A Study to Evaluate the Persistence and Immune Response to a Booster Dose of MenACWY

Study Overview
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Brief Summary
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The primary objective is to evaluate the persistence of bactericidal antibodies in adolescent subjects who completed study V59P6 in which they received either Novartis Meningococcal (MenACWY) Conjugate Vaccine or Licensed polysaccharide Men ACWY vaccine (Menomune®). The study will also enroll age-matched subjects who have never received any other meningococcal vaccine (naïve subjects) to serve as an additional control group.

Detailed Description
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Persistence of antibody response at 5 years after one dose of MenACWY or Menomune

Official Title
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A Phase 2b, Open-Label, Multi-Center Study to Evaluate the Persistence of Antibody Response and to Assess the Immune Response to a Booster Dose of MenACWY Conjugate Vaccine in Subjects Previously Vaccinated as Adolescents With Either MenACWY Conjugate Vaccine or Menomune®.

Conditions
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Meningococcal Disease, Meningococcal Meningitis

Intervention / Treatment
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* Biological: Novartis Meningococcal (MenACWY-CRM) vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adolescents or adults (age 16-23 years inclusive), either previously enrolled in the parent study or naïve to meningococcal vaccination. Female subjects were to be negative for pregnancy Exclusion Criteria: History of meningococcal disease Receipt of any meningococcal vaccine outside of parent study (V59P6) Serious, acute, or chronic illnesses including HIV infection/disease and any malignancy receipt of any vaccine 14 days prior to the study, or expected through the duration of the study any condition which in the eyes of the investigator would pose a health risk to the subject or render them inappropriate for a research study

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 23 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I: MenACWY-CRM vaccine<br>Subjects had been given one dose of Meningococcal ACWY (MenACWY) vaccine conjugated to CRM197 (cross-reactive material-mutant of diptheria toxin) 5 years ago. All subjects were given one dose of the Men ACWY in the present study. | Biological: Novartis Meningococcal (MenACWY-CRM) vaccine<br>* All subjects will have blood draws at Day 1, Day 8, and Day 29.<br>|
| Experimental: II: Licensed Polysaccharide Meningococcal vaccine<br>Subjects had been given one dose of a licensed MenACWY polysaccharide meningococcal vaccine (Menomune) 5 years ago. All subjects were given one dose of Men ACWY vaccine in the present study. | Biological: Novartis Meningococcal (MenACWY-CRM) vaccine<br>* All subjects will have blood draws at Day 1, Day 8, and Day 29.<br>|
| Experimental: III: Meningococcal Naive<br>Subjects were age matched with groups 1 and 2 (age inclusive: 16 years to 23 years) and enrolled at visit 1 and given one dose of Men ACWY vaccine during the present study. | Biological: Novartis Meningococcal (MenACWY-CRM) vaccine<br>* All subjects will have blood draws at Day 1, Day 8, and Day 29.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Serum Bactericidal Activity >=8 at 5 Years After Primary Vaccination | Persistence of antibody response was measured by the percentage of subjects who showed a serum bactericidal activity with human complement(hSBA) >= 8 [i.e. percentage of subjects with hsBA titer >=8] in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y | Day 1 (5 years after primary vaccination) | 
| Geometric Mean Titer After Booster Vaccination | Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) and reported as hSBA Geometric mean titer (GMT) in previously vaccinated subjects and in age-matched meningococcal vaccine-naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y | Day 8, Day 29 (5 years after primary vaccination) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Serum Bactericidal Activity >=4 at 5 Years After Primary Vaccination | Persistence was measured by percentage of subjects with serum bactericidal activity with human complement (hSBA) >= 4 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y | Day 1 (5 years after primary vaccination ) | 
| Geometric Mean Titer at 5 Years After Primary Vaccination | Persistence was measured by serum bactericidal assay with human complement(hSBA) and expressed as hSBA GMT in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y | Day 1 (5 years after primary vaccination ) | 
| Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination | Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) >= 4 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y. | Day 7, Day 28 post booster (5 years after primary vaccination) | 
| Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination | Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) >= 8 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y. | Day 7, Day 28 post booster (5 years after primary vaccination) | 
| Geometric Mean Ratio After Booster Vaccination | Ratios are expressed as geometric mean titer at Day 8: Day 1 and at Day 29:Day 1 | Day 8 and Day 29 (at 5 Years After Primary Vaccination) | 
| Percentage of Subjects With hSBA Seroresponse After Booster Vaccination | For a subject with hSBA titer <4 at baseline, seroresponse is defined as a postvaccination hSBA titer >=8; and for a subject with hSBA titer >=4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y. | Day 8, Day 29 (5 years after primary vaccination) | 
| Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination | Local and systemic reactions were solicited to assess safety and tolerability of vaccination | Up to Day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Meningococcal, ACWY, Conjugate Vaccine, Meningitis, Adolescents, Persistence