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A Phase I Study to Assess the Safety and Immunogenicity of ChAd63 ME-TRAP - MVA ME-TRAP Heterologous Prime-boost Vaccination Co-administered With EPI Vaccines in Gambian Infants (VAC058)

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ClinicalTrials.gov Identifier: NCT02083887
Recruitment Status : Completed
First Posted : March 11, 2014
Last Update Posted : December 3, 2015
Sponsor:
Collaborator:
Malaria Vectored Vaccines Consortium
Information provided by (Responsible Party):
University of Oxford

Tracking Information
First Submitted Date  ICMJE February 28, 2014
First Posted Date  ICMJE March 11, 2014
Last Update Posted Date December 3, 2015
Study Start Date  ICMJE February 2014
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2014)
Safety of ChAd63 ME-TRAP / MVA ME-TRAP prime boost immunisation co-administered with EPI vaccines [ Time Frame: Participants will be followed for the duration of the study, an expected average of 36 weeks ]
Recording of all solicited and unsolicited local and systemic adverse events (including laboratory abnormalities considered adverse events) and the assessment of their causal relationships to the investigative medicinal products (IMPs).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2014)
Immunogenicity of ChAd63 ME-TRAP / MVA ME-TRAP prime boost immunisation co-administered with EPI vaccines. [ Time Frame: Participants will be followed for the duration of the study, an expected average of 36 weeks ]
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 A Phase I Study to Assess the Safety and Immunogenicity of ChAd63 ME-TRAP - MVA ME-TRAP Heterologous Prime-boost Vaccination Co-administered With EPI Vaccines in Gambian Infants
Official Title  ICMJE A Phase I Study to Assess the Safety and Immunogenicity of ChAd63 ME-TRAP - MVA ME-TRAP Heterologous Prime-boost Vaccination Co-administered With EPI Vaccines in Gambian Infants
Brief Summary Two vaccines, ChAd63 ME-TRAP and MVA ME-TRAP, are being tested to see if they will form a safe and effective vaccination strategy against malaria. The vaccines have been found to be well tolerated when tested in Gambian adults, young children and infants, who are at risk of severe malaria. Both vaccines will be given to participating infants at the same time as some EPI (Expanded Program on Immunization) vaccines, and assess whether they are safe and still helpful in making the body's defense system respond.
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: ChAd63 ME-TRAP / MVA ME-TRAP
Intramuscular administration of ChAd63 ME-TRAP 5 x 10^10 vp and MVA ME-TRAP 1 x 10^8 pfu
Study Arms  ICMJE
  • Active Comparator: Group 1: ChAd63 ME-TRAP / MVA ME-TRAP at 16/24 weeks old
    ChAd63 ME-TRAP / MVA ME-TRAP. 15 infants aged 16 weeks at time of first vaccination vaccinated with ChAd63 ME-TRAP 5 x 10^10 vp (virus particles) intramuscular (IM) at 16 weeks and MVA ME-TRAP 1 x 10^8 pfu (plaque forming units) IM at 24 weeks.
    Intervention: Biological: ChAd63 ME-TRAP / MVA ME-TRAP
  • Active Comparator: Group 2: ChAd63 ME-TRAP / MVA ME-TRAP at 8/16 weeks old
    ChAd63 ME-TRAP / MVA ME-TRAP. 15 healthy infants aged 8 weeks at the time of first vaccination vaccinated with ChAd63 ME-TRAP 5 x 10^10 vp IM at 8 weeks and MVA ME-TRAP 1 x 10^8 pfu IM at 16 weeks
    Intervention: Biological: ChAd63 ME-TRAP / MVA ME-TRAP
  • Active Comparator: Group 3: ChAd63 ME-TRAP / MVA ME-TRAP at 1/8 weeks old
    ChAd63 ME-TRAP / MVA ME-TRAP. 15 healthy infants aged 1 week will be vaccinated with ChAd63 ME-TRAP 5 x 10^10 vp IM at 1 week and MVA ME-TRAP 1 x 10^8 pfu IM at 8 weeks.
    Intervention: Biological: ChAd63 ME-TRAP / MVA ME-TRAP
  • No Intervention: Group 4: Control
    20 healthy infants aged 16, 8 and 1 weeks will be enrolled into this group. (Five infants will be randomised to each of Groups 1 and 2 respectively while 10 infants aged 1 week will be randomised to Group 3). All twenty infants will receive EPI vaccinations only.
Publications * Mensah VA, Roetynck S, Kanteh EK, Bowyer G, Ndaw A, Oko F, Bliss CM, Jagne YJ, Cortese R, Nicosia A, Roberts R, D'Alessio F, Leroy O, Faye B, Kampmann B, Cisse B, Bojang K, Gerry S, Viebig NK, Lawrie AM, Clarke E, Imoukhuede EB, Ewer KJ, Hill AVS, Afolabi MO. Safety and Immunogenicity of Malaria Vectored Vaccines Given with Routine Expanded Program on Immunization Vaccines in Gambian Infants and Neonates: A Randomized Controlled Trial. Front Immunol. 2017 Nov 20;8:1551. doi: 10.3389/fimmu.2017.01551. eCollection 2017.

*   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: March 6, 2014)
65
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Group 1: 15 healthy infants aged 16 weeks at the time of enrolment with signed consent obtained from parents
  • Group 2: 15 healthy infants aged 8 weeks at the time of enrolment with signed consent obtained from parents
  • Group 3: 15 healthy infants aged 1 week at the time of enrolment with signed consent obtained from parents
  • Group 4 (control): 20 healthy infants aged 16, 8 and 1 weeks at the time of enrolment with signed consent obtained from parents
  • Groups 1 and 2: Receipt of all EPI vaccines according to schedule defined as follows: Bacillus Calmette-Guérin (BCG), and first dose of oral polio (OPV) and Hepatitis B vaccine within 2 weeks of birth; Penta, pneumococcal vaccine, OPV, rotavirus vaccine for Group 1 at 8 weeks +/- 2 weeks

Exclusion Criteria:

  • Birth weight less than 2.5kg
  • Significant antenatal, perinatal or early postnatal complications as judged by the PI or other delegated individual
  • Any signs of acute illness as judged by the PI or other delegated individual
  • Axillary temperature of greater than 37.5 °C
  • Clinically significant congenital abnormalities as judged by the PI or other delegated individual
  • 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 as judged by the PI or other delegated individual.
  • Weight for age z-scores below 2 standard deviations of normal for age
  • 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 10 g/dL at > 4 weeks of age or less than 13.0 g/dl at < 4 weeks of age.
  • White cell count <5.0 x 109/L
  • Serum Creatinine concentration greater than 60 micromol/L,
  • Serum alanine aminotransferase (ALT) concentration greater than 45 U/L,
  • Clinically significant jaundice
  • Any other clinically significant laboratory abnormality as judged by the PI or other delegated individual
  • Blood transfusion within one month of enrolment.
  • History of vaccination with previous experimental malaria vaccines.
  • Administration of any 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 PI or other delegated individual would increase the risk of an adverse outcome from participation in the trial.
  • Likelihood of travel away from the study area
  • Maternal HIV infection (a negative maternal HIV test will be required prior to study enrolment)
  • Positive malaria antigen test at screening
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 16 Weeks   (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 NCT02083887
Other Study ID Numbers  ICMJE VAC058
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 Malaria Vectored Vaccines Consortium
Investigators  ICMJE
Principal Investigator: Muhammed Afolabi Medical Research Council Unit, The Gambia Unit
PRS Account University of Oxford
Verification Date December 2015

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