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

Meningococcal Disease Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01782066
• Other study ID #: MENID-1
• Secondary ID: 2012-003085-41
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 30, 2013
• Last updated: October 28, 2014
• Start date: January 2013
• Est. completion date: February 2014

Study information

• Verified date: October 2014
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Meningococcal Disease
• Meningococcal Infections

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center	Leiden	South-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Leiden University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seroprotection rate against meningococcal serogroups ACYW135 (anti-meningococcal antibody titre at baseline and 28 days after vaccination)		28 days	No
Secondary	Local and systemic adverse events (subject log and investigator inspection).		28 days	Yes