Oxford’s antimalarial vaccine confirms its efficacy and safety in a phase 3 trial

The R21/Matrix-M malaria vaccine confirmed “high” efficacy (78% on average) and “a good” safety profile in children aged 5 to 17 months during the first year, according to data from a new phase-in clinical trial 3 carried out in Burkina Faso, Kenya, Mali and Tanzania.

The R21/Matrix-M vaccine was designed in 2011 as a potential improvement to the RTS, S/AS01 designed in the 1980s.

The phase 3 study, whose results are published today by Lancet, immunized more than 4,800 children and found an average vaccine efficacy of 78% during the first year of follow-up in all centers in the age group 5 to 17 months.

That is the age group in which most malaria vaccines are studied, said in a statement the University of Oxford, which developed the vaccine and which is manufactured by the Serum Institute of India.

Efficacy over the one-year period was very similar in all study sites and in different transmission environments.

No other vaccine has recorded an efficacy greater than 55% in the same age group and, in addition, a booster dose per year maintained good efficacy for the following 6-12 months, the note adds.

The vaccine also reduced infection rates in children at 12 and 18 months after receiving the preparation, “suggesting a potentially beneficial effect in reducing malaria transmission.”

Significantly greater immune responses to R21/Matrix-M and slightly higher efficacy were observed in children aged 5 to 17 months compared to the other vaccines aged 18 to 36 months, “supporting the planned rollout of the vaccine initially starting in 5 months of age in young African children.

The safety data from the trial “have been reassuring,” with no “serious adverse events related to immunization” occurring, the note adds.

The vaccine was well tolerated, with pain at the injection site and fever being the most frequent adverse events, and there were no deaths related to the treatment.

The results of this phase 3 trial have supported regulatory approval and licensing in several African countries, the statement recalls.

Malaria is the leading cause of death among young African children, with more than 600,000 deaths each year worldwide. With EFE

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