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



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 55
Updated:4/21/2016
Start Date:June 2015
End Date:September 2015

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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.

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.

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
We found this trial at
1
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Towson, Maryland 21204
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Towson, MD
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