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

University of Oxford

Status and phase: Completed; Phase 1

Conditions: Malaria

Treatments: Biological: HDCRV; Biological: AdCh63 ME-TRAP, MVA ME-TRAP

Study type: Interventional

Funder types: Other

Identifiers

NCT01373879

VAC041

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: Male

Ages: 2 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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52 participants in 8 patient groups

Group 1A

Experimental group

Description:

Adults (18-50 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME-TRAP

Treatment:

Biological: AdCh63 ME-TRAP, MVA ME-TRAP

Biological: AdCh63 ME-TRAP, MVA ME-TRAP

Biological: AdCh63 ME-TRAP, MVA ME-TRAP

Biological: AdCh63 ME-TRAP, MVA ME-TRAP

Biological: AdCh63 ME-TRAP, MVA ME-TRAP

Biological: AdCh63 ME-TRAP, MVA ME-TRAP

Group 1B

Experimental group

Description:

Adults (18-50 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME TRAP

Treatment:

Biological: AdCh63 ME-TRAP, MVA ME-TRAP

Biological: AdCh63 ME-TRAP, MVA ME-TRAP

Biological: AdCh63 ME-TRAP, MVA ME-TRAP

Biological: AdCh63 ME-TRAP, MVA ME-TRAP

Biological: AdCh63 ME-TRAP, MVA ME-TRAP

Biological: AdCh63 ME-TRAP, MVA ME-TRAP

Group 2A

Experimental group

Description:

Children (2-6 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME-TRAP

Treatment:

Biological: AdCh63 ME-TRAP, MVA ME-TRAP

Biological: AdCh63 ME-TRAP, MVA ME-TRAP

Biological: AdCh63 ME-TRAP, MVA ME-TRAP

Biological: AdCh63 ME-TRAP, MVA ME-TRAP

Biological: AdCh63 ME-TRAP, MVA ME-TRAP

Biological: AdCh63 ME-TRAP, MVA ME-TRAP

Group 2B

Experimental group

Description:

Children (2-6 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME-TRAP

Treatment:

Biological: AdCh63 ME-TRAP, MVA ME-TRAP

Biological: AdCh63 ME-TRAP, MVA ME-TRAP

Biological: AdCh63 ME-TRAP, MVA ME-TRAP

Biological: AdCh63 ME-TRAP, MVA ME-TRAP

Biological: AdCh63 ME-TRAP, MVA ME-TRAP

Biological: AdCh63 ME-TRAP, MVA ME-TRAP

Group 2C

Active Comparator group

Description:

Children (2-6 years old) vaccinated with human diploid cell rabies vaccine

Treatment:

Biological: HDCRV

Biological: HDCRV

Group 3A

Experimental group

Description:

Children (2-6 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME-TRAP

Treatment:

Biological: AdCh63 ME-TRAP, MVA ME-TRAP

Biological: AdCh63 ME-TRAP, MVA ME-TRAP

Biological: AdCh63 ME-TRAP, MVA ME-TRAP

Biological: AdCh63 ME-TRAP, MVA ME-TRAP

Biological: AdCh63 ME-TRAP, MVA ME-TRAP

Biological: AdCh63 ME-TRAP, MVA ME-TRAP

Group 3B

Experimental group

Description:

Children (2-6 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME-TRAP

Treatment:

Biological: AdCh63 ME-TRAP, MVA ME-TRAP

Biological: AdCh63 ME-TRAP, MVA ME-TRAP

Biological: AdCh63 ME-TRAP, MVA ME-TRAP

Biological: AdCh63 ME-TRAP, MVA ME-TRAP

Biological: AdCh63 ME-TRAP, MVA ME-TRAP

Biological: AdCh63 ME-TRAP, MVA ME-TRAP

Group 3C

Active Comparator group

Description:

Children (2-6 years old) vaccinated with human diploid cell rabies vaccine

Treatment:

Biological: HDCRV

Biological: HDCRV