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

L

Leiden University Medical Center (LUMC)

Status and phase

Completed
Phase 2
Phase 1

Conditions

Meningococcal Disease

Treatments

Biological: MEN-ACYW135 reduced-dose intradermal administration

Study type

Interventional

Funder types

Other

Identifiers

NCT01782066
2012-003085-41 (EudraCT Number)
MENID-1

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

12 participants in 2 patient groups

Menveo, dose escalating
Experimental group
Treatment:
Biological: MEN-ACYW135 reduced-dose intradermal administration
Nimenrix, dose escalating
Experimental group
Treatment:
Biological: MEN-ACYW135 reduced-dose intradermal administration

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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