A Study of Safety and Immunogenicity of a Malaria Vaccine Candidate

This study has been completed.
Sponsor:
Collaborators:
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Second Military Medical University
World Health Organization
PATH
Information provided by:
PATH
ClinicalTrials.gov Identifier:
NCT00284973
First received: January 30, 2006
Last updated: May 1, 2007
Last verified: April 2007
  Purpose

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.


Condition Intervention Phase
Prophylaxis Against Plasmodium Falciparum Malaria
Biological: Plasmodium falciparum Chimeric Prot. 2.9 - Montanide ISA 720
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by PATH:

Primary Outcome Measures:
  • To assess the safety and reactogenicity of the PfCP-2.9 /Montanide ISA 720 vaccine in healthy adult volunteers.

Secondary Outcome Measures:
  • 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.
  • For exploratory analysis:
  • To assess in vitro inhibition of parasite growth by vaccine-induced antibodies as measured by the GIA
  • 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
  • To assess antigen-specific antibody responses by IFA after each vaccination
  • To assess the relationship between antibody levels as measured by ELISA with IFA titers that recognize the conformational antigens of the parasite.

Estimated Enrollment: 70
Study Start Date: January 2006
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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00284973

Locations
China
Shanghai Changhai Hospital
Shanghai, China
Sponsors and Collaborators
Shanghai Wanxing Bio-Pharmaceuticals
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Second Military Medical University
World Health Organization
PATH
Investigators
Principal Investigator: Jinhong Hu, Dr. Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00284973     History of Changes
Other Study ID Numbers: WanMal002
Study First Received: January 30, 2006
Last Updated: May 1, 2007
Health Authority: China: Food and Drug Administration

Keywords provided by PATH:
malaria

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Parasitic Diseases
Protozoan Infections
Mannitol
Cardiovascular Agents
Diuretics
Diuretics, Osmotic
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014