Advanced search
Start date
Betweenand
Related content
(Reference retrieved automatically from SciELO through information on FAPESP grant and its corresponding number as mentioned in the publication by the authors.)

Efficacy and safety of the Brazilian vaccine against Hepatitis B in newborns

Full text
Author(s):
Expedito José de Albuquerque Luna [1] ; José Cássio de Moraes [2] ; Lygia Silveira [3] ; Hilda Souza Neves Salinas [4]
Total Authors: 4
Affiliation:
[1] Universidade de São Paulo. Instituto de Medicina Tropical de São Paulo - Brasil
[2] Santa Casa de Misericórdia de São Paulo. Faculdade de Ciências Médicas. Departamento de Medicina Social - Brasil
[3] Santa Casa de Misericórdia de São Paulo. Faculdade de Ciências Médicas. Departamento de Medicina Social - Brasil
[4] Hospital Geral de Guarulhos - Brasil
Total Affiliations: 4
Document type: Journal article
Source: Revista de Saúde Pública; v. 43, n. 6, p. 1014-1020, 2009-12-18.
Field of knowledge: Health Sciences - Collective Health
Abstract

OBJECTIVE: To analyze the efficacy and safety of a recombinant Hepatitis B vaccine in newborns. METHODS: The study was carried out in a general hospital in the city of Guarulhos, Southeastern Brazil, between 2002 and 2005. The recombinant Hepatitis B vaccine from Instituto Butantan (VrHB-IB) was tested in two clinical trials. In both trials, newborns were randomly allocated to the experimental or control (reference vaccine) groups. Newborns were given three doses of vaccine, one up to 24 hours after birth and the other two 30 and 180 days later. In the first trial, 538 newborns completed the immunization protocol, and 486 in the second. Vaccines were considered equivalent when seroprotection difference was below 5%. RESULTS: Seroprotection in the first trial (anti-HBs > 10mUI/ml) was 92.5% (247/267) in the experimental group, compared to 98.5% (267/271) in the control (p = 0.001). With this result, VrHB-IB did not fulfill the pre-established criterion for equivalence. After increasing the concentration of antigen in the vaccine to 25¼g, seroprotection reached 100% in the experimental group and 99.2% in the control. No severe adverse effects were recorded. CONCLUSIONS: The reformulated VrHB-IB is considered equivalent to the reference vaccine, and its use is recommended in newborns. (AU)