Prophylaxis Against Plasmodium Falciparum Malaria Clinical Trial
Official title:
Ph-1 Double-Blind Randomized Control Study-Evaluate Safety & Immunogenicity of Wanxing Bio-Pharmaceuticals AMA-1/MSP-1 Recombinant Malaria Vaccine (PfCP-2.9) Adj. w/ Montanide ISA 720 Compared to Montanide ISA 720 Alone in Adult Volunteers
| NCT number | NCT00284973 |
| Other study ID # | WanMal002 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 1 |
| First received | January 30, 2006 |
| Last updated | April 13, 2015 |
| Start date | January 2006 |
| Verified date | April 2007 |
| Source | PATH |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | China: Food and Drug Administration |
| Study type | Interventional |
Shanghai Wanxing Bio-Pharmaceuticals is currently evaluating one malaria vaccine candidate,
PfCP2.9 adjuvanted with Montanide ISA 720. This trial is designed to test the safety and
immunogenicity of 3 doses and 2 vaccination schedules.
This blood stage candidate malaria vaccine is being developed for the routine immunization
of infants and children living in malaria-endemic areas.
| Status | Completed |
| Enrollment | 70 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 45 Years |
| Eligibility |
Inclusion Criteria: - Healthy male or female = 18 and = 45 years of age - Agrees not to donate blood during the course of the trial. - Signed written informed consent provided. - Available to participate for the study duration. Exclusion Criteria: - History of allergic reactions following any vaccination. - Involvement in drug or other vaccine trial within four weeks prior to the trial. - Acute illness within four weeks prior to the trial. - Presence of fever at the time of vaccination, i.e. body temperature (by axillary) > 37.5 C. - Presence of any chronic illness/disease including diabetes mellitus, tuberculosis, leprosy, epilepsy and hypertension determined by medical history or examination. - Persons on systemic corticosteroids, immunomodulators or anticoagulants within four weeks prior to vaccination. - Persons with a history of allergic manifestations requiring treatment with injectable antihistamines, adrenaline or steroids. - Pregnancy. Women should not be pregnant, lactating, or planning pregnancy throughout the study period. A urinary pregnancy test (immuno-chromatography) will be performed for all women of child-bearing potential at entry and prior to each vaccination. Adequate contraception throughout the study should be used if applicable. - Sexually active woman not using contraceptives. - Current smoker ( = 20 cigarettes/day). - History of malaria: persons with a known history of malaria or with positive markers for antibodies to malaria parasite by IFA and/or ELISA. - History of residing in a malaria endemic region or malaria exposure (travel) within last two years. - Abnormal hematology and clinical chemistry considered to be clinically significant. - Abnormal urine routine test considered to be clinically significant - Persons with positive markers for HBV (HBsAg) and/or HCV (Anti-HCV) infection. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| China | Shanghai Changhai Hospital | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| Shanghai Wanxing Bio-Pharmaceutical Co. Ltd. | PATH, Second Military Medical University, World Health Organization, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To assess the safety and reactogenicity of the PfCP-2.9 /Montanide ISA 720 vaccine in healthy adult volunteers. | |||
| Secondary | To assess the immunogenicity of the PfCP-2.9/Montanide ISA 720 vaccine in healthy adult volunteers by evaluating and comparing antigen-specific antibody responses (anti-PfCP-2.9 ELISA) after each vaccination. | |||
| Secondary | For exploratory analysis: | |||
| Secondary | To assess in vitro inhibition of parasite growth by vaccine-induced antibodies as measured by the GIA | |||
| Secondary | To assess the relationship between antibody levels as measured by ELISA with the corresponding degree of in vitro parasite growth inhibition as measured by GIA | |||
| Secondary | To assess antigen-specific antibody responses by IFA after each vaccination | |||
| Secondary | To assess the relationship between antibody levels as measured by ELISA with IFA titers that recognize the conformational antigens of the parasite. |