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A Phase Ib Trial of MSP 3 LSP in 1-2 Year Old Children in Burkina Faso

NCT00452088 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2008-05-07

No results posted yet for this study

Summary

This will be a study of the safety of MSP 3 LSP candidate malaria vaccine in children aged 1-2 years in Burkina Faso. Three imminizations at 28 day intervals will be administratered subcuteneously on the shoulder region. The study will compare MSP3 with Engerix B vaccine to evaluate whether it is just as safe to give to children in malaria endemic country. The study will also evaluate whether the vaccine induces the expected immune responses. Two dose levels of MSP 3 will be evaluated; 15µg and 30µg to determine the one with the best safety and immune response profile.

Conditions

Interventions

BIOLOGICAL

MSP 3 Long Synthetic Peptide

Lyophilized vaccine given at 15 or 30 microgrammes

BIOLOGICAL

Hepatitis B vaccine

Hepatitis vaccine adjuvanted in Aluminium hydroxide

BIOLOGICAL

Hepatitis B control vaccince

Hepatitis B vaccine adjuvanted in Aluminium hydroxide

Sponsors & Collaborators

  • London School of Hygiene and Tropical Medicine

    collaborator OTHER

  • African Malaria Network Trust

    lead NETWORK

Principal Investigators

  • Issa Nebie, PhD · Projet de Développement de Vaccins Anti-Paludique- Centre National de Recherche et de Formation sur le Paludisme

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
2 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2008-05-31
Completion
2008-05-31

Countries

  • Burkina Faso

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 NCT00452088 on ClinicalTrials.gov