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PfSPZ Vaccine Trial in Malian Children

NCT04940130 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 290

Last updated 2024-02-07

Study results available
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Summary

In this randomized, double-blind, placebo-controlled trial, 268 healthy Malian children aged 6-10 years, residing in Bancoumana and surrounding villages, will be administered three doses of 9.0x10\^5 Pf sporozoites (PfSPZ) of PfSPZ Vaccine (or placebo) at 1, 8, and 29-days using direct venous inoculation (DVI).

The study is composed of a single cohort with two arms (categorized by placebo control/experimental groups) designed to assess the safety, immunogenicity and protective efficacy of PfSPZ Vaccine.

All subjects will receive artemether-lumefantrine (AL) approximately 1- 2 weeks before the first dose of PfSPZ Vaccine or normal saline for clearance of Pf parasitemia. Vaccinated participants and non-immunized controls will be followed for safety and monitored for development of parasitemia through the natural malaria transmission season to estimate vaccine efficacy (VE).

Conditions

Interventions

BIOLOGICAL

Sanaria® PfSPZ Vaccine

non-adjuvanted, live (metabolically active), radiation-attenuated, non-replicating, whole sporozoite (SPZ) vaccine designed to prevent malaria infection caused by Plasmodium falciparum (Pf).

OTHER

Normal Saline

placebo control- saline

Sponsors & Collaborators

  • Malaria Research and Training Center, Bamako, Mali

    collaborator OTHER

  • University of the Sciences, Techniques and Technologies of Bamako

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Sanaria Inc.

    lead INDUSTRY

Principal Investigators

  • Patrick Duffy, MD · National Institute of Allergy and Infectious Diseases (NIAID)

  • Issaka Sagara, MD MSPH PhD · Malaria Research and Training Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2022-12-10
Completion
2022-12-10
FDA Drug
Yes

Countries

  • Mali

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04940130 on ClinicalTrials.gov