Condition category
Infections and Infestations
Date applied
01/09/2004
Date assigned
05/10/2004
Last edited
11/03/2013
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 Vasee Moorthy

ORCID ID

Contact details

6290 Montrose Road
Rockville
20814
United States of America

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 measures

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

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

Sponsor information

Organisation

London School of Hygiene and Tropical Medicine (UK)

Sponsor details

Keppel Street
London
WC1E 7HT
United Kingdom

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=15526058

Publication citations

  1. 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.

Additional files

Editorial Notes