IAVI, Partners Release Data Redefining Laboratory Reference Ranges in Africa

Researchers from the International AIDS Vaccine Initiative (IAVI), the U.S. Centers for Disease Control and Prevention (CDC) and the U.S. Military HIV Research Program (USMHRP) presented final results from a collection of independent studies reexamining the medical criteria for including African volunteers in AIDS vaccine trials.

The findings suggest that many healthy Southern and East Africans have, in the past, been excluded from participating in trials based on laboratory reference ranges that were developed for western populations and may not be appropriate locally, IAVI said.

Implementation of the results of the studies should improve participation of African volunteers in clinical trials for new drugs and vaccines against emerging infectious diseases currently ravaging Africa, including AIDS, TB and malaria, and enable clinicians to better monitor and define adverse events in trials, the organization added.

In the first reference range studies conducted on such a large scale, researchers from the involved organizations examined the blood tests of approximately 5,500 clinically healthy HIV-negative volunteers across a dozen clinical sites in four African countries.

For some markers, the studies revealed differences between the norms usually found in healthy Africans and the reference values developed for populations in North America and Europe.

Pat Fast, executive director of medical affairs at IAVI, said these studies will prove valuable to those designing trials in Africa.