A Study of Safety and Immunogenicity of a Malaria Vaccine Candidate

April 13, 2015 updated by: Shanghai Wanxing Bio-Pharmaceutical Co. Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

70

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Shanghai Changhai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Wanxing Bio-Pharmaceutical Co. Ltd.

Collaborators

PATH
World Health Organization
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Second Military Medical University

Investigators

  • Principal Investigator: Jinhong Hu, Dr., Changhai hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Study Registration Dates

First Submitted

January 30, 2006

First Submitted That Met QC Criteria

January 30, 2006

First Posted (ESTIMATE)

February 1, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

April 14, 2015

Last Update Submitted That Met QC Criteria

April 13, 2015

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WanMal002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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