(BIPAS) A prospective trial to assess Pneumococcal vaccine B cell response in patients without a spleen: a controlled study.

Conditions

Asplenia

Brief summary

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.

Detailed description

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, 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, 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, Mean fold change of PS specific IgG GMCs 2-3 weeks after PCV21 vaccination, for PS unique in PCV21.

Related papers

No related papers found yet.

Interventions

DRUGCAPVAXIVE solution for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (21-valent)

DRUGPrevenar 20 suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (20-valent

DRUGadsorbed)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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, 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, 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, Mean fold change of PS specific IgG GMCs 2-3 weeks after PCV21 vaccination, for PS unique in PCV21.	—

Measure

Time frame

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, 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, 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, Mean fold change of PS specific IgG GMCs 2-3 weeks after PCV21 vaccination, for PS unique in PCV21.

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Countries

Netherlands

Outcome results

None listed