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

April 8, 2016 updated by: JN-International Medical Corporation

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Towson, Maryland, United States, 21204
        • IRC Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects who seroconverted for serogroups A and C after vaccination with NmVac4-A/C/Y/W-135-DT in study JN-NM-001

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Antibody titer
Time Frame: 12-24 months after vaccination in study JN-NM-002
12-24 months after vaccination in study JN-NM-002

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JN-International Medical Corporation

Investigators

  • Principal Investigator: Alberto Yataco, MD, IRC Clinics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

July 14, 2015

First Submitted That Met QC Criteria

July 15, 2015

First Posted (Estimate)

July 16, 2015

Study Record Updates

Last Update Posted (Estimate)

April 12, 2016

Last Update Submitted That Met QC Criteria

April 8, 2016

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JN-NM-002E1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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