A Phase Ib Trial of MSP 3 LSP in 1-2 Year Old Children in Burkina Faso
MSP3LSP
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.
1 other identifier
interventional
45
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Apr 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2007
CompletedFirst Posted
Study publicly available on registry
March 26, 2007
CompletedStudy Start
First participant enrolled
April 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedMay 7, 2008
November 1, 2007
1.1 years
March 23, 2007
May 6, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Immediate reactogenicity (within 1 hour, with emphasis on allergic reactions)
7 days
Local and systemic reactogenicity during the 7 days following the vaccine
7 days
Unsolicited adverse events occurring within 28 days following each vaccination
28 Days
Serious adverse events (SAE) throughout the study period
1 year
Secondary Outcomes (3)
Humoral immune responses by ELISA before and four weeks after each vaccination
84 Days
Cellular immune response to the vaccine antigens by measuring the
84 Days
number of cells producing IFNγ/106 cells by Elispot to MSP3-LSP and
84 Days
Study Arms (4)
1
EXPERIMENTAL15 microgramme candidate vaccine group
2
ACTIVE COMPARATORHepatitis B comprator group
3
EXPERIMENTAL30 microgrammes candidate vaccine group
4
ACTIVE COMPARATORHepatitis B vaccine group
Interventions
Eligibility Criteria
You may qualify if:
- Children aged 1-2 years old
- Healthy by medical history and physical examination
- Signed Informed Consent by guardian/parent
- Resident in the study area village during the whole trial period
You may not qualify if:
- Symptoms, physical signs of disease that could interfere with the interpretation of the trial results or compromising the health of the subjects
- Immunosuppressive therapy (steroids, immune modulators or immune suppressors) within 3 months prior recruitment. (for corticosteroids, this will mean prednisone, or equivalent,0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
- Cannot be followed for any social, psychological or geographical reasons.
- Use of any investigational drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use up to 30 days after the third dose.
- Suspected or known hypersensitivity to any of the vaccine components or to previous vaccine.
- Laboratory abnormalities on screened blood samples out of range, more specifically refer to table 2.
- Planned administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of vaccine. An exception, is the receipt of an EPI or licensed vaccine (measles, oral polio, Hib, meningococcal and combined diphtheria, pertussis,tetanus vaccines) which may be given 14 days or more before or after vaccination
- Evidence of chronic or active hepatitis B infection
- Presence of chronic illness that, in the judgement of the investigator, would interfere with the study outcomes or pose a threat to the participant's health.
- Administration of immunoglobulin andor any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period
- History of surgical splenectomy.
- Moderate or severe malnutrition at screening defined as weight for age Z score less than 2
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Projet de Développement de Vaccins Anti-Paludique- Centre National de Recherche et de Formation sur le Paludisme
Ouagadougou, Sapone, Burkina Faso
Related Publications (1)
Sirima SB, Tiono AB, Ouedraogo A, Diarra A, Ouedraogo AL, Yaro JB, Ouedraogo E, Gansane A, Bougouma EC, Konate AT, Kabore Y, Traore A, Chilengi R, Soulama I, Luty AJ, Druilhe P, Cousens S, Nebie I. Safety and immunogenicity of the malaria vaccine candidate MSP3 long synthetic peptide in 12-24 months-old Burkinabe children. PLoS One. 2009 Oct 26;4(10):e7549. doi: 10.1371/journal.pone.0007549.
PMID: 19855847DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Issa Nebie, PhD
Projet de Développement de Vaccins Anti-Paludique- Centre National de Recherche et de Formation sur le Paludisme
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
Study Record Dates
First Submitted
March 23, 2007
First Posted
March 26, 2007
Study Start
April 1, 2007
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
May 7, 2008
Record last verified: 2007-11