Clinical trial NCT01782066: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Meningococcal Disease
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2013-02-01
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Seroprotection rate against meningococcal serogroups ACYW135 (anti-meningococcal antibody titre at baseline and 28 days after vaccination)
timeFrame: 28 days
Secondary outcomes:
measure: Local and systemic adverse events (subject log and investigator inspection).
timeFrame: 28 days
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
state: South-Holland
Study officials:
affiliation: Leiden University Medical Center
name: Leo Visser, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.