http://allafrica.com/stories/200305270487.html

Aids Vaccine Network Launches Clinical Trials

The Daily News (Harare)

May 27, 2003
Posted to the web May 27, 2003

Staff Reporter
 

THE HIV Vaccine Trials Network (HVTN), a global network of trial sites linking scientists and governments in an effort to develop a vaccine for the killer disease, has launched the first ever international clinical trial in Africa to test a promising vaccine.

The vaccine, called EP HIV-1090, will be tested on 42 volunteers in the United States and Botswana. This will be the first trial to be conducted simultaneously in the US and Africa.

In a statement, Dr Larry Corey, the HVTN principal investigator, said: "Africa is carrying the greatest burden of the AIDS epidemic, and it is therefore crucial that HIV vaccine development includes African leadership, participation and support. This trial marks a new stage in global HIV research."

Claire Barnard, the public affairs and strategic communications officer at one of the HVTNs in South Africa, said previous human trials conducted by the organisation had always followed a US trial, but this time participants would receive the same inoculations at the same time in both the US and Botswana.

She said the vaccine was a multi-epitope vaccine developed by Epimmune, a pharmaceutical company based in San Diego, Carlifornia.

"EP HIV-1090 is assembled from sythentically 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 prepares the body to recognise real HIV. There is no way that any part of this vaccine candidate can cause HIV infection and we hope as the body learns to mount a defence against the vaccine, it will also learn to fight off real HIV, should the body be exposed to the actual virus."

Barnard said the EP HIV-1090 trial was a phase one trial, meaning that it was intended to test the safety and immuno-genecity (effect on the immune system) of the drug.

The trial would enroll 42 volunteers, 36 of whom would receive the candidate vaccine and six who would receive the control substance.

"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 and from there the vaccine will then be considered for the next stage of testing," she said.

She said initial laboratory studies had shown that the vaccine might have the potential to induce an initial immune response against sub-types of HIV seen in the US and in Africa.

Testing the product in both countries in the same trial would allow for a more thorough understanding of the best way to proceed with the vaccine candidate.

Joy Phumaphi, the Botswana Minister of Health, commended the HVTN for coming up with the trial.

"This study is a significant and hopeful step not only in Botswana's battle against the scourge of AIDS, but in Africa as a whole," Phumaphi said.

The network currently has three sites in Africa - one in Botswana, one in South Africa and another in Malawi. Additional HVTN trials are scheduled to begin soon in some parts of southern Africa.