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Safety and Protective Efficacy of Genetically Attenuated PfSPZ-GA1 Vaccine in Healthy Dutch Volunteers

NCT03163121 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2019-03-05

No results posted yet for this study

Summary

This is a first-in-human, randomized clinical trial of PfSPZ-GA1 Vaccine (genetically attenuated PfSPZ) in healthy malaria-naïve adult volunteers. This Phase 1 trial is divided into two stages, Stage A and B. Stage A is an open label, single center, dose escalation study in 19 volunteers. Stage B is a multi-center, double blind, randomized, placebo-controlled trial in 48 volunteers. The primary objective of this study is to determine the safety and tolerability of direct venous inoculation (DVI) of PfSPZ-GA1 Vaccine in healthy adults.

Conditions

Interventions

BIOLOGICAL

PfSPZ-GA1 Vaccine

Aseptic, purified, cryopreserved, genetically attenuated P. falciparum sporozoites (Pf∆b9∆slarp), strain NF54

BIOLOGICAL

PfSPZ Vaccine

Aseptic, purified, cryopreserved, radiation attenuated P. falciparum sporozoites (PfSPZ Vaccine), strain NF54

OTHER

Normal Saline

0.9% sodium chloride

BIOLOGICAL

Mosquito-bite CHMI

Bites of 5 infected mosquitoes of NF54 strain

Sponsors & Collaborators

  • Radboud University Medical Center

    collaborator OTHER

  • Leiden University Medical Center

    collaborator OTHER

  • Sanaria Inc.

    lead INDUSTRY

Principal Investigators

  • Robert W. Sauerwein, MD · Radboud University Medical Center, Geert Grooteplein 28, 6525 GA Nijmegen, The Netherlands

  • Leo G Visser, MD · Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, The Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-12
Primary Completion
2018-10-25
Completion
2018-10-25
FDA Drug
Yes

Countries

  • Netherlands

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 NCT03163121 on ClinicalTrials.gov