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

NCT00652275 | Unknown Phase 2 DMC

• 2 other identifiers: MSP3_ML_0304MMVDU-007
• Study Type: interventional
• Target: 378
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Malaria

Keywords

Malaria; vaccine; Merozoite surface Antigene; Mali; Children

Outcome Measures

Primary Outcomes (1)

• Number of clinical malaria episodes occurring during the consecutive malaria transmission season after the third vaccination

  27 Months

Secondary Outcomes (6)

• Solicited adverse events measured from day 0 to day 7 after each dose

  7 days

• Unsolicited adverse events measured up to one month after each dose

  Day 84

• Serious Adverse Events measured during the 12 months of study duration

  2 years

• The humoral response to the vaccine antigen: assessed by measuring the level of IgG by ELISA

  Day 84

• IgG ability to recognize the native protein on Merozoite using Western Blot(WB) method

  Day 84

Study Arms (2)

A

EXPERIMENTAL

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

B

ACTIVE COMPARATOR

189 volunteers will receive standard vaccine against rabies on the similar schedule on days 0, 28, and 56

Biological: Verorab vaccine

Interventions

MSP3 Long Synthetic Peptide 30 micrograms of MSP3 LSP BIOLOGICAL

189 children will receive 3 doses of experimental vaccine

A

Verorab vaccine BIOLOGICAL

189 volunteers will receive Verorab vaccine, 0.5 Ml at day 0, 28 and 56.

B

Eligibility Criteria

• Age: 12 Months - 48 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

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. (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

Sponsors & Collaborators

• African Malaria Network Trust: lead

Study Sites (1)

Malaria Research Training Center

Bamako, BP 1805,point G, Mali

RECRUITING

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Mahamadou S Sissoko, MD, MSPH

  Malaria Research and Training Center (MRTC), Bamako Mali

  PRINCIPAL INVESTIGATOR

• Roma Chilengi, MBChB, MSc

  African Malaria Network Trust

  STUDY DIRECTOR

Central Study Contacts

Mahamadou S Sissoko, MD, MSPH

CONTACT

223-222-8109; mssissoko@mrtcbko.org

Issaka Sagara, MD, MSPH

CONTACT

223-222-8109; isagara@mrtcbko.org

Study Design

• Study Type: interventional
• Phase: phase 2
• 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 18, 2008
• First Posted: April 3, 2008
• Study Start: May 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: December 1, 2010
• Last Updated: May 7, 2008

Record last verified: 2008-04

Locations

MA (1)