KHOPOTSO: The experimental vaccine, called Fit-biotech, shifts away from conventional practice in that participants in the study don’€™t have to be HIV-negative. The trial recruits people who are already infected. Dr Eftyhia Vardas is the Director of the HIV/AIDS Vaccine Division at the Peri-natal HIV Research Unit, based on the ground floor of the nurses’€™ home at Chris Hani Baragwanath Hospital, in Soweto.      

Dr EFTYHIA VARDAS: It’€™s very exciting for us to be doing this trial. It’€™s a so-called therapeutic HIV vaccine. Up until now we’€™ve tested preventative HIV vaccines, which have been for uninfected people to prevent them from getting HIV in future if they do get exposed to HIV. What we have now is a vaccine to be tested in HIV positive people in order to try and help them control their infection so that they do not progress to AIDS’€¦ Theoretically, this vaccine is meant to help them maintain their CD 4 counts and keep a very low viral load so that they don’€™t get ill.

KHOPOTSO: The first study participants will receive the vaccinations tomorrow (Friday, 07th). These are healthy individuals who have HIV, meaning that their immune system is still strong and their CD 4 count is above 400. A 25-year young Soweto woman, referred to SM, is one of the first two South African participants set to be vaccinated.

S.M: My CD 4 count is 698, which is good’€¦ I do qualify with that because your CD 4 count has to be from 400. It doesn’€™t have to be below.

KHOPOTSO: In addition to being healthy and having a high CD 4 count, participants should not currently be, or should not have previously been, on antiretroviral therapy. Dr Vardas explains why.

Dr EFTYHIA VARDAS: The reason for that is that we need to work out if they get this vaccine and they start to control their disease ‘€“ is it because of the vaccine or is it because of something else? The other aspect of it is that if they are ill already, then, we don’€™t want to endanger their health.

KHOPOTSO: The vaccine was developed in Finland and the initial Phase 1 studies to determine whether it’€™s safe for human trials were conducted in the Scandinavian country before it could be introduced in South Africa for trials.

Dr EFTYHIA VARDAS: It was about 20 ‘€“ 30 people’€¦ So, it was relatively small. And it was absolutely safe’€¦ from a safety perspective.

From the immunological perspective it showed that people can maintain their CD 4 counts. But in such a small group of people we really cannot use that as data to show that the vaccine works.

KHOPOTSO: Dr Vardas says the trial that’€™s just started in South Africa is at a Phase 2 level.

Dr EFTYHIA VARDAS: We’€™re still looking at safety because it’€™s the first time in South Africans. But we’€™re also looking at the various doses and how to give the vaccine ‘€“ do we give it into the muscle, do we give it into skin’€¦?

Again, this is a small study with only 60 people in total, including the South Africans and the people from Finland. We will look at end-points to show if people control their virus. But that will not be enough to actually say it actually works. And we will have to go on to Phase 3 studies to prove efficacy. What it will show is that there is some function in that direction, so we should pursue it into bigger studies.                              

KHOPOTSO: The 60 participants will be recruited from both Finland and South Africa, but will be weighted more towards South Africa ‘€“ with 54 coming from here.

Dr EFTYHIA VARDAS: The reason for that is that in Finland if you are diagnosed as HIV positive you get treatment immediately. So, they don’€™t have this group of treatment naïve people that are healthy as we do in South Africa.

KHOPOTSO: Meanwhile, SM, is aware that some view such trials with scepticism. But, she believes that participating will benefit the vast majority of her fellow citizens.

S.M: It’€™s not only about me. I think HIV is not about who is positive or not. It affects all of us. So, I’€™m doing this for all of us’€¦

KHOPOTSO: If the vaccine proves successful, says Dr Eftyhia Vardas, it could potentially change the way doctors are currently treating individuals with AIDS.

DR EFTYHIA VARDAS: Well, ultimately, the benefits would be that if in an ideal world this vaccine works 100%, we could then say you get 4 or 5 vaccines a year and no drugs. So, it would be a much easier way to manage HIV infection in people.

KHOPOTSO: But she admits that this is a bit on the ambitious side.

Dr EFTYHIA VARDAS: That we’€™re not sure if it’€™ll ever be the case’€¦ What we are aiming to do is that we could use the vaccine in conjunction with drugs, but reduce the number of drugs, therefore, reducing the side-effects that people are exposed to and reducing the issues around compliance and having to take these drugs every day. So, we’€™re seeing it as an extra tool to help control HIV infection.