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02 September 2010
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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 |
| ClinicalTrials.gov identifier | |
| 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. |
| 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 |
| 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 |
| 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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| © 2010 ISRCTN unless otherwise stated. | |
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