{"title":"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","authors":"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","doi":"10.1016/j.lansea.2025.100650","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>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).</div></div><div><h3>Methods</h3><div>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 (<span><span>ClinicalTrials.gov</span><svg><path></path></svg></span>: <span><span>NCT05930730</span><svg><path></path></svg></span>).</div></div><div><h3>Findings</h3><div>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).</div></div><div><h3>Interpretation</h3><div>Comvigen demonstrated non-inferiority immunogenicity to Comirnaty and had a comparable safety profile, supporting mRNA vaccine development for global access and pandemic preparedness.</div></div><div><h3>Funding</h3><div>Covid-19 Pandemic Emergency Fund granted by <span>Thailand's National Economic and Social Development Council</span> provided major funding. Supplementary funding was provided by <span>National Vaccine Institute (NVI)</span>, Thailand; Center of Excellence in Vaccine Research and Development (Chula VRC), <span>Faculty of Medicine, Chulalongkorn University</span>; <span>Chulalongkorn University Second Century Fund (C2F)</span>; BioNet-Asia and Public Donation through Covid-19 vaccine development fund of the <span>Faculty of Medicine, Chulalongkorn University</span> and the <span>Thai Red Cross Society</span>, Thailand.</div></div>","PeriodicalId":75136,"journal":{"name":"The Lancet regional health. Southeast Asia","volume":"40 ","pages":"Article 100650"},"PeriodicalIF":6.2000,"publicationDate":"2025-08-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"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\",\"authors\":\"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\",\"doi\":\"10.1016/j.lansea.2025.100650\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><div>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).</div></div><div><h3>Methods</h3><div>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 (<span><span>ClinicalTrials.gov</span><svg><path></path></svg></span>: <span><span>NCT05930730</span><svg><path></path></svg></span>).</div></div><div><h3>Findings</h3><div>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).</div></div><div><h3>Interpretation</h3><div>Comvigen demonstrated non-inferiority immunogenicity to Comirnaty and had a comparable safety profile, supporting mRNA vaccine development for global access and pandemic preparedness.</div></div><div><h3>Funding</h3><div>Covid-19 Pandemic Emergency Fund granted by <span>Thailand's National Economic and Social Development Council</span> provided major funding. Supplementary funding was provided by <span>National Vaccine Institute (NVI)</span>, Thailand; Center of Excellence in Vaccine Research and Development (Chula VRC), <span>Faculty of Medicine, Chulalongkorn University</span>; <span>Chulalongkorn University Second Century Fund (C2F)</span>; BioNet-Asia and Public Donation through Covid-19 vaccine development fund of the <span>Faculty of Medicine, Chulalongkorn University</span> and the <span>Thai Red Cross Society</span>, Thailand.</div></div>\",\"PeriodicalId\":75136,\"journal\":{\"name\":\"The Lancet regional health. Southeast Asia\",\"volume\":\"40 \",\"pages\":\"Article 100650\"},\"PeriodicalIF\":6.2000,\"publicationDate\":\"2025-08-15\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"The Lancet regional health. Southeast Asia\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2772368225001210\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"HEALTH CARE SCIENCES & SERVICES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"The Lancet regional health. Southeast Asia","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2772368225001210","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"HEALTH CARE SCIENCES & SERVICES","Score":null,"Total":0}
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
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.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
