Long-term follow-up of study participants from prophylactic HIV vaccine clinical trials in Africa

Claudia Schmidt*, Walter Jaoko, Gloria Omosa-Manyonyi, Pontiano Kaleebu, Juliet Mpendo, Annet Nanvubya, Etienne Karita, Roger Bayingana, Linda Gail Bekker, Elwyn Chomba, William Kilembe, Maphoshane Nchabeleng, Julien Nyombayire, Gwynn Stevens, Paramesh Chetty, Jennifer Lehrman, Josephine Cox, Susan Allen, Len Dally, Carol SmithPatricia E. Fast

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

6 Citations (Scopus)


Long-term safety is critical for the development and later use of a vaccine to prevent HIV/AIDS. Likewise, the persistence of vaccine-induced antibodies and their impact on HIV testing must be established. IAVI has sponsored several Phase I and IIA HIV vaccine trials enrolling healthy, HIV-seronegative African volunteers. Plasmid DNA and viral vector based vaccines were tested. No vaccine-related serious adverse events were reported. After completion of vaccine trials conducted between 2001-2007, both vaccine and placebo recipients were offered enrolment into an observational long-term follow-up study (LTFU) to monitor potential late health effects and persistence of immune responses. At scheduled 6-monthly clinic visits, a health questionnaire was administered; clinical events were recorded and graded for severity. Blood was drawn for HIV testing and cellular immune assays. 287 volunteers were enrolled; total follow-up after last vaccination was 1463 person years (median: 5.2 years). Ninety-three (93)% of volunteers reported good health at their last LTFU visit. Infectious diseases and injuries accounted for almost 50% of the 175 reported clinical events, of which over 95% were mild or moderate in severity. There were 30 six pregnancies, six incident HIV infections and 14 volunteers reported cases of social harm. Persistence of immune responses was rare. No safety signal was identified. No potentially vaccine-related medical condition, no immune mediated disease, or malignancy was reported. HIV vaccines studied in these trials had a low potential of induction of persisting HIV antibodies.

Original languageEnglish
Pages (from-to)714-723
Number of pages10
JournalHuman Vaccines and Immunotherapeutics
Issue number3
Publication statusPublished - Mar 2014


  • Africa
  • HIV vaccine trials
  • Healthy adult volunteers
  • Long term follow-up
  • Safety


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