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Safety, Immunogenicity and Efficacy Against of a Combined Malaria Vaccine in Healthy Malaria-naïve Adults

NCT01366534 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2019-06-18

Study results available
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Summary

This study will evaluate whether administration of two investigational malaria vaccines (257049 and Ad35.CS.01 vaccines) combined in one immunization schedule increases protection against malaria infection as compared to protection induced by the 257049 vaccine alone. The study will also evaluate the safety and the immune response to the new combination of the two experimental malaria vaccines.

Conditions

Interventions

BIOLOGICAL

Crucell's replication deficient adenovirus type 35 circumsporozoite malaria vaccine (Ad35.CS.01)

One dose will be administered intramuscularly at Study Day 0.

BIOLOGICAL

GSK Biologicals' malaria vaccine 257049 (2 doses)

Two doses will be administered intramuscularly at monthly intervals

BIOLOGICAL

GSK Biologicals' malaria vaccine 257049 (3 doses)

Three doses will be administered intramuscularly at monthly intervals

OTHER

Sporozoite challenge

Subjects were challenged with sporozoite-infected mosquitoes to determine whether immune protective response had been induced by vaccination.

Sponsors & Collaborators

  • The PATH Malaria Vaccine Initiative (MVI)

    collaborator OTHER

  • Crucell Holland BV

    collaborator INDUSTRY

  • GlaxoSmithKline

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-08-10
Primary Completion
2012-02-27
Completion
2012-07-03

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT01366534 on ClinicalTrials.gov