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

Phase 1

Completed

• Conditions: Malaria
• Interventions: Biological: AdCh63 ME-TRAP, MVA ME-TRAP; Biological: HDCRV

• Registration Number: NCT01373879
• Lead Sponsor: University of Oxford

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2011-06-14
• Study First Submitted QC: 2011-06-14
• Study First Posted: 2011-06-15
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-13
• Last Update Posted: 2013-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 52

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2A	AdCh63 ME-TRAP, MVA ME-TRAP	Children (2-6 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME-TRAP
Group 1A	AdCh63 ME-TRAP, MVA ME-TRAP	Adults (18-50 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME-TRAP
Group 1B	AdCh63 ME-TRAP, MVA ME-TRAP	Adults (18-50 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME TRAP
Group 2B	AdCh63 ME-TRAP, MVA ME-TRAP	Children (2-6 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME-TRAP
Group 2C	HDCRV	Children (2-6 years old) vaccinated with human diploid cell rabies vaccine
Group 3A	AdCh63 ME-TRAP, MVA ME-TRAP	Children (2-6 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME-TRAP
Group 3B	AdCh63 ME-TRAP, MVA ME-TRAP	Children (2-6 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME-TRAP
Group 3C	HDCRV	Children (2-6 years old) vaccinated with human diploid cell rabies vaccine

Primary Outcome Measures

Name	Time	Method
Safety of a heterologous prime-boost vaccine strategy with AdCh63 ME-TRAP and MVA ME-TRAP	Participants will be followed for the duration of the study, an expected average of 12 months	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

Secondary Outcome Measures

Name	Time	Method
Immunogenicity of a heterologous prime-boost vaccine strategy with AdCh63 ME-TRAP and MVA ME-TRAP	Participants will be followed for the duration of the study, an expected average of 12 months	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.

Trial Locations

Locations (1)

Dr Kalifa Bojang; 🇬🇲 Banjul, Gambia