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Immunogenicity and safety of a pediatric dose of a virosomal hepatitis A vaccine in healthy children in India.
Hum Vaccin Immunother. 2014; 10(7):2089-97.HV

Abstract

As India is transitioning from high to intermediate hepatitis A endemicity, the need for hepatitis A vaccination programs increases. This study investigated the immunogenicity and safety of a virosomal hepatitis A vaccine (HAVpur Junior) compared with an aluminum-adsorbed hepatitis A vaccine (Havrix 720 Junior) in Indian children. Healthy children aged 18-47 months, stratified by age, were randomized to either HAVpur Junior or Havrix 720 Junior. The first dose of vaccine was administered on Day 1 and the second (booster) dose 6 months later. Antibodies against hepatitis A virus (HAV) were measured using a microparticle enzyme immunoassay. The primary objective assessed non-inferiority of HAVpur Junior to Havrix 720 Junior in terms of seroprotection rates (≥ 10 mIU/mL anti-HAV antibodies) at 1 month after the first vaccination. Non-inferiority was demonstrated if the lower limit of the 90% confidence interval of the group difference was greater than -10%. Local and systemic adverse events were recorded. The seroprotection rate at 1 month was 95.9% in the HAVpur Junior group and 96.6% in the Havrix 720 Junior group. As the lower limit of the 90% confidence interval of the group difference was greater than -10% (-4.7), non-inferiority of HAVpur Junior to Havrix 720 Junior was established. The overall incidence of adverse events (solicited and unsolicited) after each vaccination was similar in both groups. In conclusion, the aluminum-free virosomal vaccine HAVpur Junior induced a similar immune response to Havrix 720 Junior in healthy Indian children aged 18 to 47 months. Both vaccines were well tolerated. The study shows that the low-dose virosomal HAV vaccine is consistently efficacious and well tolerated in children of all age groups and is suitable for inclusion into Indian childhood vaccination schedules.

Authors+Show Affiliations

a MGM Medical College & Chacha Nehru Bal Chikitsalay; Indore, India.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase IV
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25424821

Citation

Jain, Hemat, et al. "Immunogenicity and Safety of a Pediatric Dose of a Virosomal Hepatitis a Vaccine in Healthy Children in India." Human Vaccines & Immunotherapeutics, vol. 10, no. 7, 2014, pp. 2089-97.
Jain H, Kumavat V, Singh T, et al. Immunogenicity and safety of a pediatric dose of a virosomal hepatitis A vaccine in healthy children in India. Hum Vaccin Immunother. 2014;10(7):2089-97.
Jain, H., Kumavat, V., Singh, T., Versteilen, A., & Sarnecki, M. (2014). Immunogenicity and safety of a pediatric dose of a virosomal hepatitis A vaccine in healthy children in India. Human Vaccines & Immunotherapeutics, 10(7), 2089-97. https://doi.org/10.4161/hv.28631
Jain H, et al. Immunogenicity and Safety of a Pediatric Dose of a Virosomal Hepatitis a Vaccine in Healthy Children in India. Hum Vaccin Immunother. 2014;10(7):2089-97. PubMed PMID: 25424821.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Immunogenicity and safety of a pediatric dose of a virosomal hepatitis A vaccine in healthy children in India. AU - Jain,Hemat, AU - Kumavat,Vandana, AU - Singh,Tejinder, AU - Versteilen,Amanda, AU - Sarnecki,Michal, PY - 2014/11/27/entrez PY - 2014/11/27/pubmed PY - 2016/2/24/medline KW - HAV vaccine KW - India KW - immunogenicity KW - pediatric KW - safety KW - virosomes SP - 2089 EP - 97 JF - Human vaccines & immunotherapeutics JO - Hum Vaccin Immunother VL - 10 IS - 7 N2 - As India is transitioning from high to intermediate hepatitis A endemicity, the need for hepatitis A vaccination programs increases. This study investigated the immunogenicity and safety of a virosomal hepatitis A vaccine (HAVpur Junior) compared with an aluminum-adsorbed hepatitis A vaccine (Havrix 720 Junior) in Indian children. Healthy children aged 18-47 months, stratified by age, were randomized to either HAVpur Junior or Havrix 720 Junior. The first dose of vaccine was administered on Day 1 and the second (booster) dose 6 months later. Antibodies against hepatitis A virus (HAV) were measured using a microparticle enzyme immunoassay. The primary objective assessed non-inferiority of HAVpur Junior to Havrix 720 Junior in terms of seroprotection rates (≥ 10 mIU/mL anti-HAV antibodies) at 1 month after the first vaccination. Non-inferiority was demonstrated if the lower limit of the 90% confidence interval of the group difference was greater than -10%. Local and systemic adverse events were recorded. The seroprotection rate at 1 month was 95.9% in the HAVpur Junior group and 96.6% in the Havrix 720 Junior group. As the lower limit of the 90% confidence interval of the group difference was greater than -10% (-4.7), non-inferiority of HAVpur Junior to Havrix 720 Junior was established. The overall incidence of adverse events (solicited and unsolicited) after each vaccination was similar in both groups. In conclusion, the aluminum-free virosomal vaccine HAVpur Junior induced a similar immune response to Havrix 720 Junior in healthy Indian children aged 18 to 47 months. Both vaccines were well tolerated. The study shows that the low-dose virosomal HAV vaccine is consistently efficacious and well tolerated in children of all age groups and is suitable for inclusion into Indian childhood vaccination schedules. SN - 2164-554X UR - https://www.unboundmedicine.com/medline/citation/25424821/Immunogenicity_and_safety_of_a_pediatric_dose_of_a_virosomal_hepatitis_A_vaccine_in_healthy_children_in_India_ L2 - https://www.tandfonline.com/doi/full/10.4161/hv.28631 DB - PRIME DP - Unbound Medicine ER -