Phase 2/3 open-label study on NVX-CoV-2601 (XBB.1.5) vaccine in previously COVID-19 mRNA vaccinated and vaccine-naive, SARS-CoV-2–seropositive participants: A 6-month follow-up

IF 2.2 Q3 IMMUNOLOGY

Vaccine: X Pub Date : 2025-09-19 DOI:10.1016/j.jvacx.2025.100728

Katia Alves , Karen Kotloff , R. Scott McClelland , E. Adrianne Hammershaimb , Alex Kouassi , Joyce S. Plested , Raj Kalkeri , Mingzhu Zhu , Shane Cloney-Clark , Zhaohui Cai , Katherine Smith , Muneer Kaba , Joy Nelson , Raburn M. Mallory , Fernando Noriega , on behalf of the 2019nCoV-313 Study Investigators

{"title":"Phase 2/3 open-label study on NVX-CoV-2601 (XBB.1.5) vaccine in previously COVID-19 mRNA vaccinated and vaccine-naive, SARS-CoV-2–seropositive participants: A 6-month follow-up","authors":"Katia Alves , Karen Kotloff , R. Scott McClelland , E. Adrianne Hammershaimb , Alex Kouassi , Joyce S. Plested , Raj Kalkeri , Mingzhu Zhu , Shane Cloney-Clark , Zhaohui Cai , Katherine Smith , Muneer Kaba , Joy Nelson , Raburn M. Mallory , Fernando Noriega , on behalf of the 2019nCoV-313 Study Investigators","doi":"10.1016/j.jvacx.2025.100728","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Seasonal (2023–2024) COVID-19 vaccine recommendations included updates against Omicron XBB.1.5. NVX-CoV2601 contains XBB.1.5 recombinant spike (rS) protein, Matrix-M® adjuvant, and is based on authorized prototype vaccine (NVX-CoV2373) technology. Immunogenicity and safety outcomes 6 months after vaccination following a single dose of monovalent NVX-CoV2601 in previously vaccinated and vaccine-naive, SARS-CoV-2–seropositive participants aged ≥18 years are reported here.</div></div><div><h3>Methods</h3><div>The phase 2/3 open-label, single-arm 2019nCoV-313 study consisted of two parts (part 1: participants with ≥3 prior mRNA vaccines; part 2: unvaccinated participants with a clinical history of COVID-19). Participants received a single dose of NVX-CoV2601. Primary endpoint analyses through day 28 were previously published. This final analysis assessed immunogenicity and safety through the end of the study (day 180). Immunogenicity data (e.g., neutralizing antibodies [nAbs] and anti-rS IgG antibodies) were summarized using geometric mean antibody levels and fold rise and seroresponse rate (SRR).</div></div><div><h3>Results</h3><div>The safety analysis set included 332 participants in part 1 and 338 participants in part 2. In previously vaccinated participants, nAb geometric mean titers (GMTs; 95% CIs) were 120.7 (101.5–143.6) at day 0, increased to 955.5 (814.0–1121.4) at day 28, and decreased to 454.8 (382.9–540.3) at day 180. SRR decreased from 64.3% at day 28 to 41.1% at day 180. Similar results were seen in vaccine-naive, SARS-CoV-2–seropositive participants, with GMTs of 67.0 (56.6–79.3), 1296.7 (1082.6–1553.2), and 303.6 (258.5–356.4) at day 0, 28, and 180, respectively. SRR waned from 74.3% at day 28 to 45.0% at day 180. Anti-rS IgG responses similarly increased at day 28 and had moderate decreases at day 180 in both groups. No new safety signals were reported.</div></div><div><h3>Conclusions</h3><div>A single dose of NVX-CoV2601 showed robust, durable immunogenicity in adult participants from study 2019nCoV-313 parts 1 and 2. These data support the use of NVX-CoV2601 in both populations.</div><div><em>Trial registration:</em> <span><span>NCT05975060</span><svg><path></path></svg></span></div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"27 ","pages":"Article 100728"},"PeriodicalIF":2.2000,"publicationDate":"2025-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Vaccine: X","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2590136225001226","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"IMMUNOLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Background

Seasonal (2023–2024) COVID-19 vaccine recommendations included updates against Omicron XBB.1.5. NVX-CoV2601 contains XBB.1.5 recombinant spike (rS) protein, Matrix-M® adjuvant, and is based on authorized prototype vaccine (NVX-CoV2373) technology. Immunogenicity and safety outcomes 6 months after vaccination following a single dose of monovalent NVX-CoV2601 in previously vaccinated and vaccine-naive, SARS-CoV-2–seropositive participants aged ≥18 years are reported here.

Methods

The phase 2/3 open-label, single-arm 2019nCoV-313 study consisted of two parts (part 1: participants with ≥3 prior mRNA vaccines; part 2: unvaccinated participants with a clinical history of COVID-19). Participants received a single dose of NVX-CoV2601. Primary endpoint analyses through day 28 were previously published. This final analysis assessed immunogenicity and safety through the end of the study (day 180). Immunogenicity data (e.g., neutralizing antibodies [nAbs] and anti-rS IgG antibodies) were summarized using geometric mean antibody levels and fold rise and seroresponse rate (SRR).

Results

The safety analysis set included 332 participants in part 1 and 338 participants in part 2. In previously vaccinated participants, nAb geometric mean titers (GMTs; 95% CIs) were 120.7 (101.5–143.6) at day 0, increased to 955.5 (814.0–1121.4) at day 28, and decreased to 454.8 (382.9–540.3) at day 180. SRR decreased from 64.3% at day 28 to 41.1% at day 180. Similar results were seen in vaccine-naive, SARS-CoV-2–seropositive participants, with GMTs of 67.0 (56.6–79.3), 1296.7 (1082.6–1553.2), and 303.6 (258.5–356.4) at day 0, 28, and 180, respectively. SRR waned from 74.3% at day 28 to 45.0% at day 180. Anti-rS IgG responses similarly increased at day 28 and had moderate decreases at day 180 in both groups. No new safety signals were reported.

Conclusions

A single dose of NVX-CoV2601 showed robust, durable immunogenicity in adult participants from study 2019nCoV-313 parts 1 and 2. These data support the use of NVX-CoV2601 in both populations.

Trial registration: NCT05975060

查看原文本刊更多论文

NVX-CoV-2601 （XBB.1.5）疫苗在先前接种过COVID-19 mRNA疫苗和未接种疫苗的sars - cov -2血清阳性参与者中的2/3期开放标签研究：6个月随访

季节性（2023-2024）COVID-19疫苗建议包括针对Omicron XBB.1.5的更新。NVX-CoV2601含有XBB.1.5重组spike （rS）蛋白，Matrix-M®佐剂，基于授权原型疫苗（NVX-CoV2373）技术。本文报告了年龄≥18岁、先前接种过疫苗和未接种疫苗的sars - cov -2血清阳性受试者接种单剂量单价NVX-CoV2601疫苗后6个月的免疫原性和安全性结果。方法2/3期开放标签单臂2019nCoV-313研究由两部分组成（第一部分：既往接种过≥3种mRNA疫苗的参与者；第二部分：未接种过COVID-19临床史的参与者）。参与者接受单剂量的NVX-CoV2601。截至第28天的主要终点分析之前已发表。最后的分析评估了研究结束时（第180天）的免疫原性和安全性。免疫原性数据（例如，中和抗体[nab]和抗rs IgG抗体）采用几何平均抗体水平、倍数上升和血清反应率（SRR）进行总结。结果第一部分共纳入332名受试者，第二部分共纳入338名受试者。在先前接种过疫苗的参与者中，nAb几何平均滴度（GMTs; 95% ci）在第0天为120.7(101.5-143.6)，在第28天增加到955.5(814.0-1121.4)，在第180天下降到454.8（382.9-540.3）。SRR由第28天的64.3%降至第180天的41.1%。在未接种疫苗的sars - cov -2血清阳性参与者中也观察到类似的结果，在第0、28和180天，GMTs分别为67.0（56.6-79.3）、1296.7（1082.6-1553.2）和303.6（258.5-356.4）。SRR从第28天的74.3%下降到第180天的45.0%。两组抗rs IgG反应在第28天同样增加，在第180天有中度下降。没有新的安全信号报道。结论单剂量NVX-CoV2601在研究2019nCoV-313第1部分和第2部分的成人受试者中显示出强大、持久的免疫原性。这些数据支持在两种人群中使用NVX-CoV2601。试验注册：NCT05975060

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊