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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01109342
First received: April 21, 2010
Last updated: August 28, 2013
Last verified: August 2013

April 21, 2010
August 28, 2013
July 2010
June 2012   (final data collection date for primary outcome measure)
  • Laboratory measures of safety, as defined in protocol [ Time Frame: Measured at baseline and on Days 120, 240, and 360 ] [ Designated as safety issue: Yes ]
  • Product-related adverse and serious adverse experiences [ Time Frame: Measured over 1 year follow-up ] [ Designated as safety issue: Yes ]
  • HIV and rAdenovirus type 5 (rAd5) T-cell and antibody immune responses [ Time Frame: Measured at baseline and on Days 120, 240, and 360 ] [ Designated as safety issue: No ]
  • Risk behaviors [ Time Frame: Measured at baseline and on Days 120, 240, and 360 ] [ Designated as safety issue: Yes ]
  • HIV status [ Time Frame: Measured on Days 14, 134, 154, and 374 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01109342 on ClinicalTrials.gov Archive Site
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Extended Follow-Up of Participants in Preventive HIV Vaccine Studies in Uganda
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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood samples

Non-Probability Sample

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)
HIV Infections
Not Provided
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Uganda
 
NCT01109342
RV 283/WRAIR 1631, 11698, RV 283
No
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP