Meningococcal Disease
Conditions
Brief summary
Invasive meningococcal disease is a worldwide problem with serious repercussions for those affected. Vaccination is recognized as the best way to combat it. The cost of vaccination is prohibitive in many low-resource settings at home and abroad. By harnessing the special immunologic properties of the skin, a dose reduction may be achieved by intradermal administration of the vaccine. The cost savings associated with dose reduction will increase availability of the vaccine.
Interventions
BIOLOGICALMEN-ACYW135 reduced-dose intradermal administration
Modified traditional dose escalation rule (TER) in an adaptive design. The study will be performed in duplicate, with 2 vaccines.
Sponsors
Leiden University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Meningococcal C naive subjects are required to fulfill all of the following criteria: * Age ≥ 30 years * Good health according to the investigator * Willingness and ability to adhere to the study regimen * Able to give informed consent Meningococcal C experienced subjects are required to fulfill all of the following criteria: * Age ≥ 18 years * Good health according to the investigator * Willingness and ability to adhere to the study regimen * Able to give informed consent
Exclusion criteria
Meningococcal C naïve subjects should not have: * Known previous invasive meningococcal infection * Known or suspected previous vaccination against meningococcal disease * Known or suspected allergy against any of the vaccine components * Close contact in the last 60 days with a person known to be Neisseria positive * History of unusual or severe reactions to any previous vaccination * Family history of Guillain-Barré Syndrome * Known or suspected immune deficiency, either congenital or acquired * Administration of plasma or blood products less than three months prior to inclusion in the study * Pregnancy (breastfeeding is allowed) * Fertile female not conforming to prescribed contraceptive use (await first menstruation after vaccination before getting pregnant) * Any infectious disease * Bleeding disorders or use of anticoagulants * Participation as a subject in another trial in the last 3 months Meningococcal C experienced subjects should not have: * Known or suspected allergy against any of the vaccine components * Known previous vaccination with a quadrivalent meningococcal vaccine (either conjugate or polysaccharide) * Close contact in the last 60 days with a person known to be Neisseria positive * History of unusual or severe reactions to any previous vaccination * Family history of Guillain-Barré Syndrome * Known or suspected immune deficiency, either congenital or acquired * Administration of plasma or blood products less than three months prior to inclusion in the study * Pregnancy (breastfeeding is allowed) * Fertile female not conforming to prescribed contraceptive use (await first menstruation after vaccination before getting pregnant) * Any infectious disease * Bleeding disorders or use of anticoagulants * Participation as a subject in another trial in the last 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seroprotection rate against meningococcal serogroups ACYW135 (anti-meningococcal antibody titre at baseline and 28 days after vaccination) | 28 days |
Secondary
| Measure | Time frame |
|---|---|
| Local and systemic adverse events (subject log and investigator inspection). | 28 days |
Countries
Netherlands
Outcome results
None listed