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Safety and Immunogenicity of Direct Venous Inoculation of a Radiation-attenuated PfSPZ Vaccine in Equatoguinean Adults

NCT02418962 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2016-03-02

No results posted yet for this study

Summary

This is a single center, randomized, placebo-controlled, double-blind trial to assess the safety and immunogenicity of PfSPZ Vaccine administered by direct venous inoculation (DVI).

The study to be conducted in Baney District, Bioko Island, Equatorial Guinea (EG), will be to establish whether three doses of the higher regimen - three doses of 2.7x10\^5 PfSPZ of the PfSPZ Vaccine administered at 8 week intervals - is as well-tolerated and efficacious in malaria exposed African adults as the five dose regimens. Specifically, the trial will address the following objectives: is the three dose regimen:

1. Safe and well tolerated in Equatoguinean (EG) adults.
2. As immunogenic in EG adults as is the five-dose regimen of 1.35x10\^5 PfSPZ in Tanzanian and U.S. adults or as three-, four- and five-dose regimens of 2.7x10\^5 PfSPZ being tested in Tanzanian, Malian and U.S. adults.

In addition, as an exploratory objective, the volunteers in the EG trial will be followed longitudinally to measure the incidence of malaria during the initial six months following immunization, providing a preliminary assessment of efficacy.

Conditions

Interventions

BIOLOGICAL

PfSPZ Vaccine

Aseptic, purified, metabolically active, non-replicating (live, radiation attenuated) cryopreserved Plasmodium falciparum sporozoites vaccine

OTHER

Normal Saline

0.9% Sodium chloride solution for injection

Sponsors & Collaborators

  • Ifakara Health Institute

    collaborator OTHER

  • Swiss Tropical & Public Health Institute

    collaborator OTHER

  • Government of Equatorial Guinea

    collaborator OTHER_GOV

  • Hospital Universitario La Paz

    collaborator OTHER

  • Marathon Oil Corporation

    collaborator INDUSTRY

  • Noble Oil Services

    collaborator INDUSTRY

  • Sanaria Inc.

    lead INDUSTRY

Principal Investigators

  • Salim Abdulla, MD, PhD · Ifakara Health Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2015-09-30
Completion
2016-02-29

Countries

  • Equatorial Guinea

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 NCT02418962 on ClinicalTrials.gov