[HTML][HTML] Immunization with full-length Plasmodium falciparum merozoite surface protein 1 is safe and elicits functional cytophilic antibodies in a randomized first-in …

A Blank, K Fürle, A Jäschke, G Mikus, M Lehmann… - npj Vaccines, 2020 - nature.com
A Blank, K Fürle, A Jäschke, G Mikus, M Lehmann, J Hüsing, K Heiss, T Giese, D Carter
npj Vaccines, 2020nature.com
A vaccine remains a priority in the global fight against malaria. Here, we report on a single-
center, randomized, double-blind, placebo and adjuvant-controlled, dose escalation phase
1a safety and immunogenicity clinical trial of full-length Plasmodium falciparum merozoite
surface protein 1 (MSP1) in combination with GLA-SE adjuvant. Thirty-two healthy
volunteers were vaccinated at least three times with MSP1 plus adjuvant, adjuvant alone, or
placebo (24: 4: 4) to evaluate the safety and immunogenicity. MSP1 was safe, well tolerated …
Abstract
A vaccine remains a priority in the global fight against malaria. Here, we report on a single-center, randomized, double-blind, placebo and adjuvant-controlled, dose escalation phase 1a safety and immunogenicity clinical trial of full-length Plasmodium falciparum merozoite surface protein 1 (MSP1) in combination with GLA-SE adjuvant. Thirty-two healthy volunteers were vaccinated at least three times with MSP1 plus adjuvant, adjuvant alone, or placebo (24:4:4) to evaluate the safety and immunogenicity. MSP1 was safe, well tolerated and immunogenic, with all vaccinees sero-converting independent of the dose. The MSP1-specific IgG and IgM titers persisted above levels found in malaria semi-immune humans for at least 6 months after the last immunization. The antibodies were variant- and strain-transcending and stimulated respiratory activity in granulocytes. Furthermore, full-length MSP1 induced memory T-cells. Our findings encourage challenge studies as the next step to evaluate the efficacy of full-length MSP1 as a vaccine candidate against falciparum malaria (EudraCT 2016-002463-33).
nature.com
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