The American journal of tropical medicine and hygiene · 2021
Immunogenicity and Protective Efficacy of Radiation-Attenuated and Chemo-Attenuated PfSPZ Vaccines in Equatoguinean Adults.
СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Jongo Said A, Urbano Vicente, Church L W Preston, Olotu Ally, Manock Stephen R, Schindler Tobias, Mtoro Ali, Kc Natasha, Hamad Ali, Nyakarungu Elizabeth, Mpina Maximillian, Deal Anna, Bijeri José Raso, Ondo Mangue Martin Eka, Ntutumu Pasialo Beltrán Ekua, Nguema Genaro Nsue, Owono Salomon Nguema, Rivas Matilde Riloha, Chemba Mwajuma, Kassim Kamaka R, James Eric R, Stabler Thomas C, Abebe Yonas, Saverino Elizabeth, Sax Julian, Hosch Salome, Tumbo Anneth-Mwasi, Gondwe Linda, Segura J Luis, Falla Carlos Cortes, Phiri Wonder Philip, Hergott Dianna E B, García Guillermo A, Schwabe Christopher, Maas Carl D, Murshedkar Tooba, Billingsley Peter F, Tanner Marcel, Ayekaba Mitoha Ondo'o, Sim B Kim Lee, Daubenberger Claudia, Richie Thomas L, Abdulla Salim, Hoffman Stephen L
Аннотация
Plasmodium falciparum sporozoite (PfSPZ) Vaccine (radiation-attenuated, aseptic, purified, cryopreserved PfSPZ) and PfSPZ-CVac (infectious, aseptic, purified, cryopreserved PfSPZ administered to subjects taking weekly chloroquine chemoprophylaxis) have shown vaccine efficacies (VEs) of 100% against homologous controlled human malaria infection (CHMI) in nonimmune adults. Plasmodium falciparum sporozoite-CVac has never been assessed against CHMI in African vaccinees. We assessed the safety, immunogenicity, and VE against homologous CHMI of three doses of 2.7 × 106 PfSPZ of PfSPZ Vaccine at 8-week intervals and three doses of 1.0 × 105 PfSPZ of PfSPZ-CVac at 4-week intervals with each arm randomized, double-blind, placebo-controlled, and conducted in parallel. There were no differences in solicited adverse events between vaccinees and normal saline controls, or between PfSPZ Vaccine and PfSPZ-CVac recipients during the 6 days after administration of investigational product. However, from days 7-13, PfSPZ-CVac recipients had significantly more AEs, probably because of Pf parasitemia. Antibody responses were 2.9 times higher in PfSPZ Vaccine recipients than PfSPZ-CVac recipients at time of CHMI. Vaccine efficacy at a median of 14 weeks after last PfSPZ-CVac dose was 55% (8 of 13, P = 0.051) and at a median of 15 weeks after last PfSPZ Vaccine dose was 27% (5 of 15, P = 0.32). The higher VE in PfSPZ-CVac recipients of 55% with a 27-fold lower dose was likely a result of later stage parasite maturation in the liver, leading to induction of cellular immunity against a greater quantity and broader array of antigens.