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Not yet recruiting NCT06271681

Evaluation of PCV21 Vaccination Among PPSV23-experienced, Immunocompromised Elderly Veterans

Phase IV Interventional Pneumococcal Vaccines Immunosuppression

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 21-valent pneumococcal conjugate vaccine.
Who it may be relevant to
Registry conditions: Pneumococcal Vaccines, Immunosuppression. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

Recommendations for optimal vaccination strategies in immunocompromised patients has been limited. Strategies focused on utilizing a conjugate vaccine alone, as either initial vaccination or booster dosing, have not demonstrated significant increased antibody expression in immunocompromised patients\[7\]. Strategies where immunocompromised patients were vaccinated with a conjugate vaccine followed by polysaccharide vaccine have demonstrated that 50% of individuals achieve functional antibodies\[7\]. Since improved antibody response in naive patients has been seen in combination vaccination, we aim to test this strategy for boosting in previously vaccinated immunocompromised patients. The 15 valent Pneumococcal Conjugate Vaccine (PCV15) is available for use in adults and contains S. Pneumoniae serotypes 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F \[5\].

In this study we postulate that booster dosing with PCV21 in immunocompromised adults who are at least 5 years from receipt of PPSV23 will elicit a strong immune response represented by change in serotype specific OPA GMT from baseline to 4 weeks post booster vaccine completion. We will specifically evaluate the change in pneumococcal opsonophagocytic activity at baseline to 6 months (Pn-OPA) for S. Pneumoniae serotypes 3, 6A, 15A, 19A, 20A, 23A, 31, 35B, 9n, 11A, and 22F. These specific serotypes have been selected due to current disease burden trends, to address current gaps in data, and have been identified as the most relevant for PCV development underway.

Interventions

  • Drug 21-valent pneumococcal conjugate vaccine
    FDA approved pneumococcal vaccines 21 valent conjugate vaccine administered at enrollment

Primary outcome measures

  • Change in opsonophagocytic assay (OPA) geometric mean titers (GMT) [Time frame: 24 months]

Eligibility criteria

Inclusion criteria

  • Subject meets the CDC definition of an immunocompromising condition

o chronic renal failure, congenital or acquired asplenia, generalized malignancy, HIV infection, Hodgkin disease, iatrogenic immunosuppression, leukemia, lymphoma, multiple myeloma, nephrotic syndrome, sickle cell disease or other hemoglobinopathies, and solid organ transplant.

  • Have received at least 1 dose of PPSV23

Exclusion criteria

  • 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
  • Less than 14 days since administration of any COVID19 vaccination
  • Previous history of Invasive Pneumococcal Disease (IPD)
  • Antibiotic treatment within the previous 90 days

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06271681 · 2120135-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗