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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00652275
Recruitment Status : Unknown
Verified April 2008 by African Malaria Network Trust.
Recruitment status was:  Recruiting
First Posted : April 3, 2008
Last Update Posted : May 7, 2008
Information provided by:
African Malaria Network Trust

Brief Summary:
This study will be the fourth time that the candidate malaria vaccine Merozoite Surface Protein - long synthetic chain, will be tested in malaria endemic 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 or disease Intervention/treatment Phase
Malaria Biological: MSP3 Long Synthetic Peptide 30 micrograms of MSP3 LSP Biological: Verorab vaccine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 378 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : May 2008
Estimated Primary Completion Date : November 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Number of clinical malaria episodes occurring during the consecutive malaria transmission season after the third vaccination [ Time Frame: 27 Months ]

Secondary Outcome Measures :
  1. Solicited adverse events measured from day 0 to day 7 after each dose [ Time Frame: 7 days ]
  2. Unsolicited adverse events measured up to one month after each dose [ Time Frame: Day 84 ]
  3. Serious Adverse Events measured during the 12 months of study duration [ Time Frame: 2 years ]
  4. The humoral response to the vaccine antigen: assessed by measuring the level of IgG by ELISA [ Time Frame: Day 84 ]
  5. IgG ability to recognize the native protein on Merozoite using Western Blot(WB) method [ Time Frame: Day 84 ]
  6. Incidence of all clinical malaria episodes occurring through two transmission seasons subsequent to the 3 doses. [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 48 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00652275

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Contact: Mahamadou S Sissoko, MD, MSPH 223-222-8109
Contact: Issaka Sagara, MD, MSPH 223-222-8109

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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
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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
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Responsible Party: Roma Chilengi, African Malaria Network Trust Identifier: NCT00652275    
Other Study ID Numbers: MSP3_ML_0304
First Posted: April 3, 2008    Key Record Dates
Last Update Posted: May 7, 2008
Last Verified: April 2008
Keywords provided by African Malaria Network Trust:
Merozoite surface Antigene
Additional relevant MeSH terms:
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Protozoan Infections
Parasitic Diseases