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NCT02500511 Clinical Trial

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

Meningococcal Meningitis Clinical Trial

Official title:
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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02500511
Other study ID # JN-NM-002E1
Secondary ID
Status Completed
Phase N/A
First received July 14, 2015
Last updated April 8, 2016
Start date June 2015
Est. completion date September 2015

Study information
Verified date July 2015
Source JN-International Medical Corporation
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date September 2015
Est. primary completion date August 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility 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

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Biological:
• NmVac4-A/C/Y/W-135-DT™
no intervention in this study, received test vaccine in trial JN-NM-002

Locations
Country Name City State
United States IRC Clinics Towson Maryland

Sponsors (1)
Lead Sponsor Collaborator
JN-International Medical Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Antibody titer 12-24 months after vaccination in study JN-NM-002 No
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