Carniel E F, Morcillo A M, Blotta M H, Da Silva M T N, Mazzola T N, Antonio M A R G M, Zanolli M L, Netto A Aranha, Higashi H G, Raw I, Vilela M M S
Center for Investigation in Pediatrics, Pediatrics Department, State University of Campinas Medical School, Rua Tessália Vieira de Camargo, 126, Campinas, São Paulo, CEP 13083-887, Brazil.
Vaccine. 2008 Jan 30;26(5):647-52. doi: 10.1016/j.vaccine.2007.11.048. Epub 2007 Dec 7.
This randomized, prospective, non-inferiority study aimed to quantify anti-HBs titers induced by recombinant Hepatitis B vaccine from healthy infants vaccinated with combined Hepatitis B and Bacillus Calmette-Guérin (BCG) vaccines (HbsAg 10 microg plus BCG suspension 0.1mg) and compare them to titers obtained with separated vaccines. Infants were immunized at birth either with combined intradermal (ID) BCG and Hepatitis B or ID BCG alone and intramuscular (IM) Hepatitis B. Both groups received IM Hepatitis B at 1 and 6 months of age. After the third dose anti-HBs titers > or =10 IU/mL were observed in 99% of vaccinees and > or =1000 IU/mL in 71%. There were no adverse events in both groups. Combination of HbsAg with BCG as first dose did not modify the profile of the humoral immune response for Hepatitis B indicating safety and immunogenicity of this vaccine in newborn.
这项随机、前瞻性、非劣效性研究旨在量化接种重组乙型肝炎疫苗的健康婴儿中，由乙型肝炎疫苗与卡介苗（BCG）联合疫苗（乙肝表面抗原10微克加卡介苗悬液0.1毫克）诱导产生的抗-HBs滴度，并将其与单独接种疫苗所获得的滴度进行比较。婴儿在出生时接受皮内（ID）接种卡介苗和乙型肝炎联合疫苗，或仅皮内接种卡介苗并肌肉注射（IM）乙型肝炎疫苗。两组婴儿均在1月龄和6月龄时接受肌肉注射乙型肝炎疫苗。第三剂疫苗接种后，99%的接种者抗-HBs滴度≥10 IU/mL，71%的接种者抗-HBs滴度≥1000 IU/mL。两组均未出现不良事件。将乙肝表面抗原与卡介苗联合作为首剂疫苗，并未改变乙型肝炎体液免疫反应的特征，表明该疫苗在新生儿中具有安全性和免疫原性。
