Researchers from the
University of Oxford
(
United Kingdom
) and their partners have reported this Friday the results of a
phase IIb
trial
of a candidate for a
malaria
vaccine
(
R21 / Matrix-M
) with a high-level efficacy of 77% during 12 months of follow-up.
In their conclusions, published this Friday in
The Lancet
magazine
before
World Malaria Day
is celebrated this Sunday
, they point out that they are the first to meet the objective of the 'Roadmap for malaria vaccine technology 'of the
World Health Organization (WHO)
, which sets at least 75% vaccine efficacy.
According to WHO, 46 of 87 countries with malaria reported fewer than 10,000 cases of the disease in 2019, compared with 26 countries in 2000. By the end of 2020, 24 states had reported interruption of malaria transmission for three years or more, of which 11 received the certification of countries free of the disease.
The authors indicate that they have achieved 77% efficacy in a randomized, controlled, double-blind,
phase IIb trial
conducted at the
Nanoro Clinical Research Unit / Health Sciences Research Institute
(
Burkina Faso
), with 450 participants from between 5 and 17 months recruited in the Burkinabe department of
Nanoro
, which includes 24 villages and a population of approximately 65,000 people.
The participants were divided into three groups.
The first two received the
R21 / Matrix-M vaccine
(with a low dose or a high dose of Matrix-M adjuvant) and the third, a rabies vaccine as a control group.
The doses were administered from early May 2019 to early August of that year, largely before the peak malaria season.
Efficacy was 77% in the higher-dose adjuvant group and 71% in the lower-dose adjuvant group, during 12 months of follow-up and no serious vaccine-related adverse events were observed.
Following these results, the phase
IIb
trial
, funded by the
EDCTP2 program
, supported by the
European Union
, was expanded a year later with a booster vaccine administered before the following malaria season.
Recruitment for Phase III
The researchers, in collaboration with the
Serum Institute
of
India
and
Novavax
have begun recruiting for a trial license
phase III
to evaluate the safety and effectiveness on
a large scale in 4,800 children aged 5 to 36 months in four countries Africans "These are very exciting results showing unprecedented levels of efficacy of a vaccine that has been well tolerated in our testing program. We look forward to the next phase III trial to demonstrate large-scale safety and efficacy data for a vaccine which is very necessary in this region, "says
Halidou Tinto
, professor of parathysology, regional director of the
Health Sciences Research Institute in Nanor
o and principal investigator of the trial.
Adrian Hill
, director of
the Jenner
and
Lakshmi Mittal
Institute
, and a family professor of vaccinology at the
University of Oxford
, stresses: "These new results support our high expectations about the potential of this vaccine, which we believe is the first to achieve the goal of WHO Malaria Vaccine With At Least 75% Efficacy ".
"With the commitment of our business partner, the Serum Institute of India, to manufacture at least 200 million doses annually in the coming years, the vaccine has the potential to have a major impact on public health if licensed. ", he points. For her part, the Minister of Health of
Burkina Faso
,
Charlemagne Ouédraogo
, emphasizes that "malaria is one of the main causes of infant mortality in Africa."
"We have been supporting the trials of a number of new vaccine candidates in
Burkina Faso
and this new data shows that the licensing of a very useful new malaria vaccine could well occur in the coming years. This would be an extremely important new tool for control malaria and save many lives, "he says.
According to the criteria of The Trust Project
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