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| Sponsor: | African Malaria Network Trust |
|---|---|
| Collaborator: |
London School of Hygiene and Tropical Medicine |
| Information provided by: | African Malaria Network Trust |
| ClinicalTrials.gov Identifier: | NCT00452088 |
Purpose
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 |
|---|---|---|
|
Malaria |
Biological: MSP 3 Long Synthetic Peptide Biological: Hepatitis B vaccine Biological: Hepatitis B control vaccince |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| 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 |
|---|---|
|
Experimental: 1
15 microgramme candidate vaccine group
|
Biological: MSP 3 Long Synthetic Peptide
Lyophilized vaccine given at 15 or 30 microgrammes
|
|
Active Comparator: 2
Hepatitis B comprator group
|
Biological: Hepatitis B vaccine
Hepatitis vaccine adjuvanted in Aluminium hydroxide
|
|
Experimental: 3
30 microgrammes candidate vaccine group
|
Biological: MSP 3 Long Synthetic Peptide
Lyophilized vaccine given at 15 or 30 microgrammes
|
|
Active Comparator: 4
Hepatitis B vaccine group
|
Biological: Hepatitis B control vaccince
Hepatitis B vaccine adjuvanted in Aluminium hydroxide
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 1 Year to 2 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 | |
| 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 |
More Information
| Responsible Party: | Dr. Roma Chilengi, African Malaria Network Trust |
| ClinicalTrials.gov Identifier: | NCT00452088 History of Changes |
| Other Study ID Numbers: | MSP3_BF_0302, MSP3_BF_0302 |
| Study First Received: | March 23, 2007 |
| Last Updated: | May 6, 2008 |
| Health Authority: | Burkina Faso: Ministry of Health |
|
Malaria vaccine Safety of MSP 3 LSP Immunogenicity of MSP 3 LSP Burkina Faso children |
|
Malaria Protozoan Infections Parasitic Diseases Aluminum Hydroxide Adjuvants, Immunologic |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antacids Molecular Mechanisms of Pharmacological Action |