trials in South Africa
14 November 2007
Ladies and gentlemen I wish to welcome you to the Department of Health and
thank you for honouring this invitation in such a short notice. I called you
today to brief me on the Phase II HIV vaccine clinical trial that was jointly
conducted by the South African Aids Vaccines Initiative (SAAVI) and the HIV
Vaccine Trials Network (HVTN) and was put on hold on Friday 21 September
2007.
In this meeting I would like us to have a discussion on this trial and
others that have experienced difficulties by way of understanding the
implications for future research. I am really concerned about the clinical
trials that are started and then stopped for safety reasons. It is a particular
concern as this has now happened more than once.
As I have a responsibility for the health and safety of the South African
public, I am often asked to answer questions on this issue.
You will recall the following:
* In 2000, a large full-scale nonoxynol-9trial showed to be unsafe when it
had been expected to be effective. Women in that trial developed a higher
incidence of HIV infection, presumably through ulcers caused by chemical
irritation.
* This year the Data and Safety Monitoring Board (DSMB) stopped the
Cellulose Sulphate microbicide trial. This particular trial received attention
at the Sydney Conference this year. Issues that were raised related to whether
is it still necessary to continue with microbicides trials given the rate of
failure in preventing the transmission of HIV and the resources that go into
such trials.
* This HVTN 503 vaccine trial was placed on hold following a regularly
scheduled meeting of the Independent Data and Safety Monitoring Board. This was
after the DSMB had reviewed safety data and results of an interim efficacy
analysis of the study. The DSMB felt that information available did not show
that the vaccination would meet efficacy endpoints.
* I have been informed that the HVTN 503 study began enrolling and
vaccinating participants in January 2007. Since that time, 799 individuals had
been enrolled and 55 were fully immunised. The study was being conducted at
five sites in Soweto, Cape Town, Klerksdorp, Pretoria and Durban.
* I therefore wish to hear what happened with this HVTN 503 trial?
* What measures have you taken thus far since the trial was stopped?
* Where are the clinical trial participants and what is happening to
them?
* What other processes and activities are you undertaking regarding this
trial?
* I also wish that the President of the Medical Research Council should
input first into the discussion as he is in charge of SAAVI.
My questions to you this morning is:
* To what extent is the evidence from Phase I and Phase II studies that the
intervention is safe?
* Secondly, has there been sufficient preparation ahead of initiating these
studies. Why are we seeing a more frequent discontinuation of studies?
* How are we responding to the debates that took place among scientists at the
Sydney conference and other scientific literature?
* And, what is the broader implication. How should we structure future studies
in such a way that is does not raise public concerns and begin to undermine the
confidence that the public have in these studies.
I trust that we will have an open and constructive discussion this
morning.
Thank you
Issued by: Department of Health
14 November 2007
