Meningococcal Vaccination in Patients on Complement Inhibitors

Active, not recruitingOBSERVATIONAL
Enrollment

35

Participants

Timeline

Start Date

March 25, 2025

Primary Completion Date

April 1, 2027

Study Completion Date

April 1, 2027

Conditions
Myasthenia Gravis GeneralisedVaccinationComplement SystemNeuromyelitis Optica Spectrum Disease (NMOSD)
Interventions
DIAGNOSTIC_TEST

Serum Bactericidal Assay

The Serum Bactericidal Assay (SBA) will be used for the analysis of the antibody titer, which represents a valid surrogate for the efficacy of the tetravalent vaccine. Subjects' sera will be serially diluted and incubated with a solution containing a certain strain of meningococcus. At this point, an exogenous source of rabbit complement will be added. Bactericidal activity will be assessed against controls. Neutralizing antibody titers will be defined as the highest dilution of sera at which at least 50% of bacteria death occurs. Antibody titers will be considered protective with a cut-off greater than or equal to 1:8.

Trial Locations (1)

00168

Fondazione Policlinico A. Gemelli IRCCS, Rome

All Listed Sponsors
lead

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER