Contact information
Type
Scientific
Primary contact
Dr Zarifah Reed
ORCID ID
Contact details
Initiative for Vaccine Research
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
+41 (0)22 791 4760
reedz@who.int
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RPC 006
Study information
Scientific title
Acronym
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.
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Malaria
Intervention
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
Intervention type
Drug
Phase
Not Specified
Drug names
Plasmodium falciparum chimeric protein 2.9 (PfCP-2.9) recombinant vaccine, Montanide ISA 720
Primary outcome measure
1. Local and systemic tolerability
2. Reported adverse events
Secondary outcome measures
1. Antibody titres by Enzyme-Linked Immuno-Sorbent Assay (ELISA)
2. Antibody titres by IFA Test (IFAT)
3. Lymphocyte stimulation indices
Overall trial start date
11/08/2003
Overall trial end date
18/11/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Healthy adult volunteers ages 18 - 45 years.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
52
Participant 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
Recruitment start date
11/08/2003
Recruitment end date
18/11/2004
Locations
Countries of recruitment
China
Trial participating centre
Initiative for Vaccine Research
Geneva-27
CH-1211
Switzerland
Sponsor information
Organisation
World Health Organization (WHO) (Switzerland)
Sponsor details
Initiative for Vaccine Research
Special Programme for Research and Training in Tropical Diseases
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
+41 (0)22 791 4760
reedz@who.int
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
World Health Organization (WHO) (Switzerland) (ref: RPC 006)
Alternative name(s)
WHO
Funding Body Type
private sector organisation
Funding Body Subtype
international
Location
Switzerland
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Results: http://www.ncbi.nlm.nih.gov/pubmed/18398475
Publication citations
-
Results
Hu J, Chen Z, Gu J, Wan M, Shen Q, Kieny MP, He J, Li Z, Zhang Q, Reed ZH, Zhu Y, Li W, Cao Y, Qu L, Cao Z, Wang Q, Liu H, Pan X, Huang X, Zhang D, Xue X, Pan W, Safety and immunogenicity of a malaria vaccine, Plasmodium falciparum AMA-1/MSP-1 chimeric protein formulated in montanide ISA 720 in healthy adults., PLoS ONE, 2008, 3, 4, e1952, doi: 10.1371/journal.pone.0001952.