Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Safety and Immunogenicity of a Malaria Vaccine Candidate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00284973
Recruitment Status : Completed
First Posted : February 1, 2006
Last Update Posted : April 14, 2015
Sponsor:
Collaborators:
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Second Military Medical University
World Health Organization
PATH
Information provided by:
PATH

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


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

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : January 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Secondary Outcome Measures :
  1. 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.
  2. For exploratory analysis:
  3. To assess in vitro inhibition of parasite growth by vaccine-induced antibodies as measured by the GIA
  4. 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
  5. To assess antigen-specific antibody responses by IFA after each vaccination
  6. To assess the relationship between antibody levels as measured by ELISA with IFA titers that recognize the conformational antigens of the parasite.

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00284973


Locations
Layout table for location information
China
Shanghai Changhai Hospital
Shanghai, China
Sponsors and Collaborators
Shanghai Wanxing Bio-Pharmaceutical Co. Ltd.
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Second Military Medical University
World Health Organization
PATH
Investigators
Layout table for investigator information
Principal Investigator: Jinhong Hu, Dr. Changhai Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00284973    
Other Study ID Numbers: WanMal002
First Posted: February 1, 2006    Key Record Dates
Last Update Posted: April 14, 2015
Last Verified: April 2007
Keywords provided by PATH:
malaria
Additional relevant MeSH terms:
Layout table for MeSH terms
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases