Safety and Immunogenicity of Radiation-Attenuated PfSPZ Vaccine in Equatoguinean Infants, Children, and Adults
Author:
Jongo Said A.1, Urbano Nsue Ndong Nchama Vicente2, Church L. W. Preston3, Olotu Ally1, Manock Stephen R.3, Schindler Tobias45, Mtoro Ali1, KC Natasha36, Devinsky Orrin7, Zan Elcin7, Hamad Ali1, Nyakarungu Elizabeth1, Mpina Maxmillian145, Deal Anna45, Bijeri José Raso2, Ondo Mangue Martin Eka2, Ntutumu Pasialo Beltrán Ekua2, Nguema Genaro Nsue2, Rivas Matilde Riloha2, Chemba Mwajuma1, Ramadhani Kamaka K.1, James Eric R.3, Stabler Thomas C.3, Abebe Yonas3, Riyahi Pouria3, Saverino Elizabeth S.3, Sax Julian4, Hosch Salome45, Tumbo Anneth145, Gondwe Linda1, Segura J. Luis45, Falla Carlos Cortes8, Phiri Wonder Philip8, Hergott Dianna E. B.8, García Guillermo A.8, Maas Carl9, Murshedkar Tooba3, Billingsley Peter F.3, Tanner Marcel45, Ayekaba Mitoha Ondo’o2, Sim B. Kim Lee36, Daubenberger Claudia45, Richie Thomas L.3, Abdulla Salim1, Hoffman Stephen L.3
Affiliation:
1. Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania; 2. Ministry of Health and Social Welfare, Government of Equatorial Guinea, Malabo, Equatorial Guinea; 3. Sanaria Inc., Rockville, Maryland; 4. Swiss Tropical and Public Health Institute, Allschwil, Switzerland; 5. University of Basel, Basel, Switzerland; 6. Protein Potential LLC, Rockville, Maryland; 7. New York University Langone Medical Center, New York, New York; 8. MCD Global Health, Silver Spring, Maryland; 9. Marathon EG Production, Ltd., Malabo Dos, Equatorial Guinea
Abstract
ABSTRACT.
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.
Publisher
American Society of Tropical Medicine and Hygiene
Subject
Virology,Infectious Diseases,Parasitology
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