Malaria Infection Diagnosed by Polymerase Chain Reaction (PCR) as a Means of Evaluating Pre-erythrocytic Candidate Malaria Vaccines

NCT00121823 | Completed Phase 1

• 2 other identifiers: ITDCVG37VAC 029
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria

Keywords

Malaria; PCR; Vaccines; Acceptability

Outcome Measures

Primary Outcomes (1)

• Suitability and acceptability of study method

Secondary Outcomes (1)

• Prevention of malaria parasitaemia

Interventions

FP9 ME-TRAP BIOLOGICAL

MVA ME-TRAP BIOLOGICAL

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Healthy volunteers aged 15-45 years
• Signed informed consent form

You may not qualify if:

• 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

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• Medical Research Council Unit, The Gambia: collaborator
• University of Oxford: collaborator
• Wellcome Trust: collaborator

Study Sites (1)

Medical Research Council Laboratories

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

Location

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector 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
• 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 1, 2004
• Study Completion: December 1, 2004
• Last Updated: January 12, 2017

Record last verified: 2017-01

Locations

TH (1)