Safety and Immunogenicity of Radiation-Attenuated PfSPZ Vaccine in Equatoguinean Infants, Children, and Adults.
Said A Jongo, Vicente Urbano Nsue Ndong Nchama, L W Preston Church, Ally Olotu, Stephen R Manock, Tobias Schindler, Ali Mtoro, Natasha Kc, Orrin Devinsky, Elcin Zan, Ali Hamad, Elizabeth Nyakarungu, Maxmillian Mpina, Anna Deal, José Raso Bijeri, Martin Eka Ondo Mangue, Beltrán Ekua Ntutumu Pasialo, Genaro Nsue Nguema, Matilde Riloha Rivas, Mwajuma Chemba, Kamaka K Ramadhani, Eric R James, Thomas C Stabler, Yonas Abebe, Pouria Riyahi, Elizabeth S Saverino, Julian Sax, Salome Hosch, Anneth Tumbo, Linda Gondwe, J Luis Segura, Carlos Cortes Falla, Wonder Philip Phiri, Dianna E B Hergott, Guillermo A García, Carl Maas, Tooba Murshedkar, Peter F Billingsley, Marcel Tanner, Mitoha Ondo'o Ayekaba, B Kim Lee Sim, Claudia Daubenberger, Thomas L Richie, Salim Abdulla, Stephen L Hoffman
Author Information
Said A Jongo: Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.
Vicente Urbano Nsue Ndong Nchama: Ministry of Health and Social Welfare, Government of Equatorial Guinea, Malabo, Equatorial Guinea.
L W Preston Church: Sanaria Inc., Rockville, Maryland.
Ally Olotu: Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.
Stephen R Manock: Sanaria Inc., Rockville, Maryland.
Tobias Schindler: Swiss Tropical and Public Health Institute, Allschwil, Switzerland.
Ali Mtoro: Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.
Natasha Kc: Sanaria Inc., Rockville, Maryland.
Orrin Devinsky: New York University Langone Medical Center, New York, New York.
Elcin Zan: New York University Langone Medical Center, New York, New York.
Ali Hamad: Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.
Elizabeth Nyakarungu: Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.
Maxmillian Mpina: Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.
Anna Deal: Swiss Tropical and Public Health Institute, Allschwil, Switzerland.
José Raso Bijeri: Ministry of Health and Social Welfare, Government of Equatorial Guinea, Malabo, Equatorial Guinea.
Martin Eka Ondo Mangue: Ministry of Health and Social Welfare, Government of Equatorial Guinea, Malabo, Equatorial Guinea.
Beltrán Ekua Ntutumu Pasialo: Ministry of Health and Social Welfare, Government of Equatorial Guinea, Malabo, Equatorial Guinea.
Genaro Nsue Nguema: Ministry of Health and Social Welfare, Government of Equatorial Guinea, Malabo, Equatorial Guinea.
Matilde Riloha Rivas: Ministry of Health and Social Welfare, Government of Equatorial Guinea, Malabo, Equatorial Guinea.
Mwajuma Chemba: Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.
Kamaka K Ramadhani: Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.
Eric R James: Sanaria Inc., Rockville, Maryland.
Thomas C Stabler: Sanaria Inc., Rockville, Maryland.
Yonas Abebe: Sanaria Inc., Rockville, Maryland.
Pouria Riyahi: Sanaria Inc., Rockville, Maryland.
Elizabeth S Saverino: Sanaria Inc., Rockville, Maryland.
Julian Sax: Swiss Tropical and Public Health Institute, Allschwil, Switzerland.
Salome Hosch: Swiss Tropical and Public Health Institute, Allschwil, Switzerland.
Anneth Tumbo: Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.
Linda Gondwe: Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.
J Luis Segura: Swiss Tropical and Public Health Institute, Allschwil, Switzerland.
Carlos Cortes Falla: MCD Global Health, Silver Spring, Maryland.
Wonder Philip Phiri: MCD Global Health, Silver Spring, Maryland.
Dianna E B Hergott: MCD Global Health, Silver Spring, Maryland.
Guillermo A García: MCD Global Health, Silver Spring, Maryland.
Carl Maas: Marathon EG Production, Ltd., Malabo Dos, Equatorial Guinea.
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.
Associated Data
ClinicalTrials.gov | NCT02859350
References
Front Immunol. 2022 Oct 25;13:1006716
[PMID: 36389797]
