NCT00121823

CompletedPhase 1/2

Malaria Infection Diagnosed by Polymerase Chain Reaction (PC...

London School of Hygiene and Tropical Medicine Source

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Other study identifiers

Sponsor study identifier

ITDCVG37

Secondary identifiers

VAC 029

Study Type

interventional

Reported enrollment (type unavailable)

120

Locations

1 country

Sites

1

Timeline

Study Start

June 2004

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

December 2004

Date type not reported

This date has not been verified as actual or estimated.

Brief Summary

The ability to test candidate pre-erythrocytic stage malaria vaccines, using a well-established sporozoite challenge model, in a field setting with group sizes of tens rather than hundreds of volunteers would greatly facilitate identification of the most promising vaccine candidates. The investigators assessed the suitability and acceptability of this method in a field trial in semi-immune volunteers exposed to natural infection during the high malaria transmission season.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): 120 participants
Study completion date: December 2004
Date type not reported
This date has not been verified as actual or estimated.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
June 2004
Date type not reported
This date has not been verified as actual or estimated.
Study Completion
December 2004
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
July 18, 2005
Actual (reported)
First Posted
July 21, 2005
Actual (reported)

Last Updated: January 12, 2017
Status Verified: January 2017
Last Update Submitted: January 11, 2017

Conditions

Malaria

Keywords

MalariaPCRVaccinesAcceptability

Outcome Measures

Primary Outcomes (1)

Suitability and acceptability of study method

Secondary Outcomes (1)

Prevention of malaria parasitaemia

Interventions

FP9 ME-TRAPBiological

MVA ME-TRAPBiological

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age15 Years - 45 Years

Sexmale

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

Healthy volunteers aged 15-45 years
Signed informed consent form

You may not qualify if:

Sponsors & Collaborators

Medical Research Council Unit, The Gambia
Othercollaborator
Wellcome Trust
Othercollaborator
London School of Hygiene and Tropical Medicine

Study Sites (1)

Medical Research Council Laboratories

Banjul, P.O.Box 273, Banjul, The Gambia

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

Adrian VS Hill, Phd
University of Oxford
STUDY CHAIR
Brian M Greenwood, MD
Gates Malaria Partnership
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: RANDOMIZED
Masking: SINGLE
Purpose: PREVENTION
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor

Study Record Dates

First Submitted

July 18, 2005

First Posted

July 21, 2005

Study Start

June 2004

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

December 2004

Date type not reported

NCT00385047

A Study to Determine Whether 2 Investigational Malaria Vaccines Are Safe, Protective Against Malaria in Adults

Phase 1/2Completed

NCT00341250

Malaria Vaccine in Children in Mali

Phase 1/2Completed

NCT01605786

Trial for Malaria Vaccine Candidate, PfPEBS (P. Falciparum Pre-Erythrocytic and Blood Stage)

Phase 1/2Unknown

NCT01603251

Trial of Artemether-Lumefantrine Alone and in Combination With Ivermectin to Reduce Post-Treatment Malaria Transmission

Phase 1/2Completed

NCT01003314

A Study of the Safety and Effectiveness of Two New Malaria Vaccines

Phase 1/2Completed

NCT05441410

Comparing Safety and Protective Efficacy of Vaccine Candidate PfSPZ-CVac and MVA ME-TRAP/ ChAd63 ME-TRAP in Adults

Phase 1/2Not Yet Recruiting

Clinically significant history of skin disorder (eczema, psoriasis, etc.), allergy, immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease or neurological illness.
Any clinical evidence of immunosuppression such as oral candida, stomatitis, aphthous or septic ulceration, septic skin lesions or any clinical or laboratory evidence of infection or immunosuppression.
History of splenectomy
Haematocrit of less than 30%
Serum creatinine concentration \>130mmol/L
Serum ALT concentration \>80 IU/L
Blood transfusion within one month of the beginning of the study
History of vaccination with a previous experimental malaria vaccine
Administration of any other vaccine or immunoglobulin within two weeks of scheduled vaccination.
Positive HIV antibody test.
Positive colorimetric test for G-6-P-D deficiency.
Current participation in another clinical trial, or within 12 weeks of this study.
Lack of parental consent if volunteer is aged under 18
Likelihood of travel away from the study area for the duration of the study
Any other finding which in the opinion of the investigators would increase the risk of an adverse outcome from participation in the trial
+3 more criteria

Contact the study team to confirm eligibility.

Otherlead

University of Oxford

Othercollaborator

This date has not been verified as actual or estimated.

Last Updated

January 12, 2017

Record last verified: 2017-01

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00121823
Data provider: ClinicalTrials.gov
Source updated: 2017-01-12
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:34:55 UTC

Locations

GM(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Source record

Locations