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

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ClinicalTrials.gov Identifier: NCT01450293
Recruitment Status : Completed
First Posted : October 12, 2011
Last Update Posted : December 12, 2013
Sponsor:
Collaborator:
European and Developing Countries Clinical Trials Partnership (EDCTP)
Information provided by (Responsible Party):
University of Oxford

Tracking Information
First Submitted Date  ICMJE October 3, 2011
First Posted Date  ICMJE October 12, 2011
Last Update Posted Date December 12, 2013
Study Start Date  ICMJE October 2011
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2011)
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 ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01450293 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2011)
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 ]
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AdCh63 ME-TRAP and MVA ME-TRAP Malaria Vaccines Evaluation in Healthy Children in a Malaria Endemic Area
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Malaria
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Group A
    5 to 12 months old infants; AdCh63 ME-TRAP, MVA ME-TRAP
    Intervention: Biological: AdCh63 ME-TRAP, MVA ME-TRAP
  • Experimental: Group B
    5 to 12 months old infants; AdCh63 ME-TRAP, MVA ME-TRAP
    Intervention: Biological: AdCH63 ME-TRAP, MVA ME-TRAP
  • 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
    Intervention: Biological: AdCh63 ME-TRAP, MVA ME-TRAP
  • Experimental: Group E
    10 week old babies; AdCh63 ME-TRAP, MVA ME-TRAP
    Intervention: Biological: AdCH63 ME-TRAP, MVA ME-TRAP
  • No Intervention: Group F
    10 week old babies; no vaccination
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 11, 2011)
72
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Weeks to 12 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Gambia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01450293
Other Study ID Numbers  ICMJE VAC042
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Oxford
Study Sponsor  ICMJE University of Oxford
Collaborators  ICMJE European and Developing Countries Clinical Trials Partnership (EDCTP)
Investigators  ICMJE
Principal Investigator: Kalifa Bojang Medical Research Council PO Box 273, Banjul The Gambia
PRS Account University of Oxford
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP