AdCh63 ME-TRAP and MVA ME-TRAP Malaria Vaccines Evaluation in Healthy Adults and Children in a Malaria Endemic Area

Malaria Clinical Trial

Official title:

Safety and Immunogenicity of Heterologous Prime-boost With the Candidate Malaria Vaccines AdCh63 ME-TRAP and MVA ME-TRAP in Healthy Adults and Children in a Malaria Endemic Area

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01373879
• Other study ID #: VAC041
• Status: Completed
• Phase: Phase 1
• First received: June 14, 2011
• Last updated: March 13, 2013
• Start date: June 2010
• Est. completion date: December 2011

Study information

• Verified date: March 2013
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Health authority: Gambia: MRC Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this trial is to assess the safety and immunogenicity of MVA ME-TRAP and AdCH63 ME-TRAP candidate vaccines in healthy children and adult volunteers in a malaria endemic region. The regimen proposed here has protected non-immune volunteers in Oxford against sporozoite challenge, and so may be protective against naturally acquired infection in The Gambia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 2 Years to 50 Years

Eligibility

Inclusion Criteria:

• Consenting adult males aged 18-50 years in good health and healthy children aged 2-6 years.with consenting parents.

Exclusion Criteria:

• Clinically significant history of skin disorder (psoriasis, contact dermatitis etc.), allergy, symptomatic immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness.

• Severe malnutrition.

• Hypersensitivity to HDCRV.

• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g. egg products, Kathon, neomycin, betapropiolactone.

• History of splenectomy Haemoglobin less than 9.0 g/dL, where judged to be clinically significant in the opinion of the investigator

• Serum Creatinine concentration greater than 70 mol/L, where judged to be clinically significant in the opinion of the investigator

• Serum ALT concentration greater than 45 U/L, where judged to be clinically significant in the opinion of the investigator

• Blood transfusion within one month of enrolment.

• History of vaccination with previous experimental malaria vaccines.

• Administration of any other vaccine or immunoglobulin within two weeks before vaccination.

• 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.

• HIV positive.

• Positive malaria antigen test

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Malaria

Intervention

Biological:
• AdCh63 ME-TRAP, MVA ME-TRAP
AdCh63 ME-TRAP 1 x 10^10vp IM followed by MVA ME-TRAP 2 x 10^8 pfu IM 8 weeks later
• AdCh63 ME-TRAP, MVA ME-TRAP
AdCh63 ME-TRAP 5 x 10^10vp IM followed by MVA ME-TRAP 2 x 10^8 pfu IM 8 weeks later
• AdCh63 ME-TRAP, MVA ME-TRAP
AdCh63 ME-TRAP 1 x 10^10vp IM followed by MVA ME-TRAP 1 x 10^8 pfu IM 8 weeks later
• AdCh63 ME-TRAP, MVA ME-TRAP
AdCh63 ME-TRAP 1 x 10^10vp IM followed by MVA ME-TRAP 2 x 10^8 pfu IM 8 weeks later
• HDCRV
HDCRV 1ml IM followed by HDCRV 1ml IM 8 weeks later
• AdCh63 ME-TRAP, MVA ME-TRAP
AdCh63 ME-TRAP 5 x 10^10vp IM followed by MVA ME-TRAP 1 x 10^8 pfu IM 8 weeks later
• AdCh63 ME-TRAP, MVA ME-TRAP
AdCh63 ME-TRAP 5 x 10^10vp IM followed by MVA ME-TRAP 2 x 10^8 pfu IM 8 weeks later
• HDCRV
HDCRV 1ml IM followed by HDCRV 1ml IM 8 weeks later

Locations

Country	Name	City	State
Gambia	Dr Kalifa Bojang	Banjul

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	European and Developing Countries Clinical Trials Partnership (EDCTP)

Country where clinical trial is conducted

Gambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of a heterologous prime-boost vaccine strategy with AdCh63 ME-TRAP and MVA ME-TRAP	To assess the safety of a heterologous prime-boost vaccine strategy with AdCh63 ME-TRAP and MVA ME-TRAP in healthy adults and children in The Gambia by recording local and systemic solicited and unsolicited adverse events	Participants will be followed for the duration of the study, an expected average of 12 months	Yes
Secondary	Immunogenicity of a heterologous prime-boost vaccine strategy with AdCh63 ME-TRAP and MVA ME-TRAP	To assess the immunogenicity of a heterologous prime-boost vaccine strategy with AdCh63 ME-TRAP and MVA ME-TRAP in healthy adults and children in The Gambia by assessing induced antibody and T cell response to the vaccine insert.	Participants will be followed for the duration of the study, an expected average of 12 months	No