http://allafrica.com/stories/200305160016.html

HIV Vaccine Trials Set to Start in Botswana, US

South African Press Association (Johannesburg)

May 15, 2003
Posted to the web May 16, 2003

Johannesburg

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

The vaccine, called EP HIV-1090, would be tested on 42 volunteers in the United States and Botswana, HVTN said on Thursday.

"This trial marks a new stage in global HIV research," said HVTN principal investigator Dr Larry Corey.

"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."

It said in a statement from Gaborone, Botswana, that previous human trials conducted by HVTN outside the US, had always followed a trial in the US.

This time, participants would receive the same inoculations at the same time 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 Botswana's health minister Joy Phumaphi.

"The volunteers for this trial exemplify the best of the traditional Botswana values of altruism and selflessness."

HVTN said the vaccine candidate was a multi-epitope vaccine developed by Epimmune, a San Diego-based pharmaceutical company.

EP HIV-1090 was assembled from synthetically-produced DNA which manufactured specific proteins such as those in HIV. These proteins had elements referred to as epitopes, which in this case prepared the body to recognise real HIV, it said.

The network said there was no way that any part of the vaccine candidate could cause HIV infection. No live HIV virus was used in making the vaccine, so there was no possible way for EP HIV-1090 to cause HIV infection in any participant.

As the body learnt to defend itself against the vaccine, the hope was that it would also learn to fight off real HIV, should the body ever be exposed to the actual virus.

It said the trial was currently in Phase I. The safety and effect of the drug on the immune system was being tested.

Of the 42 volunteers, six of them would receive a placebo.

Participants would be healthy, HIV-1-uninfected people between the ages of 18 and 40.

The trial would last 18 months, after which time the data would be evaluated. The candidate vaccine would then be considered for the next stage of testing, HVTN said.

Initial lab studies had shown that EP HIV-1090 may have the potential to induce an initial immune response against subtypes of HIV seen in the US and Africa.

It said 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.

"Our understanding of HIV vaccine science grows with each human trial we undertake," said Max Essex, principal investigator of the Botswana HIV Vaccine Trial Unit.

"Vaccine development is a complicated process, and the HIV virus is particularly intricate. Clinical trials are crucial to building the body of knowledge we need to achieve a working HIV vaccine."

-- HVTN is a global network of trial sites, linking scientists, community members, governments and industry in an effort to develop an HIV vaccine. It currently has four sites in Africa: Gaborone, Durban and Soweto in South Africa, and Blantyre in Malawi.

Additional HVTN trials are scheduled to begin in South Africa soon.

On the web: www.hvtn.org