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First HIV Vaccine Trial to Be Conducted in the US and Africa
 

The Chronicle Newspaper (Lilongwe)

June 2, 2003
Posted to the web June 2, 2003

Lilongwe

The HIV Vaccine Trials Network (HVTN) has launched an international clinical trial that will test a promising HIV prevention vaccine candidate in humans.

The vaccine, called EP HIV-1090, will be tested in 42 volunteers in the U.S. and Botswana. This trial has the multiple distinctions of being the first trial to be conducted simultaneously in the U.S. and Africa, the first HVTN trial to take place in Africa, and the first HVTN trial to be conducted simultaneously in the U.S. and abroad.

'This trial marks a new stage in global HIV research,' stated Dr. Larry Corey, Principal Investigator for the HVTN. 'Africa is carrying the greatest burden of the AIDS epidemic, and it is therefore crucial that HIV vaccine development include African leadership, participation and support.' Previous human trials conducted by the HVTN outside the U.S. have always followed a U.S. trial. This time participants will receive the same inoculations during the same time period in the Boston, Massachusetts area, in St. Louis, Missouri, and in Gaborone, Botswana.

'This study is a significant and hopeful step in Botswana's battle against the scourge of AIDS,' said Joy Phumaphi, Botswana's Minister of Health. 'The volunteers for this trial exemplify the best of the traditional Botswana values of altruism and selflessness.' The vaccine candidate is a multi-epitope vaccine developed by Epimmune, a San Diego, California based pharmaceutical company. EP HIV-1090 is assembled from synthetically produced DNA. These small pieces of DNA manufacture specific proteins like the ones in HIV. These proteins have elements referred to as epitopes, which in this case prepare the body to recognize real HIV. There is no way that any part of this vaccine candidate can cause HIV infection. As the body learns to mount a defense against the vaccine, the hope is that it will also learn to fight off real HIV, should the body ever be exposed to the actual virus.

The EP HIV-1090 trial is a Phase I trial, meaning that it is intended to test the safety and immunogenicity (effect on the immune system) of the drug. The double-blinded trial will enrol 42 volunteers, 36 of whom will receive the candidate vaccine and six of whom will receive the placebo.

Participants will be healthy, HIV-1-uninfected adults between the ages of 18 and 40. The trial will last 18 months, after which time the data will be evaluated. The candidate vaccine will then be considered for the next stage of testing.

Initial lab studies have shown that EP HIV-1090 may have the potential to induce an initial immune response against subtypes of HIV seen in the U.S. and in Africa. Testing the product in both countries in the same trial will allow for a more thorough understanding of the best way to proceed with this vaccine candidate.