A Phase Ib Trial of MSP 3 LSP in 1-2 Year Old Children in Burkina Faso (MSP3LSP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by African Malaria Network Trust.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
London School of Hygiene and Tropical Medicine
Information provided by:
African Malaria Network Trust
ClinicalTrials.gov Identifier:
NCT00452088
First received: March 23, 2007
Last updated: May 6, 2008
Last verified: November 2007
  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 1

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.

Resource links provided by NLM:


Further study details as provided by African Malaria Network Trust:

Primary Outcome Measures:
  • Immediate reactogenicity (within 1 hour, with emphasis on allergic reactions) [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
  • Local and systemic reactogenicity during the 7 days following the vaccine [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
  • Unsolicited adverse events occurring within 28 days following each vaccination [ Time Frame: 28 Days ] [ Designated as safety issue: Yes ]
  • Serious adverse events (SAE) throughout the study period [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Humoral immune responses by ELISA before and four weeks after each vaccination [ Time Frame: 84 Days ] [ Designated as safety issue: No ]
  • Cellular immune response to the vaccine antigens by measuring the [ Time Frame: 84 Days ] [ Designated as safety issue: No ]
  • number of cells producing IFNγ/106 cells by Elispot to MSP3-LSP and [ Time Frame: 84 Days ] [ Designated as safety issue: No ]

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
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00452088

Contacts
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

Locations
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         
Sponsors and Collaborators
African Malaria Network Trust
London School of Hygiene and Tropical Medicine
Investigators
Study Director: Issa Nebie, PhD Projet de Développement de Vaccins Anti-Paludique- Centre National de Recherche et de Formation sur le Paludisme
  More Information

No publications provided by African Malaria Network Trust

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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

Keywords provided by African Malaria Network Trust:
Malaria vaccine
Safety of MSP 3 LSP
Immunogenicity of MSP 3 LSP
Burkina Faso children

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Aluminum Hydroxide
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antacids
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014