Predictors of severity of SARS-CoV-2 infections in Brazil: Post hoc analyses of a randomised controlled trial DOI Creative Commons

Kerry Conlin,

Daniel Jenkin,

Philip de Whalley

et al.

Vaccine, Journal Year: 2024, Volume and Issue: 45, P. 126582 - 126582

Published: Dec. 14, 2024

To identify demographic, clinical and immunological factors associated with adverse COVID-19 outcomes. A large randomised controlled trial of ChAdOx1 nCoV-19 was undertaken in Brazil. Participants were 1:1 either to receive nCov-19 or a control group. infections confirmed by nucleic acid amplification test (NAAT) classified using the WHO progression scale. Anti-spike antibody responses serum neutralising activity measured 28 days after second vaccination some participants. Exploratory analyses conducted into infection severity hospitalisation, logistic regression models adjusted for demographic factors. 10,416 participants enrolled; 1790 had NAAT-positive infection; 63 cases required hospitalisation. More severe greater body-mass index (BMI) (odds ratio [OR] = 1.06 [95 %CI: 1.01-1.10], p 0.01) diabetes (OR 3.67 [1.59-8.07], 0.003). Hospitalisation risk increased age [1.03-1.08], < 0.001) BMI 1.10 [1.05-1.16], 0.001). hospitalisation risks >180 last vaccination. In fully vaccinated subgroup (n 841), only predicted 1.07 [1.03-1.12], Serological two vaccine doses diminished age. Unvaccinated individuals high risked more Vaccination mitigated this risk. NCT04536051.

Language: Английский

The role of real-world evidence for regulatory and public health decision-making for Accelerated Vaccine Deployment- a meeting report DOI Creative Commons
Kaatje Bollaerts, Chloé Wyndham-Thomas, Elizabeth Miller

et al.

Biologicals, Journal Year: 2024, Volume and Issue: 85, P. 101750 - 101750

Published: Feb. 1, 2024

The COVID-19 pandemic underscored the need for rapid evidence generation to inform public health decisions beyond limitations of conventional clinical trials. This report summarises presentations and discussions from a conference on role Real-World Evidence (RWE) in expediting vaccine deployment. Attended by regulatory bodies, entities, industry experts, gathering was collaborative exchange experiences recommendations leveraging RWE proved instrumental refining decision-making processes optimise dosing regimens, enhance guidance target populations, steer vaccination strategies against emerging variants. Participants felt that successfully integrated into lifecycle management, encompassing boosters safety considerations. However, challenges emerged, prompting call improvements data quality, standardisation, availability, acknowledging variability potential inaccuracies across diverse healthcare systems. Regulatory transparency should also be prioritised foster trust, improved collaborations with governments are needed streamline collection navigate privacy regulations. Moreover, building sustaining resources, expertise, infrastructure LMICs emerged as imperative RWE-generating capabilities. Continued stakeholder collaboration securing adequate funding vital pillars advancing use shaping responsive effective strategies.

Language: Английский

Citations

10
Effectiveness of the AZD1222 vaccine against COVID-19 hospitalization in Europe: final results from the COVIDRIVE test-negative case–control study DOI Creative Commons
Leonie de Munter, Wilhelmine Meeraus,

Akshat Dwivedi

et al.

European Journal of Public Health, Journal Year: 2025, Volume and Issue: unknown

Published: Jan. 21, 2025

Abstract Marketing authorization holders of vaccines typically need to report brand-specific vaccine effectiveness (VE) the regulatory authorities as part their obligations. COVIDRIVE (now id. DRIVE) is a European public–private partnership for respiratory pathogen surveillance and studies VE with long-term follow-up. We final results from two-dose primary series AZD1222 (ChAdOx1 nCoV-19) schedule in ≥18-year-old individuals not receiving boosters. Patients (N = 1,333) hospitalized severe acute infection at 14 hospitals Austria, Belgium, Italy, Spain were included test-negative case–control study 2021–2023. Absolute was calculated using generalized additive model (GAM), estimating equation (GEE), spline-based area under curve (AUC, measuring up 6 months after last dose AZD1222). Overall (against coronavirus disease 2019 [COVID-19] hospitalization) an estimated 65% GEE (95% confidence interval [CI]: 52.9–74.5), 69% GAM CI: 50.1–80.9) over 22-month period (comparator group: unvaccinated patients). The AUC estimate 74.1% 60.0–88.3). against hospitalization participants who received second 2 or less before 86% 77.8–91.4), 93% 67.2–98.6). During this period, where mainly syndrome Omicron variant circulating, vaccination conferred protection COVID-19 least dose.

Language: Английский

Citations

0
Vaccine effectiveness of JCOVDEN single-dose against COVID-19 hospitalisation in Europe: an id.DRIVE test-negative case-control study DOI Creative Commons
Chloé Wyndham-Thomas, E. Claire Newbern, Ainara Mira‐Iglesias

et al.

Journal of Infection and Public Health, Journal Year: 2025, Volume and Issue: 18(5), P. 102700 - 102700

Published: Feb. 11, 2025

JCOVDEN (Ad26.COV2.S), a viral-vector vaccine, was granted conditional marketing authorisation in the European Union for prevention of COVID-19 early 2021. We present single-dose vaccine effectiveness (VE) estimates against hospitalisation. The id.DRIVE (previously COVIDRIVE) VE study is an ongoing non-interventional, multi-centre with test-negative case-control design. Study participants were adults ≥ 18 years old, hospitalised severe acute respiratory infection between 1 May 2021 and 28 February 2023. Estimated as single measure over entire period, stratified by risk group, time since vaccination intervals (14 days-12 weeks, 12-to-25 25-to-52 >52 weeks), SARS-CoV-2 variant calendar categories. All adjusted symptom-onset date, age, sex, number pre-defined chronic conditions. Overall, 55.6 % (95 CI 23.6; 74.2) median 146 days. For 18- to 49-year-olds, 61.6 16.2; 82.4), 57.7 3.4; 81.5) 50- to-64-years-olds, 40.8 -6.0; 66.9) 65-year-olds. Most precise obtained 12-to- 25-week interval (59.2 [95 25.0; 77.8]) period Aug -30 Nov (Delta predominant; 51.2 21.7; 69.6]). protected It effective at least six months, comparatively lower older age groups. Results had low medium levels certainty are be interpreted caution.

Language: Английский

Citations

0
Phase II/III Double-Blind Study Evaluating Safety and Immunogenicity of a Single Intramuscular Booster Dose of the Recombinant SARS-CoV-2 Vaccine “Patria” (AVX/COVID-12) Using an Active Newcastle Disease Viral Vector (NDV) during the Omicron Outbreak in Healthy Adults with Elevated Baseline Antibody Titers from Prior COVID-19 and/or SARS-CoV-2 Vaccination DOI Open Access
Constantino López‐Macías, Martha Torres,

Brenda Armenta-Copca

et al.

medRxiv (Cold Spring Harbor Laboratory), Journal Year: 2024, Volume and Issue: unknown

Published: Feb. 14, 2024

Abstract Background The urgent need for safe, effective, and economical coronavirus disease 2019 (COVID-19) vaccines, especially booster campaigns targeting vulnerable populations, prompted the development of AVX/COVID-12 vaccine candidate. AVX/COVD-12 is based in a Newcastle virus La Sota (NDV-LaSota) recombinant viral vector. This expresses stabilized version spike protein severe acute respiratory syndrome 2 (SARS-CoV-2), specifically ancestral Wuhan strain. study aimed to assess its safety, immunogenicity, potential efficacy as an anti-COVID-19 vaccine. Methods In phase II/III clinical trial conducted from November 9, 2022, September 11, 2023, total 4,056 volunteers were enrolled. Participants received intramuscular dose either or AZ/ChAdOx-1-S vaccines. Safety, assessed through various measures, including neutralizing antibody titers, interferon (IFN)-γ-producing CD4+ T cells, CD8+ cells. evaluation also involved immunobridging, utilizing active comparator, monitoring incidence COVID-19 cases. Findings induced antibodies against both SARS-CoV-2 BA.2 BA.5 Omicron variants. geometric mean ratio titers between individuals immunized with those at 14 days 0.96, confidence interval (CI) 0.85-1.06. outcome aligns non-inferiority criterion recommended by World Health Organization (WHO), indicating lower limit CI greater than equal 0.67. Induction IFN-γ-producing cells day post-immunization was exclusively observed group. Finally, trend suggested potentially cases boosted compared recipients. Conclusion proved well-tolerated, immunogenic. meets WHO standard AZ/ChAdOx-1-S. These results strongly advocate viable dose, supporting utilization population.

Language: Английский

Citations

1
Predictors of severity of SARS-CoV-2 infections in Brazil: Post hoc analyses of a randomised controlled trial DOI Creative Commons

Kerry Conlin,

Daniel Jenkin,

Philip de Whalley

et al.

Vaccine, Journal Year: 2024, Volume and Issue: 45, P. 126582 - 126582

Published: Dec. 14, 2024

To identify demographic, clinical and immunological factors associated with adverse COVID-19 outcomes. A large randomised controlled trial of ChAdOx1 nCoV-19 was undertaken in Brazil. Participants were 1:1 either to receive nCov-19 or a control group. infections confirmed by nucleic acid amplification test (NAAT) classified using the WHO progression scale. Anti-spike antibody responses serum neutralising activity measured 28 days after second vaccination some participants. Exploratory analyses conducted into infection severity hospitalisation, logistic regression models adjusted for demographic factors. 10,416 participants enrolled; 1790 had NAAT-positive infection; 63 cases required hospitalisation. More severe greater body-mass index (BMI) (odds ratio [OR] = 1.06 [95 %CI: 1.01-1.10], p 0.01) diabetes (OR 3.67 [1.59-8.07], 0.003). Hospitalisation risk increased age [1.03-1.08], < 0.001) BMI 1.10 [1.05-1.16], 0.001). hospitalisation risks >180 last vaccination. In fully vaccinated subgroup (n 841), only predicted 1.07 [1.03-1.12], Serological two vaccine doses diminished age. Unvaccinated individuals high risked more Vaccination mitigated this risk. NCT04536051.

Language: Английский

Citations

0