NCT02500511

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

Duration of Protection Based on Persistent Antibody Titers 12-24 Months After Vaccination: Follow Up to Phase 2 Study of Meningococcal Serogroups A, C, Y & W-135 Polysaccharide Diphtheria Toxoid Conjugate Vaccine (NmVac4-A/C/Y/W-135-DT)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: JN-International Medical Corporation · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	NmVac4-A/C/Y/W-135-DT™	no intervention in this study, received test vaccine in trial JN-NM-002

Timeline

• Start date: 2015-06-01
• Primary completion: 2015-08-01
• Completion: 2015-09-01
• First posted: 2015-07-16
• Last updated: 2016-04-12

Locations

1 site across 1 country: United States