Immunogenicity, clinical efficacy and safety of additional second COVID‐19 booster vaccines against Omicron and its subvariants: A systematic review

Reviews in Medical Virology, Год журнала: 2024, Номер 34(1)

Опубликована: Янв. 1, 2024

Abstract The Omicron variant of severe acute respiratory syndrome coronavirus 2 is a new concern (VOC) and an emerging subvariant that exhibits heightened infectivity, transmissibility, immune evasion, escalating the incidence moderate to disease 2019 (COVID‐19). It resists monoclonal antibodies diminishes vaccine efficacy. Notably, sublineages have outpaced earlier predominant sublineages. Although primary vaccination series initial boosters were robust against previous VOCs, their efficacy waned its subvariants. In this systematic review, we assessed real‐world evidence on immunogenicity, clinical efficacy, safety second booster or fourth COVID‐19 dose VOC A comprehensive literature search was conducted in Medline/PubMed, Google Scholar, bioRxiv, medRxiv, relevant studies published between 2022 30 May 2023 reviewed. We found total 40 articles focusing for COVID‐19, including trials observational studies, involving 3,972,856 patients. results consistently revealed additional restored prolonged waning immunity, activating both humoral cellular responses treatment correlated with enduring protection notably preventing substantial symptomatic mortality associated infection. Both monovalent messenger RNA (mRNA) nonmRNA vaccines demonstrated similar safety, bivalent mRNA exhibiting broader subvariants Omicron. profiles favourable only mild systemic local symptoms reported some recipients. conclusion, review underscores boosters, particularly multivalent vaccines, countering highly infectious

Язык: Английский

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Beyond the Pandemic Era: Recent Advances and Efficacy of SARS-CoV-2 Vaccines Against Emerging Variants of Concern

Vaccines, Год журнала: 2025, Номер 13(4), С. 424 - 424

Опубликована: Апрель 17, 2025

Vaccination has been instrumental in curbing the transmission of SARS-CoV-2 and mitigating severity clinical manifestations associated with COVID-19. Numerous COVID-19 vaccines have developed to this effect, including BioNTech-Pfizer Moderna’s mRNA vaccines, as well adenovirus vector-based such Oxford–AstraZeneca. However, emergence new variants subvariants SARS-CoV-2, characterized by enhanced transmissibility immune evasion, poses significant challenges efficacy current vaccination strategies. In review, we aim comprehensively outline landscape emerging concern (VOCs) sub-lineages that recently surfaced post-pandemic years. We assess effectiveness existing their booster doses, against these subvariants, BA.2-derived sub-lineages, XBB BA.2.86 (Pirola). Furthermore, discuss latest advancements vaccine technology, multivalent pan-coronavirus approaches, along development several next-generation coronavirus exosome-based, virus-like particle (VLP), mucosal, nanomaterial-based vaccines. Finally, highlight key critical areas for future research address evolving threat develop strategies combating viral threats, thereby improving preparedness pandemics.

Язык: Английский

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The safety, immunogenicity, and efficacy of heterologous boosting with a SARS-CoV-2 mRNA vaccine (SYS6006) in Chinese participants aged 18 years or more: a randomized, open-label, active-controlled phase 3 trial

Emerging Microbes & Infections, Год журнала: 2024, Номер 13(1)

Опубликована: Фев. 29, 2024

Continuous emergence of new variants severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), enhanced transmissibility, significant immune escape, and waning immunity call for booster vaccination. We evaluated the safety, immunogenicity, efficacy heterologous with a SARS-CoV-2 mRNA vaccine SYS6006 versus an active control in randomized, open-label, active-controlled phase 3 trial healthy adults aged 18 years or more who had received two three doses inactivated China. The started December 2022 lasted 6 months. participants were randomized (overall ratio: 3:1) to receive one dose (N = 2999) ancestral receptor binding region-based, alum-adjuvanted recombinant protein 1000), including 520 immunogenicity subgroup. boosting showed good safety profiles most AEs being grade 1 2, induced robust wild-type Omicron BA.5 neutralizing antibody response on Days 14 28, demonstrating superiority meeting primary objective. relative against COVID-19 any severity was 51.6% (95% CI, 35.5–63.7) variant, 66.8% (48.6–78.5) BA.5, 37.7% (2.4–60.3) XBB, from Day 7 through Month 6. In vaccinated infected hybrid participants, 68.4% (31.1–85.5) caused by second infection. All cases mild. demonstrated superior high BA.5-associated COVID-19, protected XBB-associated particularly population.

Язык: Английский

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Safety and immunogenicity of heterologous boosting with a bivalent SARS-CoV-2 mRNA vaccine (XBB.1.5/BQ.1) in Chinese participants aged 18 years or more: A randomised, double-blinded, active-controlled phase 1 trial

Vaccine, Год журнала: 2024, Номер 42(9), С. 2438 - 2447

Опубликована: Март 8, 2024

Язык: Английский

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Long‐term immunogenicity and safety of heterologous boosting with a SARS‐CoV‐2 mRNA vaccine (SYS6006) in Chinese participants who had received two or three doses of inactivated vaccine

Journal of Medical Virology, Год журнала: 2024, Номер 96(3)

Опубликована: Март 1, 2024

Abstract The emerging new variants of severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) needs booster vaccination. We evaluated the long‐term safety and immunogenicity heterologous boosting with a SARS‐CoV‐2 messenger RNA vaccine SYS6006. A total 1000 participants aged 18 years or more who had received two (Group A) three B) doses inactivated were enrolled vaccinated one dose SYS6006 which was designed based on prototype spike protein introduced mutation sites. Adverse events (AEs) through 30 days serious AEs during study collected. Live‐virus pseudovirus neutralizing antibody (Nab), binding (immunoglobulin G [IgG]) cellular immunity tested 180 days. Solicited all, injection‐site systemic reported by 618 (61.8%), 498 (49.8%), 386 (38.6%) participants, respectively. Most grade 1. groups similar profile. No vaccination‐related SAEs reported. Robust wild‐type (WT) live‐virus Nab response elicited peak geometric mean titers (GMTs) 3769.5 5994.7 day 14, corresponding to 1602.5‐ 290.8‐fold increase versus baseline, BA.5 GMTs 87.7 93.2 14. All seroconverted for WT Nab. IgG responses wild type also elicited. ELISpot assay showed robust immune response, not obviously affected virus variation. In conclusion, demonstrated good in vaccine.

Язык: Английский

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A retrospective survey on the effectiveness of vaccines administered to individuals in China with regard to inactivated COVID-19 vaccines, Ad5-nCoV and/or aerosolized Ad5-nCoV

Emerging Microbes & Infections, Год журнала: 2024, Номер 13(1)

Опубликована: Авг. 23, 2024

We administered a questionnaire to participants who received different vaccination regimens evaluate the effectiveness of Ad5-vectored COVID-19 vaccines. The results showed that administration intramuscular Ad5-nCoV provided 21.32% more protection against SARS-CoV-2 infection than inactivated vaccine in people had only one type vaccine. Furthermore, aerosolized exhibited good protection, whether it was as homologous booster vaccinated with or heterologous Our research indicates is an effective booster. This finding supports future selection immunization strategies.

Язык: Английский

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Modeling COVID-19 vaccine booster-elicited antibody response and impact of infection history

Vaccine, Год журнала: 2023, Номер 41(52), С. 7655 - 7662

Опубликована: Ноя. 25, 2023

The 3-dose COVID-19 vaccine (booster vaccination) has been offered worldwide. As booster vaccinations continue, it is important to understand the antibody dynamics elicited by vaccination in order evaluate and develop needs strategies. Here, we investigated longitudinal data monitoring IgG antibodies against receptor binding domain (RBD) health care workers. We extended our previously developed mathematical model vaccines successfully fitted titers over time absence presence of past SARS-CoV-2 infection. Quantitative analysis using indicated that anti-RBD increase a comparable extent after vaccination, regardless or infection, but infection history extends duration response 1.28 times. Such modeling approach can be used inform future strategies on basis an individual's immune history. Our simple quantitative any kind therefore form for policy decisions regarding distribution strengthen immunity pandemics.

Язык: Английский

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Bivalent (Omicron BA.5/ancestral) recombinant spike protein vaccine: a promising booster

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

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Estimating All-Cause Deaths Averted in the First Two Years of the COVID-19 Vaccination Campaign in Italy

Vaccines, Год журнала: 2024, Номер 12(4), С. 413 - 413

Опубликована: Апрель 13, 2024

Comparing deaths averted by vaccination campaigns is a crucial public health endeavour. Excess all-cause better reflect the impact of pandemic than COVID-19 deaths. We used seasonal autoregressive integrated moving average with exogenous factors model to regress daily on annual trend, seasonality, and environmental temperature in three Italian regions (Lombardy, Marche Sicily) from 2015 2019. The was forecast excess during vaccinal period (December 2020–October 2022). prevented fraction estimate observed campaigns, those which would have occurred without vaccination, campaigns. At end period, Lombardy region proceeded more intensive campaign other (on average, 1.82 doses per resident, versus 1.67 1.56 Sicily, respectively). A higher consistently found (65% avoided deaths, as opposed 60% 58% Sicily). Nevertheless, because lower mortality rate compared Sicily (12, 24 23 10,000 person-years, respectively), (22 36 32 In Lombardy, early full implementation adult associated largest reduction Sicily.

Язык: Английский

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Immunogenicity during 6 months after SARS-CoV-2 infection is significantly different depending on previous COVID-19 vaccine regimens and a booster dose received

Vaccine, Год журнала: 2024, Номер 42(22), С. 126025 - 126025

Опубликована: Июнь 12, 2024

Язык: Английский

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