AN OPEN LABEL, SINGLE CENTRE PILOT STUDY TO EVALUATE THE KINETICS OF THE SYSTEMIC B-CELL IMMUNE RESPONSE TO A MENINGOCOCCAL SEROGROUP C CONJUGATE VACCINE IN HEALTHY ADULTS - Improving protection with meningitis vaccines
- Conditions
- Meningococcal serogroup C infection
- Registration Number
- EUCTR2006-001723-19-GB
- Lead Sponsor
- niversity of Bristol
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
-Written informed consent for the study to be performed according to the study schedule.-Adults between 18 and 40 years.-Available throughout the study period.-Ability to understand the written information provided.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
-Receipt of any vaccination or investigational agent within 50 days of enrolment to the study.-Chronic administration (defined as treatment for more than 14 days) of any immunosuppressant or immune modifying drug (topical or inhaled steroids will be excluded from this definition). -A history of meningococcal infection or contact with a proven index case within 60 days of enrolment to the study.-Pregnancy or plans to become pregnant during the study. -Breast feeding.-Any chronic cardiac, respiratory, gastrointestinal, renal, neurological or psychiatric condition.-Any confirmed or suspected immunodeficiency (congenital or acquired).-Administration of immunoglobulins or any other blood products within one-year of study enrolment or planned administration during the study period.-History of anaphylactic shock or allergic reaction to a previous vaccination or to any vaccine component.-Acute illness or fever during the three days preceding study enrolment-Lack of availability at any time during the study period.-Any other condition which, in the opinion of the clinical research fellow (EC), may interfere with the evaluation of the study objectives for any reason.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Describe the characteristics of the antibody secreting cell (ASC) response generated in the circulation following immunization describing the changes occurring in ASC number and immunophenotype over time. ;Secondary Objective: Assess the relationship between ASC number and serum and salivary antibody levels;Primary end point(s): Quantification of the number of antibody secreting cells generated in the blood following the intramuscular immunisation of 21 healthy adult volunteers
- Secondary Outcome Measures
Name Time Method