Malaria vectored vaccines and EPI co-administration trial (VAC 058)
- Conditions
- Malaria
- Registration Number
- PACTR201402000749217
- Lead Sponsor
- THE JENNER INSTITUTE, UNIVERSITY OF OXFORD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 65
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.
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 10^9/L
Serum Creatinine concentration greater than 60 micromol/L,
Serum 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method All solicited and unsolicited local and systemic adverse events (including laboratory abnormalities considered adverse events) and the assessment of their causal relationships to the study vaccines
- Secondary Outcome Measures
Name Time Method Measures of immunogenicity of ChAD63 ME-TRAP/MVA ME-TRAP prime boost immunisation where practibable to include: 1) ex vivo ELISPOT responses to overlapping pools of ME-TRAP peptides; 2) ICS and floe cytometry; 3) Antibodies to TRAP by ELISA; 4) Anti-vector immune responses; 6) Exploratory immunology including RNA analysis