Clinical trial NCT01018732: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Meningococcal Disease
Meningococcal Meningitis
Keywords: Meningococcal
ACWY
Conjugate Vaccine
Meningitis
Adolescents
Persistence
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Novartis
First posted: 2009-11-25
Enrollment: 155
Sex: ALL
Minimum age (years): 16
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: Percentage of Participants With Serum Bactericidal Activity >=8 at 5 Years After Primary Vaccination
timeFrame: Day 1 (5 years after primary vaccination)
measure: Geometric Mean Titer After Booster Vaccination
timeFrame: Day 8, Day 29 (5 years after primary vaccination)
Secondary outcomes:
measure: Percentage of Participants With Serum Bactericidal Activity >=4 at 5 Years After Primary Vaccination
timeFrame: Day 1 (5 years after primary vaccination )
measure: Geometric Mean Titer at 5 Years After Primary Vaccination
timeFrame: Day 1 (5 years after primary vaccination )
measure: Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination
timeFrame: Day 7, Day 28 post booster (5 years after primary vaccination)
measure: Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination
timeFrame: Day 7, Day 28 post booster (5 years after primary vaccination)
measure: Geometric Mean Ratio After Booster Vaccination
timeFrame: Day 8 and Day 29 (at 5 Years After Primary Vaccination)
measure: Percentage of Subjects With hSBA Seroresponse After Booster Vaccination
timeFrame: Day 8, Day 29 (5 years after primary vaccination)
measure: Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination
timeFrame: Up to Day 7
Other outcomes:
Locations:
city: Rochester
country: United States
state: Minnesota
city: Pittsburgh
country: United States
state: Pennsylvania
city: Seattle
country: United States
state: Washington
Study officials:
References:
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.
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.