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NCT05316831
Immune Response After Pneumococcal Vaccination in Patient With Chronic Lymphocytic Leukemia
Phase 4 trial testing PCV13 in CLL in 77 participants. Completed in 1 October 2022.
30 June 2021
Quick facts
| Lead sponsor | Region Örebro County |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 77 |
| Start date | 1 January 2019 |
| Primary completion | 30 June 2021 |
| Estimated completion | 1 October 2022 |
| Sites | 1 location across Sweden |
Drugs / interventions tested
Conditions studied
- CLL — all drugs for CLL →
- Vaccine Response — all drugs for Vaccine Response →
Sponsor
Region Örebro County — full company profile →
Who can join
18 and older, any sex, with CLL or Vaccine Response. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A randomized, multi-centre trial was conducted between 2013-2016, including 128 patients with untreated CLL from eight hematological clinics in Sweden. Vaccination with polysaccharide pneumococcal vaccine (PPSV23) or conjugated pneumococcal vaccine (PCV13) was performed and the results were published 2018. PCV13 showed a superior immune response, measured as OPA (opsonophagocytic assays) and ELISA (enzyme-linked immunosorbent assay), compared to PPSV23. Immune cells analyses after primary immunization will be performed. Between 2019-2021 a prospective follow up study was conducted of the same cohort and also included a control group. The study participants have been revaccinated with pneumococcal vaccines with the aim to evaluate the effect of repeated dose of PCV13. The antibody response (measured as titer with FMIA (fluorescent multiplexed bead-based immunoassay) and antibody function with MOPA (multiplexed opsonophagocytic assay) will be performed. Studies investigating the dynamics of immune cells before and after primary immunization and revaccination will be performed. The study will give important answers about the optimal vaccination strategy in patients with CLL and can improve the vaccination recommendations in immunocompromised patients.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Revaccination with pneumococcal conjugate vaccine five years after primary immunization improves immunity in patients with chronic lymphocytic leukemia.
Kättström M, Uggla B, Virta C, Melin M, et al · · 2025 · cited 2× · PMID 40045895 · DOI 10.3324/haematol.2024.286942
Verify or expand the search:
- PubMed search for NCT05316831
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of PCV13
Trials testing the same drug.
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- NCT04525599 — A Study to Assess the Safety, Tolerability and Immunogenicity of ASP3772, a Pneumococcal Vaccine, in Toddlers 12 to 15 M · Phase 1 · completed
- NCT04384107 — Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants (V114-033) · Phase 3 · completed
- NCT04275284 — Persistence of Immunogenicity Following Reduced PCV Dosing Schedules in South African Children · completed
- NCT06210737 — A Study to Evaluate Persistence of Immunity of PCV13 in Healthy Population Aged 2 Months，7 Months-5 Years · Phase 4 · completed
Other recruiting trials for CLL
Currently open trials in the same condition.
- NCT07120633 — Anti CD19 CAR-T Combined With BTKi to Treat Newly Diagnosed High-risk CLL/SLL · NA · recruiting
- NCT07108998 — Study of Epcoritamab as a Consolidation Therapy in CLL/SLL · Phase 2 · recruiting
- NCT06846671 — A Study of BGB-16673 Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lympho · Phase 3 · recruiting
- NCT06506643 — Safety and Efficacy of KLS-1 Monotherapy in Malignant Neoplasms · Phase 1, PHASE2 · recruiting
- NCT05869279 — Allogeneic CARCIK-CD19 in Adults/Pediatric B-cell NHL or Chronic Lymphocytic Leukemia · Phase 1, PHASE2 · recruiting
Other Region Örebro County trials
Trials by the same sponsor.
- NCT07406750 — Hemodynamic Venous Congestion Ultrasound (VExUS) by ICU Nurses in Sepsis Patients. · not yet recruiting
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- NCT07158138 — A Digitally Distributed Yoga Intervention in Prostate Cancer Rehabilitation : Protocol for a Randomized Controlled Trial · NA · not yet recruiting
- NCT07206147 — Physical Exercise as Treatment Post-stroke Fatigue - a Feasibilty Study. · NA · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05316831 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Region Örebro County
- Last refreshed: 30 March 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05316831.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing