Dose-finding and Safety of 2 Intradermal MEN-ACYW135-conjugate Vaccines
- Conditions
- Meningococcal Disease
- Interventions
- Biological: MEN-ACYW135 reduced-dose intradermal administration
- Registration Number
- NCT01782066
- Lead Sponsor
- Leiden University Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Menveo, dose escalating MEN-ACYW135 reduced-dose intradermal administration - Nimenrix, dose escalating MEN-ACYW135 reduced-dose intradermal administration -
- Primary Outcome Measures
Name Time Method Seroprotection rate against meningococcal serogroups ACYW135 (anti-meningococcal antibody titre at baseline and 28 days after vaccination) 28 days
- Secondary Outcome Measures
Name Time Method Local and systemic adverse events (subject log and investigator inspection). 28 days
Trial Locations
- Locations (1)
Leiden University Medical Center
🇳🇱Leiden, South-Holland, Netherlands