Safety and Immunogenicity of Monovalent Omicron KP.2-Adapted BNT162b2 COVID-19 Vaccine in Adults: Single-Arm Substudy from a Phase 2/3 Trial.

IF 4.7 3区医学 Q1 INFECTIOUS DISEASES

Infectious Diseases and Therapy Pub Date : 2025-07-01 DOI:10.1007/s40121-025-01185-4

Oyeniyi Diya, Juleen Gayed, Francine S Lowry, Hua Ma, Vishva Bangad, Federico Mensa, Jing Zou, Xuping Xie, Yanping Hu, Mark Cutler, Todd Belanger, David Cooper, Xia Xu, Robin Mogg, Özlem Türeci, Uǧur Şahin, Kena A Swanson, Kayvon Modjarrad, Annaliesa S Anderson, Alejandra Gurtman, Nicholas Kitchin

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引用次数: 0

Abstract

Introduction: COVID-19 continues to cause substantial health burden, particularly among vulnerable populations. Vaccines remain a vital tool in preventing severe disease outcomes. As the causative pathogen, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to evolve; therefore, updates may be needed to closely match COVID-19 vaccine composition to predominant circulating lineages to confer optimal protection.

Methods: In this cohort from a substudy of an ongoing phase 2/3 trial, 102 healthy adults (18‒55 and > 55 years of age, n = 51 each) were vaccinated with Omicron KP.2-adapted BNT162b2. Serum neutralizing titers against Omicron KP.2, JN.1, and KP.3 were assessed before and through 1 month after vaccination. Immunogenicity in KP.2-adapted BNT162b2 recipients was compared with participants who received JN.1-adapted BNT162b2 in an earlier cohort of this substudy. Local reactions and systemic events through 7 days and adverse events (AEs) through 1 month are reported.

Results: One month after vaccination, KP.2-adapted BNT162b2-elicited neutralizing titers against Omicron KP.2, JN.1, and KP.3 were numerically higher than those induced by JN.1-adapted BNT162b2. Geometric mean fold rises from before to 1 month after vaccination were numerically higher in those who received KP.2-adapted BNT162b2 compared with those who received JN.1-adapted BNT162b2 (9.4 vs. 6.8 for KP.2; 7.8 vs. 5.7 for JN.1; 9.2 vs. 7.0 for KP.3). Percentages of participants with seroresponses were numerically higher against KP.2 after KP.2-adapted BNT162b2 than JN.1-adapted BNT162b2 (75% vs. 65%) and similar against JN.1 and KP.3 for both vaccines (69% vs. 67% for JN.1; 74% vs. 73% for KP.3). Local reactions and systemic events were all mild to moderate in severity, AEs were infrequent, and no serious AEs or AEs leading to withdrawal were reported.

Conclusions: Collectively, these immunogenicity, safety, and tolerability data support administration of KP.2-adapted BNT162b2 to protect against contemporaneous circulating lineages.

Clinicaltrials:

Gov identifier: NCT05997290.

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单价Omicron k2 -适应型BNT162b2成人COVID-19疫苗的安全性和免疫原性：来自2/3期试验的单组亚研究

导言：COVID-19继续造成巨大的健康负担，特别是在弱势人群中。疫苗仍然是预防严重疾病后果的重要工具。严重急性呼吸综合征冠状病毒2型（SARS-CoV-2）作为病原不断进化；因此，可能需要更新COVID-19疫苗组成，使其与主要流行谱系密切匹配，以提供最佳保护。方法：在一项正在进行的2/3期试验的亚研究中，102名健康成人（18-55岁和55岁，n = 51）接种了Omicron kp .2-适应型BNT162b2。在接种前和接种后1个月评估血清对欧米克隆蛋白KP.2、JN.1和KP.3的中和效价。在该亚研究的早期队列中，比较了适应kp .2的BNT162b2受体与接受适应jn .1的BNT162b2受体的免疫原性。7天的局部反应和全身事件以及1个月的不良事件（ae）报告。结果：接种1个月后，KP.2改编的BNT162b2诱导的对Omicron的KP.2、JN.1和KP.3的中和效价明显高于JN.1改编的BNT162b2。从疫苗接种前到接种后1个月，与接受jn1适应的BNT162b2组相比，接受KP.2适应的BNT162b2组的几何平均倍数上升幅度更高(9.4比6.8；7.8 vs. 5.7；9.2 vs. 7.0 KP.3)。与JN.1改编的BNT162b2相比，接受KP.2改编的BNT162b2后对KP.2的血清应答百分比更高（75%对65%），两种疫苗对JN.1和KP.3的血清应答百分比相似(69%对67%；（74% vs. 73%）。局部反应和全身事件的严重程度均为轻至中度，不良事件很少发生，未见严重不良事件或导致停药的不良事件的报道。结论：总的来说，这些免疫原性、安全性和耐受性数据支持给药kp - 2适应的BNT162b2来预防同期循环谱系。临床试验：政府标识符：NCT05997290。

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来源期刊

Infectious Diseases and Therapy Medicine-Microbiology (medical)

CiteScore

8.60

自引率

1.90%

发文量

136

审稿时长

6 weeks

期刊介绍： Infectious Diseases and Therapy is an international, open access, peer-reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of infectious disease therapies and interventions, including vaccines and devices. Studies relating to diagnostic products and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. Areas of focus include, but are not limited to, bacterial and fungal infections, viral infections (including HIV/AIDS and hepatitis), parasitological diseases, tuberculosis and other mycobacterial diseases, vaccinations and other interventions, and drug-resistance, chronic infections, epidemiology and tropical, emergent, pediatric, dermal and sexually-transmitted diseases.