BACKGROUND AND AIMS: The anamnestic response to a challenge dose of vaccine can assess immune memory and protection against hepatitis B infection. This study investigated responses to a challenge dose of monovalent hepatitis B vaccine in children immunised with three doses of either Hexavac or Infanrix-Hexa during infancy. METHODS: This open-label, randomised, controlled, four-arm study enrolled 410 healthy children aged 4-7 years who had received either Hexavac (n=201) or Infanrix-Hexa (n=209) at 3, 5 and 11 months of life. Children received a single intramuscular challenge dose of either hepatitis B vaccine, HBVaxPro (Hexavac, n=34; Infanrix-Hexa, n=28) or Engerix-B (Hexavac, n=167; Infanrix-Hexa, n=181). Hepatitis B surface antibody (anti-HBs) concentrations were measured before and 1 month after the challenge vaccine dose. The analysis was descriptive and no formal hypothesis was tested. RESULTS: One month post-challenge, 91.2% of children in the Hexavac group (95% confidence interval [CI] 86.3, 94.8) and 98.0% (95% CI 94.9, 99.4) in the Infanrix-Hexa group had anti-HBs concentrations ≥10 mIU/ml (primary endpoint). In a post hoc analysis, most children with pre-challenge anti-HBs concentration <10 mIU/ml achieved anti-HBs concentrations ≥10 mIU/ml (Hexavac group, 85.3% [95% CI 77.6, 91.2]; Infanrix-Hexa group, 91.9% [95% CI 78.1, 98.3]). Both challenge vaccines were well tolerated. CONCLUSIONS: These data suggest that immune memory persists for long-term (5 years) after a primary vaccination in infancy with a hexavalent vaccine (Hexavac or Infanrix-Hexa).
RCT Entities:
BACKGROUND AND AIMS: The anamnestic response to a challenge dose of vaccine can assess immune memory and protection against hepatitis B infection. This study investigated responses to a challenge dose of monovalent hepatitis B vaccine in children immunised with three doses of either Hexavac or Infanrix-Hexa during infancy. METHODS: This open-label, randomised, controlled, four-arm study enrolled 410 healthy children aged 4-7 years who had received either Hexavac (n=201) or Infanrix-Hexa (n=209) at 3, 5 and 11 months of life. Children received a single intramuscular challenge dose of either hepatitis B vaccine, HBVaxPro (Hexavac, n=34; Infanrix-Hexa, n=28) or Engerix-B (Hexavac, n=167; Infanrix-Hexa, n=181). Hepatitis B surface antibody (anti-HBs) concentrations were measured before and 1 month after the challenge vaccine dose. The analysis was descriptive and no formal hypothesis was tested. RESULTS: One month post-challenge, 91.2% of children in the Hexavac group (95% confidence interval [CI] 86.3, 94.8) and 98.0% (95% CI 94.9, 99.4) in the Infanrix-Hexa group had anti-HBs concentrations ≥10 mIU/ml (primary endpoint). In a post hoc analysis, most children with pre-challenge anti-HBs concentration <10 mIU/ml achieved anti-HBs concentrations ≥10 mIU/ml (Hexavac group, 85.3% [95% CI 77.6, 91.2]; Infanrix-Hexa group, 91.9% [95% CI 78.1, 98.3]). Both challenge vaccines were well tolerated. CONCLUSIONS: These data suggest that immune memory persists for long-term (5 years) after a primary vaccination in infancy with a hexavalent vaccine (Hexavac or Infanrix-Hexa).
Authors: Iman I Salama; Samia M Sami; Zeinab Nabil Ahmed Said; Manal H El-Sayed; Lobna A El Etreby; Thanaa M Rabah; Dalia M Elmosalami; Amany T Abdel Hamid; Somaia I Salama; Aida M Abdel Mohsen; Hanaa M Emam; Safaa M Elserougy; Amal I Hassanain; Naglaa F Abd Alhalim; Fatma A Shaaban; Samia A Hemeda; Nihad A Ibrahim; Ammal M Metwally Journal: World J Hepatol Date: 2015-10-08
Authors: Thomas G O'Connor; Jan A Moynihan; Peter A Wyman; Jennifer Carnahan; Gerry Lofthus; Sally A Quataert; Melissa Bowman; Mary T Caserta Journal: Dev Psychopathol Date: 2014-11
Authors: Iman I Salama; Samia M Sami; Safaa M Elserougy; Hanaa M Emam; Somaia I Salama; Hazem M Elhariri; Samia A Hemeda; Amal I Hassanain; Aida M Abdel Mohsen; Walaa A Fouad; Lobna A El Etreby; Zeinab N Said Journal: Oman Med J Date: 2020-09-30
Authors: Timo Vesikari; Jin Xu; David R Johnson; Jessie Hall; Tomáš Marček; Michelle G Goveia; Camilo J Acosta; Andrew Wen-Tseng Lee Journal: Hum Vaccin Immunother Date: 2019-11-05 Impact factor: 3.452
Authors: Samia M Sami; Iman I Salama; Ghada A Abdel-Latif; Lobna A El Etreby; Ahmed I Metwally; Naglaa F Abd El Haliem Journal: Open Access Maced J Med Sci Date: 2016-05-24