Jan 3, 2007:AMMREN visits Kintampo Health Research
Centre, Ghana
The objectives of the
visit were to acquire first hand information on malaria clinical
vaccine trial taking place at the centre, seek the views of the
parents of children participating in the trials, interview field
workers and researchers working on the malaria clinical trials and
produce stories and a documentary on the malaria vaccine trials
taking place at the centre.
Eight (8) African Media and Malaria Research Network (AMMREN) members from eight (8) top media houses (TV, Print and Radio) in Ghana visited the Kintampo Health Research Centre (KHRC) in the Brong Ahafo Region of Ghana to familiarize themselves on the malaria vaccine trials currently taking place at the Centre.
In a media briefing,
Dr. Seth Owusu-Agyei, The Director of the Kintampo Health Research
Centre (KHRC) said the centre has successfully started a Phase IIb
RTS,S vaccine trial in Kintampo, Ghana to evaluate the
administration of RTS,S candidate malaria vaccine in children 5
months to 17 months old.
The objective of the malaria vaccine trial is to assess its safety in this age group and compare the impact of three potential immunization schedules on the immune response of children. This will help partners to identify the most effective immunization schedule prior to the commencement of Phase 111 of the studies.
About 540 children are
involved in the trial in Ghana with half of the children coming from
the Kintampo North and South Districts with the other half recruited
in Agogo, Ghana under the coordination of the Kumasi Centre for
Collaborative Research/School of Medical Sciences, Ghana (KCCR/SMS).
The vaccination of 270 recruited participants started on 30th September 2006. 180 children have received all their scheduled trial vaccines. The other 90 children will receive their last dose in April 2007. All the children will be followed up until 20 months after recruitment.
The malaria vaccines being used for the trial are only for experimental use with the aim of gathering enough information required for licensure and use by the general population. The malaria vaccine is being developed for immunization of infants and children living in places such as Kintampo and its surrounding communities where malaria is common.
The RTS,S malaria vaccine was created in 1987 and it is being developed by GlaxoSmithKline Kline (GSK) Biological in close collaboration with Walter Reed Army Institute of Research in the USA.
A version of RTS,S
vaccine has also been given to about 2000 children aged 1 to 4 years
of age in Mozambique. Results showed that eighteen months after the
children were immunized; the risk of severe malaria was lowered by
about one half and all children who received the vaccine were
protected against Hepatitis B. Researchers found that the protective
effect of the malaria vaccine did not wane 24 months after vaccine
administration.
The safety of participants in the trial is paramount to the researchers. The plans and conduct of the trial at KHRC have been reviewed and authorized by a number of regulatory authorities to ensure the safety of participating children. These include the:
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Ghana Health Service Ethical Review Committee,
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Food and Drug Board of Ghana,
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Kintampo Health Research Centre Institutional Ethics Committee,
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Kintampo Health Research Centre Scientific Review Committee,
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Western Institutional Review Board in the USA
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Ethics Committee of the London School of Hygiene and Tropical Medicine
In addition, an independent group called the Data Safety Monitoring Board including a Ghanaian review the study and all safety reports during the trial to make sure that the safety and health of every child is protected.
The trial team is
committed to ensuring the safety of participants. Field workers, who
live with participants’ in the communities, visit participants on
daily basis to ensure that the children are well. Dr Sam Newton, the
Local Safety Monitoring Expert said the safety of participants in
the vaccine trial is paramount to the Safety and Monitoring Board
both locally and internationally. The local monitoring of the trials
ensures that researchers and scientists adhere to an outline set
before the start of the trials. If the trial is found to be having
any adverse effect on participants, the Local Safety Monitor can
stop the trial and inform the Data Safety Monitoring Board.
Ghana is one of the
six African countries participating in the malaria clinical trial
aimed at assessing the safety of a malaria candidate vaccine, RTS,S
(rpt. RTS,S), which is expected to help control malaria in Africa.
The other countries are Senegal, Gabon, Tanzania, Kenya and
Mozambique.
In an interaction with the Nicholsa Nabare, Head Doctor of Kintampo Government Hospital, he said the hospital record an average of 80 cases a day with malaria cases amounting to over 50% of recorded cases. Those mostly affected are children under five and pregnant women. He linked the high incidence malaria attacks to the geographical location of district.
Mr. Moses Anane, the Field Supervisor in Jema one of the trial communities, informed the journalist that to ensure the safety of the trial participants at all times, well-equipped field workers who live in the various trial communities visit participants on daily basis to ensure that the children are well.
All parents
interviewed showed high level of satisfaction and lauded the initiative
describing it as “very effective” and wished the trial had
started earlier.
“I have never regretted for allowing my child take part in this trial. My older children used to have frequent malaria attacks but since I sent my last baby to participate in the trial, I have my peace of mind because she hardly get malaria attacks, I can now work and safe for the future instead of paying hospital bills as I used to” say a mothers
“……….I’m so happy my child is involved in this trial. In fact initially, I didn’t want my child to be part but after they explained everything to me, I decided to let my baby take part in the trial. As I speak today (5th January, 2007) some of my friends who did not allow their children to take part in the study have regretted, because the babies involved in the study are healthier than those who are not involved. They wish they had allowed their babies to take part in the trials” a father declares.
The journalists
visited some interesting places in Kintampo such the Kintampo
Waterfalls and The Centre of Ghana.
Over 21 stories on
malaria ad other related news items (TV, Radio and print) were
produced by members.
The field visit was sponsored by Malaria Clinical Trials Alliance (MCTA) of INDEPTH Network.
