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

NCT01018732 | Completed Phase 2 Results

• 1 other identifier: V59P6E1
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 3

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.

Conditions

Meningococcal Disease; Meningococcal Meningitis

Keywords

Meningococcal; ACWY; Conjugate Vaccine; Meningitis; Adolescents; Persistence

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Percentage of Participants With Serum Bactericidal Activity >=4 at 5 Years After Primary Vaccination

  Day 1 (5 years after primary vaccination )

• Geometric Mean Titer at 5 Years After Primary Vaccination

  Day 1 (5 years after primary vaccination )

• Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination

  Day 7, Day 28 post booster (5 years after primary vaccination)

• Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination

  Day 7, Day 28 post booster (5 years after primary vaccination)

• Geometric Mean Ratio After Booster Vaccination

  Day 8 and Day 29 (at 5 Years After Primary Vaccination)

Study Arms (3)

I: MenACWY-CRM vaccine

EXPERIMENTAL

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

II: Licensed Polysaccharide Meningococcal vaccine

EXPERIMENTAL

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

III: Meningococcal Naive

EXPERIMENTAL

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

Interventions

Novartis Meningococcal (MenACWY-CRM) vaccine BIOLOGICAL

All subjects will have blood draws at Day 1, Day 8, and Day 29.

I: MenACWY-CRM vaccine; II: Licensed Polysaccharide Meningococcal vaccine; III: Meningococcal Naive

Eligibility Criteria

• Age: 16 Years - 23 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Vaccines: lead
• Novartis: collaborator

Study Sites (3)

Unknown Facility

Rochester, Minnesota, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, United States

Location

Unknown Facility

Seattle, Washington, United States

Location

Related Publications (2)

• 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.

  PMID: 21177912 RESULT

• 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.

  PMID: 23114372 RESULT

MeSH Terms

Conditions

Meningococcal Infections; Meningitis, Meningococcal; Meningitis

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Meningitis, Bacterial; Central Nervous System Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Results Point of Contact

• Title: Posting Director
• Organization: Novartis Vaccines and Diagnostics

RegistryContactVaccinesUS@novartis.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2009
• First Posted: November 25, 2009
• Study Start: January 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: July 15, 2015
• Results First Posted: September 13, 2011

Record last verified: 2015-07

Locations

US (3)