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 naÃ¯ve 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.