Immunogenicity and safety of a monovalent Omicron XBB.1.5 SARS-CoV-2 recombinant spike protein vaccine in previously unvaccinated, SARS-CoV-2 seropositive participants: Primary day-28 analysis of a phase 2/3 open-label study

IF 4.5 3区医学 Q2 IMMUNOLOGY

Vaccine Pub Date : 2025-04-02 DOI:10.1016/j.vaccine.2025.127046

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

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引用次数: 0

Abstract

Background

Most of the population has been infected with SARS-CoV-2 and, thus, is primed by natural exposure. As such, it was assessed whether a single dose of the monovalent XBB.1.5 vaccine, NVX-CoV2601, elicited a comparable immune response to XBB.1.5 in seropositive unvaccinated participants to that in previously vaccinated participants, thereby allowing the former to forego a two-dose primary series.

Methods

In this phase 2/3, open-label, single-arm study (2019nCoV-313/NCT05975060 [group 2]), vaccine-naive participants ≥18 years with previous SARS-CoV-2 infection received one dose of NVX-CoV2601. This analysis compared the 28-day immunogenicity and safety of NVX-CoV2601 in vaccine-naive and previously vaccinated (≥3 prior mRNA-based vaccines, from 2019nCoV-313 group 1) participants. Noninferiority of neutralizing antibody (nAb) response in vaccine-naive versus vaccinated participants was the primary objective. The day-28 geometric mean titer (GMT) ratio (GMTR) and seroresponse rate (SRR; percentage of participants with a ≥4-fold rise in antibody response from baseline) were measured, and safety was assessed.

Results

Of the participants enrolled from September 11 to November 15, 2023, per-protocol sets included 306/338 (90.5%) vaccine-naive and 309/332 (93.1%) vaccinated participants. At day 28, adjusted GMTs (95% CI) against XBB.1.5 in the vaccine-naive and vaccinated groups were 1491.5 (1277.5–1741.4) and 841.4 (723.9–978.0), respectively. The vaccine-naive–vaccinated nAb GMTR was 1.8 (95% CI 1.43–2.20) and SRRs were 74.3% and 64.3% for vaccine-naive and vaccinated participants, respectively (SRR difference: 10.0 [95% CI 2.6–17.4]). No new safety signals or events of special interest were reported.

Conclusions

A single dose of NVX-CoV2601 in vaccine-naive participants with a history of SARS-CoV-2 infection elicited a robust neutralizing antibody response that was noninferior to that observed in vaccinated participants. The vaccine was well-tolerated. These data support the use of NVX-CoV2601 as a single dose, regardless of prior vaccination history.

Trial registration

NCT05975060.

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单价Omicron XBB.1.5 SARS-CoV-2重组刺突蛋白疫苗在未接种过SARS-CoV-2血清阳性受试者中的免疫原性和安全性：一项2/3期开放标签研究的第28天分析

大多数人都感染过SARS-CoV-2，因此，自然暴露会使他们中毒。因此，研究人员评估了单剂量单价XBB.1.5疫苗NVX-CoV2601是否在血清阳性未接种疫苗的参与者中引起与先前接种疫苗的参与者相当的XBB.1.5免疫反应，从而允许前者放弃两剂初级系列。方法在这项2/3期、开放标签、单臂研究（2019nCoV-313/NCT05975060[2组]）中，年龄≥18岁且既往有SARS-CoV-2感染的未接种疫苗的参与者接受了一剂NVX-CoV2601。该分析比较了NVX-CoV2601在未接种疫苗和先前接种疫苗（来自2019nCoV-313组1的≥3种先前基于mrna的疫苗）的参与者中的28天免疫原性和安全性。中和抗体（nAb）反应在未接种疫苗者和未接种疫苗者中的非劣效性是主要目标。第28天几何平均滴度（GMT）比（GMTR）和血清反应率（SRR）；测量抗体反应较基线上升≥4倍的参与者百分比，并评估安全性。在2023年9月11日至11月15日入组的参与者中，每个方案集包括306/338（90.5%）未接种疫苗的参与者和309/332（93.1%）接种疫苗的参与者。第28天，未接种疫苗组和接种疫苗组对XBB.1.5的校正gmt （95% CI）分别为1491.5（1277.5-1741.4）和841.4（723.9-978.0）。未接种疫苗者的nAb GMTR为1.8 (95% CI 1.43-2.20)，未接种疫苗者和已接种疫苗者的SRR分别为74.3%和64.3% （SRR差异：10.0 [95% CI 2.6-17.4]）。没有新的安全信号或特别有趣的事件报告。结论：在有SARS-CoV-2感染史的未接种疫苗的参与者中，单剂量的NVX-CoV2601可引起强大的中和抗体反应，其效果不逊于接种疫苗的参与者。这种疫苗耐受性良好。这些数据支持将NVX-CoV2601作为单剂使用，而不考虑之前的疫苗接种史。registrationNCT05975060审判。

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来源期刊

Vaccine 医学-免疫学

CiteScore

8.70

自引率

5.50%

发文量

992

审稿时长

131 days

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