Jiri Beran1, Olivier Van Der Meeren2, Maarten Leyssen3, Priya D'silva4. 1. Vaccination and Travel Medicine Centre, Hradec Kralove, Czech Republic. 2. GSK Vaccines, Wavre, Belgium. Electronic address: olivier.x.van-der-meeren@gsk.com. 3. GSK Vaccines, Wavre, Belgium. 4. GSK Pharmaceuticals, Mumbai, India.
Abstract
BACKGROUND: The exact duration of antibody persistence to hepatitis A and B and the need for booster dosing following primary immunisation remains undefined. A long-term study was designed to follow antibody persistence and immune memory on an annual basis for up to 15 years following vaccination during adolescence. METHODS: Subjects received a combined hepatitis A and B vaccine (Twinrix™, GSK Vaccines, Belgium) at 12-15 years of age, either as 2-dose of the adult formulation or 3-dose of the paediatric formulation. Blood samples were taken every year thereafter to assess antibody persistence and immune memory to hepatitis A and B. Antibodies to hepatitis A virus (anti-HAV) and hepatitis B surface antigen (anti-HBs) were measured at Years 11-15. At Year 15 immune memory was further assessed by measuring the anamnestic response to a challenge dose of the monovalent vaccine, which was administered to subjects whose antibody concentrations fell below the pre-defined cut-offs (anti-HAV: <15mIU/mL; anti-HBs: <10mIU/mL). RESULTS:209 subjects returned for follow-up at Year 15 of whom 162 were included in the long-term according-to-protocol immunogenicity cohort. All subjects remained seropositive for anti-HAV antibodies, while 81.1% and 81.8% still had anti-HBs antibodies ≥10mIU/mL in the 2- and 3-dose groups, respectively. Following hepatitis B vaccine challenge dose administration to 19 subjects, all except one in the 3-dose group, mounted a robust anamnestic response. The safety and reactogenicity profile of the hepatitis B challenge was consistent with previous experience. CONCLUSION: Immunity to hepatitis A and B persists 15 years after adolescent vaccination with a combined hepatitis A and B vaccine. Highly effective anamnestic response indicates that a booster dose should not be required for 15 years after primary vaccination. TRIAL REGISTRATION: http://www.clinicaltrials.govNCT00875485.
RCT Entities:
BACKGROUND: The exact duration of antibody persistence to hepatitis A and B and the need for booster dosing following primary immunisation remains undefined. A long-term study was designed to follow antibody persistence and immune memory on an annual basis for up to 15 years following vaccination during adolescence. METHODS: Subjects received a combined hepatitis A and B vaccine (Twinrix™, GSK Vaccines, Belgium) at 12-15 years of age, either as 2-dose of the adult formulation or 3-dose of the paediatric formulation. Blood samples were taken every year thereafter to assess antibody persistence and immune memory to hepatitis A and B. Antibodies to hepatitis A virus (anti-HAV) and hepatitis B surface antigen (anti-HBs) were measured at Years 11-15. At Year 15 immune memory was further assessed by measuring the anamnestic response to a challenge dose of the monovalent vaccine, which was administered to subjects whose antibody concentrations fell below the pre-defined cut-offs (anti-HAV: <15mIU/mL; anti-HBs: <10mIU/mL). RESULTS: 209 subjects returned for follow-up at Year 15 of whom 162 were included in the long-term according-to-protocol immunogenicity cohort. All subjects remained seropositive for anti-HAV antibodies, while 81.1% and 81.8% still had anti-HBs antibodies ≥10mIU/mL in the 2- and 3-dose groups, respectively. Following hepatitis B vaccine challenge dose administration to 19 subjects, all except one in the 3-dose group, mounted a robust anamnestic response. The safety and reactogenicity profile of the hepatitis B challenge was consistent with previous experience. CONCLUSION: Immunity to hepatitis A and B persists 15 years after adolescent vaccination with a combined hepatitis A and B vaccine. Highly effective anamnestic response indicates that a booster dose should not be required for 15 years after primary vaccination. TRIAL REGISTRATION: http://www.clinicaltrials.govNCT00875485.
Authors: Pierre Van Damme; Geert Leroux-Roels; P Suryakiran; Nicolas Folschweiller; Olivier Van Der Meeren Journal: Hum Vaccin Immunother Date: 2017-03-10 Impact factor: 3.452
Authors: Birgit Weinberger; Mariëlle C Haks; Roelof A de Paus; Tom H M Ottenhoff; Tanja Bauer; Beatrix Grubeck-Loebenstein Journal: Front Immunol Date: 2018-05-15 Impact factor: 7.561