Safety, Immunogenicity, and Protective Efficacy against Controlled Human Malaria Infection of Plasmodium falciparum Sporozoite Vaccine in Tanzanian Adults
| العنوان: | Safety, Immunogenicity, and Protective Efficacy against Controlled Human Malaria Infection of Plasmodium falciparum Sporozoite Vaccine in Tanzanian Adults |
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| المؤلفون: | Anneth Tumbo, Stephen L. Hoffman, Tobias Rutishauser, Claudia Daubenberger, Salim Abdulla, Maximillian Mpina, Catherine Mkindi, Adam Ruben, B. Kim Lee Sim, Sumana Chakravarty, Eric R. James, Said Jongo, Seif Shekalaghe, Andrew S. Ishizuka, Julian Rothen, Yonas Abebe, Omar Juma, Robert A. Seder, Bakari M Bakari, Solomon Mwakasungula, Peter F. Billingsley, L. W. Preston Church, Tobias Schindler, Beatus Simon, Elizabeth Saverino, Marcel Tanner, Florence A. Milando, Isabelle Zenklusen, Thomas L. Richie, Munira Qassim, Kamaka R Kassim, Natasha Kc, Ali Mtoro |
| المصدر: | The American Journal of Tropical Medicine and Hygiene |
| بيانات النشر: | American Society of Tropical Medicine and Hygiene, 2018. |
| سنة النشر: | 2018 |
| مصطلحات موضوعية: | Adult, Male, 0301 basic medicine, Plasmodium falciparum, Mosquito bite, Tanzania, Young Adult, 03 medical and health sciences, Immunogenicity, Vaccine, Double-Blind Method, Virology, Malaria Vaccines, parasitic diseases, medicine, Humans, Malaria, Falciparum, biology, business.industry, Immunogenicity, Articles, medicine.disease, Vaccine efficacy, biology.organism_classification, PfSPZ vaccine, 3. Good health, Regimen, Human Experimentation, 030104 developmental biology, Infectious Diseases, Tolerability, Sporozoites, Administration, Intravenous, Immunization, Parasitology, business, Malaria |
| الوصف: | In 2015 and in 2016, there were an estimated 429,000–730,500 deaths caused by malaria.1–3 Plasmodium falciparum (Pf) is the cause of > 98% of malaria deaths and > 80% of malaria cases in sub-Saharan Africa. Our goal is to field a vaccine that will prevent infection with Pf and thereby prevent all manifestations of Pf malaria and parasite transmission from humans to mosquitoes.4 Plasmodium falciparum sporozoites (SPZ) are the only immunogens that have ever prevented Pf infection in > 90% of subjects.5–7 Sanaria® PfSPZ Vaccine (Sanaria Inc., Rockville, MD) is composed of radiation-attenuated, aseptic, purified, cryopreserved PfSPZ.8,9 When administered by rapid intravenous injection, PfSPZ Vaccine protected 100% (6/6) of malaria-naive subjects in the United States against mosquito bite–controlled human malaria infection (CHMI) with Pf parasites similar to those in the vaccine (homologous) 3 weeks after the last immunization,10 and 65% at 24 weeks.11 Protection was durable against homologous mosquito bite CHMI for at least 59 weeks12 and heterologous (parasites different than in vaccine) mosquito bite CHMI for at least 33 weeks.13 PfSPZ Vaccine also prevented naturally transmitted heterogeneous Pf in adults in Mali for at least 24 weeks (vaccine efficacy [VE] 52% by time to event and 29% by proportional analysis).14 We used the same dosage regimen as in the United States and Mali to evaluate the tolerability, safety, immunogenicity, and VE of PfSPZ Vaccine in young adult male Tanzanians. Previously, we had conducted the first modern CHMI in Africa and showed that injection of aseptic, purified, cryopreserved PfSPZ, Sanaria® PfSPZ Challenge, consistently infected Tanzanian volunteers and subsequently repeated in multiple other countries.15–21 In this study, we took advantage of this capability to assess VE of PfSPZ Vaccine by CHMI with PfSPZ Challenge (NF54). The same PfSPZ Vaccine dosage regimen was less immunogenic and protective in Tanzanians than in Americans,11 and VE against homologous CHMI in Tanzania was lower (or similar) to VE against intense field exposure to heterogeneous Pf parasites in Mali.14 |
| تدمد: | 1476-1645 0002-9637 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4ee836d0883474a5fb16df833a8f5a71 https://doi.org/10.4269/ajtmh.17-1014 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....4ee836d0883474a5fb16df833a8f5a71 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 14761645 00029637 |
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