Immunogenicity and safety of ‘Comvigen’, a bivalent SARS-CoV-2 vaccine, in comparison to Comirnaty bivalent vaccine in Thailand: a phase 2, non-inferiority randomised trial

IF 6.2 Q1 HEALTH CARE SCIENCES & SERVICES

The Lancet regional health. Southeast Asia Pub Date : 2025-08-15 DOI:10.1016/j.lansea.2025.100650

Watsamon Jantarabenjakul , Rapisa Nantanee , Thanyawee Puthanakit , Sivaporn Gatechompol , Anchalee Avihingsanon , Suda Punrin , Terapong Tantawichien , Sorachai Nitayaphan , Arunee Thitithanyanont , Supranee Buranapraditkun , Anan Jongkaewwattana , Chutitorn Ketloy , Eakachai Prompetchara , Saranath Lawpoolsri , Wassana Wijagkanalan , Mohamad-Gabriel Alameh , Lina Hong , Mijo Samija , Drew Weissman , Kiat Ruxrungtham , Nanthida Wonglertnirant

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Abstract

Background

Strengthening mRNA vaccine development in LMICs is essential for enhancing global pandemic preparedness. This study evaluated the safety and immunogenicity of Comvigen, a bivalent SARS-CoV-2 vaccine, in comparison to the Comirnaty bivalent vaccine (Comirnaty).

Methods

This phase II, randomised, open-label, non-inferiority trial was conducted in Thailand across four centres. Participants (n = 450) were randomly assigned (2:1) to receive either Comvigen (50 μg) or Comirnaty (30 μg), using block randomisation (size = 9). Eligible participants had completed at least 2 doses of any approved COVID-19 vaccine, with the last mRNA-vaccine dose given over 3 months before enrolment. The non-inferiority margin of a geometric mean ratio (GMR) of 0.67. The primary immunogenicity endpoint was pseudovirus neutralisation titres (psVNT-50) against SARS-CoV-2 wild-type and Omicron BA.4/BA.5 at Day 29. Safety outcomes included local and systemic adverse reactions up to six months post-vaccination. Immunogenicity analyses were conducted on the Per-Protocol (PP) population and the modified Intent-to-Treat (mITT) population; safety analyses included all participants. Laboratory personnel were blinded to vaccine assignment (ClinicalTrials.gov: NCT05930730).

Findings

Between October and November 2023, 450 participants were enrolled (median age of 36 years, IQR 30–45). At day 29, the geometric mean titre (GMT) of psVNT-50 against wild-type virus increased from 475.9 to 2062.9 for Comvigen and from 458.8 to 1905.1 for Comirnaty (GMR 1.1, 95% CI: 1.0–1.2), meeting non-inferiority criteria. Against Omicron BA.4/BA.5, GMTs were 3909.8 for Comvigen and 3288.6 for Comirnaty (GMR 1.2, 95% 1.0–1.4). Local and systemic reactions were more frequent with Comvigen (91% vs. 78%, p = 0.0002, 79% vs. 70%, p = 0.028) but were mild or moderate and transient with no difference in fever (6% vs. 5%, p = 0.84).

Interpretation

Comvigen demonstrated non-inferiority immunogenicity to Comirnaty and had a comparable safety profile, supporting mRNA vaccine development for global access and pandemic preparedness.

Funding

Covid-19 Pandemic Emergency Fund granted by Thailand's National Economic and Social Development Council provided major funding. Supplementary funding was provided by National Vaccine Institute (NVI), Thailand; Center of Excellence in Vaccine Research and Development (Chula VRC), Faculty of Medicine, Chulalongkorn University; Chulalongkorn University Second Century Fund (C2F); BioNet-Asia and Public Donation through Covid-19 vaccine development fund of the Faculty of Medicine, Chulalongkorn University and the Thai Red Cross Society, Thailand.

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与泰国Comvigen二价SARS-CoV-2疫苗相比，Comvigen二价疫苗的免疫原性和安全性：一项2期非劣效性随机试验

背景：加强中低收入国家mRNA疫苗的开发对于加强全球大流行防范至关重要。本研究评估了Comvigen（一种二价SARS-CoV-2疫苗）与Comirnaty二价疫苗（Comirnaty）的安全性和免疫原性。该II期随机、开放标签、非劣效性试验在泰国的4个中心进行。参与者（n = 450）被随机分配（2:1）接受Comvigen （50 μg）或Comirnaty (30 μg)，采用分组随机（size = 9）。符合条件的参与者已完成至少2剂任何批准的COVID-19疫苗，最后一次mrna疫苗剂量在入组前3个多月进行。几何平均比（GMR）的非劣效边际为0.67。主要免疫原性终点是针对SARS-CoV-2野生型和Omicron BA.4/BA的假病毒中和效价（psVNT-50）。第29天。安全性指标包括接种疫苗后6个月的局部和全身不良反应。免疫原性分析对按方案（PP）群体和改良意向治疗（mITT）群体进行；安全性分析包括所有参与者。实验室人员对疫苗分配不知情（ClinicalTrials.gov: NCT05930730）。在2023年10月至11月期间，有450名参与者被纳入研究（中位年龄36岁，IQR 30-45岁）。在第29天，psVNT-50对野生型病毒的几何平均滴度（GMT）从Comvigen的475.9增加到2062.9，comiry的458.8增加到1905.1 (GMR 1.1, 95% CI: 1.0-1.2)，符合非劣效性标准。抗欧米克隆BA.4/BA。5、Comvigen的GMTs为3909.8，comirity的GMTs为3288.6 （GMR为1.2,95%为1.0 ~ 1.4）。Comvigen的局部和全身反应更频繁（91%对78%，p = 0.0002, 79%对70%，p = 0.028），但轻度或中度和短暂性反应，发热无差异（6%对5%，p = 0.84）。comvigen显示出对Comirnaty的非劣效性免疫原性，并且具有相当的安全性，支持mRNA疫苗开发用于全球可及性和大流行防范。泰国国家经济和社会发展理事会批准的2019冠状病毒病大流行应急基金提供了主要资金。补充资金由泰国国家疫苗研究所提供；朱拉隆功大学医学院疫苗研究与开发卓越中心；朱拉隆功大学第二世纪基金；亚洲生物网与朱拉隆功大学医学院和泰国红十字会新冠病毒疫苗开发基金的公众捐赠。

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来源期刊

The Lancet regional health. Southeast Asia

CiteScore

2.20

自引率

0.00%

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