MedTrace Logo

PfSPZ Vaccine: Dose Optimization With Heterologous Challenge in Healthy Malaria-Naïve Adults

NCT02601716 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2018-10-16

No results posted yet for this study

Summary

This is an open-label evaluation of the safety, tolerability, immunogenicity and efficacy of PfSPZ Vaccine administered by direct venous inoculation (DVI) in healthy, malaria-naïve adult subjects.

Conditions

Interventions

BIOLOGICAL

PfSPZ Vaccine

Aseptic, purified, cryopreserved, radiation-attenuated, Plasmodium falciparum (Pf) sporozoites

BIOLOGICAL

CHMI (7G8)

CHMI is conducted by exposure to the bites of five mosquitoes infected with heterologous (7G8) Pf parasites.

BIOLOGICAL

CHMI (NF135.C10)

CHMI is conducted by exposure to the bites of three to five mosquitoes infected with heterologous (NF135.C10) Pf parasites.

Sponsors & Collaborators

  • Naval Medical Research Center

    collaborator FED

  • University of Maryland

    collaborator OTHER

  • Walter Reed Army Institute of Research (WRAIR)

    collaborator FED

  • Joint Warfighter Medical Research Program

    collaborator OTHER

  • Sanaria Inc.

    lead INDUSTRY

Principal Investigators

  • Alexandra Singer, MD · Naval Medical Research Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2017-09-30
Completion
2017-11-30

Countries

  • United States

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 NCT02601716 on ClinicalTrials.gov