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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

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : February 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
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.
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

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
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

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.
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

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.



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 16 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT02083887


Locations
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Gambia
Medical Research Council Unit, Fajara
Banjul, Gambia, PO Box 273
Sponsors and Collaborators
University of Oxford
Malaria Vectored Vaccines Consortium
Investigators
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Principal Investigator: Muhammed Afolabi Medical Research Council Unit, The Gambia Unit
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT02083887    
Other Study ID Numbers: VAC058
First Posted: March 11, 2014    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: December 2015
Keywords provided by University of Oxford:
Immune response
Vaccine
Malaria
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases