First-in-Human Phase I Trial to Assess the Safety and Immunogenicity of an Orf Virus-Based COVID-19 Vaccine Booster DOI Creative Commons

Meral Esen,

Johanna Fischer-Herr, Julian Gabor

и другие.

Vaccines, Год журнала: 2024, Номер 12(11), С. 1288 - 1288

Опубликована: Ноя. 18, 2024

The emergence of SARS-CoV-2 has necessitated the development versatile vaccines capable addressing evolving variants. Prime-2-CoV_Beta, a novel Orf virus-based COVID-19 vaccine, was developed to express spike and nucleocapsid antigens. This first-in-human, phase I, dose-finding clinical trial conducted assess safety, reactogenicity, immunogenicity Prime-2-CoV_Beta as booster in healthy adults. From June 2022 2023, 60 participants Germany received varying doses Prime-2-CoV_Beta. study demonstrated favorable safety profile, with no serious adverse events (AEs) reported. All AEs were mild (107) or moderate (10), most common symptoms being pain at injection site, fatigue, headache. Immunogenicity assessments revealed robust vaccine-induced antigen-specific immune responses. High notably elicited significant increases antibodies against proteins well neutralizing its Additionally, vaccine did not induce ORFV-neutralizing antibodies, indicating potential for repeated administration. In conclusion, safe, tolerated, immunogenic, demonstrating broadly protective These promising results support further evaluation higher additional studies confirm efficacy long-term protection. registered ClinicalTrials, NCT05389319.

Язык: Английский

Immunogenicity and safety of a monovalent omicron XBB.1.5 SARS-CoV-2 recombinant spike protein vaccine as a heterologous booster dose in US adults: interim analysis of a single-arm phase 2/3 study DOI

Katia Alves,

Karen L. Kotloff,

R. Scott McClelland

и другие.

The Lancet Infectious Diseases, Год журнала: 2025, Номер unknown

Опубликована: Янв. 1, 2025

Язык: Английский

Процитировано

2
Interim analysis of SARS-CoV-2 vaccine NVX-CoV2601 as a heterologous booster dose DOI
Pragya D. Yadav,

Deepak Y Patil

The Lancet Infectious Diseases, Год журнала: 2025, Номер unknown

Опубликована: Янв. 1, 2025

Язык: Английский

Процитировано

1
Neutralizing antibody test supports booster strategy for young individuals after SARS-CoV-2 Omicron breakthrough DOI Creative Commons
Yichuan Yao,

Yunru Yang,

Qiqin Wu

и другие.

European journal of medical research, Год журнала: 2025, Номер 30(1)

Опубликована: Янв. 6, 2025

The SARS-CoV-2 Omicron variant, since its initial detection, has rapidly spread across the globe, becoming dominant strain. It is important to study immune response of variant due remarkable ability escape majority existing neutralizing antibodies. surge in infections among most Chinese residents by end 2022 provides a unique opportunity understand system's populations with limited exposure prior variants. We tested levels IgG, IgA, and IgM specific prototype RBD (receptor-binding domain) blood samples from 636 individuals chemical luminescence assay, ELISA pseudovirus-based neutralization assay. Inoculation inactivated vaccines or recombinant protein showed higher IgG after infection than unvaccinated individuals. Moreover, age resulted different as level patients aged > 60 years was lower that < years. This indicates induced breakthrough between old young found booster dose vaccine led significant increase against helped induce antibodies BA.5 BF.7 variants an individuals, which previous report on older people. These data suggest vaccination helps high Trial registration: purely observational study.

Язык: Английский

Процитировано

0
Limitations of neutralizing antibody titers in COVID-19 vaccine efficacy trials and a call for additional correlates of protection DOI Creative Commons
Young Hoon Hwang, Dal‐Hee Min, Wan Beom Park

и другие.

Human Vaccines & Immunotherapeutics, Год журнала: 2025, Номер 21(1)

Опубликована: Март 7, 2025

The coronavirus disease (COVID-19) pandemic accelerated development of various vaccine platforms. Among them, mRNA vaccines played a crucial role in controlling the due to their swift and efficacy against virus variants. Despite success these vaccines, recent studies highlight challenges evaluating efficacy, especially individuals with prior COVID-19 infection. Weakened neutralizing antibody responses after additional doses are observed populations, raising concerns about using titers as sole immune correlate protection. While antibodies remain primary endpoint immunogenicity trials, they may not fully capture response populations widespread infection or vaccination. This review explores reduced previously infected individuals, impact on evaluation. It also offers recommendations for improving assessment, stressing incorporation markers such cell-mediated immunity enable more comprehensive understanding vaccine-induced immunity.

Язык: Английский

Процитировано

0
A Meta-Analysis on the Immunogenicity of Prototype, Monovalent-adapted and Bivalent vaccines against SARS-CoV-2 Wildtype, Omicron BA.1 and Omicron BA.4/5 in Healthy Adults. DOI
Jo‐Lewis Banga Ndzouboukou, Abdul A. Kamara, Nadeem Ullah

и другие.

Virology, Год журнала: 2025, Номер 606, С. 110509 - 110509

Опубликована: Март 20, 2025

Язык: Английский

Процитировано

0
Immunogenicity and safety of monovalent and bivalent SARS-CoV-2 variant adapted RBD-based protein booster vaccines in adults previously immunized with different vaccine platforms: A phase II/III, randomized clinical trial DOI Creative Commons

Gonzalo Pérez Marc,

Lorena M. Coria, Ana Ceballos

и другие.

Vaccine, Год журнала: 2025, Номер 54, С. 127045 - 127045

Опубликована: Апрель 1, 2025

Язык: Английский

Процитировано

0
Approved natural products-derived nanomedicines for disease treatment DOI
Xiaotong Li,

Yu-Ying Lai,

Guihong Wan

и другие.

Chinese Journal of Natural Medicines, Год журнала: 2024, Номер 22(12), С. 1100 - 1116

Опубликована: Дек. 1, 2024

Язык: Английский

Процитировано

1
Bivalent (Omicron BA.5/ancestral) recombinant spike protein vaccine: a promising booster DOI Creative Commons
Ruiqi Zhang, Ivan Fan‐Ngai Hung

The Lancet Infectious Diseases, Год журнала: 2024, Номер 24(6), С. 558 - 559

Опубликована: Март 6, 2024

With the emergence of Omicron variants, which carry several immune escape-related mutations in spike protein, effectiveness COVID-19 prototype vaccines was weakened.1Cao Y Wang J Jian F et al.Omicron escapes majority existing SARS-CoV-2 neutralizing antibodies.Nature. 2022; 602: 657-663Crossref PubMed Scopus (1072) Google Scholar, 2Sritipsukho P Khawcharoenporn T Siribumrungwong B al.Real-life vaccine during variant-dominant pandemic: how many booster doses do we need?.Emerg Microbes Infect. 2023; 12: 2174779Crossref (7) Scholar To overcome such weakness, strategies have been adopted to update for new including updated mRNA (mRNA-1273.214 and CS-2034) recombinant protein (V-01), can induce higher response against variants than vaccines.3Chalkias S Harper C Vrbicky K al.A bivalent Omicron-containing Covid-19.N Engl Med. 387: 1279-1291Crossref (309) 4Wu JD Li JX Liu al.Safety, immunogenicity, efficacy CS-2034 as a heterologous versus homologous with BBIBP-CorV adults aged ≥18 years: randomised, double-blind, phase 2b trial.Lancet Infect Dis. 23: 1020-1030Summary Full Text PDF (11) 5Wang XY Mahmood SF Jin al.Efficacy boosting using interferon-armed fusion (V-01): randomized, double-blind placebo-controlled III trial.Emerg 11: 1910-1919Crossref (21) In this issue The Lancet Infectious Diseases, Chijioke Bennett colleagues6Bennett Woo W Bloch M al.Immunogenicity safety (omicron BA.5 plus ancestral) dose: interim analysis 3, non-inferiority, clinical 2024; (published online March 6. https://doi.org/10.1016/S1473-3099(24)00077-X.)PubMed reported results 3 study that conducted evaluate immunogenicity subunit (NVX-CoV2373 + NVX-CoV2540), contained ancestral strain previously vaccinated vaccine.6Bennett determine vaccine, tested IgG neutralising antibody levels strain, BA.5, XBB.1.5. induced better activity XBB.1.5 when compared (NVX-CoV2373) at day 28 after two-dose booster. authors found geometric mean titre (GMT) anti-Omicron antibodies second dose 1017·8 (95% CI 891·0–1162·6), there 3·6-fold 3·2–4·2) increase GMT comparison from level 0. group, 515·1 (450·4–589·0) 1·8-fold monovalent before adjustment 1507·3 (1259·0 1804·5) 28, corresponding highest fold change seen 4.4 participants recruited received least three or vaccines. concluded strategy significantly enhance pre-existing triggered by previous As various platforms approved emergency use, prime-boost vaccination has shown strategies.4Wu 7Leung NHL Cheng SMS Cohen CA al.Comparative cell-mediated responses, reactogenicity, CoronaVac BNT162b2 (Cobovax): an open-label, randomised Microbe. 4: e670-e682Summary (4) 8Costa Clemens SA Weckx L R al.Heterologous recipients two Brazil (RHH-001): 4, single blind, study.Lancet. 399: 521-529Summary (279) 9Khong KW D Leung KY al.Antibody combination variant.Vaccines. 10: 160Crossref (32) 2 trial Wu colleagues,4Wu boosted 45·7-fold, whereas inactivated virus 2·9-fold. Furthermore, responses are also vaccination, ChAdOx1-S ChAdOx1-S.7Leung 10Borobia AM Carcas AJ Pérez-Olmeda reactogenicity ChAdOx1-S-primed (CombiVacS): multicentre, controlled, trial.Lancet. 2021; 398: 121-130Summary (286) Even though not involved study, it improved humoral population primed vaccine. For safety, tolerated well, no withdrew due adverse events.6Bennett Although cellular elicited were studied, robust XBB.1·5 showed be used effective variants. Heterologous highly effective, likely those who adenovirus vectored This will provide useful option older people high-risk individuals, particular, cannot want variant final report should include on is eagerly awaited. Of note, recently, further version. IF-NH honoraria Pfizer, Merck, Gilead lectures; offered consultative advice Fosun, Sinovac, Sinopharm; Moderna data monitoring board anti-SARS-CoV-2 monoclonal treatment AstraZeneca; support attending meetings AstraZeneca Merck. RZ declares competing interests. Immunogenicity trialAll coprimary endpoints met part ongoing 2019nCoV-311 study. These development and/or most currently circulating optimise protection. findings, investigation omicron-based subvariant supported evidence. Full-Text

Язык: Английский

Процитировано

0
First-in-Human Phase I Trial to Assess the Safety and Immunogenicity of an Orf Virus-Based COVID-19 Vaccine Booster DOI Creative Commons

Meral Esen,

Johanna Fischer-Herr, Julian Gabor

и другие.

Vaccines, Год журнала: 2024, Номер 12(11), С. 1288 - 1288

Опубликована: Ноя. 18, 2024

The emergence of SARS-CoV-2 has necessitated the development versatile vaccines capable addressing evolving variants. Prime-2-CoV_Beta, a novel Orf virus-based COVID-19 vaccine, was developed to express spike and nucleocapsid antigens. This first-in-human, phase I, dose-finding clinical trial conducted assess safety, reactogenicity, immunogenicity Prime-2-CoV_Beta as booster in healthy adults. From June 2022 2023, 60 participants Germany received varying doses Prime-2-CoV_Beta. study demonstrated favorable safety profile, with no serious adverse events (AEs) reported. All AEs were mild (107) or moderate (10), most common symptoms being pain at injection site, fatigue, headache. Immunogenicity assessments revealed robust vaccine-induced antigen-specific immune responses. High notably elicited significant increases antibodies against proteins well neutralizing its Additionally, vaccine did not induce ORFV-neutralizing antibodies, indicating potential for repeated administration. In conclusion, safe, tolerated, immunogenic, demonstrating broadly protective These promising results support further evaluation higher additional studies confirm efficacy long-term protection. registered ClinicalTrials, NCT05389319.

Язык: Английский

Процитировано

0