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Published on: December 1, 2017
Comparison of two recombinant hepatitis B vaccines and their interchangeability in Argentine infants
Miguel Tregnaghi1, José Ussher, Ana María Baudagna
1Hospital Infantil Municipal de Córdoba, Centro de Desarrollo de Proyectos Avanzados, Córdoba, Córdoba, Argentina. miguelt@millicom.com.ar
Insights
Euvax-B and Engerix-B are comparable pediatric hepatitis B vaccines. Both are safe, immunogenic, and interchangeable for infant immunization programs.
Area of Science:
- Pediatrics
- Immunology
- Vaccinology
Background:
- Hepatitis B remains a significant global health concern, particularly in infants.
- Recombinant vaccines are crucial for preventing hepatitis B virus (HBV) infection.
- Assessing the immunogenicity and interchangeability of different vaccine formulations is vital for public health strategies.
Purpose of the Study:
- To compare the immunogenicity and reactogenicity of two pediatric recombinant hepatitis B vaccines: Engerix-B and Euvax-B.
- To evaluate the interchangeability of Euvax-B and Engerix-B in a three-dose vaccination schedule.
- To determine if a vaccination series initiated with Engerix-B can be completed with Euvax-B.
Main Methods:
- A randomized controlled trial involving three groups of 100 Argentine newborns each.
- Vaccination schedules included: three doses of Euvax-B, three doses of Engerix-B, or one dose of Engerix-B followed by two doses of Euvax-B.
- Immunogenicity assessed by seroprotection rates (anti-HBsAg >/= 10 mIU/mL) and reactogenicity by parental reporting of adverse events.
Main Results:
- Both vaccines demonstrated low reactogenicity across all groups.
- High seroprotection rates were observed shortly after the second dose (90.2%–95.9%) and universally after the third dose.
- Geometric mean concentrations of anti-HBsAg were robust in all groups post-vaccination.
Conclusions:
- Euvax-B is clinically identical (non-inferior) to Engerix-B in terms of immunogenicity and reactogenicity.
- Both vaccines are well-tolerated and highly immunogenic in infants.
- Euvax-B can be safely interchanged with Engerix-B, supporting flexible infant immunization schedules to meet WHO goals.
Objective:
To compare two pediatric recombinant hepatitis B vaccines-the Engerix-B reference vaccine and the Euvax-B vaccine-in terms of immunogenicity and reactogenicity, and also to investigate their interchangeability, that is, whether a three-dose hepatitis B vaccination schedule begun with a first dose of Engerix-B could be completed with two doses of Euvax-B.
Methods:
This study was conducted in the city of Córdoba, Argentina, from March 1999 through February 2000. Three groups of Argentine newborns (100 per group) were vaccinated at 0, 1, and 6 months of age with hepatitis B vaccine: group A, three doses of Euvax-B; group B, three doses of Engerix-B; and group C, one dose of Engerix-B followed by two doses of Euvax-B. Reactogenicity was evaluated based on parental reporting of any solicited local or systemic event occurring during the 7-day period following vaccination. Whether Euvax-B and Engerix-B were clinically identical was assessed in terms of the seroprotection rates (antibodies to hepatitis B surface antigen (anti-HBsAg) >/= 10 milli-international units per mL (mIU/mL) 2 months after the third vaccination).
Results:
Reactogenicity was low in all three groups. Five months after the second dose (that is, immediately prior to the third vaccination), seroprotection rates were 95.9%, 94.7%, and 90.2% for groups A, B, and C, respectively. Two months after the third dose all subjects were seroprotected, with geometric mean concentrations of anti-HBsAg of 2 468.1, 1 714.8, and 2 075.3 mIU/mL for groups A, B, and C, respectively.
Conclusions:
Both of the recombinant hepatitis B vaccines that we studied were well tolerated and highly immunogenic. Euvax-B was clinically identical (not inferior) to the EngerixB reference vaccine, and either vaccine could be used to achieve the World Health Organization goal of immunizing all infants against hepatitis B. Further, Euvax-B can be safely used in infants given an initial dose of either Euvax-B or Engerix-B.
