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

This study is currently recruiting participants.
Verified January 2013 by Leiden University Medical Center
Sponsor:
Information provided by (Responsible Party):
L.G. Visser, MD, PhD, Leiden University Medical Center
ClinicalTrials.gov Identifier:
NCT01782066
First received: January 30, 2013
Last updated: January 31, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Meningococcal Disease
 Biological: MEN-ACYW135 reduced-dose intradermal administration
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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).

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Leiden University Medical Center:

Primary Outcome Measures:
  • Seroprotection rate against meningococcal serogroups ACYW135 (anti-meningococcal antibody titre at baseline and 28 days after vaccination) [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Local and systemic adverse events (subject log and investigator inspection). [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 16
Study Start Date: January 2013
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Menveo, dose escalating Biological: MEN-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.
Other Names:
  • Menveo
  • Nimenrix
Experimental: Nimenrix, dose escalating Biological: MEN-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.
Other Names:
  • Menveo
  • Nimenrix

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01782066

Locations
Netherlands
Leiden University Medical Center Recruiting
Leiden, South-Holland, Netherlands, 2333ZA
Contact: Leo Visser, MD, PhD         l.g.visser@lumc.nl    
Sub-Investigator: Emile Jonker, MD            
Principal Investigator: Leo Visser, MD, PhD            
Sponsors and Collaborators
Leiden University Medical Center
Investigators
Principal Investigator: Leo Visser, MD, PhD Leiden University Medical Center
  More Information

No publications provided

Responsible Party: L.G. Visser, MD, PhD, Associate professor of Internal Medicine, Senior Consultant Infectious Diseases, Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT01782066     History of Changes
Other Study ID Numbers: MENID-1, 2012-003085-41
Study First Received: January 30, 2013
Last Updated: January 31, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on May 23, 2013