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

NCT06271681 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: 2120135-1
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pneumococcal Vaccines; Immunosuppression

Keywords

immunosuppression; pneumococcal vaccines

Outcome Measures

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

  24 months

Study Arms (1)

All participants

OTHER

This will be a single population open label trial evaluating immune response to PCV21 in subjects with immunocompromising conditions or receiving immunosuppressive medications.

Drug: 21-valent pneumococcal conjugate vaccine

Interventions

21-valent pneumococcal conjugate vaccine DRUG

FDA approved pneumococcal vaccines 21 valent conjugate vaccine administered at enrollment

Also known as: PCV21

All participants

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Sierra Nevada Health Care System: lead
• Merck Sharp & Dohme LLC: collaborator

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief of Pharmacy for Informatics, Education, Health Outcomes, and Research

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: February 22, 2024
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share