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A Phase 1/2b Study of an Investigational Malaria Vaccination Strategy in 5-17 Month Old Infants and Children in Burkina Faso

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.
 
ClinicalTrials.gov Identifier: NCT01635647
Recruitment Status : Completed
First Posted : July 9, 2012
Last Update Posted : February 15, 2016
Sponsor:
Collaborator:
European and Developing Countries Clinical Trials Partnership (EDCTP)
Information provided by (Responsible Party):
University of Oxford

Brief Summary:
Prime boost vaccination with ChAd63 ME-TRAP followed eight weeks later with MVA ME-TRAP shows efficacy against malaria infection when tested in UK volunteers using sporozoite challenge experiments. It is a leading candidate vaccination strategy against malaria. In the field, Phase I studies have been conducted in adults in Kenya and The Gambia and children and infants in The Gambia. The vaccination strategy appears safe and well tolerated in these populations, and also shows impressive immunogenicity, not significantly different to that seen in the UK trials where efficacy was shown. In particular, recent data from The Gambia shows excellent safety and immunogenicity in infants in malaria endemic areas, who would be the ones to benefit most from such a vaccine against malaria. With this clinical development as background, the investigators now propose to evaluate efficacy against natural malaria infection in this important target group for an effective malaria vaccine, that is, 5-17 month infants and children living in malaria endemic areas. The proposed study area, Banfora, Burkina Faso, is highly endemic for Plasmodium falciparum malaria.

Condition or disease Intervention/treatment Phase
Malaria Biological: ChAd63 ME-TRAP and MVA ME-TRAP Biological: Rabies vaccine Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 730 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: A Phase 1/2b Double Blind Randomised Controlled Trial of the Efficacy, Safety and Immunogenicity of Heterologous Prime-boost Immunisation With the Candidate Malaria Vaccines ChAd63 ME-TRAP and MVA ME-TRAP in 5-17 Month Old Burkinabe Infants and Children
Study Start Date : November 2012
Actual Primary Completion Date : August 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Active Comparator: ChAd63 ME-TRAP and MVA ME-TRAP
ChAd63 ME-TRAP / MVA ME-TRAP heterologous prime-boost immunisation
Biological: ChAd63 ME-TRAP and MVA ME-TRAP
ChAd63 ME-TRAP: 5 x 10^10vp MVA ME-TRAP: 1 x 10^8 pfu heterologous prime-boost immunisation

Placebo Comparator: Rabies vaccine
2 x 2.5IU Verorab
Biological: Rabies vaccine
Two doses eight weeks apart into anterolateral thigh. 2 x 2.5IU Verorab




Primary Outcome Measures :
  1. Time to first episode of malaria meeting the primary case definition of clinical malaria episode [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Duration of Protective efficacy against clinical malaria [ Time Frame: 12 and 24 months ]
    To assess the protective efficacy against clinical malaria of ChAd63 ME-TRAP / MVA ME-TRAP prime-boost immunisation, in 5-17 month old infants and children living in a malaria-endemic area, for 12 and 24* months after the last vaccination.

  2. Efficacy against asymptomatic P. falciparum infection [ Time Frame: 6, 12 and 24 months ]
    To assess the protective efficacy against asymptomatic P. falciparum infection of ChAd63 ME-TRAP / MVA ME-TRAP prime-boost immunisation, in 5-17 month old infants and children living in a malaria-endemic area, 6, 12 and 24* months after the last vaccination

  3. Efficacy against secondary case definitions of clinical malaria [ Time Frame: 6, 12 and 24 months ]
    To assess the protective efficacy against secondary case definitions of clinical malaria of ChAd63 ME-TRAP / MVA ME-TRAP prime-boost immunisation, in 5-17 month old infants and children living in a malaria-endemic area, for 6, 12 and 24 months after the last vaccination

  4. Safety Objective [ Time Frame: 6, 12 and 24 months ]
    To assess the safety and reactogenicity of ChAd63 ME-TRAP / MVA ME-TRAP heterologous prime-boost immunisation, in 5-17 month old infants and children living in a malaria-endemic area, for 6, 12 and 24 months after the last vaccination.

  5. Immunogenicity Objectives [ Time Frame: 24 months ]
    • To assess the immunogenicity of ChAd63 ME-TRAP / MVA ME- TRAP heterologous prime-boost immunisation, in 5-17 month old infants and children living in a malaria-endemic area.
    • To explore the immunologic correlates of protective efficacy of ChAd63 ME-TRAP / MVA ME-TRAP prime-boost immunisation, in 5-17 month old infants and children living in a malaria-endemic area.



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Ages Eligible for Study:   5 Months to 17 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy infant/child aged 5-17 months at the time of first study vaccination
  2. Informed consent of parent/guardian
  3. Infant / child and parent/guardian resident in the study area villages and anticipated to be available for vaccination and follow-up

Exclusion Criteria:

  • Clinically significant skin disorder (psoriasis, contact dermatitis etc.), immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness.
  • Weight-for-age Z score of less than -3 or other clinical signs of malnutrition
  • History of allergic reaction, significant IgE-mediated event, or anaphylaxis to immunisation
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g. egg products, Kathon, neomycin, beta-propiolactone.
  • 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 µmol/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
  • Previous vaccination with experimental malaria vaccines.
  • Administration of any other vaccine or immunoglobulin less than one week before vaccination with any study vaccine.
  • 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 or result in incomplete or poor quality data
  • Known maternal HIV infection (No testing will be done by the study team)
  • Immunosuppressive therapy (steroids, immune modulators or immune suppressors) within 3 months prior recruitment. (For corticosteroids, this will mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)

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): NCT01635647


Locations
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Burkina Faso
Centre for Clinical Vaccinology and 1. Centre National de Recherche et de Formation sur le Paludisme (CNRFP)/ Unité de Recherche Clinique de Banfora (URC-B)
Ouagadougou, Burkina Faso, BP 2208
Sponsors and Collaborators
University of Oxford
European and Developing Countries Clinical Trials Partnership (EDCTP)
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01635647    
Other Study ID Numbers: VAC050
First Posted: July 9, 2012    Key Record Dates
Last Update Posted: February 15, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases