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A Study of Safety and Immunogenicity of a Malaria Vaccine Candidate

Primary Purpose

Prophylaxis Against Plasmodium Falciparum Malaria

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Plasmodium falciparum Chimeric Prot. 2.9 - Montanide ISA 720
Sponsored by
Shanghai Wanxing Bio-Pharmaceutical Co. Ltd.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prophylaxis Against Plasmodium Falciparum Malaria focused on measuring malaria

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Shanghai Changhai Hospital

Outcomes

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.

Full Information

First Posted
January 30, 2006
Last Updated
April 13, 2015
Sponsor
Shanghai Wanxing Bio-Pharmaceutical Co. Ltd.
Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Second Military Medical University, World Health Organization, PATH
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1. Study Identification

Unique Protocol Identification Number
NCT00284973
Brief Title
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

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Shanghai Wanxing Bio-Pharmaceutical Co. Ltd.
Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Second Military Medical University, World Health Organization, PATH

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prophylaxis Against Plasmodium Falciparum Malaria
Keywords
malaria

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
70 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Plasmodium falciparum Chimeric Prot. 2.9 - Montanide ISA 720
Primary Outcome Measure Information:
Title
To assess the safety and reactogenicity of the PfCP-2.9 /Montanide ISA 720 vaccine in healthy adult volunteers.
Secondary Outcome Measure Information:
Title
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.
Title
For exploratory analysis:
Title
To assess in vitro inhibition of parasite growth by vaccine-induced antibodies as measured by the GIA
Title
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
Title
To assess antigen-specific antibody responses by IFA after each vaccination
Title
To assess the relationship between antibody levels as measured by ELISA with IFA titers that recognize the conformational antigens of the parasite.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinhong Hu, Dr.
Organizational Affiliation
Changhai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Changhai Hospital
City
Shanghai
Country
China

12. IPD Sharing Statement

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A Study of Safety and Immunogenicity of a Malaria Vaccine Candidate

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