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Response to pneumococcal en Hib vaccination in lymphoma patients treated with chemotherapy and rituximab.

Response to pneumococcal en Hib vaccination in lymphoma patients treated with chemotherapy and rituximab. - PNEUMOTUXIVAC

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON39920
Enrollment
152
Registered
2012-06-18
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-11

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

Conditions

cancer of the lymph nodes Lymphoma

Interventions

- At the first visit when patients are randomized, blood will be drawn and the first vaccination with Prevnar 13 and Act-Hib will be given. - 3 weeks later, blood will be drawn. - 2 months later, the

Sponsors

Sint Antonius Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Patients with non-Hodgkin*s lymphoma, treated with rituximab (with a range of 6-12 cycles) and who are in remission. 2. Completion of rituximab therapy in the last five months before start of the study. 3. Age * 18 years. 4. Signing of informed consent.

Exclusion criteria

Exclusion criteria: 1. Completion of rituximab therapy >5-6 months before start of the study. 2. Fever at time of vaccination. 3. Previous/known allergic reaction to any of the components of the vaccines given. 4. Vaccination with Hib or pneumococcal vaccine in the last fifteen months before start of the study

Design outcomes

Primary

MeasureTime frame
Antibody titres against S. Pneumonia and H. influenzae type b (in *g/mL) vaccine before and after vaccinations. Titres will be interpreted and classified in responder or non-responder.

Secondary

MeasureTime frame
- Immunoglobulin levels and subclass. - Lymphocyte subsets (number of B cells and memory-B cells, CD3, CD4, CD8 and NK cells). - Production of IFN-gamma by CD4+ cells. This will be measured in order to investigate if cellular mediated immune responses are intact after rituximab treatment. - Cytokines and genetic factors (for example BAFF, CXCL13, APRIL) influencing B cell development and survival will be measured in order to determine if there is a correlation between specific cytokines/genetic factors and the observed B-cell depletion/reconstitution. - Serum rituximab levels.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)