Back to resultsA Study to Evaluate the Persistence and Immune Response to a Booster Dose of MenACWY
Primary Purpose
Meningococcal Disease, Meningococcal Meningitis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Novartis Meningococcal (MenACWY-CRM) vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Meningococcal Disease focused on measuring Meningococcal, ACWY, Conjugate Vaccine, Meningitis, Adolescents, Persistence
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
I: MenACWY-CRM vaccine
II: Licensed Polysaccharide Meningococcal vaccine
III: Meningococcal Naive
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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
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
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.
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.
Geometric Mean Ratio After Booster Vaccination
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
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
Local and systemic reactions were solicited to assess safety and tolerability of vaccination
Full Information
NCT ID
NCT01018732
First Posted
November 18, 2009
Last Updated
July 14, 2015
Sponsor
Novartis Vaccines
Collaborators
Novartis
1. Study Identification
Unique Protocol Identification Number
NCT01018732
Brief Title
A Study to Evaluate the Persistence and Immune Response to a Booster Dose of MenACWY
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®.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines
Collaborators
Novartis
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
Persistence of antibody response at 5 years after one dose of MenACWY or Menomune
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningococcal Disease, Meningococcal Meningitis
Keywords
Meningococcal, ACWY, Conjugate Vaccine, Meningitis, Adolescents, Persistence
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
155 (Actual)
8. Arms, Groups, and Interventions
Arm Title
I: MenACWY-CRM vaccine
Arm Type
Experimental
Arm Description
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.
Arm Title
II: Licensed Polysaccharide Meningococcal vaccine
Arm Type
Experimental
Arm Description
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.
Arm Title
III: Meningococcal Naive
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Novartis Meningococcal (MenACWY-CRM) vaccine
Intervention Description
All subjects will have blood draws at Day 1, Day 8, and Day 29.
Primary Outcome Measure Information:
Title
Percentage of Participants With Serum Bactericidal Activity >=8 at 5 Years After Primary Vaccination
Description
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
Time Frame
Day 1 (5 years after primary vaccination)
Title
Geometric Mean Titer After Booster Vaccination
Description
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
Time Frame
Day 8, Day 29 (5 years after primary vaccination)
Secondary Outcome Measure Information:
Title
Percentage of Participants With Serum Bactericidal Activity >=4 at 5 Years After Primary Vaccination
Description
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
Time Frame
Day 1 (5 years after primary vaccination )
Title
Geometric Mean Titer at 5 Years After Primary Vaccination
Description
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
Time Frame
Day 1 (5 years after primary vaccination )
Title
Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination
Description
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.
Time Frame
Day 7, Day 28 post booster (5 years after primary vaccination)
Title
Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination
Description
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.
Time Frame
Day 7, Day 28 post booster (5 years after primary vaccination)
Title
Geometric Mean Ratio After Booster Vaccination
Description
Ratios are expressed as geometric mean titer at Day 8: Day 1 and at Day 29:Day 1
Time Frame
Day 8 and Day 29 (at 5 Years After Primary Vaccination)
Title
Percentage of Subjects With hSBA Seroresponse After Booster Vaccination
Description
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.
Time Frame
Day 8, Day 29 (5 years after primary vaccination)
Title
Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination
Description
Local and systemic reactions were solicited to assess safety and tolerability of vaccination
Time Frame
Up to Day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
23 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
City
Rochester
State/Province
Minnesota
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
City
Seattle
State/Province
Washington
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21177912
Citation
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.
Results Reference
result
PubMed Identifier
23114372
Citation
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.
Results Reference
result
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A Study to Evaluate the Persistence and Immune Response to a Booster Dose of MenACWY
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