Evaluating a combined pneumococcal vaccination for patients with acute leukemia or lymphoma
Immunogénicité de la Vaccination Anti-pneumococcique (PCV13+PPV23 Versus PREVENAR20) Dans le Lymphome Chez l'Adulte
This study is testing a new combined pneumonia vaccine to see if it helps people with acute leukemia or lymphoma who are getting chemotherapy stay healthier and avoid serious infections.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Poitiers University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 7 sites (Angers and 6 other locations) |
| Trial ID | NCT04460235 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the immunogenicity of a combined pneumococcal vaccination strategy in patients with acute leukemia or lymphoma who are undergoing chemotherapy. The vaccination consists of a 13-valent conjugated pneumococcal vaccine followed by a 23-valent polysaccharide vaccine two months later. Given that these patients have compromised immune systems, the study aims to assess their response to the vaccination by measuring anti-pneumococcal immunoglobulin G titers and opsonophagocytic activity. The goal is to determine the effectiveness of this vaccination approach in reducing the risk of pneumococcal invasive diseases in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with acute leukemia or lymphoma who have received at least one course of chemotherapy.
Not a fit: Patients currently receiving treatments that significantly alter the immune response or those with uncontrolled infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the immune response to pneumococcal vaccination in immunocompromised patients, potentially reducing their risk of severe infections.
How similar studies have performed: While the efficacy of pneumococcal vaccination in this specific patient population is not well-documented, similar vaccination strategies have shown promise in other immunocompromised groups.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient ≥ 18 year-old. * AND medical follow-up in hematology unit * AND had received a first course of chemotherapy for diffuse large B cell lymphoma or for follicular lymphoma * Life expectancy \> 6 months. * Negative pregnancy test. * Having signed the consent form. * Having an health insurance. Exclusion Criteria: * Receiving monoclonal antibodies or biotherapies altering the immune response, other than anti-CD20 antibodies in the chemotherapy protocol. * Uncontrolled bacterial, viral or fungal infection less than 7 days. * Previous vaccination with PCV13 or PPV23 (unless PCV13 was administered in childhood. The last injection must be performed at least five years ago). * Preexisting condition that altered the immune response: splenectomy, HIV, primary or secondary immune deficiency, nephrotic syndrome, sickle cell anemia, autoimmune disorder, solid organ transplantation, immunosuppressive drugs or biotherapy not included in the chemotherapy. * Patient who already received chemotherapy for malignancy in the previous 2 years before the inclusion. * Major blood clotting disorders preventing intramuscular injection. * Medical history of anaphylactic reaction to vaccination. * Known allergy to one of the vaccine components. * Involvement to another vaccine biomedical research. * Protected person. * Pregnant women or women of childbearing age without appropriate contraceptive measures. * Perfusion of polyvalent immunoglobulins during follow-up. * Participants with hypersensitivity to aluminum phosphate, phenol or CRM197 protein, protein derived from Corynebacterium diphtheria.
Where this trial is running
Angers and 6 other locations
- Chu Angers — Angers, France (Recruiting)
- CHU Bordeaux — Bordeaux, France (Recruiting)
- CHU Limoges — Limoges, France (Recruiting)
- Chu Nantes — Nantes, France (Recruiting)
- Ch Perigueux — Périgueux, France (Recruiting)
- CHU Poitiers — Poitiers, France (Recruiting)
- CHU Tours — Tours, France (Recruiting)
Study contacts
- Study coordinator: Mathieu Puyade, MD, PhD
- Email: mathieu.puyade@chu-poitiers.fr
- Phone: 0033 5 49 44 32 76
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.