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
Recruitment status was Recruiting
Sponsor:
African Malaria Network Trust
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
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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
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 May 22, 2013