Malaria Candidate Vaccines FP9 Circumsporozoite (CS) and MVA CS in Adult Gambian Men

NCT00121771 | Completed Phase 1

• 2 other identifiers: ITDCVG28VAC 026
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Animal and human studies have shown that the prime-boost immunization strategy using malaria antigens expressed in plasmid or viral vectors induces strong cellular immune responses. An immunization regimen with the malaria vaccines DNA ME-TRAP followed by MVA ME-TRAP induced strong T cell responses in adults in the United Kingdom (UK) and in the Gambia but did not provide significant clinical protection against infection. The investigators assessed two new vaccines which utilize a similar immunization strategy but a different malaria antigen, a circumsporozoite (CS) protein. The entire CS protein was expressed either in a modified vaccinia virus Ankara (MVA) CS, or an attenuated fowlpox virus strain (FP9) CS.

Conditions

Malaria

Keywords

Malaria; Vaccines; Safety; Immunogenicity

Outcome Measures

Primary Outcomes (1)

• Safety and immunogenicity

Secondary Outcomes (1)

• Comparison of immunogenicity with non-immune UK adults

Interventions

FP9 CS BIOLOGICAL

MVA CS BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult male aged 18-45 years

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 immunocompromise
• History of splenectomy
• Haematocrit of less than 30%
• Serum creatinine concentration \>130mmol/L
• Serum ALT concentration \>42IU/L
• Blood transfusion within one month of the beginning of the study
• Administration of any other vaccine or immunoglobulin within two weeks before scheduled MVA vaccination
• Positive HIV antibody test
• Current participation in another clinical trial, or within 12 weeks of this study
• Any other finding which, in the opinion of the investigators, would increase the risk of an adverse outcome from participation in the trial
• Likelihood of travel away from the study area for the duration of the study

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• Medical Research Council: collaborator
• University of Oxford: 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, MD, Phd

  Centre for Human Genetics, University of Oxford

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• 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: January 1, 2004
• Study Completion: July 1, 2004
• Last Updated: January 12, 2017

Record last verified: 2017-01

Locations

TH (1)