Jamaica (population 2.6 million, adult HIV prevalence 1.5%) is applying for one Clinical Research Unit (CTU) is at the Epidemiology Research and Training Unit (ERTU) of the Ministry of Health (MOH), with two clinical research sites (CRS). The HIV Vaccine Trials Network (HVTN) has formally invited an application from the ERTU HIV Vaccine Trials Unit (HVTU) established since 2003. This HVTU is already involved in a HIV vaccine preparedness trial (903) and two HIV vaccine trials (060 and 204) and has ready access to black women and men at high risk of HIV/AIDS. The HVTU aims to evaluate the safety, immunogenicity and efficacy of candidate HIV Vaccines in adults and perform Microbicide and ARV drug trials. The University of the West Indies (UWI) through the long established Kingston Pediatric and Perinatal HIV/AIDS (K-PAIDS) Program, is also applying through the International Maternal, Pediatric and Adolescent Clinical Trials (IMPAACT) Network to be the other CRS participating in pMTCT, optimization and translational drug and vaccine trials in HIV infected pregnant women, infants and children. K-PAIDS is a long established partnership between UWI and MOH with access to 20,000 pregnant black women per year (HIV prevalence 2.1%) and established cohorts of 300 HIV-exposed and 160 HIV-infected children, 100 of whom are on HAART. The Principal Investigator, Dr J. Peter Figueroa and Lead Co-Investigator, Professor Celia D.C. Christie, have considerable experience in HIV research and clinical trials. The CTU and CRS already operate within US federal regulations (FWA: ERTU 00002774 and UWI 0001539). The supporting National Public Health Laboratory has a quality system that is based on the international standard ISO 17025. In short, Jamaica can contribute to the NIH-DAIDS international HIV research agenda by implementing clinical [trials of the highest ethical standards, with good clinical practices and adherence to QA/QC principles in a population with ready access to black women and minorities in the most cost efficient manner. Research datasets will be shared locally, regionally and internationally according to the consortium agreement and principles established by the participating networks. The research is of considerable public health significance as a contribution to the international search for a HIV preventive vaccine and improved HAART regimens. ADMINISTRATIVE COMPONENT:
| Fitzgerald, D W; Janes, H; Robertson, M et al. (2011) An Ad5-vectored HIV-1 vaccine elicits cell-mediated immunity but does not affect disease progression in HIV-1-infected male subjects: results from a randomized placebo-controlled trial (the Step study). J Infect Dis 203:765-72 |
| Barnabas, Ruanne V; Wasserheit, Judith N; Huang, Yunda et al. (2011) Impact of herpes simplex virus type 2 on HIV-1 acquisition and progression in an HIV vaccine trial (the Step study). J Acquir Immune Defic Syndr 57:238-44 |
| Churchyard, Gavin J; Morgan, Cecilia; Adams, Elizabeth et al. (2011) A phase IIA randomized clinical trial of a multiclade HIV-1 DNA prime followed by a multiclade rAd5 HIV-1 vaccine boost in healthy adults (HVTN204). PLoS One 6:e21225 |
