Advancing global health through development and clinical trials partnerships: A randomized, placebo-controlled, double-blind assessment of safety, tolerability, and immunogenicity of pfspz vaccine for malaria in healthy equatoguinean men
Date
2018Journal
American Journal of Tropical Medicine and HygienePublisher
American Society of Tropical Medicine and HygieneType
Article
Metadata
Show full item recordAbstract
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.Identifier to cite or link to this item
https://www.scopus.com/inward/record.uri?eid=2-s2.0-85040525706&doi=10.4269%2fajtmh.17-0449&partnerID=40&md5=55b5ab048938ceffc5fa6617286cfa9b; http://hdl.handle.net/10713/9774ae974a485f413a2113503eed53cd6c53
10.4269/ajtmh.17-0449
Scopus Count
Collections
Related articles
- Safety, Immunogenicity, and Protective Efficacy against Controlled Human Malaria Infection of <i>Plasmodium falciparum</i> Sporozoite Vaccine in Tanzanian Adults.
- Authors: Jongo SA, Shekalaghe SA, Church LWP, Ruben AJ, Schindler T, Zenklusen I, Rutishauser T, Rothen J, Tumbo A, Mkindi C, Mpina M, Mtoro AT, Ishizuka AS, Kassim KR, Milando FA, Qassim M, Juma OA, Mwakasungula S, Simon B, James ER, Abebe Y, Kc N, Chakravarty S, Saverino E, Bakari BM, Billingsley PF, Seder RA, Daubenberger C, Sim BKL, Richie TL, Tanner M, Abdulla S, Hoffman SL
- Issue date: 2018 Aug
- Safety and Differential Antibody and T-Cell Responses to the <i>Plasmodium falciparum</i> Sporozoite Malaria Vaccine, PfSPZ Vaccine, by Age in Tanzanian Adults, Adolescents, Children, and Infants.
- Authors: Jongo SA, Church LWP, Mtoro AT, Chakravarty S, Ruben AJ, Swanson PA, Kassim KR, Mpina M, Tumbo AM, Milando FA, Qassim M, Juma OA, Bakari BM, Simon B, James ER, Abebe Y, Kc N, Saverino E, Gondwe L, Studer F, Fink M, Cosi G, El-Khorazaty J, Styers D, Seder RA, Schindler T, Billingsley PF, Daubenberger C, Sim BKL, Tanner M, Richie TL, Abdulla S, Hoffman SL
- Issue date: 2019 Jun
- Immunization of Malaria-Preexposed Volunteers With PfSPZ Vaccine Elicits Long-Lived IgM Invasion-Inhibitory and Complement-Fixing Antibodies.
- Authors: Zenklusen I, Jongo S, Abdulla S, Ramadhani K, Lee Sim BK, Cardamone H, Flannery EL, Nguyen T, Fishbaugher M, Steel RWJ, Betz W, Carmago N, Mikolajczak S, Kappe SHI, Hoffman SL, Sack BK, Daubenberger C
- Issue date: 2018 Apr 23
- Sterile protection against human malaria by chemoattenuated PfSPZ vaccine.
- Authors: Mordmüller B, Surat G, Lagler H, Chakravarty S, Ishizuka AS, Lalremruata A, Gmeiner M, Campo JJ, Esen M, Ruben AJ, Held J, Calle CL, Mengue JB, Gebru T, Ibáñez J, Sulyok M, James ER, Billingsley PF, Natasha KC, Manoj A, Murshedkar T, Gunasekera A, Eappen AG, Li T, Stafford RE, Li M, Felgner PL, Seder RA, Richie TL, Sim BK, Hoffman SL, Kremsner PG
- Issue date: 2017 Feb 23
- Progress with Plasmodium falciparum sporozoite (PfSPZ)-based malaria vaccines.
- Authors: Richie TL, Billingsley PF, Sim BK, James ER, Chakravarty S, Epstein JE, Lyke KE, Mordmüller B, Alonso P, Duffy PE, Doumbo OK, Sauerwein RW, Tanner M, Abdulla S, Kremsner PG, Seder RA, Hoffman SL
- Issue date: 2015 Dec 22