Sex-disaggregated effectiveness data reporting in COVID-19 vaccine research: a systematic review DOI Creative Commons
Giorgia Sulis, Ji Yoon Kim, Valérie Rodrigue

et al.

Communications Medicine, Journal Year: 2023, Volume and Issue: 3(1)

Published: May 19, 2023

Sex and gender are believed to influence vaccine response. Yet, the relationship between sex COVID-19 efficacy is poorly understood remains under-investigated.We conducted a systematic review determine whether what extent post-approval effectiveness (VE) studies report sex-disaggregated VE data. We searched four publication pre-publication databases additional grey literature sources for relevant published/preprint released 1 January 2020 October 2021 (i.e., pre-Omicron era). included observational providing estimates one or more licensed/approved vaccines including both males females. Two reviewers independently assessed study eligibility, extracted data, risk-of-bias through modified version of Cochrane's ROBINS-I tool. A qualitative data synthesis was performed.Here we show that, among 240 eligible publications, 68 (28.3%) do not distribution participants. Only 21/240 (8.8%) provide estimates, high between-study heterogeneity regarding design, target population, outcomes, type/timing prevent assessment in determining across studies.Our findings indicate that few research publications account sex. Improved adherence recommended reporting guidelines will ensure evidence generated can be used better understand VE.The level protection against might depend on person’s gender. However, always reported vaccines. Here, systematically reviewed looked at found separated out their by participants’ Out identified, did participants study, only 21 These results substantial proportion Efforts should made researchers effectiveness, help optimise vaccination strategies so all people adequately protected.

Language: Английский

Serological Response to Three, Four and Five Doses of SARS-CoV-2 Vaccine in Kidney Transplant Recipients DOI Open Access
Bilgin Osmanodja, Simon Ronicke, Klemens Budde

et al.

Journal of Clinical Medicine, Journal Year: 2022, Volume and Issue: 11(9), P. 2565 - 2565

Published: May 4, 2022

Mortality from COVID-19 among kidney transplant recipients (KTR) is high, and their response to three vaccinations against SARS-CoV-2 strongly impaired. We retrospectively analyzed the serological of up five doses vaccine in KTR 27 December 2020 until 31 2021. Particularly, influence different dose adjustment regimens for mycophenolic acid (MPA) on fourth vaccination was analyzed. In total, 4277 1478 patients were Serological 19.5% after 1203 basic immunizations, increased 29.4%, 55.6%, 57.5% 603 third, 250 fourth, 40 fifth vaccinations, resulting a cumulative rate 88.7%. with calcineurin inhibitor MPA maintenance immunosuppression, pausing adding 5 mg prednisolone equivalent before 75% comparison no (52%) or reduction (46%). Belatacept-treated had 8.7% (4/46) 12.5% (3/25) four vaccinations. Except belatacept-treated patients, repeated times effectively induces recipients. It can be enhanced by at time vaccination.

Language: Английский

Citations

77
The prevalence and risk of developing major depression among individuals with subthreshold depression in the general population DOI Creative Commons
Ruibin Zhang, Xiaoling Peng, Xiaoqi Song

et al.

Psychological Medicine, Journal Year: 2022, Volume and Issue: 53(8), P. 3611 - 3620

Published: Feb. 14, 2022

Subthreshold depression could be a significant precursor to and risk factor for major depression. However, reliable estimates of the prevalence its contribution developing under different terminologies depicting subthreshold have established.

Language: Английский

Citations

74
Vaccine Side Effects Following COVID-19 Vaccination Among the Residents of the UAE—An Observational Study DOI Creative Commons
Subhashini Ganesan, Latifa Baynouna AlKetbi, Nawal Al Kaabi

et al.

Frontiers in Public Health, Journal Year: 2022, Volume and Issue: 10

Published: May 6, 2022

COVID-19 vaccines have proven to be very safe in the clinical trials, however, there is less evidence comparing safety of these real-world settings. Therefore, we aim investigate nature and severity adverse effects reported differences based on type vaccine received. A survey was conducted among 1,878 adult (≥18 years) recipients through online platforms telephonic interviews during March September 2021. The factors potentially associated with side like age, gender, ethnicity, comorbidities, previous infection were analyzed Differences events compared between inactivated mRNA recipients. major by pain at site injection, fatigue drowsiness, headache followed joint/muscle pain. more common Pfizer-BioNTech than inactive Sinopharm odds ratio 1.39 (95% CI 1.14–1.68). average number individuals who had received 1.61 ± 2.08 2.20 2.58, respectively, difference statistically significant ( p <0.001). Severe after vaccinations rare 95% either an or mild requiring no home-based treatment. study found that 55 years female history one comorbid conditions, Pfizer- BioNTech vaccine, infections are higher developing effect post vaccination others.

Language: Английский

Citations

73
Safety and efficacy of COVID‐19 vaccines in children and adolescents: A systematic review of randomized controlled trials DOI
Fangyuan Tian, Ruonan Yang, Zhaoyan Chen

et al.

Journal of Medical Virology, Journal Year: 2022, Volume and Issue: 94(10), P. 4644 - 4653

Published: June 16, 2022

To systematically review and synthesize the safety efficacy of coronavirus disease-2019 (COVID-19) vaccines in children adolescents. PubMed, EMBASE, Web Science, Cochrane Library databases, International Clinical Trials Registry Platform (ICTRP), Chinese (ChiCTR), ClinicalTrials.gov website were searched to collect accessible randomized controlled trials (RCTs) about human COVID-19 adolescents until May 1, 2022. Three steps, including duplicate removal, title abstract screening, full-text review, used screen studies. The risk-of-bias tool for RCTs was assess bias risk included Microsoft Excel 16.57 (2021) software data extraction analysis. (PROSPERO Code No: CRD42021295422). evaluated a total 10 950 seven published studies over 49 530 participants 26 ongoing trials. Descriptive findings reported stratified by vaccine type. overall, local, systemic adverse events following immunization (AEFIs) most similar between placebo groups. Most reactions mild moderate, whereas few severe. common injection-site pain, fever, headache, cough, fatigue, muscle pain. Few clinical serious events, but them unrelated vaccination. In terms efficacy, investigated messenger RNA (mRNA) found be 90.7%-100% efficacious preventing among adolescents, revealing good profiles this age group. Among current is acceptable, have suggested that mRNA can provide high protection against infection pediatric

Language: Английский

Citations

65
Effectiveness of COVID-19 vaccines against SARS-CoV-2 variants of concern in real-world: a literature review and meta-analysis DOI Creative Commons
Weihao Shao, Xiaorui Chen,

Caifang Zheng

et al.

Emerging Microbes & Infections, Journal Year: 2022, Volume and Issue: 11(1), P. 2383 - 2392

Published: Sept. 7, 2022

Knowing vaccine effectiveness (VE) against variants of concern (VOCs) in the real-world setting is essential for public health decision-making. A systematic landscape VE a series clinical outcomes caused by VOCs needed. We systematically searched studies that evaluated and collected individual data. identified 113 meeting eligibility criteria. found full vaccination provided strong protection each outcome with summary ranging from 86.8% to 96.0% Alpha, moderate infection Beta, Gamma Delta 70.9% 72.8%, severe disease 84.9% 90.3%, limited 23.5% (95% CI, 17.0-29.5) 56.5% 82.4% diseases Omicron. Booster can provide substantial improvement Omicron, but not as much Delta. The meta-regression analysis showed Omicron wanned over time, hospitalization declined relatively slowly, compared infection. Those findings supported need measures, increasing booster coverage response current new infectious waves driven developing broadly protective vaccines confront virus evolution.

Language: Английский

Citations

62
Association of Frailty, Age, and Biological Sex With Severe Acute Respiratory Syndrome Coronavirus 2 Messenger RNA Vaccine–Induced Immunity in Older Adults DOI
Janna R. Shapiro, Ioannis Sitaras,

Han Sol Park

et al.

Clinical Infectious Diseases, Journal Year: 2022, Volume and Issue: 75(Supplement_1), P. S61 - S71

Published: May 24, 2022

Male sex and old age are risk factors for severe coronavirus disease 2019, but the intersection of aging on antibody responses to acute respiratory syndrome 2 (SARS-CoV-2) vaccines has not been characterized.

Language: Английский

Citations

43
GRT-R910: a self-amplifying mRNA SARS-CoV-2 vaccine boosts immunity for ≥6 months in previously-vaccinated older adults DOI Creative Commons
Christine D. Palmer,

Ciaran D. Scallan,

Lauren D. Kraemer Tardif

et al.

Nature Communications, Journal Year: 2023, Volume and Issue: 14(1)

Published: June 6, 2023

Abstract SARS-CoV-2 has resulted in high levels of morbidity and mortality world-wide, severe complications can occur older populations. Humoral immunity induced by authorized vaccines wanes within 6 months, frequent boosts may only offer transient protection. GRT-R910 is an investigational self-amplifying mRNA (samRNA)-based vaccine delivering full-length Spike selected conserved non-Spike T cell epitopes. This study reports interim analyses for a phase I open-label dose-escalation trial evaluating previously vaccinated healthy adults (NCT05148962). Primary endpoints safety tolerability were assessed. Most solicited local systemic adverse events (AEs) following dosing mild to moderate transient, no treatment-related serious AEs observed. The secondary endpoint immunogenicity was assessed via IgG binding assays, neutralization interferon-gamma ELISpot, intracellular cytokine staining. Neutralizing antibody titers against ancestral variants concern boosted or and, contrasting vaccines, persisted through at least months after the booster dose. increased and/or broadened functional Spike-specific responses primed limited due small sample size, additional data from ongoing studies will be required corroborate these findings.

Language: Английский

Citations

23
Antibody responses to COVID‐19 vaccination in people with obesity: A systematic review and meta‐analysis DOI Creative Commons

Xiaodan Ou,

Jialin Jiang,

Bingqian Lin

et al.

Influenza and Other Respiratory Viruses, Journal Year: 2022, Volume and Issue: 17(1)

Published: Dec. 19, 2022

COVID-19 vaccine is critical in preventing SARS-CoV-2 infection and transmission. However, obesity's effect on immune responses to vaccines still unknown. We performed a meta-analysis of the literature compared antibody with among persons without obesity. used Pubmed, Embase, Web Science, Cochrane Library identify all related studies up April 2022. The Stata.14 software was analyze selected data. Eleven were included present meta-analysis. Five them provided absolute values titers obese group non-obese group. Overall, we found that population significantly associated lower (standardized mean difference [SMD] = -0.228, 95% CI [-0.437, -0.019], P < 0.001) after vaccination. Significant heterogeneity most pooled analyses but reduced subgroup analyses. No publication bias observed analysis. Trim Fill method did not change results primary suggested obesity decreased vaccines. Future should be unravel mechanism response individuals.

Language: Английский

Citations

35
Efficacy, immunogenicity and safety of COVID-19 vaccines in older adults: a systematic review and meta-analysis DOI Creative Commons
Zejun Li,

Shouhuan Liu,

Fengming Li

et al.

Frontiers in Immunology, Journal Year: 2022, Volume and Issue: 13

Published: Sept. 13, 2022

Older adults are more susceptible to severe health outcomes for coronavirus disease 2019 (COVID-19). Universal vaccination has become a trend, but there still doubts and research gaps regarding the COVID-19 in elderly. This study aimed investigate efficacy, immunogenicity, safety of vaccines older people aged ≥ 55 years their influencing factors.Randomized controlled trials from inception April 9, 2022, were systematically searched PubMed, EMBASE, Cochrane Library, Web Science. We estimated summary relative risk (RR), rates, or standardized mean difference (SMD) with 95% confidence interval (CI) using random-effects meta-analysis. was registered PROSPERO (CRD42022314456).Of 32 eligible studies, 21, 25 analyzed safety, respectively. In adults, efficacious against (79.49%, CI: 60.55-89.34), excellent seroconversion rate (92.64%, 86.77-96.91) geometric titer (GMT) (SMD 3.56, 2.80-4.31) neutralizing antibodies, provided significant protection (87.01%, 50.80-96.57). Subgroup meta-regression analyses consistently found vaccine types number doses be primary factors efficacy immunogenicity. Specifically, mRNA showed best (90.72%, 86.82-93.46), consistent its highest (98.52%, 93.45-99.98) GMT 6.20, 2.02-10.39). Compared control groups, significantly increased incidence total adverse events (AEs) (RR 1.59, 1.38-1.83), including most local systemic AEs, such as pain, fever, chill, etc. For inactivated DNA vaccines, any AEs similar between groups (p > 0.1), while had range 1.74 7.22).COVID-19 acceptable immunogenicity people, especially providing high disease. The efficacious, it is worth surveillance some caused. Increased booster coverage warranted, additional studies urgently required longer follow-up periods variant strains.

Language: Английский

Citations

32
Evaluation of humoral and cellular response to four vaccines against COVID-19 in different age groups: A longitudinal study DOI Creative Commons
Giorgio Fedele, Filippo Trentini, Ilaria Schiavoni

et al.

Frontiers in Immunology, Journal Year: 2022, Volume and Issue: 13

Published: Oct. 31, 2022

To date there has been limited head-to-head evaluation of immune responses to different types COVID-19 vaccines. A real-world population-based longitudinal study was designed with the aim define magnitude and duration immunity induced by each four vaccines available in Italy at time this study. Overall, 2497 individuals were enrolled their first vaccination (T0). Vaccine-specific antibody over Comirnaty, Spikevax, Vaxzevria, Janssen Ad26.COV2.S heterologous compared up six months after immunization. On a subset Comirnaty vaccinees, serology data correlated ability neutralize reference SARS-CoV-2 B strain, as well Delta AY.4 Omicron BA.1. The frequency SARS-CoV-2-specific CD4+ T cells, CD8+ memory cells assessed We found that mRNA are stronger inducer anti-Spike IgG B-memory cell responses. Humoral lower frail elderly subjects. Neutralization BA.1 variants is severely impaired, especially older individuals. Most vaccinees display vaccine-specific T-cell vaccination. By describing immunological response during phase campaign cohorts considering several aspects response, allowed collect key information could facilitate implementation effective prevention control measures against SARS-CoV-2.

Language: Английский

Citations

30