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

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).