R21 / Matrix-M Malaria Vaccine Description
The R21 vaccine candidate is produced by expressing recombinant HBsAg virus-like particles in Hansenula polymorpha, comprising the central repeat and the C-terminus of the circumsporozoite protein (CSP) fused to the N-terminal end of HBsAg10. R21 was created by the University of Oxford, located in England.
In 2017, Oxford published an abstract: High-level efficacy in humans of a next-generation plasmodium falciparum anti-sporozoite vaccine: R21 in Matrix-M (TM) adjuvant.
The vaccine candidate is manufactured by the Serum Institute of India Private Ltd (SIIPL).
R21 was mixed immediately before administration with Matrix-M™, a saponin-based vaccine adjuvant produced by Novavax AB, Uppsala, Sweden. The Matrix-M component of the malaria vaccine will be manufactured and supplied to SII by Novavax. Under Novavax's agreement with Serum Institute, SII has rights to use Matrix-M in the vaccine in regions where the disease is endemic and will pay Novavax royalties on its market sales of the vaccine. Additionally, Novavax will have commercial rights to sell and distribute the SII-manufactured vaccine in certain countries, primarily in the travelers' and military vaccine markets.
On April 23, 2021, Adrian Hill, Director of the Jenner Institute and Lakshmi Mittal and Family Professor of Vaccinology at the University of Oxford, and co-author of a non-peer-reviewed paper, said in a press release, ‘These new results support our high expectations for the potential of this vaccine, which we believe is the first to reach the WHO’s goal of a vaccine for malaria with at least 75% efficacy. With the commitment by our commercial 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 major public health impact if licensure is achieved.’ The Phase 2b clinical trial targeted children 5-17 months.
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R21 / Matrix-M Malaria Vaccine Indication
R21/Matrix-M Malaria Vaccine is indicated to prevent Plasmodium falciparum malaria, which is a mosquito-borne disease. There were an estimated 229 million cases of malaria worldwide in 2019, with an estimated 409,000 deaths. According to the WHO, children under the age of five are the most vulnerable, accounting for 67 percent of deaths worldwide in 2019.
R21 / Matrix-M Malaria Vaccine Dosage
R21/Matrix-M Malaria Vaccine dosage is being tested in the Phase 2b clinical trial. Participants aged 5-17 months received 5 mg of R21 with either 25 mg or 50 mg of Matrix-M or a rabies vaccine as a control.
R21 / Matrix-M Malaria Vaccine News
May 10, 2021 - National Geographic article: At last, a malaria vaccine has passed important clinical trials.
May 5, 2021 - The Lancet published an editorial: R21/Matrix-M: a second malaria vaccine?
May 4, 2021 - News article: Explained: Why a malaria vaccine candidate has raised new hope, and what went into its making.
April 30, 2021 - BMC article: The new vaccine, R21, is very similar to RTS,S/AS01, in that it still contains the central repeat and the C-terminus of the circumsporozoite protein (CSP) fused to the N-terminal end of HBsAg. However, in contrast with RTS,S/AS01, it does not contain the HBsAg in monomer form, only as fusion protein moieties, providing more surface for the CSP on the virus-like particle, making for a more specific immune response. In addition, R21 is mixed with a different, saponin-based adjuvant called Matrix-M, produced by Novavax. The vaccines used in the trial were produced at the Serum Institute of India, the world's largest vaccine producer.
April 23, 2021 - A pre-print publication of data from a Phase 2b clinical trial in children demonstrating 77 percent efficacy for a malaria vaccine candidate, R21, created by the University of Oxford that includes Novavax' Matrix-M™ adjuvant and is licensed to Serum Institute of India (SII). The Phase 2b randomized, controlled, double-blind trial was conducted at the Clinical Research Unit of Nanoro / Institut de Recherche en Sciences de la Santé (IRSS), Burkina Faso, and recruited 450 participants from the catchment area of Nanoro, a setting with highly seasonal malaria transmission.
April 23, 2021 - Malaria vaccine becomes first to achieve WHO-specified 75% efficacy goal. Researchers from the University of Oxford and their partners have reported findings from a Phase IIb trial of a candidate malaria vaccine, R21/Matrix-M, which demonstrated high-level efficacy of 77% over 12-months of follow-up.
April 20, 2021 - The Lancet published a non-peer-reviewed study: High Efficacy of a Low Dose Candidate Malaria Vaccine, R21 in 1 Adjuvant Matrix-M™, with Seasonal Administration to Children in Burkina Faso. Interpretation: R21/Matrix-M appears safe and very immunogenic in African children and demonstrates promising high-level efficacy.
R21 / Matrix-M Malaria Vaccine Clinical Trials
R21/Matrix-M Malaria Vaccine candidate continues to progress through the Clinical Trial process. After a successful Phase1/2 trial, a Phase 3 trial has begun recruitment to assess large-scale safety and efficacy in 4,800 children 5-36 months across four African Countries.