PACTR201402000749217
Not Yet Recruiting
N/A
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
THE JENNER INSTITUTE, UNIVERSITY OF OXFORD0 sites65 target enrollmentJanuary 22, 2014
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- THE JENNER INSTITUTE, UNIVERSITY OF OXFORD
- Enrollment
- 65
- Status
- Not Yet Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
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: BCG, and first dose of 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.
Outcomes
Primary Outcomes
Not specified
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