López Pio, Rubiano Luisa, del Pilar Rubio Maria, David Marie-Pierre, Safary Assad
Universidad del Valle-Cali, Centro Materno Infantil Los Farallones, Colombia.
Expert Rev Vaccines. 2002 Oct;1(3):277-83. doi: 10.1586/14760584.1.3.277.
To evaluate, in an open study, the immunogenicity, safety and reactogenicity of a birth dose of hepatitis B vaccine followed by a three-dose course of diphtheria-tetanus whole-cell pertussis-hepatitis B vaccine, extemporaneously mixed with Haemophilus influenzae b (Hib) vaccine.
At 2, 4 and 6 months of age, a single group of 120 Colombian infants were enrolled in this study to receive a regimen consisting of three doses of the combination vaccine following a dose of hepatitis B vaccine at birth.
Seroprotection/vaccine response rates to all vaccine antigens was 98-100% 1 month after completion of the full vaccination course. The vaccine had an acceptable reactogenicity profile and the incidence of reported local and general symptoms decreased with the administration of subsequent vaccine doses.
The mixed DTPw-HB/Hib vaccine was safe and well-tolerated, with high immunogenicity against all component antigens. Compared with previous studies, reactogenicity did not increase with the additional dose of hepatitis B vaccine given at birth. The DTPw-HB/Hib combination can be used to provide primary vaccination of infants who have already received a first dose of hepatitis B vaccine at birth.
在一项开放性研究中，评估出生剂量乙肝疫苗，随后接种一剂由白喉-破伤风全细胞百日咳-乙肝疫苗与b型流感嗜血杆菌（Hib）疫苗临时混合而成的疫苗的免疫原性、安全性和反应原性。
在2、4和6月龄时，一组120名哥伦比亚婴儿入组本研究，在出生时接种一剂乙肝疫苗后，接受三剂联合疫苗的接种方案。
在完成全程疫苗接种后1个月，对所有疫苗抗原的血清保护/疫苗应答率为98%-100%。该疫苗具有可接受的反应原性特征，且随着后续疫苗剂量的接种，报告的局部和全身症状发生率降低。
白喉-破伤风全细胞百日咳-乙肝/Hib混合疫苗安全且耐受性良好，对所有组分抗原具有高免疫原性。与既往研究相比，出生时额外接种一剂乙肝疫苗并未增加反应原性。白喉-破伤风全细胞百日咳-乙肝/Hib联合疫苗可用于为已在出生时接种第一剂乙肝疫苗的婴儿提供基础免疫。
