Splenectomized PatientsPhase 2SPLENEVACNCT02052154
Multicenter Pilot Study Evaluating the Immunogenicity of an Innovative Pneumococcal Vaccination Strategy in Splenectomized Adults
A Phase 2 study testing Prime-boost pneumococcal immunization in people with Splenectomized Patients, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Evaluate the immunogenicity of an innovative pneumococcal vaccination strategy in splenectomized adults comprising 1 dose of Prevenar13® conjugate vaccine (PCV) at M0 followed by 1 dose of Pneumo23® or Pneumovax® polysaccharide vaccine (PPSV) at M2. Duration of follow-up of 36 months. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Splenectomized Patients
- What is being tested?
- Prime-boost pneumococcal immunization
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 10 Mar 2014to 2 Apr 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years and ≤ 75 years
- Splenectomized since at least 2 weeks, with Howell-Jolly bodies on a blood smear and ultrasonographic confirmation
- No immunosppressived conditions : mainly trauma , idiopathic thrombocytopathic purpura or autoimmune hemolytic anemia, with no active treatment
- Available for 37 months of follow-up starting from the screening visit
- Contraception that the investigator judges effective for the first 2 months of the trial, with a negative pregnancy test
- Women not planning to become pregnant in the 6 months following inclusion (M0)
- Signed informed consent
Who cannot join
- Pregnancy or planned pregnancy in the 2 months following inclusion (M0)
- Pathology or conditions which modify immune response (excluding splenectomy) : HIV infection, immunosuppressive therapy ongoing or in 6 months before inclusion (M0), including corticosteroids > 10 mg daily, topic inhaled or dermic corticoid treatments are allowed, hematopoietic stem cell allo / autograft, primary immune deficiency, nephrotic syndrome, sickle cell disease, evolutive neoplasia
- History of anaphylactic reaction following vaccination
- Known allergy to any of the ingredients of the vaccines: aluminium phosphate, phenol, Corynebacterium diphtheriae CRM-197 protein
- Previous vaccination with 7-valent or 13-valent pneumococcal conjugate vaccine (in the 5 last years)
- Previous vaccination with the pneumococcal polysaccharidic vaccine in the 3 years before inclusion (M0)
Show all 11Show fewer
- Other vaccination in the month before inclusion (M0)
- Polyvalent immunoglobulin infusion in the 3 months before inclusion (M0) or during the planned duration of the study
- Anticoagulant treatment current or stopped less than 7 days before inclusion (M0); or clotting disorder contra-indicating intramuscular injection
- Participation to an other vaccine study in the 28 days before inclusion till the end of study
- Not covered by national health insurance (beneficiary or assignee)
Trial locations and contacts
1 site in 1 country.
France1 site
Service des Maladies Infectieuses et Tropicales - Centre d'Infectiologie Necker-Pasteur, IHU Imagine - Hôpital Necker-Enfants
Paris, 75015
About this study
Evaluate the immunogenicity of an innovative pneumococcal vaccination strategy in splenectomized adults comprising 1 dose of Prevenar13® conjugate vaccine (PCV) at M0 followed by 1 dose of Pneumo23® or Pneumovax® polysaccharide vaccine (PPSV) at M2. Duration of follow-up of 36 months.
The main endpoint will be the proportion of subjects responsive to 9 of the 13 serotypes common to the PCV and PPSV vaccines, selected because of their frequency in invasive infections in adults in France and their potentially reduced susceptibility to penicillin (serotypes 1, 3, 6A, 7F, 9V, 14, 19A, 19F, 23F).
Read the detailed description
The splenectomized patient is more susceptible to infections because of the lack of specific response to the polysaccharide antigens that compose the capsules of certain bacteria. These very severe infections are known as Overwhelming Post Splenectomy Infections, or OPSI; they are characterized by very rapid onset with no prodrome and carry a high mortality rate. The annual incidence of OPSI is estimated at 0.23-0.42% with a lifetime risk of 5%. The role of pneumococcus in particular has been clearly established in these infections.
The most effective strategy to minimize the risk of pneumococcal infection is pneumococcal vaccination. Currently there are two types of vaccines available in France: polysaccharide and conjugate, both of which induce the production of anti-capsular IgG with both neutralizing and opsonic activity.
Since one of the consequences of asplenia is the absence of IgM production elicited by a polysaccharide challenge, due to an absence of splenic B cells, it is difficult to imagine that such patients would mount a satisfactory immune response to PPSV vaccination. And in fact, several studies have described the occurrence of pneumococcal OPSI in patients who were correctly vaccinated.
The study hypothesis is that a vaccination strategy combining PCV vaccine followed by PPSV vaccine will induce a good immune response in splenectomized patients, with good tolerability. All available data suggest that the optimum schedule consists of a primovaccination with one dose of PCV followed two months later by one dose of PPSV, in order to achieve a T-dependent memory response to the 13 serotypes common to the two vaccines.
The proposed endpoint is therefore to evaluate the immunogenicity and safety of a vaccination strategy comprising priming with one dose of Prevenar13® PCV vaccine (serotypes 4, 6B, 9V, 14, 18C, 19F, 23F, + 1, 3, 5, 6A, 7F, 19A) to induce a T cell memory response, followed by the classical administration of one dose of Pneumo23® or Pneumovax® vaccine (serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, 33F). Secondary endpoints will evaluate the safety of this strategy in terms of post-immunization local and systemic side effects, frequency of invasive pneumococcal infections, predictors of immunogenicity, and persistence of immunogenicity 30 months post-immunization.
- Conditions
- Splenectomized Patients
- Being tested
- Prime-boost pneumococcal immunization
- Keywords
- Pneumococcal infection, Splenectomized, vaccination
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prime-boost pneumococcal immunizationBiological
Also called Prevenar13® followed by Pneumo23®
2 months between the 2 vaccines
| Study group | Role | What they receive |
|---|---|---|
| Prime-boost pneumococcal immunization | Experimental | Not described Receives: Biological: Prime-boost pneumococcal immunization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects responsive to 9 of the 13 serotypes common (serotypes 1, 3, 6A, 7F, 9V, 14, 19A, 19F, 23F).
According to currently accepted international guidelines, a subject is considered to be responsive to a given serotype if one month after PPSV vaccination (at M3) the specific IgG titer is ≥ 1 μg/mL by ELISA and the opsonophagocytosis assay (OPA) threshold response is ≥ at LLOQ (Lower limit of quantification)
Measured: M3
Secondary outcomes (10)
IgG dosage
Immunologic Response after one injection PnCj (Specific IgG ≥1 µg/ml)
Measured: one month
ELISA dosages
Evaluation of persistent responses 4 months after PPSV vaccine
Measured: 4 months after PPSV vaccine
ELISA dosages
Evaluation of persistent responses 10 months after PPSV vaccine
Measured: 10 months after PPSV vaccine
ELISA dosages
Evaluation of persistent responses 34 months after PPSV vaccine
Measured: 34 months after PPSV vaccine
Identification of predictive factors for immunogenicity
Identification of predictive factors for immunogenicity: age, gender, indication for splenectomy, time since splenectomy, time since previous vaccination with polysaccharide vaccine, number of PPSV vaccinations previously received
Measured: M0 to M36
Percentage of patients presenting local or systemic reactions post-immunization
Estimate the clinical and biological tolerance of the vaccinal strategy
Measured: M0 to M36
Evaluation of severe infectious episode
the evaluation of severe infectious episode are assessed with microbiological documentation (with serotype if Streptococcus pneumoniae), site of infection, occurrence under antibiotic prophylaxis or not.
this will allow to list and characterize the serotype involved during possible episodes of invasive infections in pneumocoque
Measured: M0 to M36
OPA dosages
Evaluation of persistent responses 4 months after PPSV vaccine
Measured: 4 months after PPSV vaccine
OPA dosages
Evaluation of persistent responses 10 months after PPSV vaccine
Measured: 10 months after PPSV vaccine
OPA dosages
Evaluation of persistent responses 34 months after PPSV vaccine
Measured: 34 months after PPSV vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study start10 Mar 2014
- Primary completion19 Jul 2016
- Study completion2 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Splenectomized PatientsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Hélène COIGNARD-BIEHLER, MD, Principal investigator, Service des Maladies Infectieuses et Tropicales, Hôpital Necker-Enfants Malades, APHPOlivier LORTHOLARY, MD, PhD, Study director, Service des Maladies Infectieuses et Tropicales, Hôpital Necker-Enfants Malades, APHPOdile LAUNAY, MD, PhD, Study director, CIC Vaccinologie Cochin-Pasteur (CIC BT505) - Hôpital CochinMarc MICHEL, MD, PhD, Study director, Service de médecine interne, Hôpital Henri MondorFrédéric BATTEUX, MD, PhD, Study chair, Assistance Publique - Hôpitaux de ParisClaude-Agnès REYNAUD, PhD, Study chair, Institut National de la Santé Et de la Recherche Médicale, FrancePierre BUFFET, MD, PhD, Study chair, INTS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02052154
- Sponsor's protocol ID
- P120131
- Other IDs
- 2013-002631-19
- Acronym
- SPLENEVAC
- Status last verified
- Oct 2025
- First submitted
- 20 Jan 2014
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Pilot Study Evaluating the Immunogenicity of an Innovative Pneumococcal Vaccination Strategy in Splenectomized Adults
- ClinicalTrials.gov ID
- NCT02052154
- Acronym / sponsor ID
- SPLENEVAC / P120131
- Conditions
- Splenectomized Patients
- Keywords
- Pneumococcal infection, Splenectomized, vaccination
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 10 Mar 2014 (actual)
- Primary completion
- 19 Jul 2016 (actual)
- Study completion
- 2 Apr 2019 (actual)
- First posted
- 31 Jan 2014 (estimated)
- 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.
Evaluate the immunogenicity of an innovative pneumococcal vaccination strategy in splenectomized adults comprising 1 dose of Prevenar13® conjugate vaccine (PCV) at M0 followed by 1 dose of Pneumo23® or Pneumovax® polysaccharide vaccine (PPSV) at M2. Duration of follow-up of 36 months.
The main endpoint will be the proportion of subjects responsive to 9 of the 13 serotypes common to the PCV and PPSV vaccines, selected because of their frequency in invasive infections in adults in France and their potentially reduced susceptibility to penicillin (serotypes 1, 3, 6A, 7F, 9V, 14, 19A, 19F, 23F).
Detailed description
The splenectomized patient is more susceptible to infections because of the lack of specific response to the polysaccharide antigens that compose the capsules of certain bacteria. These very severe infections are known as Overwhelming Post Splenectomy Infections, or OPSI; they are characterized by very rapid onset with no prodrome and carry a high mortality rate. The annual incidence of OPSI is estimated at 0.23-0.42% with a lifetime risk of 5%. The role of pneumococcus in particular has been clearly established in these infections.
The most effective strategy to minimize the risk of pneumococcal infection is pneumococcal vaccination. Currently there are two types of vaccines available in France: polysaccharide and conjugate, both of which induce the production of anti-capsular IgG with both neutralizing and opsonic activity.
Since one of the consequences of asplenia is the absence of IgM production elicited by a polysaccharide challenge, due to an absence of splenic B cells, it is difficult to imagine that such patients would mount a satisfactory immune response to PPSV vaccination. And in fact, several studies have described the occurrence of pneumococcal OPSI in patients who were correctly vaccinated.
The study hypothesis is that a vaccination strategy combining PCV vaccine followed by PPSV vaccine will induce a good immune response in splenectomized patients, with good tolerability. All available data suggest that the optimum schedule consists of a primovaccination with one dose of PCV followed two months later by one dose of PPSV, in order to achieve a T-dependent memory response to the 13 serotypes common to the two vaccines.
The proposed endpoint is therefore to evaluate the immunogenicity and safety of a vaccination strategy comprising priming with one dose of Prevenar13® PCV vaccine (serotypes 4, 6B, 9V, 14, 18C, 19F, 23F, + 1, 3, 5, 6A, 7F, 19A) to induce a T cell memory response, followed by the classical administration of one dose of Pneumo23® or Pneumovax® vaccine (serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, 33F). Secondary endpoints will evaluate the safety of this strategy in terms of post-immunization local and systemic side effects, frequency of invasive pneumococcal infections, predictors of immunogenicity, and persistence of immunogenicity 30 months post-immunization.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prime-boost pneumococcal immunization | Experimental | Biological: Prime-boost pneumococcal immunization |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years and ≤ 75 years
- Splenectomized since at least 2 weeks, with Howell-Jolly bodies on a blood smear and ultrasonographic confirmation
- No immunosppressived conditions : mainly trauma , idiopathic thrombocytopathic purpura or autoimmune hemolytic anemia, with no active treatment
- Available for 37 months of follow-up starting from the screening visit
- Contraception that the investigator judges effective for the first 2 months of the trial, with a negative pregnancy test
Key exclusion criteria (11 listed)
- Pregnancy or planned pregnancy in the 2 months following inclusion (M0)
- Pathology or conditions which modify immune response (excluding splenectomy) : HIV infection, immunosuppressive therapy ongoing or in 6 months before inclusion (M0), including corticosteroids > 10 mg daily, topic inhaled or dermic corticoid treatments are allowed, hematopoietic stem cell allo / autograft, primary immune deficiency, nephrotic syndrome, sickle cell disease, evolutive neoplasia
- History of anaphylactic reaction following vaccination
- Known allergy to any of the ingredients of the vaccines: aluminium phosphate, phenol, Corynebacterium diphtheriae CRM-197 protein
- Previous vaccination with 7-valent or 13-valent pneumococcal conjugate vaccine (in the 5 last years)
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 |
|---|---|---|
| Prime-boost pneumococcal immunizationAlso: Prevenar13® followed by Pneumo23®2 months between the 2 vaccines | Biological | Prime-boost pneumococcal immunization |
Primary outcome
Proportion of subjects responsive to 9 of the 13 serotypes common (serotypes 1, 3, 6A, 7F, 9V, 14, 19A, 19F, 23F).
Time frame: M3
According to currently accepted international guidelines, a subject is considered to be responsive to a given serotype if one month after PPSV vaccination (at M3) the specific IgG titer is ≥ 1 μg/mL by ELISA and the opsonophagocytosis assay (OPA) threshold response is ≥ at LLOQ (Lower limit of quantification)
10 secondary outcomes
IgG dosage
Time frame: one month
ELISA dosages
Time frame: 4 months after PPSV vaccine
ELISA dosages
Time frame: 10 months after PPSV vaccine
ELISA dosages
Time frame: 34 months after PPSV vaccine
Identification of predictive factors for immunogenicity
Time frame: M0 to M36
Percentage of patients presenting local or systemic reactions post-immunization
Time frame: M0 to M36
Evaluation of severe infectious episode
Time frame: M0 to M36
OPA dosages
Time frame: 4 months after PPSV vaccine
OPA dosages
Time frame: 10 months after PPSV vaccine
OPA dosages
Time frame: 34 months after PPSV vaccine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
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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. This study is not recruiting at the moment.
Hélène COIGNARD-BIEHLER, MD principal investigator
Service des Maladies Infectieuses et Tropicales, Hôpital Necker-Enfants Malades, APHP
Olivier LORTHOLARY, MD, PhD study director
Service des Maladies Infectieuses et Tropicales, Hôpital Necker-Enfants Malades, APHP
Odile LAUNAY, MD, PhD study director
CIC Vaccinologie Cochin-Pasteur (CIC BT505) - Hôpital Cochin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prime-boost pneumococcal immunization in people with Splenectomized Patients, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 11 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: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects responsive to 9 of the 13 serotypes common (serotypes 1, 3, 6A, 7F, 9V, 14, 19A, 19F, 23F). (time frame: M3). 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 20 Nov 2025.