UnknownPhase 4

B Memory Cell Response to Vaccination With the 13-valent Pneumococcal Conjugate Vaccine in Asplenic Individuals

Greece37 participantsStarted 2010-10

Plain-language summary

The purpose of this study is to determine whether one dose of the 13-valent pneumococcal conjugate vaccine (PCV13) induces immunological memory in asplenic adults and whether previously administered immunizations with the 23-valent polysaccharide pneumococcal vaccine influence the cellular immune response to PCV13 in this group.

Who can participate

Age range18 Years – 60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Asplenia * β-thalassemia major * older than 18 years Exclusion Criteria: * no previously recorded allergy to PCV * no intravenous immunoglobulin (IVIG) given within the previous 6 months * no other vaccine given within the previous 6 months

What they're measuring

immunoglobulin G (IgG) B memory cell response one month post vaccination (measured by ELISpot)

Timeframe: One month post-PCV13

immunoglobulin M (IgM) B memory cell response one month post vaccination (measured by ELISpot)

Timeframe: one month post PCV13

Trial details

NCT IDNCT01846923

SponsorAghia Sophia Children's Hospital of Athens

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-02

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