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 |
| Protocol serial number | 060147 |
| Sponsor | London School of Hygiene and Tropical Medicine (UK) |
| Funders | The Wellcome Trust (UK) (grant ref: 060147), Gates' Partnership at London School of Hygiene and Tropical Medicine (UK) |
- 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
Scientific
6290 Montrose Road
Rockville
20814
United States of America
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| 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(s) |
1. Vaccine safety |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 01/12/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
20814
United States of America
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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.
