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

• Register: ClinicalTrials.gov
• Last refreshed on: 14 December 2015
• Main ID: NCT02083887
• Date of registration: 28/02/2014
• Prospective Registration: No
• Primary sponsor: University of Oxford
• Public 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 VAC058
• Scientific 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
• Date of first enrolment: February 2014
• Target sample size: 65
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02083887
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
• Phase: Phase 1

Countries of recruitment

Gambia

Contacts

• Name: Muhammed Afolabi
• Affiliation: Medical Research Council Unit, The Gambia Unit

Key inclusion & exclusion 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



Age minimum: N/A
Age maximum: 16 Weeks
Gender: Both

Health Condition(s) or Problem(s) studied

Malaria

Intervention(s)

Biological: ChAd63 ME-TRAP / MVA ME-TRAP

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

Secondary ID(s)

VAC058

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Malaria Vectored Vaccines Consortium