Last Updated: 04/05/2024

Safety, tolerability and efficacy of PfSPZ Vaccine against heterologous controlled human malaria infection in healthy adults

Objectives

The aim of this study is to determine if individuals living in a non-malaria endemic area such as the United States (US) are protected against heterologous CHMI conducted at these time points.

Principal Institution

Sanaria, United States

Principal Investigators / Focal Persons

Kirsten E. Lyke

Rationale and Abstract

USSPZV7 is a randomized, phase 1, double-blind, placebo-controlled trial of Sanaria® PfSPZ Vaccine administered on Days 1, 8 and 29 by direct venous inoculation (DVI) to assess safety, tolerability, immunogenicity, and vaccine efficacy (VE) against heterologous controlled human malaria infection (CHMI) with the 7G8 clone of Plasmodium falciparum (Pf) conducted at 3 or 12 weeks after the third immunization.

Study Design

Study type: Interventional
Enrollment: 60 participants
Primary purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel assignment
Masking : Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
NCT number: NCT05604521
Phase: Phase I

Thematic Categories

Vaccines (Immune Correlates)

Date

Dec 2022 — Sep 2023

Project Site

United States

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