Immunogenicity and safety of SARS-CoV-2 recombinant spike protein vaccine in South African people living with and without HIV-1 infection: A phase 2 randomised trial

IF 14.3 1区 医学 Q1 INFECTIOUS DISEASES Journal of Infection Pub Date : 2024-09-27 DOI:10.1016/j.jinf.2024.106285
{"title":"Immunogenicity and safety of SARS-CoV-2 recombinant spike protein vaccine in South African people living with and without HIV-1 infection: A phase 2 randomised trial","authors":"","doi":"10.1016/j.jinf.2024.106285","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Response data for COVID-19 vaccines in immunosuppressed individuals are typically limited to standard dosing in small populations. Adjusting number or interval of doses may impact immune responses based on HIV status.</div></div><div><h3>Methods</h3><div>This phase 2 randomised, observer-blinded, placebo-controlled South African study (2019nCoV-505/NCT05112848) enrolled medically stable people living with HIV (PLWH) and HIV-uninfected participants aged 18–65 years. PLWH were randomised 1:1:1 to receive NVX-CoV2373 on day 0 (D0) and either D21 (2-Dose<sub>D0/D21</sub>) or D70 (2-Dose<sub>D0/D70</sub>), or on D0, D21, and D70 (3-Dose). HIV-uninfected participants were randomised 1:1 to each 2-Dose regimen. PLWH were stratified into well-controlled and less–well-controlled subgroups. The primary immunologic endpoint included serum IgG and neutralising antibody responses (per geometric mean fold rise [GMFR] in titre and seroconversion rate) to ancestral SARS-CoV-2 at D35 (2-Dose<sub>D0/D21</sub>) and D84 (2-Dose<sub>D0/D70</sub> and 3-Dose). The primary safety endpoints were participants with an unsolicited adverse event through D84, at D120, and at D180, or reactogenicity ≤7 days post-vaccination.</div></div><div><h3>Results</h3><div>Of 288 PLWH, 98, 96, and 94 were randomised into the 2-Dose<sub>D0/D21</sub>, 2-Dose<sub>D0/D70</sub>, and 3-Dose groups, respectively; 96 HIV-uninfected participants were randomised to the 2-Dose<sub>D0/D21</sub> (n = 47) or 2-Dose<sub>D0/D70</sub> (n = 49) regimens. Most (&gt;85%) of the population were SARS-CoV-2 positive at baseline. Ancestral anti-spike IgG GMFRs in PLWH and HIV-uninfected participants, respectively, were 12·4 and 12·9 (D35) and 12·2 and 13·6 (D84). Comparable outcomes occurred across dosing regimens and in well-controlled and less–well-controlled PLWH. Microneutralization GMFRs at D84 in PLWH and HIV-uninfected participants, respectively, were: 6·9 and 10·1 (2-Dose<sub>D0/D21</sub>), 11·0 and 11·3 (2-Dose<sub>D0/D70</sub>), and 17·2 (PLWH 3-Dose). Antibody responses against BA.1 trended similar to those against the ancestral virus. Safety outcomes were comparable among PLWH and HIV-uninfected participants.</div></div><div><h3>Conclusion</h3><div>This study demonstrated that NVX-CoV2373 produced consistent immunogenicity responses to SARS-CoV-2 among PLWH and HIV-uninfected participants, with no new safety signals.</div></div>","PeriodicalId":50180,"journal":{"name":"Journal of Infection","volume":null,"pages":null},"PeriodicalIF":14.3000,"publicationDate":"2024-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Infection","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0163445324002196","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"INFECTIOUS DISEASES","Score":null,"Total":0}
引用次数: 0

Abstract

Background

Response data for COVID-19 vaccines in immunosuppressed individuals are typically limited to standard dosing in small populations. Adjusting number or interval of doses may impact immune responses based on HIV status.

Methods

This phase 2 randomised, observer-blinded, placebo-controlled South African study (2019nCoV-505/NCT05112848) enrolled medically stable people living with HIV (PLWH) and HIV-uninfected participants aged 18–65 years. PLWH were randomised 1:1:1 to receive NVX-CoV2373 on day 0 (D0) and either D21 (2-DoseD0/D21) or D70 (2-DoseD0/D70), or on D0, D21, and D70 (3-Dose). HIV-uninfected participants were randomised 1:1 to each 2-Dose regimen. PLWH were stratified into well-controlled and less–well-controlled subgroups. The primary immunologic endpoint included serum IgG and neutralising antibody responses (per geometric mean fold rise [GMFR] in titre and seroconversion rate) to ancestral SARS-CoV-2 at D35 (2-DoseD0/D21) and D84 (2-DoseD0/D70 and 3-Dose). The primary safety endpoints were participants with an unsolicited adverse event through D84, at D120, and at D180, or reactogenicity ≤7 days post-vaccination.

Results

Of 288 PLWH, 98, 96, and 94 were randomised into the 2-DoseD0/D21, 2-DoseD0/D70, and 3-Dose groups, respectively; 96 HIV-uninfected participants were randomised to the 2-DoseD0/D21 (n = 47) or 2-DoseD0/D70 (n = 49) regimens. Most (>85%) of the population were SARS-CoV-2 positive at baseline. Ancestral anti-spike IgG GMFRs in PLWH and HIV-uninfected participants, respectively, were 12·4 and 12·9 (D35) and 12·2 and 13·6 (D84). Comparable outcomes occurred across dosing regimens and in well-controlled and less–well-controlled PLWH. Microneutralization GMFRs at D84 in PLWH and HIV-uninfected participants, respectively, were: 6·9 and 10·1 (2-DoseD0/D21), 11·0 and 11·3 (2-DoseD0/D70), and 17·2 (PLWH 3-Dose). Antibody responses against BA.1 trended similar to those against the ancestral virus. Safety outcomes were comparable among PLWH and HIV-uninfected participants.

Conclusion

This study demonstrated that NVX-CoV2373 produced consistent immunogenicity responses to SARS-CoV-2 among PLWH and HIV-uninfected participants, with no new safety signals.
查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
南非 HIV-1 感染者和非 HIV-1 感染者接种 SARS-CoV-2 重组尖峰蛋白疫苗的免疫原性和安全性:2 期随机试验。
背景:COVID-19疫苗在免疫抑制个体中的应答数据通常仅限于小群体中的标准剂量。根据艾滋病病毒感染状况调整剂量的数量或间隔可能会影响免疫反应:这项 2 期随机、观察者盲法、安慰剂对照南非研究(2019nCoV-505/NCT05112848)招募了年龄在 18-65 岁、病情稳定的 HIV 感染者(PLWH)和未感染 HIV 的参与者。HIV感染者按1:1:1随机分配,在第0天(D0)和第21天(2-剂量D0/D21)或第70天(2-剂量D0/D70)接受NVX-CoV2373,或在第0天、第21天和第70天(3-剂量)接受NVX-CoV2373。未感染艾滋病毒的参与者按 1:1 随机分配到每种 2 剂量方案中。艾滋病毒感染者被分为控制良好亚组和控制较差亚组。主要免疫学终点包括在D35(2-DoseD0/D21)和D84(2-DoseD0/D70和3-Dose)对祖先SARS-CoV-2的血清IgG和中和抗体反应(滴度的几何平均倍数上升[GMFR]和血清转换率)。主要安全性终点是在D84、D120和D180期间出现主动不良事件或接种后7天内出现反应性的参与者:在288名艾滋病毒感染者中,分别有98人、96人和94人被随机分配到2剂量D0/D21组、2剂量D0/D70组和3剂量组;96名未感染艾滋病毒的参与者被随机分配到2剂量D0/D21组(47人)或2剂量D0/D70组(49人)。大多数人(>85%)在基线时为 SARS-CoV-2 阳性。PLWH 和 HIV 未感染者的祖先抗尖峰抗体 IgG GMFR 分别为 12-4 和 12-9 (D35),以及 12-2 和 13-6 (D84)。不同给药方案、控制良好和控制较差的艾滋病毒感染者的结果具有可比性。感染艾滋病毒的 PLWH 和未感染艾滋病毒的参与者在 D84 时的微中性 GMFR 分别为 6-9 和 10-1 (2-D):6-9和10-1(2-剂量D0/D21)、11-0和11-3(2-剂量D0/D70)以及17-2(PLWH 3-剂量)。针对 BA.1 的抗体反应与针对祖先病毒的抗体反应趋势相似。感染艾滋病毒的 PLWH 和未感染艾滋病毒的参与者的安全性结果相当:这项研究表明,NVX-CoV2373 能在 PLWH 和未感染 HIV 的参与者中产生一致的针对 SARS-CoV-2 的免疫原性反应,而且没有新的安全性信号:Novavax, Inc.
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 去求助
来源期刊
Journal of Infection
Journal of Infection 医学-传染病学
CiteScore
45.90
自引率
3.20%
发文量
475
审稿时长
16 days
期刊介绍: The Journal of Infection publishes original papers on all aspects of infection - clinical, microbiological and epidemiological. The Journal seeks to bring together knowledge from all specialties involved in infection research and clinical practice, and present the best work in the ever-changing field of infection. Each issue brings you Editorials that describe current or controversial topics of interest, high quality Reviews to keep you in touch with the latest developments in specific fields of interest, an Epidemiology section reporting studies in the hospital and the general community, and a lively correspondence section.
期刊最新文献
Clinical Profile of Herpes Zoster-related Hospitalizations and Complications: A French Population-Based Database Study. Genomic analysis confirmed the importation of first mPox Clade Ib case in Kerala, India from Dubai, UAE. Characterization of a novel HIV-1 second-generation circulating recombinant form (CRF172_0755) among men who have sex with men in China. Near real-time severe acute respiratory illness surveillance characterising influenza and COVID-19 epidemiology in hospitalised adults, 2021-22 Global Meningococcal Initiative: Insights on antibiotic resistance, control strategies and advocacy efforts in Western Europe.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1