Clinical trial NCT00284973: A Study of Safety and Immunogenicity of a Malaria Vaccine Candidate
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prophylaxis Against Plasmodium Falciparum Malaria
Keywords: malaria
Lead sponsor: PATH
Sponsor class: OTHER
Collaborators: name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Second Military Medical University
name: World Health Organization
name: PATH
First posted: 2006-02-01
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: This is a double blind, randomized, controlled Phase I study of PfCp2.9, an experimental malaria vaccine candidate, adjuvanted with Montanide ISA 720.

The primary objective of this study is to assess the safety and reactogenicity of the vaccine in healthy Chinese adult volunteers.

Eligibility criteria: 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.

Primary outcomes:
measure: To assess the safety and reactogenicity of the PfCP-2.9 /Montanide ISA 720 vaccine in healthy adult volunteers.
Secondary outcomes:
measure: 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.
measure: For exploratory analysis:
measure: To assess in vitro inhibition of parasite growth by vaccine-induced antibodies as measured by the GIA
measure: 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
measure: To assess antigen-specific antibody responses by IFA after each vaccination
measure: To assess the relationship between antibody levels as measured by ELISA with IFA titers that recognize the conformational antigens of the parasite.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Changhai Hospital
Study officials:
affiliation: Changhai Hospital
name: Jinhong Hu, Dr.
role: PRINCIPAL_INVESTIGATOR
References: