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Immunogenicity and Protective Efficacy of Radiation-Attenuated and Chemo-Attenuated PfSPZ Vaccines in Equatoguinean Adults.


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 × 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.

SUBMITTER: Jongo SA 

PROVIDER: S-EPMC7790068 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Immunogenicity and Protective Efficacy of Radiation-Attenuated and Chemo-Attenuated PfSPZ Vaccines in Equatoguinean Adults.

Jongo Said A SA   Urbano Vicente V   Church L W Preston LWP   Olotu Ally A   Manock Stephen R SR   Schindler Tobias T   Mtoro Ali A   Kc Natasha N   Hamad Ali A   Nyakarungu Elizabeth E   Mpina Maximillian M   Deal Anna A   Bijeri José Raso JR   Ondo Mangue Martin Eka ME   Ntutumu Pasialo Beltrán Ekua BE   Nguema Genaro Nsue GN   Owono Salomon Nguema SN   Rivas Matilde Riloha MR   Chemba Mwajuma M   Kassim Kamaka R KR   James Eric R ER   Stabler Thomas C TC   Abebe Yonas Y   Saverino Elizabeth E   Sax Julian J   Hosch Salome S   Tumbo Anneth-Mwasi AM   Gondwe Linda L   Segura J Luis JL   Falla Carlos Cortes CC   Phiri Wonder Philip WP   Hergott Dianna E B DEB   García Guillermo A GA   Schwabe Christopher C   Maas Carl D CD   Murshedkar Tooba T   Billingsley Peter F PF   Tanner Marcel M   Ayekaba Mitoha Ondo'o MO   Sim B Kim Lee BKL   Daubenberger Claudia C   Richie Thomas L TL   Abdulla Salim S   Hoffman Stephen L SL  

The American journal of tropical medicine and hygiene 20210101 1


<i>Plasmodium falciparum</i> 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. <i>Plasmodium falciparum</i> sporozoite-CVac has never been assessed against CHMI in African vaccinees. We assessed the  ...[more]

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