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Retrovirology

Volume 6 Supplement 3

AIDS Vaccine 2009

Open Access

P14-13. Long-term follow-up of study participants in HIV prophylactic vaccine clinical trials in Africa

  • C Schmidt1, 5,
  • W Jaoko2,
  • P Kaleebu3,
  • E Karita4,
  • Lehrman5,
  • S Allen6,
  • L Dally7,
  • C Smith7 and
  • PE Fast5
Retrovirology20096(Suppl 3):P201

https://doi.org/10.1186/1742-4690-6-S3-P201

Published: 22 October 2009

Background

The International AIDS Vaccine Initiative (IAVI) has conducted phase I and IIA HIV vaccine clinical trials in healthy HIV-uninfected African adults. Different recombinant DNA and vector-based vaccines encoding HIV-1 genes from subtypes A, B and C were tested. Between 2001 and 2006, 391 volunteers were enrolled in 5 countries at 8 collaborating centers. All vaccines tested were found to be generally safe and well-tolerated, with no vaccine-related serious adverse events reported. This study is designed to monitor any late health effects in prior study participants.

Methods

At the end of the clinical trial, enrollment into a long-term follow-up study is offered. Visits are scheduled 6-monthly. Follow-up is at least 5 years after the last vaccination. A health questionnaire is administered investigating any health problems, hospitalizations, new diagnoses of chronic disease, medications prescribed for more than 4 weeks, problems in the vaccinated arm(s), pregnancies and outcomes, and social harm. HIV testing is performed to detect incident HIV infection and/or to monitor persistence of vaccine-induced antibodies in HIV-uninfected volunteers testing HIV positive at final study visit.

Results

So far, 242 individuals have been enrolled in long-term follow-up. To date, follow up is 301.2 person years. New diseases lasting over 4 weeks include dermatological (fungal infections), gastrointestinal and musculoskeletal conditions. Seventeen 17 pregnancies, 12 hospitalizations (mostly pregnancy-related) and 1 new HIV infection have been reported; 9 volunteers experienced some social harm. There were no congenital abnormalities. Vaccine induced antibodies were detected until 2 years and longer after final study visit.

Conclusion

No significant medical problems have been detected through long-term follow-up of HIV vaccine study participants. Overall, more than 92% of study participants report to be in good health at any visit. These data contribute to the long-term safety profile of HIV vaccines tested in healthy, HIV-negative African adults.

Authors’ Affiliations

(1)
International AIDS Vaccine Initiative, New York, USA
(2)
Kenya AIDS Vaccine Initiative, University of Nairobi, Nairobi, Kenya
(3)
UVRI-IAVI HIV Vaccine Program, Entebbe, Uganda
(4)
Project San Francisco, Kigali, Rwanda
(5)
International AIDS Vaccine Initiative, New York, USA
(6)
Emory University, Atlanta, USA
(7)
The EMMES Corporation, Rockville, USA

Copyright

© Schmidt et al; licensee BioMed Central Ltd. 2009

This article is published under license to BioMed Central Ltd.

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