Immunogenicity and Safety of an Inactivated Hepatitis A Vaccine Given with Measles-Mumps-Rubella Vaccine to 12-13 Month Old Turkish Children
- *Corresponding Author:
- Kadriye YURDAKÖK
Pediatric Health and Diseases Department
Social Pediatrics Unit
Hacettepe University Faculty of Medicine, Ankara, Turkey
Tel: +90 312 305 11 33
Fax: +90 312 324 32 84
E-mail: [email protected]
Received date: September 10, 2012; Accepted date: September 20, 2012; Published date: September 25, 2012
Citation: YURDAKÖK K, BAKIR M, SOYSAL A, İNCE T, YALÇIN S, et al. (2012) Immunogenicity and Safety of an Inactivated Hepatitis A Vaccine Given with Measles-Mumps-Rubella Vaccine to 12-13 Month Old Turkish Children. J Vaccines Vaccin 3:146. doi:10.4172/2157-7560.1000146
Copyright: © 2012 YURDAKÖK K, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Background: The epidemiology of hepatitis A in Turkey favor routine vaccination of children. This study assessed compatibility of a monovalent hepatitis A vaccine with the measles-mumps-rubella (MMR) combination vaccine used in the national immunization calendar at 12-15 months of age. Methods: Hepatitis A seronegative participants were randomized equally to hepatitis A vaccine followed by MMR vaccine 28 days later (Group A), MMR vaccine followed by hepatitis A vaccine 28 days later (Group B), or one dose each of hepatitis A and MMR vaccines given on Day 0 (Group C). All participants received a hepatitis A booster dose 6 months later. Results: A total of 470 seronegative (anti-hepatitis A concentration ≥20 mIU/mL) participants were randomized: 188 to Group A, 94 to Group B and 188 to Group C. The hepatitis A seroprotection rates (≥20 mIU/mL), 1 month after the first vaccination were 93.6% (Group A) and 92.7% (Group C) by a microparticle enzyme immunoassay (MEIA). Using a more sensitive electrochemiluminescence immunoassay (ECLIA), the corresponding seropositivity rates were 100 and 99.4%. Non-inferiority of seroprotection against hepatitis A was demonstrated for concomitant versus non-concomitant vaccination using ECLIA, but not MEIA. After booster, all participants had anti-hepatitis titers ≥20 mIU/mL and anti-hepatitis geometric mean concentrations of 5,078 mIU/mL (Group A), 3,271 mIU/mL (Group B) and 4,314 mIU/mL (Group C). Following primary vaccination, measles (≥120 mIU/mL) and mumps (≥ 10 AU/mL) seroprotection rates were 96.5% with both separate and concomitant vaccination. The rubella seroprotection (≥ 10 AU/mL) rates were 97.6 and 96.7% following separate and concomitant vaccination, respectively. Reactogenicity increased slightly with concomitant administration; both vaccines were well tolerated. Conclusions: The immune response to the hepatitis A vaccine was not impaired by concomitant administration with MMR vaccine. Non-inferiority of seroprotection was demonstrated with the more sensitive of two assays used to evaluate anti-hepatitis A antibody.