Clinical trial NCT02500511: Persistence of Protective Antibody Titers 12-24 Months After NmVac4-A/C/Y/W-135-DT Vaccination: Follow Up Study
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Meningococcal Meningitis
Meningococcal Infections
Lead sponsor: JN-International Medical Corporation
Sponsor class: INDUSTRY
First posted: 2015-07-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Antibody titer
timeFrame: 12-24 months after vaccination in study JN-NM-002
Secondary outcomes:
Other outcomes:
Locations:
city: Towson
country: United States
facility: IRC Clinics
state: Maryland
Study officials:
affiliation: IRC Clinics
name: Alberto Yataco, MD
role: PRINCIPAL_INVESTIGATOR
References: