Long-term efficacy and immune response of CoronaVac in Brazilian health care workers: Insights from PROFISCOV unblinded trial

IF 4.5 3区医学 Q2 IMMUNOLOGY

Vaccine Pub Date : 2025-07-28 DOI:10.1016/j.vaccine.2025.127527

Maria da Graça Salomão, Caroline de Almeida Leitão Curimbaba, Patrícia Emília Braga, João Italo Dias França, Elizabeth Gonzalez Patino, Fernanda Castro Boulos, José Alfredo de Sousa Moreira, PROFISCOV Study Group

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引用次数: 0

Abstract

Covid-19 remains a global threat due to vaccine-waning immune responses, and the need to update to emerging variants. This study presents the post-unblinding analysis of the PROFISCOV trial (NCT04456595), a double-blind, randomized, placebo-controlled phase 3, among adult healthcare workers (HCWs≥18y). A cohort (N = 12,688) was randomized to receive a two-dose regimen of the inactivated COVID-19 vaccine (CoronaVac) or placebo (1:1), 14 days apart. ANVISA granted emergency use authorization for CoronaVac in January 2021, prompting the study's unblinding. Outcomes included incidence of symptomatic confirmed COVID-19 cases (RT-PCR), immune response over one year, and effects of boosters among the vaccinees. Population (N = 1554) exhibited a reduction in confirmed cases from November 2021, peaking from December 2021 to February 2022, when the Omicron wave prevailed. Mean IgG-RBD titres increased from baseline to the 52nd week. IgG-N titres peaked in the 13th week and declined. The homologous booster enhanced significantly the immune response compared to the heterologous one (Pfizer).

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CoronaVac在巴西医护人员中的长期疗效和免疫反应：来自PROFISCOV非盲试验的见解

由于疫苗免疫反应减弱，需要更新以应对新出现的变体，Covid-19仍然是全球威胁。本研究介绍了PROFISCOV试验（NCT04456595）的开盲后分析，这是一项双盲、随机、安慰剂对照的3期试验，在成年医护人员（HCWs≥18岁）中进行。一组队列（N = 12,688）随机接受两剂量的COVID-19灭活疫苗（CoronaVac）或安慰剂（1:1），间隔14天。ANVISA于2021年1月批准了CoronaVac的紧急使用授权，促使该研究解除了盲法。结果包括有症状的COVID-19确诊病例的发生率（RT-PCR）、一年以上的免疫反应以及疫苗接种者的增强剂效果。人口（N = 1554）从2021年11月开始确诊病例减少，在2021年12月至2022年2月欧米克隆波盛行期间达到高峰。平均IgG-RBD滴度从基线到第52周增加。IgG-N滴度在第13周达到峰值后逐渐下降。与异种增强剂相比，同源增强剂显著增强了免疫应答（辉瑞）。

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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