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Advancing global health through development and clinical trials partnerships: a randomized, placebo-controlled, double-blind assessment of safety, tolerability, and Immunogenicity of Plasmodium falciparum sporozoites vaccine for malaria in healthy Equatoguinean men

Olotu, Ally and Urbano, Vicente and Hamad, Ali and Eka, Martin and Chemba, Mwajuma and Nyakarungu, Elizabeth and Raso, Jose and Eburi, Esther and Mandumbi, Dolores O. and Hergott, Dianna and Maas, Carl D. and Ayekaba, Mitoha O. and Milang, Diosdado N. and Rivas, Matilde R. and Schindler, Tobias and Embon, Oscar M. and Ruben, Adam J. and Saverino, Elizabeth and Abebe, Yonas and Kc, Natasha and James, Eric R. and Murshedkar, Tooba and Manoj, Anita and Chakravarty, Sumana and Li, Minglin and Adams, Matthew and Schwabe, Christopher and Segura, J. Luis and Daubenberger, Claudia and Tanner, Marcel and Richie, Thomas L. and Billingsley, Peter F. and Lee Sim, B. Kim and Abdulla, Salim and Hoffman, Stephen L.. (2018) Advancing global health through development and clinical trials partnerships: a randomized, placebo-controlled, double-blind assessment of safety, tolerability, and Immunogenicity of Plasmodium falciparum sporozoites vaccine for malaria in healthy Equatoguinean men. American Journal of Tropical Medicine and Hygiene, 98 (1). pp. 308-318.

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Abstract

Equatorial Guinea (EG) has implemented a successful malaria control program on Bioko Island. A highly effective vaccine would be an ideal complement to this effort and could lead to halting transmission and eliminating malaria. Sanaria® PfSPZ Vaccine (Plasmodium falciparum sporozoite Vaccine) is being developed for this purpose. To begin the process of establishing the efficacy of and implementing a PfSPZ Vaccine mass vaccination program in EG, we decided to conduct a series of clinical trials of PfSPZ Vaccine on Bioko Island. Because no clinical trial had ever been conducted in EG, we first successfully established the ethical, regulatory, quality, and clinical foundation for conducting trials. We now report the safety, tolerability, and immunogenicity results of the first clinical trial in the history of the country. Thirty adult males were randomized in the ratio 2:1 to receive three doses of 2.7 × 105 PfSPZ of PfSPZ Vaccine (N = 20) or normal saline placebo (N = 10) by direct venous inoculation at 8-week intervals. The vaccine was safe and well tolerated. Seventy percent, 65%, and 45% of vaccinees developed antibodies to Plasmodium falciparum (Pf) circumsporozoite protein (PfCSP) by enzyme-linked immunosorbent assay, PfSPZ by automated immunofluorescence assay, and PfSPZ by inhibition of sporozoite invasion assay, respectively. Antibody responses were significantly lower than responses in U.S. adults who received the same dosage regimen, but not significantly different than responses in young adult Malians. Based on these results, a clinical trial enrolling 135 subjects aged 6 months to 65 years has been initiated in EG; it includes PfSPZ Vaccine and first assessment in Africa of PfSPZ-CVac. ClinicalTrials.gov identifier: NCT02418962.
Faculties and Departments:03 Faculty of Medicine > Departement Public Health > Sozial- und Präventivmedizin > Malaria Vaccines (Tanner)
09 Associated Institutions > Swiss Tropical and Public Health Institute (Swiss TPH) > Department of Epidemiology and Public Health (EPH) > Health Interventions > Malaria Vaccines (Tanner)
09 Associated Institutions > Swiss Tropical and Public Health Institute (Swiss TPH)
09 Associated Institutions > Swiss Tropical and Public Health Institute (Swiss TPH) > Department of Medical Parasitology and Infection Biology (MPI) > Clinical Immunology (Daubenberger)
09 Associated Institutions > Swiss Tropical and Public Health Institute (Swiss TPH) > Department of Swiss Centre for International Health (SCIH) > Systems Performance and Monitoring (Pham-Tan)
UniBasel Contributors:Schindler, Christian and Segura, Luis and Segura, Luis and Daubenberger, Claudia and Tanner, Marcel
Item Type:Article, refereed
Article Subtype:Research Article
Publisher:American Society of Tropical Medicine and Hygiene
ISSN:0002-9637
e-ISSN:1476-1645
Note:Publication type according to Uni Basel Research Database: Journal article
Language:English
Identification Number:
Last Modified:07 Sep 2018 12:51
Deposited On:02 Feb 2018 13:55

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