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

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®.

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.

Study Overview

• Status: Completed
• Conditions: Meningococcal Disease; Meningococcal Meningitis
• Intervention / Treatment: Biological: Novartis Meningococcal (MenACWY-CRM) vaccine

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 155
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States
  • Washington
    • Seattle, Washington, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 23 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: I: MenACWY-CRM vaccine; 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; All subjects will have blood draws at Day 1, Day 8, and Day 29.
Experimental: II: Licensed Polysaccharide Meningococcal vaccine; 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; All subjects will have blood draws at Day 1, Day 8, and Day 29.
Experimental: III: Meningococcal Naive; 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; All subjects will have blood draws at Day 1, Day 8, and Day 29.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Novartis Vaccines
• Collaborators: Novartis

Publications and helpful links

General Publications

• Kimura A, Toneatto D, Kleinschmidt A, Wang H, Dull P. Immunogenicity and safety of a multicomponent meningococcal serogroup B vaccine and a quadrivalent meningococcal CRM197 conjugate vaccine against serogroups A, C, W-135, and Y in adults who are at increased risk for occupational exposure to meningococcal isolates. Clin Vaccine Immunol. 2011 Mar;18(3):483-6. doi: 10.1128/CVI.00304-10. Epub 2010 Dec 22.
• Jacobson RM, Jackson LA, Reisinger K, Izu A, Odrljin T, Dull PM. Antibody persistence and response to a booster dose of a quadrivalent conjugate vaccine for meningococcal disease in adolescents. Pediatr Infect Dis J. 2013 Apr;32(4):e170-7. doi: 10.1097/INF.0b013e318279ac38.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: November 18, 2009
• First Submitted That Met QC Criteria: November 24, 2009
• First Posted (Estimate): November 25, 2009

Study Record Updates

• Last Update Posted (Estimate): July 15, 2015
• Last Update Submitted That Met QC Criteria: July 14, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Adolescents; Meningitis; Persistence; Conjugate Vaccine; Meningococcal; ACWY
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Infections; Central Nervous System Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Meningitis, Bacterial; Central Nervous System Bacterial Infections; Neisseriaceae Infections; Meningitis, Meningococcal; Meningitis; Meningococcal Infections; Gastrointestinal Agents; Cathartics; Lactitol
• Other Study ID Numbers: V59P6E1