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 | https://doi.org/10.1186/ISRCTN66850051 |
| Protocol serial number | RPC 006 |
| Sponsor | World Health Organization (WHO) (Switzerland) |
| Funder | World Health Organization (WHO) (Switzerland) (ref: RPC 006) |
- Submission date
- 01/10/2007
- Registration date
- 01/10/2007
- Last edited
- 15/04/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Zarifah Reed
Scientific
Scientific
Initiative for Vaccine Research
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
| Phone | +41 (0)22 791 4760 |
|---|---|
| reedz@who.int |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Rondomised single-blind placebo-controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | 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) |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Plasmodium falciparum chimeric protein 2.9 (PfCP-2.9) recombinant vaccine, Montanide ISA 720 |
| Primary outcome measure(s) | 1. Local and systemic tolerability 2. Reported adverse events |
| Key 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 |
| Completion date | 18/11/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 45 Years |
| Sex | Female |
| Target sample size at registration | 52 |
| Key inclusion criteria | Healthy adult volunteers ages 18 - 45 years. |
| Key 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 |
| Date of first enrolment | 11/08/2003 |
| Date of final enrolment | 18/11/2004 |
Locations
Countries of recruitment
- China
- Switzerland
Study participating centre
Initiative for Vaccine Research
Geneva-27
CH-1211
Switzerland
CH-1211
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results: | 09/04/2008 | Yes | No |
