在墨西哥开展关于单剂量肌肉注射或鼻内注射 AVX/COVID-12 "Patria "重组新城疫病毒疫苗作为 COVID-19 异源加强剂的安全性和免疫原性的 II 期研究。

IF 4.5 3区医学 Q2 IMMUNOLOGY

Vaccine Pub Date : 2024-11-10 DOI:10.1016/j.vaccine.2024.126511

Constantino López-Macías , Martha Torres , Brenda Armenta-Copca , Niels H. Wacher , Laura Castro-Castrezana , Andrea Alicia Colli-Domínguez , Tania Rivera-Hernández , Alejandro Torres-Flores , Matilde Damián-Hernández , Luis Ramírez-Martínez , Georgina Paz-De la Rosa , Oscar Rojas-Martínez , Alejandro Suárez-Martínez , Gustavo Peralta-Sánchez , Claudia Carranza , Esmeralda Juárez , Horacio Zamudio-Meza , Laura E. Carreto-Binaghi , Mercedes Viettri , Damaris Romero-Rodríguez , Bernardo Lozano-Dubernard

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引用次数: 0

摘要

背景：COVID-19 疫苗在全球范围内的分布不均突出表明，迫切需要创新且具有成本效益的疫苗技术来解决接种不均的问题，并实现本地化生产。这对于实现和维持广泛的免疫力以及确保在中低收入国家（LMICs）未来的强化免疫活动中及时保护易感人群至关重要：为了满足这一需求，我们开展了一项 II 期临床试验，以评估本地生产的 AVX/COVID-12 "Patria"（AVX）疫苗作为加强剂量的安全性和免疫原性。该疫苗通过肌肉注射（IM）或鼻内注射（IN）给曾使用腺病毒载体、灭活病毒或基于 mRNA 的疫苗接种过严重急性呼吸系统综合征冠状病毒 2（SARS-CoV-2）的参与者。我们纳入了初始抗穗IgG滴度低于1,200 U/mL的参与者，以便观察疫苗接种引起的增效作用：结果：使用 AVX 进行 IM 和 IN 免疫接种均安全且耐受性良好。疫苗诱导的针对武汉祖毒株和相关变异株（VOCs）（包括 Alpha、Beta、Delta 和 Omicron（BA.2 和 BA.5））的中和抗体显著增加（>2.5 倍）。细胞产生的γ干扰素（IFN-γ）增加进一步支持了这种免疫反应，显示了一种强健的、多方面的免疫反应：结论：通过 IM 或 IN 途径注射 AVX 作为加强剂量是安全和耐受性良好的。该疫苗不仅能增强针对武汉-1 祖毒株的免疫反应，还能增强针对各种挥发性有机化合物的免疫反应。其增强原有免疫反应的能力表明，它可能有助于扩大和维持人群的群体免疫力。

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Phase II study on the safety and immunogenicity of single-dose intramuscular or intranasal administration of the AVX/COVID-12 “Patria” recombinant Newcastle disease virus vaccine as a heterologous booster against COVID-19 in Mexico

Background

The global inequity in the distribution of COVID-19 vaccines underscores the urgent need for innovative and cost-effective vaccine technologies to address access disparities and implement local manufacturing capabilities. This is essential for achieving and sustaining widespread immunity, and for ensuring timely protection of vulnerable populations during future booster campaigns in lower- middle income countries (LMICs).

Methods

To address this need, we conducted a phase II clinical trial to evaluate the safety and immunogenicity of the locally manufactured AVX/COVID-12 “Patria” (AVX) vaccine as a booster dose. The vaccine was administered either intramuscularly (IM) or intranasally (IN) to participants who had previously completed a vaccination regimen for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using adenoviral vector, inactivated virus, or mRNA-based vaccines. Participants with initial anti-spike IgG titers below 1,200 U/mL were included, allowing us to observe the booster effect induced by vaccination.

Results

Both IM and IN immunization with AVX were found to be safe and well-tolerated. The vaccine induced a significant (>2.5-fold) increase in neutralizing antibodies against the ancestral Wuhan strain and variants of concern (VOCs), including Alpha, Beta, Delta, and Omicron (BA.2 and BA.5). This immune response was further supported by increased cellular production of interferon-gamma (IFN-γ), demonstrating a robust and multifaceted immune reaction.

Conclusions

The administration of AVX as a booster dose, whether through IM or IN routes, was safe and well-tolerated. The vaccine extended immune responses not only against the ancestral Wuhan-1 strain but also against various VOCs. Its ability to enhance preexisting immune responses suggests a potential contribution to expanding and sustaining herd immunity within the population.

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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

期刊介绍： Vaccine is unique in publishing the highest quality science across all disciplines relevant to the field of vaccinology - all original article submissions across basic and clinical research, vaccine manufacturing, history, public policy, behavioral science and ethics, social sciences, safety, and many other related areas are welcomed. The submission categories as given in the Guide for Authors indicate where we receive the most papers. Papers outside these major areas are also welcome and authors are encouraged to contact us with specific questions.