, Robertson MN; Step Study Protocol Team. Efficacy assessment of a cell-mediated immunity HIV-1 vaccine (the Step Study): a double-blind, randomised, placebo-controlled, test-of-concept trial. Lancet. 2008 Nov 29;372(9653):1881-1893. doi: 10.1016/S0140-6736(08)61591-3. Epub 2008 Nov 13. — View Citation

McElrath MJ, De Rosa SC, Moodie Z, Dubey S, Kierstead L, Janes H, Defawe OD, Carter DK, Hural J, Akondy R, Buchbinder SP, Robertson MN, Mehrotra DV, Self SG, Corey L, Shiver JW, Casimiro DR; Step Study Protocol Team. HIV-1 vaccine-induced immunity in the test-of-concept Step Study: a case-cohort analysis. Lancet. 2008 Nov 29;372(9653):1894-1905. doi: 10.1016/S0140-6736(08)61592-5. Epub 2008 Nov 13. — View Citation

Robb ML. Failure of the Merck HIV vaccine: an uncertain step forward. Lancet. 2008 Nov 29;372(9653):1857-1858. doi: 10.1016/S0140-6736(08)61593-7. Epub 2008 Nov 13. — View Citation

Outcome

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

External Links

•   Click here for information on study RV 172/WRAIR 1218 (NCT00123968)