Safety, immunogenicity and efficacy of the self-amplifying mRNA ARCT-154 COVID-19 vaccine: pooled phase 1, 2, 3a and 3b randomized, controlled trials DOI Creative Commons

Nhân Thị Hồ,

Steven G. Hughes,

Van Thanh Ta

et al.

Nature Communications, Journal Year: 2024, Volume and Issue: 15(1)

Published: May 14, 2024

Combination of waning immunity and lower effectiveness against new SARS-CoV-2 variants approved COVID-19 vaccines necessitates vaccines. We evaluated two doses, 28 days apart, ARCT-154, a self-amplifying mRNA vaccine, compared with saline placebo in an integrated phase 1/2/3a/3b controlled, observer-blind trial Vietnamese adults (ClinicalTrial.gov identifier: NCT05012943). Primary safety reactogenicity outcomes were unsolicited adverse events (AE) after each dose, solicited local systemic AE 7 serious AEs throughout the study. immunogenicity outcome was immune response as neutralizing antibodies second dose. Efficacy assessed primary secondary 3b. ARCT-154 well tolerated generally mild-moderate transient AEs. Four weeks dose 94.1% (95% CI: 92.1-95.8) vaccinees seroconverted for antibodies, geometric mean-fold rise from baseline 14.5 13.6-15.5). Of 640 cases confirmed eligible efficacy analysis most due to Delta (B.1.617.2) variant. 56.6% 48.7- 63.3) any COVID-19, 95.3% (80.5-98.9) severe COVID-19. vaccination is tolerated, immunogenic efficacious, particularly disease.

Language: Английский

Effects of Previous Infection and Vaccination on Symptomatic Omicron Infections DOI Open Access
Heba N. Altarawneh, Hiam Chemaitelly, Houssein H. Ayoub

et al.

New England Journal of Medicine, Journal Year: 2022, Volume and Issue: 387(1), P. 21 - 34

Published: June 15, 2022

The protection conferred by natural immunity, vaccination, and both against symptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection with the BA.1 or BA.2 sublineages of omicron (B.1.1.529) variant is unclear.

Language: Английский

Citations

484
Effect of mRNA Vaccine Boosters against SARS-CoV-2 Omicron Infection in Qatar DOI Open Access
Laith J. Abu‐Raddad, Hiam Chemaitelly, Houssein H. Ayoub

et al.

New England Journal of Medicine, Journal Year: 2022, Volume and Issue: 386(19), P. 1804 - 1816

Published: March 9, 2022

Waning of vaccine protection against coronavirus disease 2019 (Covid-19) and the emergence omicron (or B.1.1.529) variant severe acute respiratory syndrome 2 (SARS-CoV-2) have led to expedited efforts scale up booster vaccination. Protection conferred by doses BNT162b2 (Pfizer–BioNTech) mRNA-1273 (Moderna) vaccines in Qatar, as compared with two-dose primary series, is unclear.

Language: Английский

Citations

367
SARS-CoV-2 reinfections: Overview of efficacy and duration of natural and hybrid immunity DOI Creative Commons
Stefan Pilz, Verena Theiler‐Schwetz, Christian Trummer

et al.

Environmental Research, Journal Year: 2022, Volume and Issue: 209, P. 112911 - 112911

Published: Feb. 8, 2022

Seroprevalence surveys suggest that more than a third and possibly half of the global population has been infected with SARS-CoV-2 by early 2022. As large numbers people continue to be infected, efficacy duration natural immunity in terms protection against reinfections severe disease is crucial significance for future. This narrative review provides an overview on epidemiological studies addressing this issue. National covering 2020-2021 documented previous infection associated significantly reduced risk lasting at least one year only relatively moderate waning immunity. Importantly, showed roughly similar effect sizes regarding reinfection across different variants, exception Omicron variant which data are just emerging before final conclusions can drawn. Risk hospitalizations deaths was also versus primary infections. Observational indicate may offer equal or greater infections compared individuals receiving two doses mRNA vaccine, but not fully consistent. The combination respective vaccination, termed hybrid immunity, seems confer greatest infections, several knowledge gaps remain Natural should considered public health policy SARS-CoV-2.

Language: Английский

Citations

238
Long-term effectiveness of COVID-19 vaccines against infections, hospitalisations, and mortality in adults: findings from a rapid living systematic evidence synthesis and meta-analysis up to December, 2022 DOI Open Access
Nana Wu, Keven Joyal‐Desmarais, Paula Aver Bretanha Ribeiro

et al.

The Lancet Respiratory Medicine, Journal Year: 2023, Volume and Issue: 11(5), P. 439 - 452

Published: Feb. 11, 2023

Language: Английский

Citations

201
Evaluation of Waning of SARS-CoV-2 Vaccine–Induced Immunity DOI Creative Commons
Francesco Menegale, Mattia Manica, Agnese Zardini

et al.

JAMA Network Open, Journal Year: 2023, Volume and Issue: 6(5), P. e2310650 - e2310650

Published: May 3, 2023

Importance Estimates of the rate waning vaccine effectiveness (VE) against COVID-19 are key to assess population levels protection and future needs for booster doses face resurgence epidemic waves. Objective To quantify progressive VE associated with Delta Omicron variants SARS-CoV-2 by number received doses. Data Sources PubMed Web Science were searched from databases’ inception October 19, 2022, as well reference lists eligible articles. Preprints included. Study Selection Selected studies this systematic review meta-analysis original articles reporting estimates over time laboratory-confirmed infection symptomatic disease. Extraction Synthesis at different points vaccination retrieved studies. A secondary data analysis was performed project any last dose administration, improving comparability across between 2 considered variants. Pooled obtained random-effects meta-analysis. Main Outcomes Measures or disease half-life vaccine-induced protection. Results total 799 149 reviews published in peer-reviewed journals 35 preprints identified. Of these, 40 included analysis. a primary cycle both lower than 20% 6 months administration. Booster restored comparable those acquired soon after administration cycle. However, 9 30% The estimated be 87 days (95% CI, 67-129 days) compared 316 240-470 Delta. Similar rates found age segments population. Conclusions Relevance These findings suggest that vaccines rapidly wanes dose. results can inform design appropriate targets timing programs.

Language: Английский

Citations

190
COVID-19 vaccine update: vaccine effectiveness, SARS-CoV-2 variants, boosters, adverse effects, and immune correlates of protection DOI Creative Commons
Wei-Yu Chi, Yen-Der Li, Hsin‐Che Huang

et al.

Journal of Biomedical Science, Journal Year: 2022, Volume and Issue: 29(1)

Published: Oct. 15, 2022

Abstract Coronavirus Disease 2019 (COVID-19) has been the most severe public health challenge in this century. Two years after its emergence, rapid development and deployment of effective COVID-19 vaccines have successfully controlled pandemic greatly reduced risk illness death associated with COVID-19. However, due to ability rapidly evolve, SARS-CoV-2 virus may never be eradicated, there are many important new topics work on if we need live for a long time. To end, hope provide essential knowledge researchers who improvement future vaccines. In review, provided an up-to-date summary current vaccines, discussed biological basis clinical impact variants subvariants, analyzed effectiveness various vaccine booster regimens against different strains. Additionally, reviewed potential mechanisms vaccine-induced adverse events, summarized studies regarding immune correlates protection, finally, next-generation

Language: Английский

Citations

178
Reduced risk of hospitalisation among reported COVID-19 cases infected with the SARS-CoV-2 Omicron BA.1 variant compared with the Delta variant, Norway, December 2021 to January 2022 DOI Creative Commons
Lamprini Veneti, Håkon Bøas, Anja Bråthen Kristoffersen

et al.

Eurosurveillance, Journal Year: 2022, Volume and Issue: 27(4)

Published: Jan. 27, 2022

We included 39,524 COVID-19 Omicron and 51,481 Delta cases reported in Norway from December 2021 to January 2022. estimated a 73% reduced risk of hospitalisation (adjusted hazard ratio: 0.27; 95% confidence interval: 0.20-0.36) for compared with Delta. Compared unvaccinated groups, who had completed primary two-dose vaccination 7-179 days before diagnosis lower than (66% vs 93%). People vaccinated three doses similar reduction (86% 88%).

Language: Английский

Citations

159
Effectiveness of a fourth dose of covid-19 mRNA vaccine against the omicron variant among long term care residents in Ontario, Canada: test negative design study DOI Creative Commons
Ramandip Grewal, Sophie A. Kitchen,

Lena Nguyen

et al.

BMJ, Journal Year: 2022, Volume and Issue: unknown, P. e071502 - e071502

Published: July 6, 2022

To estimate the marginal effectiveness of a fourth versus third dose and vaccine mRNA covid-19 vaccines BNT162b2 mRNA-1273 against any infection, symptomatic severe outcomes (hospital admission or death) related to omicron variant.

Language: Английский

Citations

142
Durability of BNT162b2 vaccine against hospital and emergency department admissions due to the omicron and delta variants in a large health system in the USA: a test-negative case–control study DOI
Sara Y. Tartof, Jeff Slezak, Laura Puzniak

et al.

The Lancet Respiratory Medicine, Journal Year: 2022, Volume and Issue: 10(7), P. 689 - 699

Published: April 22, 2022

Language: Английский

Citations

134
Effectiveness of COVID-19 vaccines against Omicron and Delta hospitalisation, a test negative case-control study DOI Creative Commons
Julia Stowe, Nick Andrews, Freja Kirsebom

et al.

Nature Communications, Journal Year: 2022, Volume and Issue: 13(1)

Published: Sept. 30, 2022

The Omicron variant has been associated with reduced vaccine effectiveness (VE) against mild disease rapid waning. Meanwhile also milder disease. Protection severe substantially higher than protection infection previous variants. We used a test-negative case-control design to estimate VE hospitalisation the and Delta variants using PCR testing linked hospital records. investigated impact of increasing specificity severity definitions on VE. Among 18-64-year-olds cases admitted via emergency care, after 3rd dose peaked at 82.4% dropped 53.6% by 15+ weeks dose; all admissions for > = 2 days stay respiratory code in primary diagnostic field ranged from 90.9% 67.4%; further restricting those oxygen/ventilated/intensive care 97.1% 75.9%. 65+ year olds equivalent estimates were 92.4% 76.9%; 91.3% 85.3% 95.8% 86.8%. Here we show that contamination hospitalisations incidental is likely reduce estimates. increase, waning reduced, when specific are used.

Language: Английский

Citations

131