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Sponsored by: |
African Malaria Network Trust |
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Information provided by: | African Malaria Network Trust |
ClinicalTrials.gov Identifier: | NCT00431808 |
This study will be the first time that the candidate malaria vaccine Apical Membrane Antigen 1 (PfAMA-1-FVO[25-545]) will be tested in malaria endemic populations. The phase Ib study will include adults who will be randomly allocated to either receive the malaria vaccine or the vaccine against Tetanus. Each participant will receive 3 immunizations, without the clinical investigators or the participants themselves knowing what has been given. They will then be follow-up up for immediate reactions to vaccination, and also over a longer term of one year. Blood will be taken to evaluate the biological safety parameters and also immune responses.
Condition | Intervention | Phase |
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Malaria |
Biological: Malaria vaccine AMA1 (PfAMA-1-FVO[25-545] Biological: AMA1 |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety Study |
Official Title: | Randomized Controlled Trial to Evaluate the Safety and Immunogenicity of Recombinant Pichia Pastoris-Expressed P. Falciparum Apical Membrane Antigen 1 (PfAMA-1-FVO[25-545]) Versus Tetanus Toxoid, in Healthy Malian Adult in Bandiagara |
Estimated Enrollment: | 40 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | June 2008 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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I, AMA1 vaccine: Experimental
20 volunteers will receive 3 doses of the vaccine
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Biological: Malaria vaccine AMA1 (PfAMA-1-FVO[25-545]
3 doses of AMA 1 vaccine
Biological: AMA1
50 micrograms of AMA1
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This will be a randomized controlled trial to evaluate the Safety and Immunogenicity of recombinant pichia pastoris blood stage malaria vaccine Apical Membrane Antigen 1 (PfAMA-1-FVO[25-545]) versus tetanus toxoid, in healthy Malian adults in Bandiagara.
A phase Ia trial is currently ongoing and its interim results will be used to select the best dose/adjuvant combination to be brought to Africa. The trial is evaluating safety and immunogenicity of AMA-1 (10 µg or 50 µg) adjuvanted with aluminum hydroxide or Montanide ISA 720, or ASO2.
Primary objective:
- To evaluate the safety of one dose of AMA-1 (10 µg or 50 µg) adjuvanted with aluminum hydroxide or Montanide ISA 720, or ASO2, given at D0, D28 and D56 in healthy Malian adults.
Secondary Objectives:
The primary immunizations will be administered on days 0, 28 and a boost given at day 56. The participants will be followed up actively during the vaccination phase, and passively for one another 9 months. The will be 19 scheduled clinic visits and following will the the schedule for obtaining serology data D-28, D0, D28, D56, D84, D140 and D365
The primary evaluation will include the following:
Secondary evaluation criteria:
Descriptive methods shall be employed to evaluate the above criteria.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Mali | |
Malaria Research and Training Center | Recruiting |
Bandiagara, Mali | |
Contact: Mahamadou A Thera, MD MPH +223 221 6361 mthera@mrtcbko.org | |
Contact: Ogobara K Doumbo, MD PhD +223 222 8109 okd@ikatelnet.net | |
Sub-Investigator: Drissa Coulibaly, MD | |
Principal Investigator: Mahamadou A Thera, MD MPH | |
Principal Investigator: Mahamadou A Thera, MD MPH |
Principal Investigator: | Mahamadou A Thera, MD MPH | Malaria Research and Training Center |
Principal Investigator: | Mahamadou A Thera, MD MPH | Malaria Research and Training Center |
Responsible Party: | African Malaria Network Trust ( Roma Chilengi ) |
Study ID Numbers: | AMA1_02_07, MU-08 |
Study First Received: | February 5, 2007 |
Last Updated: | April 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00431808 |
Health Authority: | Mali: Ministry of Health |
Malaria vaccine Apical Membrane Antigene Mali Adults |
Protozoan Infections Parasitic Diseases Malaria Healthy Tetanus |
Coccidiosis |