A cohort study to evaluate persistence of hepatitis B immunogenicity after administration of hexavalent vaccines

BACKGROUND: In 2001, two hexavalent vaccines were licensed in Italy (Hexavac, Infanrix Hexa), and since 2002 were extensively used for primary immunization in the first year of life (at 3, 5, 11/12 months of age). In 2005, the market authorization of Hexavac was precautionary suspended by EMEA, because of doubts on long-term protection against hepatitis B virus. The objectives of this study were to evaluate the persistence of antibodies to anti-HBs, in children in the third year of life, and to investigate the response to a booster dose of hepatitis B vaccine.

METHODS: Participant children were enrolled concomitantly with the offering of anti-polio booster dose, in the third year of life. Anti-HBs titers were determined on capillary blood samples. A booster dose of hepatitis B vaccine was administered to children with anti-HBs titers < 10 mIU/ml, with the monovalent precursor product of the previously received hexavalent vaccine. HBsAb titers were tested again one month after the booster.

RESULTS: Sera from 113 children previously vaccinated with Hexavac, and from 124 vaccinated with Infanrix Hexa were tested for anti-HBs. Titers were > or = 10 mIU/ml in 69% and 96% (p < 0,0001) respectively. The proportion of children with titers > or = 100 mIU/ml did also significantly differ among groups (27% and 78%; p < 0,0001).Post-booster, 93% of children achieved titers > or = 10 mIU/ml, with no significant difference by vaccine group.

DISCUSSION: Fifteen months after third dose administration, a significant difference in anti-HBs titers was noted in the two vaccine groups considered. Monovalent hepatitis B vaccine administration in 3-year old children induced a proper booster response, confirming that immunologic memory persists in children with anti-HBs titers < 10 mIU/ml. However, long-term persistence of HBV protection after hexavalent vaccines administration should be further evaluated over time.

Medienart:

E-Artikel

Erscheinungsjahr:

2008

Erschienen:

2008

Enthalten in:

Zur Gesamtaufnahme - volume:8

Enthalten in:

BMC infectious diseases - 8(2008) vom: 28. Juli, Seite 100

Sprache:

Englisch

Beteiligte Personen:

Giambi, Cristina [VerfasserIn]
Bella, Antonino [VerfasserIn]
Barale, Antonella [VerfasserIn]
Montù, Domenico [VerfasserIn]
Marchisio, Maria [VerfasserIn]
Oddone, Maurizio [VerfasserIn]
Zito, Salvatore [VerfasserIn]
Rapicetta, Maria [VerfasserIn]
Chionne, Paola [VerfasserIn]
Madonna, Elisabetta [VerfasserIn]
Ciofi degli Atti, Marta L [VerfasserIn]

Links:

Volltext

Themen:

Comparative Study
Diphtheria-Tetanus-Pertussis Vaccine
Hepatitis B Antibodies
Hepatitis B Vaccines
Hexavac
Journal Article
Poliovirus Vaccine, Inactivated
Vaccines, Combined

Anmerkungen:

Date Completed 06.10.2008

Date Revised 20.10.2021

published: Electronic

Citation Status MEDLINE

doi:

10.1186/1471-2334-8-100

funding:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

NLM181216604