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

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT01018732
First received: November 18, 2009
Last updated: July 11, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Meningococcal Disease
Meningococcal Meningitis
Biological: Novartis Meningococcal (MenACWY-CRM) vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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®.

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Percentage of Participants With Serum Bactericidal Activity >=8 at 5 Years After Primary Vaccination [ Time Frame: Day 1 (5 years after primary vaccination) ] [ Designated as safety issue: No ]
    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

  • Geometric Mean Titer After Booster Vaccination [ Time Frame: Day 8, Day 29 (5 years after primary vaccination) ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Percentage of Participants With Serum Bactericidal Activity >=4 at 5 Years After Primary Vaccination [ Time Frame: Day 1 (5 years after primary vaccination ) ] [ Designated as safety issue: No ]
    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

  • Geometric Mean Titer at 5 Years After Primary Vaccination [ Time Frame: Day 1 (5 years after primary vaccination ) ] [ Designated as safety issue: No ]
    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

  • Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination [ Time Frame: Day 7, Day 28 post booster (5 years after primary vaccination) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination [ Time Frame: Day 7, Day 28 post booster (5 years after primary vaccination) ] [ Designated as safety issue: No ]
    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.

  • Geometric Mean Ratio After Booster Vaccination [ Time Frame: Day 8 and Day 29 (at 5 Years After Primary Vaccination) ] [ Designated as safety issue: No ]
    Ratios are expressed as geometric mean titer at Day 8: Day 1 and at Day 29:Day 1

  • Percentage of Subjects With hSBA Seroresponse After Booster Vaccination [ Time Frame: Day 8, Day 29 (5 years after primary vaccination) ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination [ Time Frame: Up to Day 7 ] [ Designated as safety issue: Yes ]
    Local and systemic reactions were solicited to assess safety and tolerability of vaccination


Enrollment: 155
Study Start Date: January 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   16 Years to 23 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01018732

Locations
United States, Minnesota
Rochester, Minnesota, United States
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States
United States, Washington
Seattle, Washington, United States
Sponsors and Collaborators
Novartis
Novartis Vaccines
  More Information

Publications:
Responsible Party: Novartis Vaccines and Diagnostics
ClinicalTrials.gov Identifier: NCT01018732     History of Changes
Other Study ID Numbers: V59P6E1
Study First Received: November 18, 2009
Results First Received: August 9, 2011
Last Updated: July 11, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Meningococcal
ACWY
Conjugate Vaccine
Meningitis
Adolescents
Persistence

Additional relevant MeSH terms:
Meningitis
Meningococcal Infections
Meningitis, Meningococcal
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Meningitis, Bacterial
Central Nervous System Bacterial Infections

ClinicalTrials.gov processed this record on September 18, 2014