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Blood Analyte Screening Data from Potential HVTN Phase I Preventive HIV Vaccine Trial Participants in Botswana Background: The Botswana screening protocol was used to identify potential volunteers for a phase I vaccine trial who were healthy, able to give informed consent, 21-40 years old, HIV negative and not planning pregnancy during the trial. Additionally, potential participants blood analyte/ hematologic values were based upon US FDA standards for combined US and Botswana protocol implementation. Methods: Various strategies were used to recruit potential volunteers from the general population. Potential volunteers meeting minimal eligibility criteria, underwent a general screening process, which involved: medical history, physical exam, urinalysis, and blood draw for HIV and Hepatitis B/C infection, and chemistry/hematology values, before undergoing trial-specific screening procedures These screening labs were performed at the Botswana Harvard HIV Reference Laboratory. Results: From May 14 to December 31, 2003, 49 (35 men, 14 women) volunteers were screened to determine their eligibility for the trial. Blood samples were collected from 45 volunteers. Thirty-two volunteers screened (71.1%) were found to be ineligible for the following reasons: 21 (65.6%) had out of range chemistry values only, 2 (6.3%) out of range hematologic values only, 2 (6.3%) were HIV infected, 3 (9.4%) multiple factors including HIV infection /blood chemistries/difficult veins, and 4 (12.5%) were disqualified for other reasons not related to laboratory test results. Of the 24 volunteers with out of range chemistries, 58.3% had >1 value out of range, the most common was elevated CPK (50%); followed by out of range GGT (33.3%), ALT (33.3%), bilirubin (33.3%) and creatinine (29.2%) values. Elevated LFTs were not explained by hepatitis B/C serology. Conclusions: Blood analyte values have excluded the majority of Batswana participants screening for phase I vaccine trial participation. As these parameters have not been previously defined for this population, normal reference ranges should be determined to enhance future vaccine trials. N= 299 Authors: Tonya L. Villafana Peninah Thumbi Joseph Makhema Bakgaki Ratshaa Keemenao Matshediso Kiston Moyo Tuduetso Maswabi Trevor Peter Max Essex Ibou Thior And NIAID HVTN |