New vaccine strategy aims to shield spleenless adults from deadly infections
NCT ID NCT02052154
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a two-step vaccine approach in 70 adults who had their spleen removed. Participants received one shot of a conjugate vaccine followed by a second shot of a polysaccharide vaccine two months later. The goal was to see if this combination triggers a strong immune response against 9 types of pneumococcal bacteria that can cause serious infections. Results were measured by antibody levels in the blood one month after the second shot.
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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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70 people
The number who actually took part.
- Started
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Mar 2014
- Finished
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Apr 2019
- 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 to 75 years
- 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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) * 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)
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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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Service des Maladies Infectieuses et Tropicales - Centre d'Infectiologie Necker-Pasteur, IHU Imagine - Hôpital Necker-Enfants
Paris, 75015, France
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Other studies related to the condition(s) this trial covers.