학술논문
Immunogenicity and Protective Efficacy of Radiation-Attenuated and Chemo-Attenuated PfSPZ Vaccines in Equatoguinean Adults.
Document Type
Academic Journal
Author
Jongo SA; 1Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.; Urbano V; 2Ministry of Health and Social Welfare, Government of Equatorial Guinea, Bioko Norte, Equatorial Guinea.; Church LWP; 3Sanaria Inc., Rockville, Maryland.; Olotu A; 1Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.; Manock SR; 3Sanaria Inc., Rockville, Maryland.; Schindler T; 4Swiss Tropical and Public Health Institute, Basel, Switzerland.; Mtoro A; 1Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.; Kc N; 3Sanaria Inc., Rockville, Maryland.; 5Protein Potential LLC, Rockville, Maryland.; Hamad A; 1Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.; Nyakarungu E; 1Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.; Mpina M; 4Swiss Tropical and Public Health Institute, Basel, Switzerland.; Deal A; 4Swiss Tropical and Public Health Institute, Basel, Switzerland.; Bijeri JR; 2Ministry of Health and Social Welfare, Government of Equatorial Guinea, Bioko Norte, Equatorial Guinea.; Ondo Mangue ME; 2Ministry of Health and Social Welfare, Government of Equatorial Guinea, Bioko Norte, Equatorial Guinea.; Ntutumu Pasialo BE; 2Ministry of Health and Social Welfare, Government of Equatorial Guinea, Bioko Norte, Equatorial Guinea.; Nguema GN; 2Ministry of Health and Social Welfare, Government of Equatorial Guinea, Bioko Norte, Equatorial Guinea.; Owono SN; 2Ministry of Health and Social Welfare, Government of Equatorial Guinea, Bioko Norte, Equatorial Guinea.; Rivas MR; 2Ministry of Health and Social Welfare, Government of Equatorial Guinea, Bioko Norte, Equatorial Guinea.; Chemba M; 1Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.; Kassim KR; 1Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.; James ER; 3Sanaria Inc., Rockville, Maryland.; Stabler TC; 3Sanaria Inc., Rockville, Maryland.; Abebe Y; 3Sanaria Inc., Rockville, Maryland.; Saverino E; 3Sanaria Inc., Rockville, Maryland.; Sax J; 4Swiss Tropical and Public Health Institute, Basel, Switzerland.; Hosch S; 4Swiss Tropical and Public Health Institute, Basel, Switzerland.; Tumbo AM; 4Swiss Tropical and Public Health Institute, Basel, Switzerland.; Gondwe L; 4Swiss Tropical and Public Health Institute, Basel, Switzerland.; Segura JL; 6Medical Care Development International, Silver Spring, Maryland.; Falla CC; 6Medical Care Development International, Silver Spring, Maryland.; Phiri WP; 6Medical Care Development International, Silver Spring, Maryland.; Hergott DEB; 6Medical Care Development International, Silver Spring, Maryland.; García GA; 6Medical Care Development International, Silver Spring, Maryland.; Schwabe C; 6Medical Care Development International, Silver Spring, Maryland.; Maas CD; 7Marathon EG Production, Ltd., Bioko Norte, Equatorial Guinea.; Murshedkar T; 3Sanaria Inc., Rockville, Maryland.; Billingsley PF; 3Sanaria Inc., Rockville, Maryland.; Tanner M; 4Swiss Tropical and Public Health Institute, Basel, Switzerland.; Ayekaba MO; 2Ministry of Health and Social Welfare, Government of Equatorial Guinea, Bioko Norte, Equatorial Guinea.; Sim BKL; 3Sanaria Inc., Rockville, Maryland.; 5Protein Potential LLC, Rockville, Maryland.; Daubenberger C; 4Swiss Tropical and Public Health Institute, Basel, Switzerland.; Richie TL; 3Sanaria Inc., Rockville, Maryland.; Abdulla S; 1Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.; Hoffman SL; 3Sanaria Inc., Rockville, Maryland.
Source
Publisher: American Society of Tropical Medicine and Hygiene Country of Publication: United States NLM ID: 0370507 Publication Model: Print Cited Medium: Internet ISSN: 1476-1645 (Electronic) Linking ISSN: 00029637 NLM ISO Abbreviation: Am J Trop Med Hyg Subsets: MEDLINE
Subject
Language
English
Abstract
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 × 10 6 PfSPZ of PfSPZ Vaccine at 8-week intervals and three doses of 1.0 × 10 5 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.