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

Meningococcal Disease Clinical Trial

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®.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01018732
• Other study ID #: V59P6E1
• Status: Completed
• Phase: Phase 2
• First received: November 18, 2009
• Last updated: July 14, 2015
• Start date: January 2010
• Est. completion date: July 2010

Study information

• Verified date: July 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 23 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Meningitis
• Meningitis, Meningococcal
• Meningococcal Disease
• Meningococcal Infections
• Meningococcal Meningitis

Intervention

Biological:
• Novartis Meningococcal (MenACWY-CRM) vaccine
All subjects will have blood draws at Day 1, Day 8, and Day 29.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Novartis Vaccines	Novartis

Country where clinical trial is conducted

United States, 

References & Publications (2)

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/IN — View 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 incr — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Secondary	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 )	No
Secondary	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 )	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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	Yes