CURRENT STUDIES

RV 156A

Is 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 Un infected adult volunteers in Uganda.

It is an open label clinical trial that enrolled eligible participants that previously participated in RV 156 and completed all three DNA injection. The study will evaluate the safety, tolerability and Immunogenicity of Adenovirus vector vaccine among the placebo recipients from RV 156 and also evaluate the safety,tolerability and immunogenicity of the same vaccine as a boost among the DNA vaccine recipients

The study was open to accrual in March 2007 and has enrolled 18 out of the 29 eligible participants . Vaccination is complete and participants are being followed.

RV 172

A Phase I/II Clinical Trial to evaluate the safety and immunogenicity of a multiclade HIV-1 DNA  6-Plasmid vaccine, VRC-HIVDNA016-00-VP, boosted by a multiclade HIV-1 Recombinant Adenovirus-5 Vector Vaccine, VRC-HIVADV014-00-VP in HIV Un infected volunteers in East Africa. This is a multi-center, randomized, placebo controlled, double-blinded study to be conducted at the 3 USMHRP, East African sites. The study was open to accrual in March 2006 and enrolled 324 healthy, HIV-1 un infected adult volunteers aged 18-50.
MUWRP enrolled 144 and all have completed vaccination.
Follow up is expected to end in August 2007

BLOOD BANK STUDY - RV 164

MUWRP recently conducted a study in collaboration with the Ugandan National Blood Transfusion Service (UNTBS) entitled: "RV-164: Determination of Laboratory Reference Data Using Anonymous Healthy Ugandan Blood Bank Donors". Approximately 6000 anonymous samples were collected from healthy blood donors in Kampala, Fort Portal, Gulu, Mbararra and Mbale to address several important objectives. The first objective of the study was to establish normal reference ranges for clinical chemistry, hematology, and lymphocyte subsets for bloodbank donors in the Kampala area. This objective was met and relevant reference ranges were established and are currently being used to evaluate the safety of ongoing HIV vaccine trials at MUWRP. A manuscript outlining these details is currently being prepared. The second objective of the study was to validate the use of rapid HIV testing using both seropositive and seronegative samples. This was accomplished in two phases, using approximately 6000 samples spread throughout Uganda. The results from this part of the study have been recently published in the Journal of Clinical Microbiology [Eller, L. A., M. A. Eller, et al. (2007). "Large-scale human immunodeficiency virus rapid test evaluation in a low-prevalence ugandan blood bank population." J Clin Microbiol 45(10): 3281-5.] A third objective of the study was to further characterize Uganda as a whole for future vaccine development by evaluating the prevalence of different subtypes of HIV in Kampala and at the different regional centers throughout Uganda. Analysis of these samples is complete and a manuscript is in preparation. A fourth objective was to determine point prevalence of antibodies to adenovirus, adenovirus associated virus and other viral vectors used in experimental HIV vaccines. MUWRP is awaiting technology transfer from laboratories in the US in order to complete this work.