Could a Two-Vaccine strategy better shield spleenless patients from pneumonia?
NCT ID NCT03873727
First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time
Summary
This trial investigates whether giving two different pneumonia vaccines—one followed by another a year later—boosts immune protection more than a single vaccine alone in adults who have had their spleen removed. People without a spleen are at higher risk for serious pneumococcal infections. The study compares a combined vaccine approach against the standard single vaccine, measuring antibody responses in blood samples.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Prevenar13 (PCV13) and Pneumovax (PPS23) vaccines
- What this could lead to
- If successful, this could establish a more effective revaccination schedule to better protect splenectomised patients from serious pneumococcal infections.
- What could go wrong
- This is a Phase 2 trial with only 39 participants, so results may not apply to all patients. The immune response measured may not translate to real-world infection prevention.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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39 people
The number who actually took part.
- Started
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Aug 2019
- Finished
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May 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥ 18 years 2. Splenectomised patients. 3. For patients not enrolled in SPLENEVAC clinical trial: presence of Jolly Body at blood smear and spelenectomy confirmation by abdominal ultrasound. 4. Vaccinated according to the schedule of SPLENEVAC clinical trial (PCV13 / PPS23 two months later (until +4 months)), enrolled or not from this study. Vaccination of PPS23 must have been administered 5 years - 6 months/+ 1 year before inclusion. 5. Patients will be followed during the 24 months from the inclusion visit. 6. Patients must give written informed consent prior to any trial procedure. 7. Women of childbearing age must have an effective contraception during the first 13 months of the study. 8. Patients must be covered by social security regimen or equivalent. Exclusion Criteria: 1. History of pneumococcal revaccination in the last five years. 2. Having received any another vaccines within 4 weeks prior to enrolment or who is planning to receive any vaccine (for example: ZOSTAVAX®) within the first 13 months of the study (excepted seasonal influenza vaccine which is permitted 4 weeks before and after each vaccination visit of the study and then allowed at any time during the study follow up. Furthermore, the vaccination against Sars-CoV-2 is allowed during the study with a minimum interval of 14 days between pneumococcal vaccine and Sars-Cov-2 vaccine injection) 3. History of known allergies to any component of both study vaccines (active substances, excipients or diphtheria toxoid). 4. History of anaphylactic reaction following vaccination. 5. Infusion of immunoglobulins within the three months preceding the inclusion. 6. Any pathology or condition that may impair the immune response, apart from splenectomy: immunosuppressive therapy in progress or in the 6 months prior to inclusion, hematopoietic stem cells allo / autograft, primary immunodeficiency, nephrotic syndrome, progressive neoplasia, evolutive cancer, cirrhosis, known infection to HIV and / or hepatitis B virus (HBV) (HBs Ag +) and / or hepatitis C virus (HCV), taking corticosteroids \> 10mg for more than 14 days within the month preceding the inclusion , inhaled corticosteroid and cutaneous topical being allowed. 7. Coagulation disorder contra-indicating intramuscularly injections. 8. Acute respiratory tract infection or severe acute febrile illness or systemic reaction which could represent a significant risk in case of vaccination within the month before inclusion. 9. Pregnancy, breastfeeding or positive pregnancy test up to 13 months after inclusion. 10. History of suspected or documented invasive pneumococcal infection within the year before inclusion. 11. Immunosuppressive factors associated. 12. Enrolment in any other clinical trial during the whole trial period except observational study. 13. Adults under protection
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CIC 1417 Cochin-Pasteur - GH Broca-Cochin-Hôtel-Dieu
Paris, 75014, France