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Oxford University researchers and their partners today reported results from a Phase IIb study of a malaria vaccine candidate, R21 / Matrix-M, that showed a high 77% efficacy over 12 months after follow-up. In their findings (published on SSRN / Preprints with The Lancet), they state that they will be the first to meet the World Health Organization's Malaria Vaccine Technology Roadmap target for a vaccine with at least 75% effectiveness.
The authors report (in press results with The Lancet) on a randomized, controlled double-blind phase IIb study that was carried out at the Clinical Research Unit of Nanoro (CRUN) / Institute for Research and Science in Santé (IRSS), Burkina Faso. 450 participants, ages 5 to 17 months, were recruited from the Nanoro catchment area, which included 24 villages and an approximate population of 65,000 people.
Participants were divided into three groups, with the first two groups receiving R21 / Matrix-M (with either a low or high dose of the Matrix-M adjuvant) and the third group receiving a rabies vaccine as a control group. The doses were largely given before the malaria peak season from early May 2019 to early August 2019.
The researchers reported vaccine effectiveness of 77% in the higher-dose adjuvant group and 71% in the low-dose adjuvant group for 12 months after follow-up with no serious vaccine-related adverse events.
Following these results, the phase IIb study, which was funded by the European Union-supported EDCTP2 program (grant number RIA2016V-1649-MMVC), was expanded to include a booster one year later before the next malaria season.
The researchers, in collaboration with the Serum Institute of India Private Ltd. and Novavax Inc. began recruiting for a Phase III licensed trial to evaluate large-scale safety and efficacy in 4,800 children aged 5 to 36 months in four African countries.
Halidou Tinto, Professor of Parasitology, Regional Director of the IRSS at Nanoro, and the study's principal investigator said, "These are very exciting results showing unprecedented levels of effectiveness of a vaccine that has been well tolerated in our study program. We look forward to the phase ahead III study to demonstrate extensive safety and efficacy data for a vaccine that is urgently needed in this region. "
Adrian Hill, director of the Jenner Institute and Lakshmi Mittal and family professor of vaccine at Oxford University and co-author of the paper, said:
"These new results support our high expectations of the potential of this vaccine, which we believe will be the first to meet WHO’s goal of developing a vaccine against malaria with at least 75% effectiveness.
"With a commitment from our trading partner, the Serum Institute of India, to produce at least 200 million doses a year over the coming years, the vaccine could have a significant public health impact if approved."
Professor Charlemagne Ouédraogo, Minister of Health in Burkina Faso, said:
"Malaria is a leading cause of child mortality in Africa. We have supported trials of a number of new vaccine candidates in Burkina Faso, and this new data shows that approval of a very useful new malaria vaccine may well be possible in the years to come an extremely important new tool in fighting malaria and saving many lives. "
Professor Alkassoum Maiga Ministry of Higher Education, Scientific Research and Innovation in Burkina Faso said:
"I am proud of the Burkina Faso researchers who have made a great contribution to this important milestone. I hope that the upcoming Phase III trial confirms these exciting results and that this vaccine could have a real impact on this disease that affects millions of children every year. ""
Dr. Cyrus Poonawalla and Adar Poonawalla, Chairman and CEO of the Serum Institute of India said:
"We are very excited to see these results in a safe and highly effective malaria vaccine that will be available to the world through an excellent collaboration between the Serum Institute, the University of Oxford and Novavax Inc. The Serum Institute is committed For Global Diseases, strategies to reduce the burden and eradicate disease through the delivery of high volume, affordable vaccines. We are very confident that, in line with the above strategy, we will be able to dispense more than 200 million doses annually once regulatory approvals are received. "
Dr. Michael Makanga, Executive Director of EDCTP said:
"We congratulate the multi-stage malaria vaccine consortium on these promising results from the Burkina Faso study of R21. This study is an important advance in the clinical development of the R21 malaria vaccine towards approval and an important step towards malaria control and elimination. "
Gareth Jenkins, Director of Advocacy at Malaria No More UK said:
"An effective and safe malaria vaccine would be an extremely important additional weapon in the armory needed to fight malaria, which still kills over 270,000 children each year. For decades, British scientists have been at the forefront of developing new ways of doing this Detect, diagnose, test and treat malaria and we must keep supporting it.
"A world free of malaria is a world that is safer both for the children who would otherwise be killed by the disease and for us here at home. Countries that are free from malaria will be much better equipped to deal with new ones Ward off disease threats when they inevitably arise in the future. "
650,000 African children get malaria: WHO
The malaria vaccine is the first to reach the WHO target of 75% effectiveness (2021, April 23).
accessed on April 23, 2021
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