Safety and Immunogenicity of Intradermal Versus Subcutaneous Doses of Menomune®

Study Overview
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Brief Summary
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The objective of this trial is to study the administration of the Menomune vaccine given intradermally and low-dose subcutaneously versus standard subcutaneously. This study will describe the immunogenicity of Menomune® - A/C/Y/W-135 administered subcutaneously (standard dose) versus intradermally over a dose range (1/10th, 2/10th, and 3/10th of standard dose) and a low dose (2/10th of standard dose) subcutaneously. The secondary objective is to describe the safety of the subcutaneous (SC) and intradermal (ID) routes at different dosages

Detailed Description
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This trial will provide a proof of concept that a dose range of Menomune given ID can induce an immune response that is comparable to standard dosing by the SC route, and is equivalent or superior to a low dose given SC. Subjects will be randomized according to a computer-generated randomization schedule to receive the vaccine by SC injection or by ID injection at different dosages.

Official Title
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Safety and Immunogenicity of Intradermal, and Low-dose Subcutaneous vs Subcutaneous Administration of Menomune® - A/C/Y/W-135

Conditions
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Meningococcal Infections, Meningitis

Intervention / Treatment
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* Biological: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
* Biological: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
* Biological: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
* Biological: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
* Biological: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria : 18 to 55 years of age. Willing to return for 3 follow-up visits and comply with a 30 day follow-up period. Signed an informed consent form. Exclusion Criteria : Allergy to any component of the vaccine and latex. Known or suspected immunodeficiency or receipt of immunosuppressive therapy or blood products within the previous two months. History of serious chronic diseases (such as cardiac or renal disease). Acute febrile illness at the time of visit. Pregnancy. Receipt of any vaccine within the 28 days prior to enrollment. Receipt of meningococcal vaccine (example in Military) within the past 5 years or history of meningococcal disease.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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 |
| --- | --- |
| Active Comparator: Group 1<br>0.5 mL Subcutaneous arm (Menomune® ) | Biological: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined<br>* 0.5 mL, Subcutaneous<br>* Other names: Menomune® - A/C/Y/W-135;|
| Experimental: Group 2<br>0.1 mL Subcutaneous arm (Menomune®) | Biological: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined<br>* 0.1 mL, Subcutaneous<br>* Other names: Menomune® - A/C/Y/W-135;|
| Experimental: Group 3<br>0.05 mL Intradermal arm (Menomune®) | Biological: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined<br>* 0.05 mL, Intradermal<br>* Other names: Menomune® - A/C/Y/W-135;|
| Experimental: Group 4<br>0.1 mL Intradermal arm (Menomune®) | Biological: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined<br>* 0.1 mL, Intradermal<br>* Other names: Menomune® - A/C/Y/W-135;|
| Experimental: Group 5<br>0.15 mL Intradermal arm (Menomune®) | Biological: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined<br>* 0.15 mL, Intradermal<br>* Other names: Menomune® - A/C/Y/W-135;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With ≥ 4-Fold Rise in Antibody Titers | Percentage of participants with a 4-fold rise in Serum bactericidal assay using baby rabbit complement (SBA-BR) antibody titers to each meningococcal serogroup from baseline to Day 28 post-vaccination. | Baseline to 28 days post vaccination | 
| Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination. | GMTs and their 95% confidence interval to the vaccine meningococcal serogroups at Day 0 and Day 28 post-vaccination. | Baseline (Day 0) and Day 28 post-vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Participants with solicited local and systemic reactions and intensity within 7 days following vaccination with Menomune® | Day 0 to 7 days post-vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Menomune® - A/C/Y/W-135, Meningococcal Infections, Meningitis