Safety, Tolerability and Immunogenicity of PfSPZ Vaccine in an Age De-escalation Trial in Equatorial Guinea.

Summary

This trial will evaluate the safety, tolerability, and immunogenicity of PfSPZ Vaccine in healthy Equatoguinean adults, adolescents, children and infants who receive doses of 0.9x10\^6, 1.8x10\^6 or 2.7x10\^6 PfSPZ Vaccine via direct venous inoculation (DVI) compared with control groups receiving normal saline (NS) placebo by DVI. In addition, the study will also assess a second PfSPZ-based vaccination approach known as PfSPZ-CVac- the administration of non-irradiated, infectious PfSPZ (PfSPZ Challenge) (1x10\^5 PfSPZ) under anti-malarial chemoprophylaxis (chloroquine) in younger adults ages 18 to 35 years for safety, tolerability, immunogenicity and efficacy against controlled human malaria infection (CHMI).

Timeline

Start

2016-11

Primary completion

2017-12

Completion

2018-02

Publications

• Jongo SA, Urbano Nsue Ndong Nchama V, Church LWP, Olotu A, Manock SR, Schindler T, Mtoro A, Kc N, Devinsky O, Zan E, Hamad A, Nyakarungu E, Mpina M, Deal A, Bijeri JR, Ondo Mangue ME, Ntutumu Pasialo BE, Nguema GN, Rivas MR, Chemba M, Ramadhani KK, James ER, Stabler TC, Abebe Y, Riyahi P, Saverino ES, Sax J, Hosch S, Tumbo A, Gondwe L, Segura JL, Falla CC, Phiri WP, Hergott DEB, Garcia GA, Maas C, Murshedkar T, Billingsley PF, Tanner M, Ayekaba MO, Sim BKL, Daubenberger C, Richie TL, Abdulla S, Hoffman SL. Safety and Immunogenicity of Radiation-Attenuated PfSPZ Vaccine in Equatoguinean Infants, Children, and Adults. Am J Trop Med Hyg. 2023 May 9;109(1):138-146. doi: 10.4269/ajtmh.22-0773. Print 2023 Jul 5.

Drugs

Indications