PubMed Health⌕ Search

Biomedical subjects

B Zambrano

Publications and source records attributed to B Zambrano.

3 recordsLinked to original sources
PubMed2006

Hepatitis A vaccination of Argentinean infants: comparison of two vaccination schedules.

BACKGROUND: Early immunization to protect infants against hepatitis A (HA) is recommended in intermediate or high endemic areas of the world, but little is known of the effects of maternal antibodies on the immune response. We studied the immunogenicity and reactogenicity of an inactivated HA vaccine administered in two different schedules to 2-month-old infants in an intermediate/high endemic area in Argentina. METHODS: In this double-blind, randomized study 131 infants received either three doses (at 2, 4, 6 months of age [Group A]) or one dose (at 6 months of age [Group B]) of the pediatric inactivated HA vaccine, Avaxim 80, and a booster dose at 15-18 months. HAV antibodies were measured (ELISA) at 2, 7, 15-18 and 16-19 months of age. Immediate (30 min after injection) and solicited local and systemic reactions were recorded for 7 days after each injection. RESULTS: Of 107/131 subjects (81.6%) who completed the study and who provided final serum samples after booster dose, 94 (87.8%) were seropositive at enrolment (>20 mIU/mL) with geometric mean concentrations (GMC) of 2989 and 3637 mIU/mL in Groups A and B, respectively. One month post-booster GMCs were 8236 mIU/ml (95% CI; 6304, 10760) and 1687 mIU/ml (1148, 2479) in Groups A and B, respectively, with 100% seroprotection. CONCLUSIONS: The HA vaccine was well tolerated and induced immunological priming in both groups during the first year of life in spite of the presence of maternal antibodies. Post-booster GMCs achieved after one or three primary doses suggest a long-term protection against HA.

Argentina↗
PubMed1999

Safety, immunogenicity and antibody persistence of an inactivated hepatitis A vaccine in 4 to 15 year old children.

Among 277 healthy Venezuelan children, aged between 4 and 15 years, who were screened for hepatitis A virus (HAV) antibodies, 118 seronegative children were enrolled in an open study. Each child received one dose of the Pasteur Mérieux Connaught inactivated hepatitis A vaccine (AVAXIM¿trade mark omitted¿, 160 antigen units), followed by a booster dose 24 weeks later. All seronegative subjects seroconverted 2 weeks after immunisation (antibody titres greater, similar20 mIU/ml), and antibody titres were still over greater, similar20 mIU/ml after 24 weeks, at the moment of the booster dose. The anti-HAV antibody geometric mean titre (GMT), as measured by a modified radio-immunoassay (HAVAB(R), Abbott Laboratories, North Chicago, IL, USA), was 73.7 mIU/ml, 2 weeks after the first dose. Four weeks after the booster, the GMT value reached 6999 mIU/ml, representing a 29.6-fold rise from pre-booster levels. One year after the booster dose, the GMT value was 1673 mIU/ml in the 92 subjects who provided blood samples at this time, all of whom were still seroconverted ( greater, similar20 mIU/ml). No serious adverse event related to the vaccination occurred during the study. No immediate systemic reaction occurred. Local reactions were reported by 9.3% of subjects who received the primary injection and 5.5% of those given the booster dose. The systemic reactions were mainly fever and myalgia reported over the 7 days following the injection by 3.4% of subjects after the first dose and 5.5% of subjects after the booster dose. A clinically significant elevation of serum transaminase from pre-immunisation levels was noted in one subject (AST level 2.2 times the upper normal limit) 2 weeks after the first injection, although this was not associated with any clinical signs of impaired liver function. This trial demonstrated that AVAXIM¿trade mark omitted¿ containing 160 antigen units is safe and highly immunogenic in healthy children aged between 4 and 15 years, and could be included in the childhood vaccination schedule to control infection in areas endemic for hepatitis A.

Adolescent↗