Vaccine. 2013 Dec 9;31(51):6136-43. doi: 10.1016/j.vaccine.2013.06.081. Epub 2013 Jul 9.
The investigational AS04-adjuvanted herpes simplex virus type 2 (HSV-2) glycoprotein D (gD2) subunit prophylactic vaccine ('HSV vaccine'; GlaxoSmithKline Vaccines) has been shown to be well tolerated in adults, but limited data exist for pre-teen and adolescent girls, a likely target population. The primary objective of this study was to compare the occurrence of serious adverse events (SAEs) over 12 months between HSV vaccine recipients and saline recipients (placebo control group) in pre-teen and adolescent girls. The immunogenicity of the HSV vaccine was also assessed.
Healthy girls aged 10-17 years, stratified by age (10-15 years; 16-17 years), were randomised 2:1:1 to receive the HSV vaccine, a hepatitis A vaccine (Havrix™; HAV control) or placebo (saline) according to a 0-, 1-, 6-month schedule. Participants and study personnel not involved in the preparation or administration of vaccines were blinded to treatment. Safety and immunogenicity analyses were performed overall and by age (10-15 years; 16-17 years) and HSV serostatus.
No statistically significant difference in the percentage of subjects with SAEs was observed between the HSV and saline group, or between the HSV and pooled control (HAV and saline) groups. The HSV vaccine was well tolerated, although a higher incidence of solicited local symptoms was observed in the HSV group than in the control group. Neither age nor HSV serostatus at the time of study entry had an impact on the safety profile of this vaccine. The HSV vaccine was immunogenic regardless of pre-vaccination HSV serostatus. Higher anti-gD geometric mean concentrations were observed in HSV-1 seropositive participants than in HSV-1 seronegative participants.
The HSV vaccine had an acceptable safety profile, and was well tolerated and immunogenic when administered to girls aged 10-17 years regardless of age or HSV pre-vaccination serostatus.
研究性 AS04 佐剂单纯疱疹病毒 2 型（HSV-2）糖蛋白 D（gD2）亚单位预防性疫苗（“HSV 疫苗”；葛兰素史克疫苗）已被证明在成年人中具有良好的耐受性，但针对少女和青少年女孩（可能的目标人群）的有限数据。本研究的主要目的是比较 HSV 疫苗接种者和生理盐水接种者（安慰剂对照组）在少女和青少年女孩中 12 个月内严重不良事件（SAE）的发生情况。还评估了 HSV 疫苗的免疫原性。
10-17 岁健康女孩，按年龄（10-15 岁；16-17 岁）分层，按 0、1、6 个月的时间表以 2:1:1 的比例随机接受 HSV 疫苗、甲型肝炎疫苗（Havrix™；HAV 对照组）或安慰剂（生理盐水）。未参与疫苗制备或管理的参与者和研究人员对治疗情况不知情。进行了总体安全性和免疫原性分析，并按年龄（10-15 岁；16-17 岁）和 HSV 血清学状态进行了分析。
在 HSV 组和生理盐水组之间，或在 HSV 组和 pooled 对照组（HAV 和生理盐水）之间，未观察到 SAE 发生率的统计学显著差异。HSV 疫苗耐受性良好，尽管 HSV 组比对照组更常出现局部症状。在研究开始时的年龄或 HSV 血清学状态均不会影响该疫苗的安全性。无论接种前 HSV 血清学状态如何，HSV 疫苗都具有免疫原性。在 HSV-1 血清阳性参与者中观察到的抗-gD 几何平均浓度高于 HSV-1 血清阴性参与者。
HSV 疫苗具有可接受的安全性，在 10-17 岁女孩中接种时耐受性良好且具有免疫原性，无论年龄或 HSV 接种前血清学状态如何。
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