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

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

Abstract

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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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。

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。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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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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