The American journal of tropical medicine and hygiene · 2023
Safety and Immunogenicity of Radiation-Attenuated PfSPZ Vaccine in Equatoguinean Infants, Children, and Adults.
Рандомизированное исследованиеСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Jongo Said A, Urbano Nsue Ndong Nchama Vicente, Church L W Preston, Olotu Ally, Manock Stephen R, Schindler Tobias, Mtoro Ali, Kc Natasha, Devinsky Orrin, Zan Elcin, Hamad Ali, Nyakarungu Elizabeth, Mpina Maxmillian, Deal Anna, Bijeri José Raso, Ondo Mangue Martin Eka, Ntutumu Pasialo Beltrán Ekua, Nguema Genaro Nsue, Rivas Matilde Riloha, Chemba Mwajuma, Ramadhani Kamaka K, James Eric R, Stabler Thomas C, Abebe Yonas, Riyahi Pouria, Saverino Elizabeth S, Sax Julian, Hosch Salome, Tumbo Anneth, Gondwe Linda, Segura J Luis, Falla Carlos Cortes, Phiri Wonder Philip, Hergott Dianna E B, García Guillermo A, Maas Carl, 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
The radiation-attenuated Plasmodium falciparum sporozoites (PfSPZ) Vaccine has demonstrated safety and immunogenicity in 5-month-old to 50-year-old Africans in multiple trials. Except for one, each trial has restricted enrollment to either infants and children or adults < 50 years old. This trial was conducted in Equatorial Guinea and assessed the safety, tolerability, and immunogenicity of three direct venous inoculations of 1.8 × 106 or 2.7 × 106 PfSPZ, of PfSPZ Vaccine, or normal saline administered at 8-week intervals in a randomized, double-blind, placebo-controlled trial stratified by age (6-11 months and 1-5, 6-10, 11-17, 18-35, and 36-61 years). All doses were successfully administered. In all, 192/207 injections (93%) in those aged 6-61 years were rated as causing no or mild pain. There were no significant differences in solicited adverse events (AEs) between vaccinees and controls in any age group (P ≥ 0.17). There were no significant differences between vaccinees and controls with respect to the rates or severity of unsolicited AEs or laboratory abnormalities. Development of antibodies to P. falciparum circumsporozoite protein occurred in 67/69 vaccinees (97%) and 0/15 controls. Median antibody levels were highest in infants and 1-5-year-olds and declined progressively with age. Antibody responses in children were greater than in adults protected against controlled human malaria infection. Robust immunogenicity, combined with a benign AE profile, indicates children are an ideal target for immunization with PfSPZ Vaccine.