search
Back to results

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

Primary Purpose

Meningococcal Disease

Status
Completed
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
MEN-ACYW135 reduced-dose intradermal administration
Sponsored by
Leiden University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Meningococcal Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Leiden University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Menveo, dose escalating

Nimenrix, dose escalating

Arm Description

Outcomes

Primary Outcome Measures

Seroprotection rate against meningococcal serogroups ACYW135 (anti-meningococcal antibody titre at baseline and 28 days after vaccination)

Secondary Outcome Measures

Local and systemic adverse events (subject log and investigator inspection).

Full Information

First Posted
January 30, 2013
Last Updated
October 28, 2014
Sponsor
Leiden University Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT01782066
Brief Title
Dose-finding and Safety of 2 Intradermal MEN-ACYW135-conjugate Vaccines
Official Title
Dose Finding and Reactogenicity of Reduced-dose Intradermal Administration of Two Quadrivalent Meningococcal Conjugate Vaccines (Menveo® and Nimenrix®) in Healthy Adults (MENID-1).
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Leiden University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningococcal Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Menveo, dose escalating
Arm Type
Experimental
Arm Title
Nimenrix, dose escalating
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
MEN-ACYW135 reduced-dose intradermal administration
Other Intervention Name(s)
Menveo, Nimenrix
Intervention Description
Modified traditional dose escalation rule (TER) in an adaptive design. The study will be performed in duplicate, with 2 vaccines.
Primary Outcome Measure Information:
Title
Seroprotection rate against meningococcal serogroups ACYW135 (anti-meningococcal antibody titre at baseline and 28 days after vaccination)
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Local and systemic adverse events (subject log and investigator inspection).
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leo Visser, MD, PhD
Organizational Affiliation
Leiden University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leiden University Medical Center
City
Leiden
State/Province
South-Holland
ZIP/Postal Code
2333ZA
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
29778515
Citation
Jonker EFF, van Ravenhorst MB, Berbers GAM, Visser LG. Safety and immunogenicity of fractional dose intradermal injection of two quadrivalent conjugated meningococcal vaccines. Vaccine. 2018 Jun 18;36(26):3727-3732. doi: 10.1016/j.vaccine.2018.05.064. Epub 2018 May 16.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs