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

Study Overview
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Brief Summary
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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.

Official Title
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Dose Finding and Reactogenicity of Reduced-dose Intradermal Administration of Two Quadrivalent Meningococcal Conjugate Vaccines (Menveo® and Nimenrix®) in Healthy Adults (MENID-1).

Conditions
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Meningococcal Disease

Intervention / Treatment
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* Biological: MEN-ACYW135 reduced-dose intradermal administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Menveo, dose escalating<br> | Biological: MEN-ACYW135 reduced-dose intradermal administration<br>* Modified traditional dose escalation rule (TER) in an adaptive design. The study will be performed in duplicate, with 2 vaccines.<br>* Other names: Nimenrix;|
| Experimental: Nimenrix, dose escalating<br> | Biological: MEN-ACYW135 reduced-dose intradermal administration<br>* Modified traditional dose escalation rule (TER) in an adaptive design. The study will be performed in duplicate, with 2 vaccines.<br>* Other names: Nimenrix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroprotection rate against meningococcal serogroups ACYW135 (anti-meningococcal antibody titre at baseline and 28 days after vaccination) |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local and systemic adverse events (subject log and investigator inspection). |  | 28 days |