Prevention of invasive disease caused by N. meningitidis serogroup B
Conditions
Interventions
Trade Name: MeNZB
Product Name: MeNZB Meningococcal Group B OMV vaccine
Product Code: MeNZB
Pharmaceutical Form: Suspension for injection
Sponsors
Health Protection Agency
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Informed written consent given for four immunisations (group 2 will receive 3 doses only) with MeNZB TM vaccine, as well as for eight blood draws to be taken as described in the patient information leaflet in appendix 2 2) Healthy adults (university students) aged 18 up to 40 years on inclusion in the study 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
Exclusion criteria
Exclusion criteria: · Previous history of bacteriologically confirmed disease caused by N. meningitidis · Prior receipt of any group B meningococcal vaccine · have had household contact with and/or intimate exposure to an individual with culture or PCR proven N. meningitidis serogroup B within the previous 60 days · have either received, or for whom there is intent to immunize with, any vaccines or investigational agents within 50 days prior to enrolment, through to 50 days following the last study vaccine administration, with the exception of influenza vaccines or post-exposure tetanus vaccination · have a history of any anaphylactic shock, urticaria or other allergic reaction after previous vaccinations or hypersensitivity to any vaccine component · have experienced significant acute or chronic infections requiring systemic antibiotic treatment within the past 14 days · have any present or suspected serious acute or chronic disease such as: cardiac or autoimmune disease, insulin dependent diabetes or progressive neurological disease or severe malnutrition, acute or progressive hepatic disease, acute or progressive renal disease; leukaemia, lymphomas, neoplasm; · have a known or suspected impairment of the immune function, or those receiving immunosuppressive therapy, or having received immunosuppressive therapy, including systemic steroids, or ACTH or inhaled steroids in dosages which are associated with hypothalamic-pituitary-adrenal axis suppression; · have received blood, blood products or a parenteral immunoglobulin preparation in the past 12 weeks; · have a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time; · have a history of seizure disorder; · have an inherited genetic anomaly (known cytogenic disorders) e.g., Down’s syndrome; · Language difficulty sufficient to preclude adequate comprehension of the information sheet, consent form or study nurse’s explanation of the study; · The possibility of pregnancy – a pregnancy test (urine) on the scheduled day of vaccination will be offered to any female wishing to participate in the study. A positive test will result in exclusion from the study. (Agreement from each female participants will be sought prior to vaccination that they will take adequate precautions to avoid pregnancy for the duration of the vaccination phase of the study until the final blood sample appointment following their final vaccination, i.e. until the week 63 – visit 8 - blood appointment); · Current regimen of chronic prescription medications other than oral contraceptives, or current regular use of any over-the-counter concomitant medications including antipyretics and non-steroidal anti-inflammatory agents; · Current participation in any other clinical trial (an undertaking will be sought from participants not to enrol in any other clinical trial for the duration of this study); · They have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives Current (to be checked prior to each vaccination): · Generalised acute systemic illness on the day of immunisation · Sublingual temperature >38,5oC on the day of im
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Safety Objectives: To determine the incidence and nature of local and systemic reactions in healthy adults (university students) receiving three or four doses of MeNZB TM vaccine. Immunogenicity Objectives: 1. To evaluate the immune response after a primary vaccination series of two or three doses of MeNZB vaccine, given twelve or six weeks apart respectively. 2. To evaluate the immune response of a booster dose given 1 year after a primary series of either 2 or three doses of MeNZB 3. To evaluate the kinetic of functional Abs after a primary series of either 2 or three doses of MeNZB 4. To measure the pre- to post-vaccination mean fold rise in SBA titre and the proportion of subjects with >4 fold rises at different time points, between samples obtained at visit 1,2,3,5,6,8. 5. To measure the pre- to post-vaccination mean fold rise in SBA titre and the proportion of subjects with a titre >4 and >8 at different time points, between samples obtained at visit 1,2,3,5,6,8. ; Secondary Objective: 6. To assess the functional nature of antibodies induced by MenZB vaccine after the primary series (visit 5), at one year after the final primary series dose (visit 6) and three weeks after the boost dose (visit 8) 7. To assess the cell mediated immunity and cytokine responses (visit 4, visit 7) 8. To assess the quantitative and functional nature of salivary antibody prior to vaccination, after the primary series (visit 1, 5), at one year after the final primary dose (visit 6) and three weeks after the boost dose (visit 8) 9. Development and refinement of assays to measure the immune response ;Primary end point(s): Immunogenicity of the investigational vaccine after a full vaccination course following two different vaccination schedules in adults as measured | — |
Countries
United Kingdom
Outcome results
None listed