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A Study to Assess Safety, Immunogenicity and Parasite Growth Inhibition of an Asexual Blood Stage Vaccine for P. Falciparum Malaria

NCT00984763 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2015-05-28

No results posted yet for this study

Summary

Malaria is a parasite, infection with which kills over 2 million people each year. It is a major problem for those who live in endemic areas and for travellers. There is a great need for a safe effective malaria vaccine. The purpose of this study is to examine a new vaccine designed to provide immunity during the blood stage of the malaria parasite's lifecycle.

The vaccine consists of AMA1-C1 which is a mixture of two recombinant synthetic AMA1 proteins from two Plasmodium falciparum strains, Alhydrogel® which is an aluminium-based adjuvant and CPG 7909 - an oligodeoxynucleotide, which enhances immune response.

This study will enable the investigators to assess:

1. The ability of of a growth inhibition assay to predict the effectiveness of a malaria vaccine.
2. The safety of the vaccine in healthy volunteers
3. The response of the human immune system to the vaccine

Conditions

Interventions

BIOLOGICAL

AMA1-C1/Alhydrogel® + CPG 7909

A 0.55 mL dose of AMA1-C1/Alhydrogel® + CPG 7909 (corresponds to 80 µg of AMA1-C1 and 564 µg of CPG 7909)

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • University of Oxford

    lead OTHER

Principal Investigators

  • Adrian VS Hill, D.Phil, FRCP · University of Oxford

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • United Kingdom

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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 NCT00984763 on ClinicalTrials.gov