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

NCT ID: NCT01109342

Last Updated: 2021-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-06-30

Brief Summary

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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

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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.

Conditions

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HIV Infections

Keywords

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HIV Prevention Vaccine Recombinant Adenovirus-5 HIV Preventative Vaccine

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Vaccine Recipients

Participants received HIV preventive vaccine VRC-HIV ADV014-00-VP in previous trials RV 156A/WRAIR 1078A or RV 172/WRAIR 1218.

No interventions assigned to this group

Placebo Recipients

Participants received a placebo vaccine in previous trials RV 156A/WRAIR 1078A or RV 172/WRAIR 1218.

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Makerere University Walter Reed Project (MUWRP)

Kampala, , Uganda

Site Status

Countries

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Uganda

References

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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.

Reference Type BACKGROUND
PMID: 19012954 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19012957 (View on PubMed)

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. No abstract available.

Reference Type BACKGROUND
PMID: 19012958 (View on PubMed)

Related Links

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http://www.clinicaltrials.gov/ct2/show/NCT00123968?term=VRC-HIVADV014-00-VP&cntry1=AF%3AUG&phase=0&rank=1

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

Other Identifiers

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11698

Identifier Type: REGISTRY

Identifier Source: secondary_id

RV 283

Identifier Type: -

Identifier Source: secondary_id

RV 283/WRAIR 1631

Identifier Type: -

Identifier Source: org_study_id