Evaluation of PCV21 Vaccination Among PPSV23-experienced, Immunocompromised Elderly Veterans
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorVA Sierra Nevada Health Care System
About this trial
The investigators will evaluate the immune response of immunocompromised adults, who have previously received at least 1 dose of 23-valent pneumococcal polysaccharide vaccine, to the booster with of 21-valent pneumococcal conjugate vaccine . Immune response will be assessed by opsonophagocytic assay reactivity.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject meets the CDC definition of an immunocompromising condition
Have received at least 1 dose of PPSV23
Disqualifiers
Less than 5 years since last receipt of PPSV23 validated to patient medical record and Immunize Nevada Website
Previous administration of PCV20
Previous administration of PCV13
Previous administration of PCV15
Trial design
Design model
Single group
Treatments tested in this trial
21-valent pneumococcal conjugate vaccine
DrugFDA approved pneumococcal vaccines 21 valent conjugate vaccine administered at enrollment
Treatment groups
45 Participants
are divided into 1 treatment groupGroup A: All participantsOther 1 intervention
Trial outcomes
Primary outcomes
1
Change in opsonophagocytic assay (OPA) geometric mean titers (GMT)
Evaluation of the change fold increase in S. Pneumonia OPA GMT from baseline to 24 weeks after the administration of a pneumococcal vaccine booster series consisting of PCV15 followed by PPSV23 8 weeks later for S. Pneumoniae serotypes 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F
Time frame
24 monthsLocations
Sponsors and contacts
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VA Sierra Nevada Health Care System
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: