Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
060147
Study information
Scientific title
Acronym
VAC020
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/07/2002
Overall trial end date
01/12/2002
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 372 Healthy Gambian men aged 15 to 45
2. Resident in villages in the North Bank Division
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
372
Participant exclusion criteria
No exclusion criteria provided at time of registration
Recruitment start date
01/07/2002
Recruitment end date
01/12/2002
Locations
Countries of recruitment
Gambia
Trial participating centre
6290 Montrose Road
Rockville
20814
United States of America
Funders
Funder type
Charity
Funder name
The Wellcome Trust (UK) (grant ref: 060147)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Gates' Partnership at London School of Hygiene and Tropical Medicine (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Basic results (scientific)
Publication list
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=15526058
Publication citations
-
Moorthy VS, Imoukhuede EB, Milligan P, Bojang K, Keating S, Kaye P, Pinder M, Gilbert SC, Walraven G, Greenwood BM, Hill AS, A randomised, double-blind, controlled vaccine efficacy trial of DNA/MVA ME-TRAP against malaria infection in Gambian adults., PLoS Med., 2004, 1, 2, e33, doi: 10.1371/journal.pmed.0010033.