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

Completed

• Conditions: Meningococcal Meningitis; Meningococcal Infections

• Registration Number: NCT02500511
• Lead Sponsor: JN-International Medical Corporation

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.

Study Timeline

• Study Start: 2015-06
• Status Verified: 2015-07
• Study First Submitted: 2015-07-14
• Study First Submitted QC: 2015-07-15
• Study First Posted: 2015-07-16
• Primary Completion: 2015-08
• Study Completion: 2015-09
• Last Update Submitted: 2016-04-08
• Last Update Posted: 2016-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Antibody titer	12-24 months after vaccination in study JN-NM-002

Trial Locations

Locations (1)

IRC Clinics; 🇺🇸 Towson, Maryland, United States