Immunogenicity, Efficacy and Safety Study of an MSP3-LSP (Long Synthetic Peptide) Malaria Vaccine

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by African Malaria Network Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
African Malaria Network Trust
ClinicalTrials.gov Identifier:
NCT00652275
First received: March 18, 2008
Last updated: May 6, 2008
Last verified: April 2008
  Purpose

This study will be the fourth time that the candidate malaria vaccine Merozoite Surface Protein - long synthetic chain, will be tested in malaria endemic populations.in the past,once tested in adults and twice in children proved to be safe in all three occasions for this phase IIb study in children to proceed. This study will include children who will be randomly allocated to either receive the malaria vaccine adjuvanted with Aluminium Hydroxide or the Verorab control. Each participant will receive 3 immunizations, without the clinical investigators or the participants themselves knowing what has been given. They will then be followed-up for immediate reactions to vaccination, extended safety profile and immunological response associated with protection from malaria. These children will be followed up for over a longer term of two years. Blood will be taken to evaluate the biological safety parameters and also the immune responses.


Condition Intervention Phase
Malaria
Biological: MSP3 Long Synthetic Peptide 30 micrograms of MSP3 LSP
Biological: Verorab vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase IIb Immunogenicity, Efficacy and Safety Study of P. Falciparum Vaccine Candidate, MSP3-LSP Adjuvanted in Aluminium Hydroxide Versus Verorab Control in Healthy Children Aged 12-48 Months in Mali.

Resource links provided by NLM:


Further study details as provided by African Malaria Network Trust:

Primary Outcome Measures:
  • Number of clinical malaria episodes occurring during the consecutive malaria transmission season after the third vaccination [ Time Frame: 27 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Solicited adverse events measured from day 0 to day 7 after each dose [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
  • Unsolicited adverse events measured up to one month after each dose [ Time Frame: Day 84 ] [ Designated as safety issue: Yes ]
  • Serious Adverse Events measured during the 12 months of study duration [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • The humoral response to the vaccine antigen: assessed by measuring the level of IgG by ELISA [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
  • IgG ability to recognize the native protein on Merozoite using Western Blot(WB) method [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
  • Incidence of all clinical malaria episodes occurring through two transmission seasons subsequent to the 3 doses. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 378
Study Start Date: May 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A

Biological/Vaccine: 189 volunteers will receive the Malaria vaccine MSP3 Long Synthetic Peptide (LSP)

Arms: MSP3 LSP vaccine Biological/Vaccine:MSP3 LSP 30 micrograms of MSP3 LSP

Arms: I, MSP3 LSP vaccine

Biological: MSP3 Long Synthetic Peptide 30 micrograms of MSP3 LSP
189 children will receive 3 doses of experimental vaccine
Active Comparator: B
189 volunteers will receive standard vaccine against rabies on the similar schedule on days 0, 28, and 56
Biological: Verorab vaccine
189 volunteers will receive Verorab vaccine, 0.5 Ml at day 0, 28 and 56.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   12 Months to 48 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children aged 12-48 months old
  • Healthy by medical history, physical examination and laboratory investigation
  • Signed/thumb printed informed Consent by guardian/parent
  • Resident in the study area villages 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. (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.
  • 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 or C 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
  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: NCT00652275

Contacts
Contact: Mahamadou S Sissoko, MD, MSPH 223-222-8109 mssissoko@mrtcbko.org
Contact: Issaka Sagara, MD, MSPH 223-222-8109 isagara@mrtcbko.org

Locations
Mali
Malaria Research Training Center Recruiting
Bamako, Mali, BP 1805,point G
Principal Investigator: Mahamadou S Sissoko, MD, MSPH         
Sponsors and Collaborators
African Malaria Network Trust
Investigators
Principal Investigator: Mahamadou S Sissoko, MD, MSPH Malaria Research and Training Center (MRTC), Bamako Mali
Study Director: Roma Chilengi, MBChB, MSc African Malaria Network Trust
  More Information

No publications provided

Responsible Party: Roma Chilengi, African Malaria Network Trust
ClinicalTrials.gov Identifier: NCT00652275     History of Changes
Other Study ID Numbers: MSP3_ML_0304, MMVDU-007
Study First Received: March 18, 2008
Last Updated: May 6, 2008
Health Authority: Mali: Ministry of Health

Keywords provided by African Malaria Network Trust:
Malaria
vaccine
Merozoite surface Antigene
Mali
Children

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on July 23, 2014