Clinical trial NCT02083887: 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: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Malaria
Keywords: Immune response
Vaccine
Malaria
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Malaria Vectored Vaccines Consortium
First posted: 2014-03-11
Enrollment: 65
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Safety of ChAd63 ME-TRAP / MVA ME-TRAP prime boost immunisation co-administered with EPI vaccines
timeFrame: Participants will be followed for the duration of the study, an expected average of 36 weeks
Secondary outcomes:
measure: Immunogenicity of ChAd63 ME-TRAP / MVA ME-TRAP prime boost immunisation co-administered with EPI vaccines.
timeFrame: Participants will be followed for the duration of the study, an expected average of 36 weeks
Other outcomes:
Locations:
city: Banjul
country: Gambia
facility: Medical Research Council Unit, Fajara
Study officials:
affiliation: Medical Research Council Unit, The Gambia Unit
name: Muhammed Afolabi
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.