Persistence of Protective Antibody Titers 12-24 Months After NmVac4-A/C/Y/W-135-DT Vaccination: Follow Up Study

NCT ID: NCT02500511

Last Updated: 2016-04-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2015-09-30

Brief Summary

To determine the persistence of protective antibody levels for subjects who seroconverted after vaccination with NmVac4-A/C/Y/W-135-DT™

Participants in trial # JN-NM-002, who seroconverted for serogroups A and C will be contacted and asked to provide a blood sample at 12-24 months after vaccination with NmVac4-A/C/Y/W-135-DT.

Serum Bactericidal Assays will be performed to evaluated duration of protective antibody titer for NmVac4-A/C/Y/W-135-DT for all four serogroups. To determine if subjects who seroconverted with lower titers retain protective levels of antibody (titer ≥:8) at 12-24 months after vaccination.

Detailed Description

The purpose of this study is to collect serum samples to evaluate duration of protection for NmVac4-A/C/Y/W-135-DT, based on titers determined by Serum Bactericidal Assay with human complement (hSBA). This assay is used to evaluate immunogenicity of meningococcal vaccines, as a surrogate for efficacy. A titer ≥ 1:8 is considered protective.

Objectives are to evaluate duration of protective antibody titer for NmVac4-A/C/Y/W-135-DT for all four serogroups, and determine if subjects with lower titers, but ≥:8 retain protective levels of antibody at 12-24 months.

Participants in trial # JN-NM-002, who seroconverted for serogroups A and C will be contacted and asked to provide a blood sample at 12-24 months after vaccination with NmVac4-A/C/Y/W-135-DT™.

Serum Bactericidal Assays will be performed to evaluated persistence of protective antibody titer for NmVac4-A/C/Y/W-135-DT for all four serogroups, to determine if subjects who seroconverted with lower titers retain protective levels of antibody (titer ≥:8) at 12-24 months after vaccination.

Conditions

Meningococcal Meningitis; Meningococcal Infections

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Interventions

NmVac4-A/C/Y/W-135-DT™

no intervention in this study, received test vaccine in trial JN-NM-002

Intervention Type: BIOLOGICAL

Other Intervention Names

meningococcal meningitis conjugate vaccine quadrivalent

Eligibility Criteria

Inclusion Criteria

• Willing and able to give informed consent
• Participant in trial JN-NM-002
• Seroconverted in trial JN-NM-002 for both serogroups A and C

Exclusion Criteria

• Chronic medication use or medical history that, in the opinion of the Investigator, may impact the quality of the sample or safety of the subject

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

JN-International Medical Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alberto Yataco, MD

Role: PRINCIPAL_INVESTIGATOR

IRC Clinics

Locations

IRC Clinics

Towson, Maryland, United States

Countries

United States

Other Identifiers

JN-NM-002E1

Identifier Type: -

Identifier Source: org_study_id