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EA to take part in historic malaria vaccine trials
A clinical officer takes a blood sample for a malaria slide. Some vaccine trial sites are located in areas where there is a year-round threat of malaria. Photo/ANTHONY KAMAU
East Africa is among regions that have been put on a malaria vaccine trial as world scientists frantically seek a lasting solution to the world’s leading killer disease.
Named RTTS and developed by GlaxoSmithkline, the vaccine is being tested in seven African countries — Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique and Tanzania — by the Path Malaria Vaccine Initiative.
A third of the 16,000 targeted children have already received the jab, according to researchers attending the 5th Multilateral Initiative on Malaria Pan-African Malaria Conference held in Nairobi recently.
A malaria vaccine has eluded scientists for decades, yet it is widely believed that only a vaccine can help eradicate the disease.
If successful, the vaccine will complement existing interventions, such as treated bednets and effective drug therapies.
“A malaria vaccine could help save countless lives and redefine the future for Africa’s children,” said Dr Patricia Njuguna, chair of the Clinical Trials Partnership Committee, a collaboration of African research institutions, the Malaria Vaccine Initiative and GSK.
The latter is leading the clinical development of the initiative.
RTSS is the first vaccine designed primarily for use in Africa, where malaria kills more than 800,000 people every year, the majority of them children under the age of five.
By conducting the trial in seven geographically diverse countries in sub-Saharan Africa, researchers will be able to evaluate the vaccine’s efficacy in a variety of settings, with diverse patterns of transmission.
For example, some trial sites are located in areas where there is a year-round threat of malaria, while others experience only seasonal transmission.
This is a tremendous moment in the fight against malaria and the culmination of more than two decades of research, including 10 years of clinical trials in Africa,” said Dr Joe Cohen, co-inventor of RTSS and vice president of Research and Development, Vaccines for Emerging Diseases and HIV, at GSK.
The Phase III trial will evaluate the vaccine’s efficacy in two groups of children.
One group, aged six to 12 weeks, will be vaccinated as part of their regular schedule of infant immunisations; the second group includes children aged five to 17 months.
The vaccine profile is intended primarily for infants, as they and children under the age of five are the most vulnerable to malaria.
If the Phase III programme progresses as expected, RTSS could be submitted for regulatory review under Article 58 as early as 2012.
Article 58 is a special review procedure that allows the European Medicines Agency, in close collaboration with the World Health Organisation, to issue a scientific opinion regarding the quality, the efficacy and the safety of a medical product that is intended for use exclusively outside the European Union.
Depending on the final clinical profile of the vaccine and the timetable of the regulatory review process, the first vaccine introduction could take place over the next three to five years.
The vaccine research was started in the late 1980s and as invented, developed and manufactured in laboratories at GSK headquarters in Belgium.
Funding for the development of this vaccine has been made possible through the support of the Bill & Melinda Gates Foundation, which has provided grants of more than $200 million since 2001.
GSK has invested more than $300 million to date and expects to invest at least another $100 million before the completion of the project.
The Malaria Vaccine Initiative, the WHO and the US Agency for International Development developed the Malaria Vaccine Decision-Making Framework to help countries prepare to make decisions related to future adoption of a malaria vaccine and thereby avoid unnecessary delay between the recommendation for use of a vaccine and its availability in low-income countries.
GSK and MVI signed a collaboration agreement in 2001 to pursue the paediatric clinical development of RTSS in Africa.
To advance the development programme, African research centres in five countries, and collaborating institutions, joined the partnership.
