AEGiS-15IAC: Laboratory support for a phase III HIV-1 vaccine trial in Thailand.

15th International AIDS Conference

Bangkok, Thailand - July 11-16, 2004

Laboratory support for a phase III HIV-1 vaccine trial in Thailand.

Int Conf AIDS 2004 Jul 11-16; 15:(abstract no. A10375)

Nitayaphan S, Eamsila C, Titasupawant B, Trichavaroj R, Chuenchitra C, Mason S, Chanbancherd P, Karnasuta C, Brown A
Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand

BACKGROUND: A phase III trial of ALVAC-HIV and AIDSVAX B/E is ongoing in Thailand. HIV diagnostic testing provides the primary end point, crucial for the interpretation of vaccine efficacy. Differentiating HIV infection from vaccine-induced sero-positivity is essential, as is the storage of high-quality specimens for immunological assessment.

METHODS: HIV laboratories at the Armed Forces Research Institute of Medical Sciences (AFRIMS) were progressively upgraded, supporting four phase I/II HIV vaccine trials. In preparation for phase III, capacity was enhanced to allow for the large specimen thru-put of the efficacy trial (over 150,000 specimens). Both Thai and U. S. FDA-approved HIV serology kits, HIV RNA and CD4 T cell quantitation, were established and validated. Computer systems and laboratory equipment underwent qualification and validation from external QA teams to monitor compliance. SOPs, training and quality improvement was put in place. A facility for specimen processing and storage [Trial Registry and Repository Center (TRRC)] was created, equipped and staffed. A motor pool was formed to meet the logistical challenges.

RESULTS: Prior to trial initiation, the AFRIMS lab received US College of American Pathologists accreditation. In the early months of the trial, enrollment began in a phased manner and approximately 1,000 samples were tested and reported from the laboratory at AFRIMS; over 1,500 samples were processed and stored at the TRRC. The prevalence of HIV infection was approximately 3% in these screened volunteers.

CONCLUSIONS: The challenges to the laboratory supporting such a large vaccine efficacy trial are multiple and critical to the trial's success. Required preparations include the following: dedicated trained personnel, fully equipped facilities which are capable of operating despite interruption of outside electricity, customized and validated computerized systems, logistical support of specimen shipment, handling and storage, stable funding, internal/external QA programs and extensive coordination among all partners.

Keywords: AEGIS, HIV-1, Clinical Trials, Phase III, AIDS Vaccines, HIV Infections, Thailand, Acquired Immunodeficiency Syndrome, HIV Envelope Protein gp120, HIV, HIV Antibodies, HIV Seronegativity, HIV Seropositivity, Clinical Trials, HIV Seroprevalence, AIDSVAX, immunology

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A10375