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

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