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

Primary Purpose

Malaria

Status
Completed
Phase
Phase 1
Locations
Gambia
Study Type
Interventional
Intervention
AdCh63 ME-TRAP, MVA ME-TRAP
AdCh63 ME-TRAP, MVA ME-TRAP
AdCh63 ME-TRAP, MVA ME-TRAP
AdCh63 ME-TRAP, MVA ME-TRAP
HDCRV
AdCh63 ME-TRAP, MVA ME-TRAP
AdCh63 ME-TRAP, MVA ME-TRAP
HDCRV
Sponsored by
University of Oxford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malaria focused on measuring Vaccine, Immune response

Eligibility Criteria

2 Years - 50 Years (Child, Adult)MaleAccepts 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

Sites / Locations

  • Dr Kalifa Bojang

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Experimental

Experimental

Active Comparator

Arm Label

Group 1A

Group 1B

Group 2A

Group 2B

Group 2C

Group 3A

Group 3B

Group 3C

Arm Description

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

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

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
June 14, 2011
Last Updated
March 13, 2013
Sponsor
University of Oxford
Collaborators
European and Developing Countries Clinical Trials Partnership (EDCTP)
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1. Study Identification

Unique Protocol Identification Number
NCT01373879
Brief Title
AdCh63 ME-TRAP and MVA ME-TRAP Malaria Vaccines Evaluation in Healthy Adults and Children in a Malaria Endemic Area
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford
Collaborators
European and Developing Countries Clinical Trials Partnership (EDCTP)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
Vaccine, Immune response

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1A
Arm Type
Experimental
Arm Description
Adults (18-50 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME-TRAP
Arm Title
Group 1B
Arm Type
Experimental
Arm Description
Adults (18-50 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME TRAP
Arm Title
Group 2A
Arm Type
Experimental
Arm Description
Children (2-6 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME-TRAP
Arm Title
Group 2B
Arm Type
Experimental
Arm Description
Children (2-6 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME-TRAP
Arm Title
Group 2C
Arm Type
Active Comparator
Arm Description
Children (2-6 years old) vaccinated with human diploid cell rabies vaccine
Arm Title
Group 3A
Arm Type
Experimental
Arm Description
Children (2-6 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME-TRAP
Arm Title
Group 3B
Arm Type
Experimental
Arm Description
Children (2-6 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME-TRAP
Arm Title
Group 3C
Arm Type
Active Comparator
Arm Description
Children (2-6 years old) vaccinated with human diploid cell rabies vaccine
Intervention Type
Biological
Intervention Name(s)
AdCh63 ME-TRAP, MVA ME-TRAP
Intervention Description
AdCh63 ME-TRAP 1 x 10^10vp IM followed by MVA ME-TRAP 2 x 10^8 pfu IM 8 weeks later
Intervention Type
Biological
Intervention Name(s)
AdCh63 ME-TRAP, MVA ME-TRAP
Intervention Description
AdCh63 ME-TRAP 5 x 10^10vp IM followed by MVA ME-TRAP 2 x 10^8 pfu IM 8 weeks later
Intervention Type
Biological
Intervention Name(s)
AdCh63 ME-TRAP, MVA ME-TRAP
Intervention Description
AdCh63 ME-TRAP 1 x 10^10vp IM followed by MVA ME-TRAP 1 x 10^8 pfu IM 8 weeks later
Intervention Type
Biological
Intervention Name(s)
AdCh63 ME-TRAP, MVA ME-TRAP
Intervention Description
AdCh63 ME-TRAP 1 x 10^10vp IM followed by MVA ME-TRAP 2 x 10^8 pfu IM 8 weeks later
Intervention Type
Biological
Intervention Name(s)
HDCRV
Intervention Description
HDCRV 1ml IM followed by HDCRV 1ml IM 8 weeks later
Intervention Type
Biological
Intervention Name(s)
AdCh63 ME-TRAP, MVA ME-TRAP
Intervention Description
AdCh63 ME-TRAP 5 x 10^10vp IM followed by MVA ME-TRAP 1 x 10^8 pfu IM 8 weeks later
Intervention Type
Biological
Intervention Name(s)
AdCh63 ME-TRAP, MVA ME-TRAP
Intervention Description
AdCh63 ME-TRAP 5 x 10^10vp IM followed by MVA ME-TRAP 2 x 10^8 pfu IM 8 weeks later
Intervention Type
Biological
Intervention Name(s)
HDCRV
Intervention Description
HDCRV 1ml IM followed by HDCRV 1ml IM 8 weeks later
Primary Outcome Measure Information:
Title
Safety of a heterologous prime-boost vaccine strategy with AdCh63 ME-TRAP and MVA ME-TRAP
Description
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
Time Frame
Participants will be followed for the duration of the study, an expected average of 12 months
Secondary Outcome Measure Information:
Title
Immunogenicity of a heterologous prime-boost vaccine strategy with AdCh63 ME-TRAP and MVA ME-TRAP
Description
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.
Time Frame
Participants will be followed for the duration of the study, an expected average of 12 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kalifa Bojang
Organizational Affiliation
Medical Research Council PO Box 273, Banjul The Gambia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr Kalifa Bojang
City
Banjul
Country
Gambia

12. IPD Sharing Statement

Citations:
PubMed Identifier
23526949
Citation
Ogwang C, Afolabi M, Kimani D, Jagne YJ, Sheehy SH, Bliss CM, Duncan CJ, Collins KA, Garcia Knight MA, Kimani E, Anagnostou NA, Berrie E, Moyle S, Gilbert SC, Spencer AJ, Soipei P, Mueller J, Okebe J, Colloca S, Cortese R, Viebig NK, Roberts R, Gantlett K, Lawrie AM, Nicosia A, Imoukhuede EB, Bejon P, Urban BC, Flanagan KL, Ewer KJ, Chilengi R, Hill AV, Bojang K. Safety and immunogenicity of heterologous prime-boost immunisation with Plasmodium falciparum malaria candidate vaccines, ChAd63 ME-TRAP and MVA ME-TRAP, in healthy Gambian and Kenyan adults. PLoS One. 2013;8(3):e57726. doi: 10.1371/journal.pone.0057726. Epub 2013 Mar 19.
Results Reference
derived

Learn more about this trial

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

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