VaccinePhase 4HEMATOVACNCT04460235
Clinical Trial Assessing the Immunogenicity of an Anti-pneumococcal Vaccination Strategy (PCV13+PPV23 Versus PREVENAR20) in Adult Patients Treated for a Lymphoma
A Phase 4 study testing Prevenar 13 + Pneumovax 23 and PREVENAR20 in people with Vaccine and Streptococcus Pneumoniae, run by Poitiers University Hospital at 7 sites in France.
Trial summary
The French Public Health Council recommended pneumococcal vaccination combined strategy for all immunocompromised patients in 2012. This strategy consisted in conjugated 13-valent pneumococcal (PCV13) injection followed 2 months later by polysaccharide 23-valent (PPV23) vaccine injection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vaccine, Streptococcus Pneumoniae, Lymphoma, Non-Hodgkin
- What is being tested?
- Prevenar 13 + Pneumovax 23 and PREVENAR20
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 7 sitesFrance
- Study dates
- 7 Sep 2021to Jun 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
France7 sites, 5 recruiting
- Recruiting
Chu Angers
Angers
Jérôme PAILLASSA, Dr
- Terminated
CHU Bordeaux
Bordeaux
- Recruiting
CHU Limoges
Limoges
Arnaud JACCARD, Pr
- Terminated
Chu Nantes
Nantes
- Recruiting
Ch Perigueux
Périgueux
Claire CALMETTES, Dr
- Recruiting
CHU Poitiers
Poitiers
Cécile GRUCHET, Dr
- Recruiting
CHU Tours
Tours
Antoine MACHET, Dr
About this study
Official title: Immunogénicité de la Vaccination Anti-pneumococcique (PCV13+PPV23 Versus PREVENAR20) Dans le Lymphome Chez l'Adulte
The French Public Health Council recommended pneumococcal vaccination combined strategy for all immunocompromised patients in 2012. This strategy consisted in conjugated 13-valent pneumococcal (PCV13) injection followed 2 months later by polysaccharide 23-valent (PPV23) vaccine injection. In 2024, Health authorities changed guidelines to recommend one injection of PREVENAR20 instead of the 2-vaccine scheme general practitioners are usually in charge of this vaccination. Conjugated pneumococcal vaccine enhances the immunogenicity of the polysaccharide vaccine. Acute leukemia and lymphoma are treated with multiple courses of chemotherapy, impairing the immune system and potentially the response to vaccination. These patients are more at risk for developing pneumococcal invasive diseases than the general population. However, efficacy of pneumococcal vaccination is poorly documented in this setting. We assume that 65% of the patients are non-responders to double compared to 45% for PCV20PREVENAR20 vaccination, according to their anti-pneumococcal immunoglobulin G (Ig) titers and the opsonophagocytic activity (OPA). To assess the immunogenicity of the pneumococcal vaccination combined strategy in adult population of acute leukemia and lymphoma, we will measure anti-pneumococcal serotype-specific IgG titers and OPA at different time-points after completion of the combined vaccine strategy. The primary objective is to assess the immunogenicity of pneumococcal vaccination combined strategy at 3 months after the PCV13 injection (corresponding to 1 month after the end of the combined strategy in cohort A) using Ig G titers and OPA, compared to 3 months post PREVENAR20 (cohort B). At different time points (day 0, 4 weeks post PCV13, and 4 weeks, 3-6 months and 9-12 months post PPV23 and in day 0, 4 weeks post PREVENAR20 and 3 months, 5-8 months and 11-14 months post PREVENAR20, the immunological response to vaccination will be monitored using specific-serotype IgG titers, OPA, and total anti-pneumococcal Ig. We will determine predictive factors of non-response to vaccination by comparing demographic data, biological data and treatment received lymphoma patients. The tolerance and safety of the vaccination strategy will also be assessed in this specific hematological population.
- Conditions
- Vaccine, Streptococcus Pneumoniae, Lymphoma, Non-Hodgkin
- Being tested
- Prevenar 13 + Pneumovax 23, PREVENAR20
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevenar 13 + Pneumovax 23Biological
Cohort study A before modification of vaccination national guidelines
PREVENAR20Biological
Health authorities changed guidelines to recommend one injection of PREVENAR20 instead of the 2-vaccine scheme general practitioners are usually in charge of this vaccination.
Cohort study B
| Study group | Role | What they receive |
|---|---|---|
| Cohort study A | Other | 80 patients already included in study cohort A. They received an injection of 13-valent conjugate vaccine (PCV13), followed by an injection of 23-valent polysaccharide vaccine (PPV23) at least 2 months later. Receives: Biological: Prevenar 13 + Pneumovax 23 |
| Cohort study B | Other | 80 patients to be included in study cohort B. They will receive a single injection of PREVENAR20 vaccine. Receives: Biological: PREVENAR20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients having an immunological response
Proportion of patients having an immunological response to combined strategy at 4 weeks after the end of the combined strategy compared to proportion of patients having an immunologicalresponse at 3 months post PREVENAR20 injection.
An immunological response to vaccination is defined by 7/10 tested serotypes responding to these 4 criteria: a serotype-specific IgG titer ≥ 1,3 μg/mL (WHO threshold), a two-fold increase of this IgG titer compare to baseline before vaccination, a serotype-specific OPA ≥1/8, and a four-fold increase of functional antibodies compare to baseline.
Measured: 4 weeks after the end of the combined strategy for cohort study A and 3 months post injection for cohort study B
Secondary outcomes (7)
Proportion of patients having an ELISA serotype-specific IgG titer and a two-fold increase of this IgG titer
Proportion of patients having an ELISA serotype-specific IgG titer ≥ 1.3 μg/mL (WHO threshold) and a two-fold increase of this IgG titer compared to baseline at 4 weeks after the PCV13 or PREVENAR20 injection
Measured: 4 weeks after injection
Proportion of patients having a sustainable response to vaccination
Proportion of patients having a sustainable response to vaccination defined by an ELISA serotype-specific IgG titer ≥ 1μg/mL (WHO threshold) and a two-fold increase of this IgG titer compared to baseline between 3-6 months after the PPV23 injection or 5-8 months post PREVENAR20.
Measured: 3-6 months after the PPV23 injection or 5-8 months post PREVENAR20
Proportion of patients having a sustainable response to vaccination
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 post PREVENAR20.
Measured: 9-12 months after the PPV23 injection or 11-14 months post PREVENAR20.
Proportion of responding patients having titers of IgG, IgG2, IgM, and IgA rising significantly
Proportion of responding patients having titers of IgG, IgG2, IgM, and IgA rising significantly at 4 weeks after PCV13 or PREVENAR20 injection, and 4 weeks, 3-6 months and 9-12 months after PPV23 injection versus respectively 3 months, 5-8 months and 11-14 months after PREVENAR20 injection.
A significant increase is defined by a 4-fold increase of IgG and IgG2 titers, a 13-fold increase of IgA titers, and a 20-fold increase of IgM titers compared to baseline at inclusion.
Measured: 4 weeks after PCV13 or PREVENAR20 injection, and 4 weeks, 3-6 months and 9-12 months after PPV23 injection versus respectively 3 months, 5-8 months and 11-14 months after PREVENAR20 injection.
Predictive factors for non-response to vaccination
To determine predictive factors for non-response to vaccination at 4 weeks, and 9-12 months after PPV23 versus respectively 3 months and 11-14 months after PREVENAR20 injection such as age, immune status, chemotherapy, immunotherapy.
Measured: 4 weeks, and 9-12 months after PPV23 versus respectively 3 months and 11-14 months after PREVENAR20 injection
Local or general reactions to vaccination and invasive pneumococcal infections
Number of patients having local or general reactions to vaccination and number of invasive pneumococcal infections with a documented serotype considered as vaccination failure.
Measured: 14 months
Concordance between the reference immuno-monitoring dosage and another kit of dosage
To assess the concordance between the reference immuno-monitoring dosage (WHO ELISA) and another kit of dosage (Vacczyme® Binding Site®).
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start7 Sep 2021
- Primary completionJun 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaccineStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04460235
- Sponsor's protocol ID
- HEMATOVAC
- Other IDs
- 2024-517288-22-01
- Acronym
- HEMATOVAC
- Status last verified
- May 2026
- First submitted
- 29 Jun 2020
- Last updated
- 29 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogénicité de la Vaccination Anti-pneumococcique (PCV13+PPV23 Versus PREVENAR20) Dans le Lymphome Chez l'Adulte
- ClinicalTrials.gov ID
- NCT04460235
- Acronym / sponsor ID
- HEMATOVAC / HEMATOVAC
- Conditions
- Vaccine, Streptococcus Pneumoniae, Lymphoma, Non-Hodgkin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 7 Sep 2021 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The French Public Health Council recommended pneumococcal vaccination combined strategy for all immunocompromised patients in 2012. This strategy consisted in conjugated 13-valent pneumococcal (PCV13) injection followed 2 months later by polysaccharide 23-valent (PPV23) vaccine injection. In 2024, Health authorities changed guidelines to recommend one injection of PREVENAR20 instead of the 2-vaccine scheme general practitioners are usually in charge of this vaccination. Conjugated pneumococcal vaccine enhances the immunogenicity of the polysaccharide vaccine. Acute leukemia and lymphoma are treated with multiple courses of chemotherapy, impairing the immune system and potentially the response to vaccination. These patients are more at risk for developing pneumococcal invasive diseases than the general population. However, efficacy of pneumococcal vaccination is poorly documented in this setting. We assume that 65% of the patients are non-responders to double compared to 45% for PCV20PREVENAR20 vaccination, according to their anti-pneumococcal immunoglobulin G (Ig) titers and the opsonophagocytic activity (OPA). To assess the immunogenicity of the pneumococcal vaccination combined strategy in adult population of acute leukemia and lymphoma, we will measure anti-pneumococcal serotype-specific IgG titers and OPA at different time-points after completion of the combined vaccine strategy. The primary objective is to assess the immunogenicity of pneumococcal vaccination combined strategy at 3 months after the PCV13 injection (corresponding to 1 month after the end of the combined strategy in cohort A) using Ig G titers and OPA, compared to 3 months post PREVENAR20 (cohort B). At different time points (day 0, 4 weeks post PCV13, and 4 weeks, 3-6 months and 9-12 months post PPV23 and in day 0, 4 weeks post PREVENAR20 and 3 months, 5-8 months and 11-14 months post PREVENAR20, the immunological response to vaccination will be monitored using specific-serotype IgG titers, OPA, and total anti-pneumococcal Ig. We will determine predictive factors of non-response to vaccination by comparing demographic data, biological data and treatment received lymphoma patients. The tolerance and safety of the vaccination strategy will also be assessed in this specific hematological population.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort study A | Other | Biological: Prevenar 13 + Pneumovax 2380 patients already included in study cohort A. They received an injection of 13-valent conjugate vaccine (PCV13), followed by an injection of 23-valent polysaccharide vaccine (PPV23) at least 2 months later. |
| Cohort study B | Other | Biological: PREVENAR2080 patients to be included in study cohort B. They will receive a single injection of PREVENAR20 vaccine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prevenar 13 + Pneumovax 23Cohort study A before modification of vaccination national guidelines | Biological | Cohort study A |
| PREVENAR20Health authorities changed guidelines to recommend one injection of PREVENAR20 instead of the 2-vaccine scheme general practitioners are usually in charge of this vaccination. Cohort study B | Biological | Cohort study B |
Primary outcome
Proportion of patients having an immunological response
Time frame: 4 weeks after the end of the combined strategy for cohort study A and 3 months post injection for cohort study B
Proportion of patients having an immunological response to combined strategy at 4 weeks after the end of the combined strategy compared to proportion of patients having an immunologicalresponse at 3 months post PREVENAR20 injection. An immunological response to vaccination is defined by 7/10 tested serotypes responding to these 4 criteria: a serotype-specific IgG titer ≥ 1,3 μg/mL (WHO threshold), a two-fold increase of this IgG titer compare to baseline before vaccination, a serotype-specific OPA ≥1/8, and a four-fold increase of functional antibodies compare to baseline.
7 secondary outcomes
Proportion of patients having an ELISA serotype-specific IgG titer and a two-fold increase of this IgG titer
Time frame: 4 weeks after injection
Proportion of patients having a sustainable response to vaccination
Time frame: 3-6 months after the PPV23 injection or 5-8 months post PREVENAR20
Proportion of patients having a sustainable response to vaccination
Time frame: 9-12 months after the PPV23 injection or 11-14 months post PREVENAR20.
Proportion of responding patients having titers of IgG, IgG2, IgM, and IgA rising significantly
Time frame: 4 weeks after PCV13 or PREVENAR20 injection, and 4 weeks, 3-6 months and 9-12 months after PPV23 injection versus respectively 3 months, 5-8 months and 11-14 months after PREVENAR20 injection.
Predictive factors for non-response to vaccination
Time frame: 4 weeks, and 9-12 months after PPV23 versus respectively 3 months and 11-14 months after PREVENAR20 injection
Local or general reactions to vaccination and invasive pneumococcal infections
Time frame: 14 months
Concordance between the reference immuno-monitoring dosage and another kit of dosage
Time frame: 14 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: Undecided. Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prevenar 13 + Pneumovax 23 and PREVENAR20 in people with Vaccine and Streptococcus Pneumoniae, run by Poitiers University Hospital at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mathieu Puyade, MD, PhD (0033 5 49 44 32 76, mathieu.puyade@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients having an immunological response (time frame: 4 weeks after the end of the combined strategy for cohort study A and 3 months post injection for cohort study B). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.