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

This study has been completed.
Sponsor:
Collaborator:
European and Developing Countries Clinical Trials Partnership (EDCTP)
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01450293
First received: October 3, 2011
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

Infants in malaria-endemic regions of Africa are an important target for vaccination against malaria in view of the enormous disease burden of malaria in this population. 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 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. Administration of AdCh63 ME-TRAP and MVA ME-TRAP to infants in this study will occur at intervals of at least two weeks from the administration of routine infant immunisations, given according to the Gambian EPI.


Condition Intervention Phase
Malaria
Biological: AdCh63 ME-TRAP, MVA ME-TRAP
Biological: AdCH63 ME-TRAP, MVA ME-TRAP
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of Heterologous Prime-boost Vaccination With the Candidate Malaria Vaccines AdCh63 ME-TRAP and MVA ME-TRAP in Healthy Infants in a Malaria- Endemic Area

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Safety of heterologous prime-boost vaccination with AdCh63 ME-TRAP followed eight weeks later by MVA ME-TRAP [ Time Frame: Participants will be followed for the duration of the study, an expected average of 16 months ] [ Designated as safety issue: Yes ]
    To assess the safety of heterologous prime-boost vaccination of healthy infants in a malaria-endemic area with AdCh63 ME-TRAP followed eight weeks later by MVA ME-TRAP by recording local and systemic solicited and unsolicited adverse events


Secondary Outcome Measures:
  • Immunogenicity of heterologous prime-boost vaccination with AdCh63 ME-TRAP followed eight weeks later by MVA ME-TRAP [ Time Frame: Participants will be followed for the duration of the study, an expected average of 16 months ] [ Designated as safety issue: No ]
    To assess the immunogenicity of heterologous prime-boost vaccination of healthy infants in a malaria-endemic area with AdCh63 ME-TRAP followed eight weeks later by MVA ME-TRAP by assessing induced antibody and T cell response to the vaccine insert


Enrollment: 72
Study Start Date: October 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
5 to 12 months old infants; AdCh63 ME-TRAP, MVA ME-TRAP
Biological: AdCh63 ME-TRAP, MVA ME-TRAP
1x10^10 vp AdCH63 ME-TRAP followed by 1x10^8 pfu MVA ME-TRAP 8 weeks later. Intramuscular needle injection into the anterolateral thigh.
Experimental: Group B
5 to 12 months old infants; AdCh63 ME-TRAP, MVA ME-TRAP
Biological: AdCH63 ME-TRAP, MVA ME-TRAP
5x10^10 vp AdCH63 ME-TRAP followed by 1x10^8 pfu MVA ME-TRAP 8 weeks later. Intramuscular needle injection into the anterolateral thigh.
No Intervention: Group C
5 to 12 months old infants; no vaccination
Experimental: Group D
10 week old babies; AdCh63 ME-TRAP, MVA ME-TRAP
Biological: AdCh63 ME-TRAP, MVA ME-TRAP
1x10^10 vp AdCH63 ME-TRAP followed by 1x10^8 pfu MVA ME-TRAP 8 weeks later. Intramuscular needle injection into the anterolateral thigh.
Experimental: Group E
10 week old babies; AdCh63 ME-TRAP, MVA ME-TRAP
Biological: AdCH63 ME-TRAP, MVA ME-TRAP
5x10^10 vp AdCH63 ME-TRAP followed by 1x10^8 pfu MVA ME-TRAP 8 weeks later. Intramuscular needle injection into the anterolateral thigh.
No Intervention: Group F
10 week old babies; no vaccination

  Eligibility

Ages Eligible for Study:   10 Weeks to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy infants aged 10 weeks and 5-12 months at the time of enrollment 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.
  • 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 8.0 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 enrollment.
  • History of vaccination with previous experimental malaria vaccines. -Administration of any other vaccine or immunoglobulin less than two weeks before vaccination with the IMPs 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
  • Maternal HIV infection Positive malaria antigen test at screening
  • Failure to have received, prior to enrollment, the routine EPI vaccinations due according to the Gambian EPI schedule.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01450293

Locations
Gambia
Medical Research Council Laboratories
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

No publications provided

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01450293     History of Changes
Other Study ID Numbers: VAC042
Study First Received: October 3, 2011
Last Updated: December 11, 2013
Health Authority: Gambia: MRC Ethics Committee

Keywords provided by University of Oxford:
Immune response

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on August 28, 2014