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A phase I randomised single-blinded single-centre study comparing doses of Plasmodium falciparum chimeric protein 2.9 (PfCP-2.9) recombinant vaccine adjuvanted with Montanide ISA 720 for safety and immunogenicity
ISRCTN ISRCTN66850051
DOI 10.1186/ISRCTN66850051
ClinicalTrials.gov identifier
EudraCT number
Public title A phase I randomised single-blinded single-centre study comparing doses of Plasmodium falciparum chimeric protein 2.9 (PfCP-2.9) recombinant vaccine adjuvanted with Montanide ISA 720 for safety and immunogenicity
Scientific title
Acronym N/A
Serial number at source RPC 006
Study hypothesis Primary hypothesis:
To assess the safety and reactogenicity of PfCP-2.9 vaccine in healthy adult volunteers.

Secondary hypothesis:
To assess the immunogenicity of PfCP-2.9 vaccine in healthy adult volunteers.
Lay summary
Ethics approval Ethics approval received from:
1. Independent Ethics Committee, Shanghai Chanhai Hospital on the 29th January 2003 (ref: S001)
2. World Health Organization (WHO) research Ethics Research Committee on the 30th April 2003 (ref: RPC 006)
Study design Rondomised single-blind placebo-controlled trial
Countries of recruitment China
Disease/condition/study domain Malaria
Participants - inclusion criteria Healthy adult volunteers ages 18 - 45 years.
Participants - exclusion criteria 1. History of malaria: persons infected with malaria or with positive markers for antibodies to malaria parasite by Indirect Fluorescent Antibody (IFA) assay
2. History of ever traveling to or residing in a malaria endemic region or malaria exposure within last two years
Anticipated start date 11/08/2003
Anticipated end date 18/11/2004
Status of trial Completed
Patient information material
Target number of participants 52
Interventions 1. Intervention dose group: 20 micrograms PfCP2.9/Montanide ISA 720; administered intramuscularly on Day 0, Day 60 and Day 180
2. Intervention dose group: 50 micrograms PfCP2.9/Montanide ISA 720; administered intramuscularly on Day 0, Day 60 and Day 180
3. Intervention dose group: 100 micrograms PfCP2.9/Montanide ISA 720;administered intramuscularly on Day 0, Day 60 and Day 180
4. Intervention dose group: 200 micrograms PfCP2.9/Montanide ISA 720; administered intramuscularly on Day 0, Day 60 and Day 180
5. Placebo control group: Montanide ISA 720; administered intramuscularly on Day 0, Day 60 and Day 180

Contact information for Principal Investigator:
Dr Jinhong Hu
Clinical Center of Pharmacology Changhai Hospital
Second Military Medical University
174 Changhai Road
Shanghai 200433
China
Tel: +86 (0)21 25070665
Fax: +86 (0)21 25070665
Email: hjhong2006@gmail.com
Primary outcome measure(s) 1. Local and systemic tolerability
2. Reported adverse events
Secondary outcome measure(s) 1. Antibody titres by Enzyme-Linked Immuno-Sorbent Assay (ELISA)
2. Antibody titres by IFA Test (IFAT)
3. Lymphocyte stimulation indices
Sources of funding World Health Organization (WHO) (Switzerland) (ref: RPC 006)
Trial website
Publications Results: http://www.ncbi.nlm.nih.gov/pubmed/18398475
Contact name Dr  Zarifah  Reed
  Address Initiative for Vaccine Research
World Health Organization
20 Avenue Appia
  City/town Geneva-27
  Zip/Postcode CH-1211
  Country Switzerland
  Tel +41 (0)22 791 4760
  Fax +41 (0)22 791 4865
  Email reedz@who.int
Sponsor World Health Organization (WHO) (Switzerland)
  Address Initiative for Vaccine Research
Special Programme for Research and Training in Tropical Diseases
20 Avenue Appia
  City/town Geneva-27
  Zip/Postcode CH-1211
  Country Switzerland
  Tel +41 (0)22 791 4760
  Fax +41 (0)22 791 4865
  Email reedz@who.int
  Sponsor website: http://www.who.int/vaccine_research/en/
Date applied 01/10/2007
Last edited 15/04/2008
Date ISRCTN assigned 01/10/2007
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