Phase Ib Trial of MSP3 LSP in Children in Tanzania
MSP3TN
A Double Blind, Randomized, Controlled Phase Ib Field Trial in 12 to 24 Month Old Children in Tanzania to Evaluate the Safety and Immunogenicity of Candidate Malaria Vaccine MSP 3 Versus Hepatitis B Vaccine
2 other identifiers
interventional
45
1 country
1
Brief Summary
This study will evaluate the safety of candidate malaria vaccine MSP3 in children aged 12-24 months in Tanzania in a highland area with low malaria transmission. Written informed consent will be sought from all guardians/parents of potentially participating children. Eligible children will be randomly allocated to receive either the the study vaccine (MSP3 for a total of 30 children)) or the control vaccine (hepatitis B for a total of 15 children). The vaccines will be given in 3 immunizations one month apart to all the study children and neither the clinical investigators nor the children's parents will be aware of which vaccine has been administered during the initial four months of the study. The study is designed to begin with a lower dose of the MSP3 vaccine (15µg of MSP3 for 15 children) and then followed by the higher dose(30µg MSP3 for 15 children). Following each immunization, children will be evaluated for a seven day solicited symptoms. Unsolicited symptoms will also be collected throughout the study duration. The study will be overseen by an international safety monitoring committee who will follow safety matters closely as the trial progresses. The study will also be approved by the Tanzania National ethics Committee, The Tanzania Food and Drugs Authority, and the London school of hygiene and tropical medicine ethics committee. The study is planned to last 13 months for each participant.
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 Oct 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
May 3, 2007
CompletedFirst Posted
Study publicly available on registry
May 4, 2007
CompletedStudy Start
First participant enrolled
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedDecember 14, 2007
December 1, 2007
May 3, 2007
December 13, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety of MSP3 by assessing the reactogenicity
Solicited and unsolicited adverse events (immediate reactogenicity within 60 minutes of each vaccination; 7-day assessment, and 28 days
Secondary Outcomes (1)
The humoral response to vaccine antigens will be assessed by measuring by ELISA
ELISA on D0, D28, D56, D84, D168 and D365
Study Arms (4)
1
EXPERIMENTAL15 microgramme candidate vaccine
2
ACTIVE COMPARATORHepatitis B vaccine
3
EXPERIMENTAL30 microgramme MSP3 candidate malaria vaccine
4
ACTIVE COMPARATORHepatitis B control vaccine
Interventions
Eligibility Criteria
You may qualify if:
- Children aged 1-2 years old
- Healthy by medical history and physical examination
- Signed /thumb printed 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 means prednisolone 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 4.
- 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, 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 judgment of the investigator, would interfere with the study outcomes or pose a threat to the participant's health.
- Administration of immunoglobulin and/or 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)
Kwashemshi village
Korogwe, Tanga, Tanzania
Related Publications (1)
Lusingu JP, Gesase S, Msham S, Francis F, Lemnge M, Seth M, Sembuche S, Rutta A, Minja D, Segeja MD, Bosomprah S, Cousens S, Noor R, Chilengi R, Druilhe P. Satisfactory safety and immunogenicity of MSP3 malaria vaccine candidate in Tanzanian children aged 12-24 months. Malar J. 2009 Jul 17;8:163. doi: 10.1186/1475-2875-8-163.
PMID: 19607731DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Martha M Lemnge, MS, PhD
National Institute For Medical Research in Tanzania
- PRINCIPAL INVESTIGATOR
John P Lusingu, MD, PhD
National Institute for Medical Research in Tanzania
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
- SINGLE GROUP
- Sponsor Type
- NETWORK
Study Record Dates
First Submitted
May 3, 2007
First Posted
May 4, 2007
Study Start
October 1, 2007
Study Completion
August 1, 2008
Last Updated
December 14, 2007
Record last verified: 2007-12