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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01373879
First Posted: June 15, 2011
Last Update Posted: March 14, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
European and Developing Countries Clinical Trials Partnership (EDCTP)
Information provided by (Responsible Party):
University of Oxford
  Purpose
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.

Condition Intervention Phase
Malaria Biological: AdCh63 ME-TRAP, MVA ME-TRAP Biological: HDCRV Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Safety of a heterologous prime-boost vaccine strategy with AdCh63 ME-TRAP and MVA ME-TRAP [ Time Frame: 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:
  • Immunogenicity of a heterologous prime-boost vaccine strategy with AdCh63 ME-TRAP and MVA ME-TRAP [ Time Frame: 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.


Enrollment: 52
Study Start Date: June 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1A
Adults (18-50 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME-TRAP
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
Experimental: Group 1B
Adults (18-50 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME TRAP
Biological: 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
Experimental: Group 2A
Children (2-6 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME-TRAP
Biological: 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
Experimental: Group 2B
Children (2-6 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME-TRAP
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
Active Comparator: Group 2C
Children (2-6 years old) vaccinated with human diploid cell rabies vaccine
Biological: HDCRV
HDCRV 1ml IM followed by HDCRV 1ml IM 8 weeks later
Experimental: Group 3A
Children (2-6 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME-TRAP
Biological: 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
Experimental: Group 3B
Children (2-6 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME-TRAP
Biological: 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
Active Comparator: Group 3C
Children (2-6 years old) vaccinated with human diploid cell rabies vaccine
Biological: HDCRV
HDCRV 1ml IM followed by HDCRV 1ml IM 8 weeks later

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01373879


Locations
Gambia
Dr Kalifa Bojang
Banjul, Gambia
Sponsors and Collaborators
University of Oxford
European and Developing Countries Clinical Trials Partnership (EDCTP)
Investigators
Principal Investigator: Kalifa Bojang Medical Research Council PO Box 273, Banjul The Gambia
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01373879     History of Changes
Other Study ID Numbers: VAC041
First Submitted: June 14, 2011
First Posted: June 15, 2011
Last Update Posted: March 14, 2013
Last Verified: March 2013

Keywords provided by University of Oxford:
Vaccine
Immune response

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs