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

NCT ID: NCT01782066

Last Updated: 2014-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-02-28

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.

Conditions

Meningococcal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Menveo, dose escalating

Group Type: EXPERIMENTAL

MEN-ACYW135 reduced-dose intradermal administration

Intervention Type: BIOLOGICAL

Modified traditional dose escalation rule (TER) in an adaptive design. The study will be performed in duplicate, with 2 vaccines.

Nimenrix, dose escalating

Group Type: EXPERIMENTAL

MEN-ACYW135 reduced-dose intradermal administration

Intervention Type: BIOLOGICAL

Modified traditional dose escalation rule (TER) in an adaptive design. The study will be performed in duplicate, with 2 vaccines.

Interventions

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

Menveo; Nimenrix

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Leiden University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

L.G. Visser, MD, PhD

Associate professor of Internal Medicine, Senior Consultant Infectious Diseases

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Leo Visser, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Leiden University Medical Center

Locations

Leiden University Medical Center

Leiden, South Holland, Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 29778515 (View on PubMed)

Other Identifiers

2012-003085-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MENID-1

Identifier Type: -

Identifier Source: org_study_id