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Sponsors and Collaborators: |
African Malaria Network Trust London School of Hygiene and Tropical Medicine |
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Information provided by: | African Malaria Network Trust |
ClinicalTrials.gov Identifier: | NCT00452088 |
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.
Condition | Intervention | Phase |
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Malaria |
Biological: MSP 3 Long Synthetic Peptide Biological: Hepatitis B vaccine Biological: Hepatitis B control vaccince |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety Study |
Official Title: | Randomized, Controlled, Dose Escalation Phase Ib Trial of MSP 3 LSP Adjuvanted in Aluminium Hydroxide Versus Hepatitis Bin 12 to 24 Month Old Children in Burkina Faso. |
Estimated Enrollment: | 45 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | May 2008 |
Estimated Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
15 microgramme candidate vaccine group
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Biological: MSP 3 Long Synthetic Peptide
Lyophilized vaccine given at 15 or 30 microgrammes
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2: Active Comparator
Hepatitis B comprator group
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Biological: Hepatitis B vaccine
Hepatitis vaccine adjuvanted in Aluminium hydroxide
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3: Experimental
30 microgrammes candidate vaccine group
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Biological: MSP 3 Long Synthetic Peptide
Lyophilized vaccine given at 15 or 30 microgrammes
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4: Active Comparator
Hepatitis B vaccine group
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Biological: Hepatitis B control vaccince
Hepatitis B vaccine adjuvanted in Aluminium hydroxide
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Ages Eligible for Study: | 1 Year to 2 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sodiomon B Sirima, MD, PhD | 226-5032-4695 ext 6 | s.sirima.cnlp@fasonet.bf |
Contact: Alfred Tiono, MD | 226-5032-4695 ext 7 | t.alfred@fasonet.bf |
Burkina Faso, Sapone | |
Projet de Développement de Vaccins Anti-Paludique- Centre National de Recherche et de Formation sur le Paludisme | Recruiting |
Ouagadougou, Sapone, Burkina Faso | |
Contact: Amidou T Konate, MD 226-5032-4695 ext 6 amidou@fasonet.bf | |
Contact: Alphonse Ouedraogo, MD 226-5032-4695 ext 8 Alphonse.ouedraogo@voila.fr | |
Principal Investigator: Sodiomon B Sirima, MD, PhD |
Study Director: | Issa Nebie, PhD | Projet de Développement de Vaccins Anti-Paludique- Centre National de Recherche et de Formation sur le Paludisme |
Responsible Party: | African Malaria Network Trust ( Dr. Roma Chilengi ) |
Study ID Numbers: | MSP3_BF_0302, MSP3_BF_0302 |
Study First Received: | March 23, 2007 |
Last Updated: | May 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00452088 History of Changes |
Health Authority: | Burkina Faso: Ministry of Health |
Malaria vaccine Safety of MSP 3 LSP Immunogenicity of MSP 3 LSP Burkina Faso children |
Hepatitis Protozoan Infections Immunologic Factors Adjuvants, Immunologic |
Antacids Parasitic Diseases Malaria Aluminum Hydroxide |
Protozoan Infections Immunologic Factors Molecular Mechanisms of Pharmacological Action Coccidiosis Physiological Effects of Drugs Adjuvants, Immunologic |
Antacids Parasitic Diseases Malaria Pharmacologic Actions Aluminum Hydroxide |