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Safety and Immunogenicity of Apical Membrane Antigen 1 (PfAMA-1-FVO[25-545])

NCT00431808 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2008-04-03

No results posted yet for this study

Summary

This study will be the first time that the candidate malaria vaccine Apical Membrane Antigen 1 (PfAMA-1-FVO\[25-545\]) will be tested in malaria endemic populations. The phase Ib study will include adults who will be randomly allocated to either receive the malaria vaccine or the vaccine against Tetanus. Each participant will receive 3 immunizations, without the clinical investigators or the participants themselves knowing what has been given. They will then be follow-up up for immediate reactions to vaccination, and also over a longer term of one year. Blood will be taken to evaluate the biological safety parameters and also immune responses.

Conditions

Interventions

BIOLOGICAL

AMA1

50 micrograms of AMA1

BIOLOGICAL

Malaria vaccine AMA1 (PfAMA-1-FVO[25-545]

3 doses of AMA 1 vaccine

Sponsors & Collaborators

  • African Malaria Network Trust

    lead NETWORK

Principal Investigators

  • Mahamadou A Thera, MD MPH · Malaria Research and Training Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2008-06-30
Completion
2008-06-30

Countries

  • Mali

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 NCT00431808 on ClinicalTrials.gov