延长间隔的9vHPV疫苗两剂方案的免疫性和安全性
Nicola P Klein1, Amy Wiesner1, Oliver Bautista2
1Kaiser Permanente Vaccine Study Center, Kaiser Permanente Northern California, Oakland, California.
Pediatrics
|July 9, 2024
概括
将人乳头瘤病毒 (HPV) 疫苗接种间隔延长到一年以上,在青少年中维持了强烈的抗体反应. 这种灵活的剂量计划显示了有利的安全性,支持其可行性.
科学领域:
- 免疫学 免疫学 免疫学
- 疫苗学 疫苗学 疫苗学
- 青少年健康 青少年健康
背景情况:
- 九价人乳头瘤病毒 (9vHPV) 疫苗通常分为两个剂量,隔6-12个月.
- 9vHPV疫苗在青少年中延长剂量间隔 (≥1年) 的免疫性和安全性尚未得到充分证实.
研究的目的:
- 在青少年中评估9vHPV疫苗的免疫性和安全性,在第一剂和第二剂之间给予12至53个月的延长剂量间隔.
- 评估延长剂量间隔对针对疫苗向型HPV类型的抗体反应的影响.
主要方法:
- 一项开放性研究招募了146名年龄在10-15岁的青少年,他们接种了两剂9vHPV疫苗,第二剂接种后≥1年.
- 血清反应在基线 (剂量2前) 和剂量2后1个月使用竞争性Luminex免疫测试来测量.
- 使用回归建模来分析剂量间隔对几何平均标位 (GMT) 的影响,并监测不良事件.
主要成果:
- 参与者在接种疫苗剂量之间的中位时间间隔为25个月 (范围:12-53个月).
- 抗体几何平均标位 (GMT) 从基线增加到第二剂后1个月,观察到100%的血清阳性.
- 回归分析表明,剂量间隔 (12-53个月) 在接种疫苗后1个月对抗HPV的GMT没有显著影响.
- 最常见的不良事件是轻度至中度的注射部位反应;没有报告严重的不良事件.
结论:
- 将第一个和第二个9vHPV疫苗剂量之间的间隔延长到12-53个月不会影响抗体反应.
- 延长间隔治疗方案在青少年中显示出有利的安全性.
- 这些发现支持9vHPV疫苗延长间隔剂量计划的可行性和潜在实施.
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