Condition category
Infections and Infestations
Date applied
01/10/2007
Date assigned
01/10/2007
Last edited
15/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.who.int/vaccine_research/en/

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

Results - basic reporting

Publication summary

Results: http://www.ncbi.nlm.nih.gov/pubmed/18398475

Publication citations

  1. 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.

Additional files

Editorial Notes