在 HIV 疫苗试验网络 702 中，与研究性 HIV 疫苗方案的致反应性相关的因素。

IF 4.5 3区医学 Q2 IMMUNOLOGY

Vaccine Pub Date : 2024-08-13 DOI:10.1016/j.vaccine.2024.05.039

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引用次数: 0

摘要

背景：致反应性为疫苗安全性提供了信息，并可能影响疫苗的接种率。方法：HVTN 702 是一项 2b/3 期双盲安慰剂对照试验，将 5404 名年龄在 18-35 岁、未感染 HIV 的非洲参与者随机分配到安慰剂或 ALVAC-HIV（vCP2438）（第 0、1 个月）以及 ALVAC-HIV (vCP2438) + Bivalent Subtype C gp120/MF59 （第 3、6、12 和 18 个月）。通过多变量逻辑回归，我们评估了反应发生率与临床、社会人口学和实验室变量之间的关系：结果：报告出现局部症状的疫苗接种者多于安慰剂接种者（所有 p v = 2.50，ORp = 1.81，均 p接种疫苗、出生时的女性性别、年龄较大和地区可能会影响反应性。

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Factors associated with reactogenicity to an investigational HIV vaccine regimen in HIV vaccine trials network 702

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_v = 2.50, OR_p = 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.

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来源期刊

Vaccine 医学-免疫学

CiteScore

8.70

自引率

5.50%

发文量

992

审稿时长

131 days

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