Pneumoccocal vaccine response in patients without a spleen, vaccinated before or after spleen removal.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Leids Universitair Medisch Centrum (LUMC)

Participant type

Patients, Healthy volunteers

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01], Phenomena and Processes [G] - Immune system processes [G12], Diseases [C] - Immune System Diseases [C20]

Trial duration

7 Nov 2025 → ongoing

Decision date (initial)

2025-08-11

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Leiden University Medical Center

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis

To assess the impact of splenectomy on the induction of immunological memory after vaccination with PCV20 primary vaccination, measured as the serological response 3 week after booster vaccination with PCV21, in asplenic patients primed before or after splenectomy, for PS present in both vaccines (common serotypes).

Secondary objectives 5

1. To investigate whether the timing of primary vaccination (before or after splenectomy) affects the initial peak response (pneumococcal serotype (PS) specific IgG response and IgG memory B cell response), for PS present in both vaccines and PS unique in PCV21
2. To analyse the IgG GMC and IgG memory B cell response after booster, for PS present in both vaccines and PS unique in PCV21
3. To analyse longevity of primary response at 12 months for PS in PCV20 and of booster response at 6-12 months (IgG GMCs), for PS present in both vaccines and PS unique in PCV21
4. To correlate IgG GMCs and IgG memory B cell response after primary and booster, for PS present in both vaccines and PS unique in PCV21
5. To set up a spleen culture system to test antigen-specific responses in spleen tissue vitro

Conditions and MedDRA coding

Asplenia

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Patients with newly induced anatomical asplenia, of which the underlying cause can be: en-bloc splenectomy during pancreatic surgery because of pancreatic cancer or precancerous pancreatic lesions, or splenectomy for haematological diseases (thalassemia or sickle cell disease)
2. Patients scheduled for (en bloc) splenectomy, of which the underlying caused can be as prescribed above
3. Participants aged 18 years and older
4. Participants should have provided signed informed consent
5. Participants should be naïve for other PCVs, except for PCV20

Exclusion criteria 8

1. Known hypersensitivity or allergy to any vaccine component
2. Pregnancy during the entire course of the study
3. Documented active haematological malignancy
4. Documented primary coagulopathy
5. Ongoing B or T cell immune deficiency such as a primary immune disorder or secondary immune disorder, such as documented HIV infection
6. Current use of any immunosuppressive drug (except NSAIDs)
7. Acute febrile illness at time inclusion
8. Receipt of PPV23 in the past year

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Mean Fold change of PS specific IgG GMCs against PS present in PCV20 and PCV21 (common serotypes) 2-3 weeks after booster vaccination with PCV21, at least 12 months after primary vaccination with PCV20 in asplenic patients primed before or after splenectomy.

Secondary endpoints 4

1. Difference in height of PS-specific IgG GMCs and PS-specific IgG B cell response, % of participants with a >2 and >4 fold change 3 weeks after primary and 2-3 weeks after booster, compared to primary vaccination before and after splenectomy and with healthy controls, for PS present in both vaccines (common serotypes) and unique for PCV21
2. PS-specific IgM GMC persistence at 12 after primary and 6-12 months after booster, for PS present in both vaccines (common serotypes) and unique for PCV21
3. Correlation between IgG GMC height and PS-specific IgG memory B cell count 3 weeks after primary and 2-3 weeks after booster, for PS present in both vaccines (common serotypes) and unique for PCV21
4. Mean fold change of PS specific IgG GMCs 2-3 weeks after PCV21 vaccination, for PS unique in PCV21.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Leids Universitair Medisch Centrum (LUMC)

Sponsor organisation

Leids Universitair Medisch Centrum (LUMC)

Address

Albinusdreef 2

City

Leiden

Postcode

2333 ZA

Country

Netherlands

Scientific contact point

Organisation

Leids Universitair Medisch Centrum (LUMC)

Contact name

Principal Investigator

Public contact point

Organisation

Leids Universitair Medisch Centrum (LUMC)

Contact name

Principal Investigator

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications