Skip to content

HEMATOVAC-Immunogenicity of an Anti-pneumococcal Combined Vaccination (PCV13+PPV23 versus PREVENAR20) in Lymphoma

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517288-22-01
Acronym
HEMATOVAC
Enrollment
160
Registered
2024-10-17
Start date
2021-01-29
Completion date
Unknown
Last updated
2025-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma

Brief summary

Proportion of patients responding to the combined vaccination strategy (PCV13 + PPV23) assessed 4 weeks after PPV23 vaccination compared with the PREVENAR20 single injection vaccination strategy assessed 3 months post-injection according to the level of anti-pneumococcal IgG

Detailed description

Proportion of patients having an ELISA serotype-specific IgG titer ≥ 1.3μg/mL (WHO threshold) and a two-fold increase of this IgG titer compared to baseline at 4 weeks after the PCV13 injection or PREVENAR20, Proportion of patients having a sustainable response to vaccination defined by an ELISA serotype-specific IgG titer ≥ 1.3μg/mL and a two-fold increase of this IgG titer compared to baseline between 3-6 months after the PPV23 injection or 5-8 months after PREVENAR20 injection, Proportion of patients having a sustainable response to vaccination defined by the same criteria as the primary outcome and measured between 9-12 months after the PPV23 injection or 11-14 months after PREVENAR20 injection, Proportion of responding patients having titers of IgG, IgG2, IgM, and IgA rising significantly at 4 weeks after PCV13 injection, and 4 weeks, 3- 6 months and 9-12 months after PPV23 injectionor at 4 weeks, 3 months, 5-8 months, 11-14 months after PREVENAR20 injection., To determine predictive factors for non-response to vaccination at 4weeks, and 6-12 months after PPV23 injection/11-14 months PREVENAR 20 such as age, hematological malignancy, immune status, chemotherapy,....., Number of patients having local or general reactions to vaccination and number of invasive pneumococcal infections with a documented serotype considered as vaccination failure, To assess the concordance between the reference immuno-monitoring dosage (WHO ELISA) and another kit of dosage (Vacczyme® Binding Site®).

Interventions

Sponsors

Centre Hospitalier Universitaire De Poitiers
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Proportion of patients responding to the combined vaccination strategy (PCV13 + PPV23) assessed 4 weeks after PPV23 vaccination compared with the PREVENAR20 single injection vaccination strategy assessed 3 months post-injection according to the level of anti-pneumococcal IgG

Secondary

MeasureTime frame
Proportion of patients having an ELISA serotype-specific IgG titer ≥ 1.3μg/mL (WHO threshold) and a two-fold increase of this IgG titer compared to baseline at 4 weeks after the PCV13 injection or PREVENAR20, Proportion of patients having a sustainable response to vaccination defined by an ELISA serotype-specific IgG titer ≥ 1.3μg/mL and a two-fold increase of this IgG titer compared to baseline between 3-6 months after the PPV23 injection or 5-8 months after PREVENAR20 injection, Proportion of patients having a sustainable response to vaccination defined by the same criteria as the primary outcome and measured between 9-12 months after the PPV23 injection or 11-14 months after PREVENAR20 injection, Proportion of responding patients having titers of IgG, IgG2, IgM, and IgA rising significantly at 4 weeks after PCV13 injection, and 4 weeks, 3- 6 months and 9-12 months after PPV23 injectionor at 4 weeks, 3 months, 5-8 months, 11-14 months after PREVENAR20 injection., To determine predic

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026