MAM’ LYNETTE: She chooses the site which she wants to be injected, so she has chosen the right to be injected’¦ This is called the right deltoid muscle.
KHOPOTSO: Mam’ Lynette, a friendly, motherly nurse is about to administer the first vaccine dose into Kedi’s right-hand shoulder. Looking into Kedi’s eyes, she smiles and using a cotton wool smoothly applies a touch of spirit onto the exposed area where the woman had rolled up the sleeve of her shirt and re-assures her that the jab will be painless.
MAM’ LYNETTE: Ke tlilo o hlaba he hanyane-nyana feela, neh?
KHOPOTSO: Kedi nods in understanding and swiftly, Mam’ Lynette pricks her shoulder with the already prepared solution. Within seconds the process is over and Kedi’s expression is calm and relaxed. Mam’ Lynette hands her a piece of cotton wool to stop the tiny bleeding following injection.
MAM’ LYNETTE: O tshware jwalo, neh, hore e stope bleeding.
Fx’¦ file being flipped open
KHOPOTSO: Flipping through a file, Mam’ Lynette writes down some details including the time of vaccination and the amount of vaccine solution used. That is followed by more counselling on what are considered to be some of the possible side-effects of the vaccine.
INSERT COUNSELLING TALK THEN FADE UNDER LINK:
KHOPOTSO: Kedi is one of just under 40 participants who have volunteered to test the latest vaccine, named MRKDAd5 HIV-1 trivalent vaccine. The test vaccine contains a weakened virus, Adenovirus 5, known to cause infections such as the common cold. But researchers say that because the virus has been stripped of its potency, no participant can contract a respiratory infection from the vaccine. That is one of three aspects that researchers are testing, according to the Perinatal HIV Research Unit’s Director of HIV Vaccines Division, Dr Eftyhia Vardas.
Dr EFTYHIA VARDAS: The first thing that we’re testing is: does this vaccine work to prevent HIV infection? The second thing that we’re testing is that this vaccine is made with a sub-type B HI virus and we are, in South Africa, a population which is infected, generally, with sub-type C. So, we are testing to see if this vaccine that is made with sub-type B, actually works in sub-type C. And the third thing that we’re testing is the actual vector of this vaccine’¦ We manipulate, in the laboratory, a certain vehicle to make sure that the body’s immune system responds to the vaccine. And the vehicle that we’re using in this instance is called Adenovirus 5, which is one of the viruses that cause the common cold. What we’ve done is we’ve manipulated this virus to just carry the vaccine inside the human body. And the important thing that we’re testing in South Africa is that most South Africans have been exposed to this Adenovirus 5, and we don’t know if the vaccine will work in this type of population’¦ This particular virus that we’re using in the vaccine has been disabled. It doesn’t cause any illness.
KHOPOTSO: As a vector, the Adenovirus 5-based test vaccine also carries three genes of the sub-type B HI virus. Dr Vardas re-assures South Africa that the test solution does not carry the actual HIV, and says that no one is at risk of infection from the vaccine itself.
Dr EFTYHIA VARDAS: We don’t use the actual genes from an HI virus because that is dangerous. What we do is that we use the recipe to make those proteins from the genes in the laboratory. We use that in the vaccine. For example, if you think of a motor-car: A motor-car would be HIV. A motor-car has got a lot of different parts that make it up. If you take out the different parts, like the spark plug and the carburettor ‘ those are the genes’¦ Those are the important parts that actually make the motor-car run, but can’t make a motor-car on their own. So, a spark plug on its own is nothing. It can’t actually make something happen. That’s how HIV works as well. So, if we take out the genes of HIV, replicate them in the laboratory, and use them in a vaccine, you can’t cause HIV.
KHOPOTSO: That is one of the key concerns that participant, Kedi, says she had before she could agree to enter the study.
KEDI: Ke ba boditse gore’¦ as ke tlo e tlhaba so: ga gona gore nka ba HIV-positive, na? Ke be ke ba botsa gore’¦ maybe ke sebedisa condom, ga e ka basta, nka se be HIV-positive, na? Ba re ‘o ka ba. That’s why ba karantiya batho ba ba tlang mo-stading gore ba sebedise condom’’¦ Ba itse ‘ha ba eso be sure gore e a sebetsa this vaccination. So, that is why ba karantiya gore re tshwanetse re sebedise di-condom’.
TRANSLATION: I asked them if I could be HIV-positive from the vaccine. I also asked them if I could be HIV-positive in the event that a condom bursts during sex. They said that ‘I could be. That’s why they advise study participants to always use condoms’. They said that ‘they are not sure that the vaccine works. So, that is why they advise us to use condoms”.
KHOPOTSO: It appears that Kedi was properly counselled that the vaccine is only a test programme and that it won’t protect her from HIV infection. This is a Phase IIb study, meaning that it tests whether the vaccine in question can prevent HIV infection, before a Phase III level trial can be conducted for licensure. The question for medical researchers is this: How is the efficacy of a preventative tool, including a test vaccine, measured if they advise people not to compromise on safe sex?
Dr EFTYHIA VARDAS: You can’t say, ‘here’s a vaccine, now go and have sex with people and we’ll expose you to HIV’’¦ It’s a life-threatening illness, so you can never do that. What you have to do is follow up people over time. In South Africa, unfortunately, we have a very high prevalence of HIV infection. So, people are being exposed to HIV even if they don’t want to be exposed to HIV’¦ During the follow up of these individuals in the trial, we ask about the sexual risks that they are taking: If they are using condoms all the time? Did they forget by any chance? Was there a condom break? Did they have sex with a partner that they did not know the status of that partner? And, unfortunately, this happens’¦ either in the control of the individual or not in the control of the individual’¦ One night-stands happen. This is very unfortunate’¦ As soon as we get the number of HIV infections in the trial, we’ll be able to find out what is happening with this vaccine: Is it protecting or is it not protecting? And those HIV infections will not be because of the vaccine’¦ It’s because of the choices that they’ve made.
KHOPOTSO: The MRKD-Ad5 HIV-1 trivalent vaccine is reported to have shown promising results in smaller studies in the Americas, Australia and the Caribbean. In South Africa, the study will enrol up to 3 000 HIV-negative participants, making it the largest vaccine trial to date in Africa. Four provinces involving five sites in Soweto, Cape Town, Klerksdorp, Medunsa and Durban are recruiting volunteers for participation.