Dose-finding and Safety of 2 Intradermal MEN-ACYW135-conjugate Vaccines

Phase 1

Completed

• Conditions: Meningococcal Disease

• 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

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-30
• Study First Submitted QC: 2013-01-31
• Study First Posted: 2013-02-01
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-28
• Last Update Posted: 2014-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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