Randomised controlled double-blind trial of DNA ME-TRAP/MVA ME-TRAP against malaria infection in Gambians aged 15 to 45

ISRCTN ISRCTN05221133
DOI https://doi.org/10.1186/ISRCTN05221133
Secondary identifying numbers 060147
Submission date
01/09/2004
Registration date
05/10/2004
Last edited
10/11/2022
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 Vasee Moorthy
Scientific

6290 Montrose Road
Rockville
20814
United States of America

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleRandomised controlled double-blind trial of DNA ME-TRAP/MVA ME-TRAP against malaria infection in Gambians aged 15 to 45
Study acronymVAC020
Study objectivesA randomised, controlled trial of Deoxyribonucleic Acid (DNA) Multiple Epitope (ME)-Thrombospondin Related Adhesion Protein (TRAP)/Modified Vaccinia virus Ankara (MVA) ME-TRAP in a rural part of Gambia to explore whether this vaccine combination could provide protection against natural P. falciparum infection.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedPlasmodium falciparum malaria
InterventionIntervention: Deoxyribonucleic Acid (DNA) Multiple Epitope (ME)-Thrombospondin Related Adhesion Protein (TRAP) malaria vaccination followed by Modified Vaccinia virus Ankara (MVA) ME-TRAP malaria vaccination
Control: Chiron Rabipur rabies vaccine
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Deoxyribonucleic Acid (DNA) Multiple Epitope (ME)-Thrombospondin Related Adhesion Protein (TRAP) malaria vaccination, Modified Vaccinia virus Ankara (MVA) ME-TRAP malaria vaccination and Chiron Rabipur rabies vaccine
Primary outcome measure1. Vaccine safety
2. Immunogenicity
3. Time to first P. falciparum infection
Secondary outcome measuresNo secondary outcome measures
Overall study start date01/07/2002
Completion date01/12/2002

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants372
Total final enrolment372
Key inclusion criteria1. 372 Healthy Gambian men aged 15 to 45
2. Resident in villages in the North Bank Division
Key exclusion criteriaNo exclusion criteria provided at time of registration
Date of first enrolment01/07/2002
Date of final enrolment01/12/2002

Locations

Countries of recruitment

  • Gambia
  • United States of America

Study participating centre

6290 Montrose Road
Rockville
20814
United States of America

Sponsor information

London School of Hygiene and Tropical Medicine (UK)
University/education

Keppel Street
London
WC1E 7HT
England
United Kingdom

ROR logo "ROR" https://ror.org/00a0jsq62

Funders

Funder type

Charity

The Wellcome Trust (UK) (grant ref: 060147)

No information available

Gates' Partnership at London School of Hygiene and Tropical Medicine (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 01/11/2004 Yes No

Editorial Notes

10/11/2022: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.