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29E群脑膜炎球菌结合疫苗在成人中的安全性和免疫原性。

Safety and immunogenicity of a group 29E meningococcal capsular polysaccharide vaccine in adults.

作者信息

Griffiss J M, Brandt B L, Altieri P L, Pier G B, Berman S L

出版信息

Infect Immun. 1983 Jan;39(1):247-52. doi: 10.1128/iai.39.1.247-252.1983.

Abstract

A serogroup 29E Neisseria meningitidis capsular polysaccharide vaccine at a dose of 50 micrograms was injected subcutaneously into 10 adult human volunteers. One vaccinate experienced a mild systemic reaction; one complained of moderate to severe local pain and tenderness. The vaccine induced significant homologous binding and bactericidal antibody by 2 weeks and significant binding antibody against the heterologous serogroup Z capsular polysaccharide by 4 weeks. Although binding antibody rose during the first 4 weeks and then declined slowly over the subsequent 4 months, bactericidal antibody response declined substantially by 4 and 8 weeks for both polysaccharides. The increase in group 29E bactericidal activity was no longer significant at 4 and 8 weeks; loss of bactericidal activity against group Z was significant by 8 weeks. Bactericidal activity again rose between 8 and 26 weeks, becoming significantly increased over prevaccination levels for group 29E and increased, though not significantly (P = 0.085), over prevaccination levels for group Z. As a result of the failure of induced antibody to increase bactericidal activity, only 40% of vaccinates achieved a greater than 2 log2 increase in lytic activity against group 29E, and none achieved this large an increase in lytic activity against group Z.

摘要

将剂量为50微克的29E群脑膜炎奈瑟菌荚膜多糖疫苗皮下注射到10名成年志愿者体内。一名接种者出现轻度全身反应;一名接种者抱怨有中度至重度的局部疼痛和压痛。疫苗在2周时诱导出显著的同源结合抗体和杀菌抗体,在4周时诱导出针对异源Z群荚膜多糖的显著结合抗体。虽然结合抗体在最初4周内上升,随后在接下来的4个月内缓慢下降,但两种多糖的杀菌抗体反应在4周和8周时大幅下降。29E群杀菌活性在4周和8周时不再显著;针对Z群的杀菌活性在8周时显著丧失。杀菌活性在8至26周之间再次上升,29E群的杀菌活性显著高于接种前水平,Z群的杀菌活性虽未显著高于接种前水平(P = 0.085),但有所增加。由于诱导抗体未能提高杀菌活性,只有40%的接种者对29E群的裂解活性有大于2 log2的增加,且无人对Z群的裂解活性有如此大幅度的增加。

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