Transcript:

Duration: 3 min 10 sec

EFTYHIA VARDAS: We have particular structures in place to make sure that safety is preserved for all the participants. And let me give you an example of some of those structures: We have built in something called safety pauses. So, after the first ten participants in Soweto, and the first five participants in Durban we have something called a safety pause, which will give us until January, whereby people will take the data that has been accumulated from these participants and review the safety. If it is safe we can then continue.

The group that reviews the data is people that are completely unattached to the trial, so that they don’€™t have any vested interest in being part of the trial. And they’€™re called the DSMB or Data Safety and Monitoring Board. And, really and truly, they are an independent body that just looks at the data.

We also have, in South Africa, the Medicines Control Council that will also get this data to review it, simultaneously usually with the DSMB, so that they can have an equal chance of making a decision.

The other safety aspect is that we do reviews. So, once an individual gets an injection we constantly review that individual’€¦ We do review them, at least, for the first week very intensely. Thereafter, it falls away to every week – we do a follow-up visit until they come for their next vaccination.’€

KHOPOTSO: How many vaccinations are people going to be having?        

EFTYHIA VARDAS: There’€™s three vaccinations for this trial and they are spaced more or less a month apart’€¦ And once again, I need to reiterate, we’€™re not the heroes. They are the heroes in this. And it really is an amazing thing to see these people coming forward. We’€™re really grateful.

KHOPOTSO: Are there any requirements, really, that participants need to follow, except to actually practice safe sex, things like diet ‘€¦you know when you are on a specific medication you get given instructions that smoking is contra-indicatory to this, drinking is contra-indicatory to this, that and the other ‘€¦ Any such specific requirements for an MVA vaccine or any other HIV vaccine, for that matter?              

EFTYHIA VARDAS: Well, basically, because we’€™re looking at safety, most people have to have a very healthy lifestyle and a healthy approach to life. And we’€™ve gone through a very intense screening process for these individuals’€¦ We need to make sure that they are psychologically well as well’€¦ You need to make sure that people are going to be around for 18 months for the follow-up. You need to make sure that they don’€™t want to have a baby right now, because if they do, then this is not a good idea. They shouldn’€™t be joining this trial.

KB: So, proper family planning methods are actually recommended?

EFTYHIA VARDAS: Absolutely. It’€™s an important safety issue. We don’€™t know how this vaccine will interact with an unborn child. So, we need to make sure that people entering the trial’€¦ have got good family planning in place and they’€™re not planning to have a family and no accidents will occur because we don’€™t want accidents to occur. This is a controlled scientific piece of research and we just can’€™t have factors like that occurring. And it’€™s too dangerous.

KB: I can be forgiven for thinking that this is particularly aimed at women ‘€“ the very concern that you’€™re raising now. Any such concern for men?

EFTYHIA VARDAS: The vaccine cannot get into sperm and cannot be spread during sex’€¦ It’€™s important to say that in the woman anything that she drinks, or takes, or has when she’€™s pregnant gets transferred to the baby. So, that’€™s a different situation. So, I think we’€™re pretty safe with men. It’€™s more important for the unborn child once it’€™s within its mother’€™s womb. So, I think it’€™s important to make that distinction.

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