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Immunogenicity, Efficacy and Safety Study of an MSP3-LSP (Long Synthetic Peptide) Malaria Vaccine

NCT00652275 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 378

Last updated 2008-05-07

No results posted yet for this study

Summary

This study will be the fourth time that the candidate malaria vaccine Merozoite Surface Protein - long synthetic chain, will be tested in malaria endemic populations.in the past,once tested in adults and twice in children proved to be safe in all three occasions for this phase IIb study in children to proceed. This study will include children who will be randomly allocated to either receive the malaria vaccine adjuvanted with Aluminium Hydroxide or the Verorab control. Each participant will receive 3 immunizations, without the clinical investigators or the participants themselves knowing what has been given. They will then be followed-up for immediate reactions to vaccination, extended safety profile and immunological response associated with protection from malaria. These children will be followed up for over a longer term of two years. Blood will be taken to evaluate the biological safety parameters and also the immune responses.

Conditions

Interventions

BIOLOGICAL

MSP3 Long Synthetic Peptide 30 micrograms of MSP3 LSP

189 children will receive 3 doses of experimental vaccine

BIOLOGICAL

Verorab vaccine

189 volunteers will receive Verorab vaccine, 0.5 Ml at day 0, 28 and 56.

Sponsors & Collaborators

  • African Malaria Network Trust

    lead NETWORK

Principal Investigators

  • Mahamadou S Sissoko, MD, MSPH · Malaria Research and Training Center (MRTC), Bamako Mali

  • Roma Chilengi, MBChB, MSc · African Malaria Network Trust

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
48 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2010-11-30
Completion
2010-12-31

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 NCT00652275 on ClinicalTrials.gov