与 HIV 疫苗试验网络 702 中研究性 HIV 疫苗方案的不良反应相关的因素。
Factors associated with reactogenicity to an investigational HIV vaccine regimen in HIV vaccine trials network 702.
机构信息
Johns Hopkins Research Project, P.O Box 1131, Blantyre, Malawi.
Fred Hutchinson Cancer Center, P.O Box 19024, Seattle, WA 98109-1024, USA.
出版信息
Vaccine. 2024 Aug 13;42(20):125991. doi: 10.1016/j.vaccine.2024.05.039. Epub 2024 May 21.
BACKGROUND
Reactogenicity informs vaccine safety, and may influence vaccine uptake. We evaluated factors associated with reactogenicity in HVTN 702, a typical HIV vaccine efficacy trial with multiple doses and products.
METHODS
HVTN 702, a phase 2b/3 double-blind placebo-controlled trial, randomized 5404 African participants aged 18-35 years without HIV to placebo, or ALVAC-HIV (vCP2438) at months 0, 1 and ALVAC-HIV (vCP2438) + Bivalent Subtype C gp120/MF59 at months 3, 6, 12 and 18. Using multivariate logistic regression, we evaluated associations between reactogenicity with clinical, sociodemographic and laboratory variables.
RESULTS
More vaccine than placebo-recipients reported local symptoms (all p < 0.001), arthralgia (p = 0.008), chills (p = 0.012) and myalgia (p < 0.001). Reactogenicity was associated with female sex at birth (OR = 2.50, OR = 1.81, both p < 0.001) and geographic region. Amongst vaccine-recipients, each year of age was associated with 3 % increase in reactogenicity (OR = 1.03, p = 0.002).
CONCLUSION
Vaccine receipt, female sex at birth, older age, and region may affect reactogenicity.
背景
疫苗接种反应性可反映疫苗安全性，可能会影响疫苗接种率。我们评估了 HVTN 702 中与疫苗接种反应性相关的因素，这是一项具有多剂次和多种产品的典型 HIV 疫苗功效试验。
方法
HVTN 702 是一项 2b/3 期、双盲、安慰剂对照试验，将 5404 名无 HIV 的 18-35 岁非洲参与者随机分为安慰剂组或 ALVAC-HIV（vCP2438）组，于 0、1 月和 ALVAC-HIV（vCP2438）+二价 C 型 gp120/MF59 组，于 3、6、12 和 18 月。我们采用多变量逻辑回归，评估了疫苗接种反应性与临床、社会人口学和实验室变量之间的关系。
结果
与安慰剂组相比，更多的疫苗接种者报告了局部症状（均 p<0.001）、关节痛（p=0.008）、寒战（p=0.012）和肌痛（p<0.001）。疫苗接种反应性与出生时的女性性别（OR=2.50，OR=1.81，均 p<0.001）和地理位置有关。在疫苗接种者中，每增加一岁，反应性增加 3%（OR=1.03，p=0.002）。
结论
疫苗接种、出生时的女性性别、年龄较大和地理位置可能会影响疫苗接种反应性。
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