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
NCT ID: NCT02083887
Last Updated: 2015-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
65 participants
INTERVENTIONAL
2014-02-28
2015-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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.
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
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
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
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.
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
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.
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
1 Week
16 Weeks
ALL
Yes
Sponsors
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Malaria Vectored Vaccines Consortium
OTHER
University of Oxford
OTHER
Responsible Party
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Principal Investigators
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Muhammed Afolabi
Role: PRINCIPAL_INVESTIGATOR
Medical Research Council Unit, The Gambia Unit
Locations
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Medical Research Council Unit, Fajara
Banjul, , The Gambia
Countries
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References
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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.
Other Identifiers
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VAC058
Identifier Type: -
Identifier Source: org_study_id