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

October 28, 2021 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uganda
      • Kampala, Uganda
        • Makerere University Walter Reed Project (MUWRP)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

People who received either vaccine or placebo in two previous trials:

  1. RV 156A/WRAIR 1078A "A Phase I Clinical Trial To Evaluate The Safety And Immunogenicity Of A Multiclade HIV-1 Recombinant Adenovirus-5 Vector Vaccine, VRC-HIVADV014-00-VP Administered Alone Or Administered As A Boost To A Multiclade HIV-1 DNA Plasmid Vaccine, VRC-HIVDNA009-00-VP, In Uninfected Adult Volunteers In Uganda," or
  2. RV 172/WRAIR 1218 "A Phase I/II Clinical Trial To Evaluate The Safety And Immunogenicity Of A Multiclade HIV-1 DNA Plasmid Vaccine, VRCHIVDNA016-00-VP, Boosted By A Multiclade HIV-1 Recombinant Adenovirus-5 Vector Vaccine, VRC-HIVADV014-00-VP, In HIV Uninfected Adult Volunteers In East Africa." (NCT00123968)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Vaccine Recipients
Participants received HIV preventive vaccine VRC-HIV ADV014-00-VP in previous trials RV 156A/WRAIR 1078A or RV 172/WRAIR 1218.
Placebo Recipients
Participants received a placebo vaccine in previous trials RV 156A/WRAIR 1078A or RV 172/WRAIR 1218.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

April 21, 2010

First Submitted That Met QC Criteria

April 21, 2010

First Posted (Estimate)

April 23, 2010

Study Record Updates

Last Update Posted (Actual)

November 1, 2021

Last Update Submitted That Met QC Criteria

October 28, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RV 283/WRAIR 1631
  • 11698 (Registry Identifier: DAIDS ES Registry Number)
  • RV 283

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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