Přestože první pneumokokové celobuněčné očkovací látky byly vyvinuty již počátkem 20. století, konjugované vakcíny, které jsou účinné u kojenců a batolat mladších 2 let, byly do klinické praxe uvedeny až v roce 2000. V současné době je k dispozici 10valentní vakcína Synflorix a 13valentní vakcína Prevenar 13. Desetivalentní pneumokoková konjugovaná vakcína obsahuje polysacharidové antigeny sérotypů 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F a 23F, z nichž osm je konjugováno k proteinu D H. influenzae a sérotypy 18C a 19F k tetanickému a difterickému toxoidu. Vakcína je indikována k aktivní imunizaci proti invazivním pneumokokovým onemocněním, pneumonii a akutnímu zánětu středouší, které jsou vyvolány sérotypy zastoupenými ve vakcíně, u dětí od 6 týdnů do 5 let věku. Předregistrační studie byly založeny na hodnocení protilátkové odpovědi a jejím srovnání s užívanou 7valentní vakcínou. Předkládaný přehledový článek uvádí výsledky klinických randomizovaných kontrolovaných studií (FinIP, COMPAS) a neintervenčních studií z postmarketingového sledování. Publikovaná data potvrzují, že vakcína je účinná nejen v prevenci závažných invazivních pneumokokových onemocnění, ale i podstatně častějších slizničních infekcí, jakými jsou akutní otitida či pneumonie. Vakcína má velmi dobrý bezpečnostní profil a četnost lokálních i systémových reakcí po její aplikaci se významněji neodlišuje od jiných pneumokokových vakcín.
Pneumococcal whole-cell vaccines have been developed in the early 1900s, however, pneumococcal conjugated vaccines (PCV), which are effective in infants and children under two years of age, have been introduced in 2000. There are two PCVs available: a 10-valent (Synflorix) and a 13-valent vaccine (Prevenar 13). The 10-valent pneumococcal conjugated vaccine (PHiD-CV) includes polysaccharide antigens of the following serotypes: 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F; eight of which are conjugated to protein D of H. influenzae and serotypes 18C and 19F are conjugated to tetanus or diphtheria toxoids. PHiD-CV is approved for active immunization against invasive pneumococcal diseases, pneumonia and acute otitis media caused by serotypes of S. pneumoniae included in the vaccine in children from 6 weeks to 5 years of age. Pre-licensure studies evaluated immune response to the vaccine and compared its immunogenicity with PCV7. This review includes the results of recently published clinical randomized controlled trials (FinIP, COMPAS) and non-interventional post-marketing studies. Published data confirm that PHiD-CV is effective in prevention of either severe invasive pneumococcal diseases or frequent superficial respiratory infections such as acute otitis media and pneumonia. The vaccine has a very good safety profile and incidence of local or systemic reactions after its administration is similar to other pneumococcal vaccines.
- Keywords
- Desetivalentní pneumokoková konjugovaná vakcína (Synflorix),
- MeSH
- Clinical Trials as Topic * MeSH
- Humans MeSH
- Otitis diagnosis etiology prevention & control MeSH
- Pneumococcal Infections prevention & control MeSH
- Pneumococcal Vaccines * administration & dosage adverse effects therapeutic use MeSH
- Pneumonia, Pneumococcal prevention & control MeSH
- Statistics as Topic MeSH
- Streptococcus pneumoniae isolation & purification pathogenicity MeSH
- Vaccines, Conjugate * adverse effects therapeutic use MeSH
- Check Tag
- Humans MeSH
- Publication type
- Review MeSH
The global burden of disease due to Streptococcus pneumoniae remains high. The licensed 7-valent pneumococcal conjugate vaccine (7vCRM, Prevenar/Prevnar) has successfully reduced invasive disease in the USA, but serotype coverage is incomplete and some evidence suggests that serotype replacement has occurred. Recently, a new 10-valent pneumococcal nontypeable Haemophilus influenzae (NTHi) protein D (PD) conjugate vaccine (PHiD-CV, Synflorix) has been licensed in more than 40 countries, including Europe, for the prevention of invasive disease and acute otitis media (AOM) due to pneumococcus in infants and children. PHiD-CV is immunogenic in infants when administered as a three-dose primary vaccination in a range of schedules and has a safety profile comparable to that of 7vCRM. Additional serotypes in PHiD-CV (1, 5 and 7F) increase overall serotype coverage and improve coverage in specific age groups and against specific disease syndromes. The use of the PD carrier, which provided protection against AOM caused by NTHi in a large efficacy trial testing a prototype of the final vaccine formulation, suggests that PHiD-CV will also provide some protection against AOM due to NTHi.
- MeSH
- Haemophilus influenzae immunology MeSH
- Haemophilus Vaccines immunology adverse effects MeSH
- Infant MeSH
- Vaccines, Combined immunology adverse effects MeSH
- Humans MeSH
- Pneumococcal Vaccines immunology adverse effects MeSH
- Child, Preschool MeSH
- Immunization, Secondary methods MeSH
- Streptococcus pneumoniae immunology MeSH
- Vaccination methods MeSH
- Vaccines, Conjugate immunology adverse effects MeSH
- Check Tag
- Infant MeSH
- Humans MeSH
- Male MeSH
- Child, Preschool MeSH
- Female MeSH
- Publication type
- Review MeSH
- Geographicals
- Europe MeSH
- Publication type
- Meeting Abstract MeSH
- MeSH
- Child MeSH
- Clinical Trials as Topic MeSH
- Congresses as Topic MeSH
- Otitis diagnosis epidemiology etiology prevention & control MeSH
- Pneumococcal Infections diagnosis epidemiology prevention & control MeSH
- Pneumococcal Vaccines * administration & dosage therapeutic use MeSH
- Primary Prevention MeSH
- Streptococcus pneumoniae classification pathogenicity growth & development MeSH
- Vaccination MeSH
- Vaccines, Conjugate MeSH
- Check Tag
- Child MeSH
- Publication type
- Newspaper Article MeSH
Streptococcus pneumoniae je bezesporu jedním z nejdůležitějších patogenů uplatňujících se při vzniku pneumonie, meningitid, otitid či sepse v dětském věku. V současné době jsou v prevenci využívány prakticky pouze dva druhy konjugovaných vakcín – Prevenar a Synflorix. Článek shrnuje dosud publikovaná data týkající se jejich účinnosti a bezpečnosti na základě evidence based medicine.
Undoubtedly, Streptococcus pneumoniae is one of the most important pathogens causing pneumonia, meningitis, otitis or sepsis in children. Currently, there are two types of conjugate vaccines used as a prophylaxis in the Czech Republic – Prevenar and Synflorix. The article summarizes so far published data on their efficacy and safety.
- Keywords
- Synflorix,
- MeSH
- Infant MeSH
- Humans MeSH
- Otitis Media prevention & control MeSH
- Pneumococcal Infections prevention & control MeSH
- Pneumococcal Vaccines therapeutic use MeSH
- Vaccines, Conjugate MeSH
- Check Tag
- Infant MeSH
- Humans MeSH
- Publication type
- Newspaper Article MeSH
- Keywords
- Synflorix,
- MeSH
- Infant MeSH
- Humans MeSH
- Otitis Media drug therapy prevention & control MeSH
- Pneumococcal Infections prevention & control prevention & control therapy MeSH
- Pneumococcal Vaccines administration & dosage MeSH
- Streptococcus pneumoniae drug effects MeSH
- Vaccination standards adverse effects MeSH
- Vaccines, Conjugate MeSH
- Check Tag
- Infant MeSH
- Humans MeSH
- Publication type
- Review MeSH
