drugset / Trial / NCT02687373
Safety, Tolerability and Efficacy of PfSPZ Vaccine in Healthy Children and Infants 5 Months - 9 Years Living in Kenya
Phase 1/2
Completed
337 enrolled
Sanaria Inc.
Centers for Disease Control and Prevention · collabKenya Medical Research Institute · collabNational Institutes of Health (NIH) · collabUniversity of Maryland · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This study will be conducted in Siaya County in Nyanza Province, western Kenya. Healthy children aged 5 months through 9 years of age living within approximately 10 km of the study clinic(s) (Siaya County Referral Hospital, or Wagai dispensary, a government health facility in Wagai division) will be eligible for participation in Part 1; healthy infants aged 5 months - 12 months inclusive will be eligible for Part 2.
Timeline
- Start
- 2016-07-21
- Primary completion
- 2018-08
- Completion
- 2018-08-14
Outcome
Missed primary endpoint
paper There was no significant protection against P. falciparum infection in any dose group at 6 months PMID 34518679 ↗
paper VE in the 9.0 × 105 dose group = -6.5%, P = 0.598, the primary statistical end point of the study PMID 34518679 ↗
Publications
- Oneko M, Steinhardt LC, Yego R, Wiegand RE, Swanson PA, Kc N, Akach D, Sang T, Gutman JR, Nzuu EL, Dungani A, Kim Lee Sim B, Oloo PN, Otieno K, Bii DK, Billingsley PF, James ER, Kariuki S, Samuels AM, Jongo S, Chebore W, Abdulla S, Daubenberger C, Mpina M, Styers D, Potter GE, Abarbanell G, Richie TL, Hoffman SL, Seder RA. Safety, immunogenicity and efficacy of PfSPZ Vaccine against malaria in infants in western Kenya: a double-blind, randomized, placebo-controlled phase 2 trial. Nat Med. 2021 Sep;27(9):1636-1645. doi: 10.1038/s41591-021-01470-y. Epub 2021 Sep 13.
- Oneko M, Cherop YR, Sang T, Gutman JR, Wiegand R, Nyang'au EM, Odila AD, Akach D, Hamel MJ, Samuels AM, Kariuki S, Abebe Y, Nzuu EL, Wijayalath W, James ER, Sim BKL, Billingsley PF, Richie TL, Hoffman SL, Seder RA, Steinhardt LC. Feasibility of direct venous inoculation of the radiation-attenuated Plasmodium falciparum whole sporozoite vaccine in children and infants in Siaya, western Kenya. Vaccine. 2020 Jun 15;38(29):4592-4600. doi: 10.1016/j.vaccine.2020.05.008. Epub 2020 May 19.
- Steinhardt LC, Richie TL, Yego R, Akach D, Hamel MJ, Gutman JR, Wiegand RE, Nzuu EL, Dungani A, Kc N, Murshedkar T, Church LWP, Sim BKL, Billingsley PF, James ER, Abebe Y, Kariuki S, Samuels AM, Otieno K, Sang T, Kachur SP, Styers D, Schlessman K, Abarbanell G, Hoffman SL, Seder RA, Oneko M. Safety, Tolerability, and Immunogenicity of Plasmodium falciparum Sporozoite Vaccine Administered by Direct Venous Inoculation to Infants and Young Children: Findings From an Age De-escalation, Dose-Escalation, Double-blind, Randomized Controlled Study in Western Kenya. Clin Infect Dis. 2020 Aug 14;71(4):1063-1071. doi: 10.1093/cid/ciz925.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PfSPZ Vaccine | Vaccine | 135000 unknown | Intravenous |
| Subject | PfSPZ Vaccine | Vaccine | 270000 unknown | Intravenous |
| Subject | PfSPZ Vaccine | Vaccine | 450000 unknown | Intravenous |
| Subject | PfSPZ Vaccine | Vaccine | 900000 unknown | Intravenous |
| Subject | PfSPZ Vaccine | Vaccine | 1.8e+06 unknown | Intravenous |