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

This study is currently recruiting participants. (see Contacts and Locations)
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Bacterial Infections
Gram-Negative Bacterial Infections
Neisseriaceae Infections

ClinicalTrials.gov processed this record on October 22, 2014