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Immunization with full-length Plasmodium falciparum merozoite surface protein 1 is safe and elicits functional cytophilic antibodies in a randomized first-in-human trial

Citation

Lanzer, Michael (2020), Immunization with full-length Plasmodium falciparum merozoite surface protein 1 is safe and elicits functional cytophilic antibodies in a randomized first-in-human trial, Dryad, Dataset, https://doi.org/10.5061/dryad.kwh70rz0f

Abstract

This file contains the original data underpinning the article in npj vaccines, in which we describe a phase 1 safety and immunogenicty study on the malaria vaccine candidate MSP1 in humans. The abstract of the article follows:

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. 32 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 six 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).

Methods

A full description of the methods used to generate the data is provided in the article in npj vaccines. The file contains the original data underpinning each figure and table of the article.

Funding

Sumaya Biotech GmbH & Co. KG, Heidelberg, Germany.