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 design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Randomised controlled double-blind trial of DNA ME-TRAP/MVA ME-TRAP against malaria infection in Gambians aged 15 to 45
Study acronym	VAC020
Study objectives	A 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) studied	Plasmodium falciparum malaria
Intervention	Intervention: 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 type	Drug
Pharmaceutical study type(s)
Phase	Not 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 measure	1. Vaccine safety 2. Immunogenicity 3. Time to first P. falciparum infection
Secondary outcome measures	No secondary outcome measures
Overall study start date	01/07/2002
Completion date	01/12/2002

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	372
Total final enrolment	372
Key inclusion criteria	1. 372 Healthy Gambian men aged 15 to 45 2. Resident in villages in the North Bank Division
Key exclusion criteria	No exclusion criteria provided at time of registration
Date of first enrolment	01/07/2002
Date of final enrolment	01/12/2002

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"	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 share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not 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.