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Appendix A | SKIN | Study design and process. Skin carotenoid levels (SCL) were measured weekly during the screening week (5 weeks before the intervention), 6-week intervention periods, and 4-week tracking periods. | PMC10490775 | |
Appendix B | RECRUITMENT | Flow diagram for the recruitment, randomization, and retention of study participants. | PMC10490775 | |
2. Results | PMC10049539 | |||
2.1. Characteristics of Study Population and Concentrations of | Fifty-seven participants were included in the present investigation: 46 adults with long COVID (47.8 ± 9.4 years; 65.2% women) enrolled in a randomized clinical trial [ | PMC10049539 | ||
2.2. | To gain insights into possible differences in The optimal model complexity was found to be 3 ± 1 latent variables and yielded an average classification accuracy of 80.2 ± 3.0%, corresponding to 78.1 ± 3.2% and 88.9 ± 5.2% correct classification rate for participants with long COVID and controls, respectively. The non-p... | PMC10049539 | ||
2.3. Effects of | ± | A PLS–DA model was built to explore the effects of 28-day supplementation with The optimal model complexity was found to be 4 ± 1 latent variables. The model had low discrimination power, with an average classification accuracy of 58.5 ± 5.8%, corresponding to 54.3 ± 6.3% and 62.6 ± 8.6% of correct classification in pa... | PMC10049539 | |
4. Materials and Methods | PMC10049539 | |||
4.1. Study Design and Participants | Participants involved in the present investigation were adults with long COVID who were enrolled in a placebo-controlled randomized clinical trial that tested the effects of a combination of Trial participants and healthy controls were asked to refrain from exercising and consuming any product with vasoactive propertie... | PMC10049539 | ||
4.3. Statistical Analysis | R2015b | REGRESSION | Personal characteristics of study participants are reported as mean ± standard deviation or median (interquartile range) for continuous variables, and as absolute values (percentages) for categorical variables. Normal distribution of data was assessed via the Shapiro–Wilk test. Changes from baseline for continuous vari... | PMC10049539 |
5. Conclusions | In the present investigation, we showed that perturbations in | PMC10049539 | ||
Author Contributions | Conceptualization, R.C., J.G., M.T. and F.L.; methodology, A.P., H.J.C.-J., C.D.M., J.G., E.G., S.L., L.S. and B.T.; validation, A.U. and E.M.; formal analysis, M.T., R.C., H.J.C.-J. and F.M.; investigation, F.C., V.G. and A.M.P.; resources, E.G., A.U. and F.L.; writing—original draft preparation, R.C.; writing—review ... | PMC10049539 | ||
Institutional Review Board Statement | DEL | The study was conducted in accordance with the Declaration of Helsinki, and approved by the ethics committee of Università Cattolica del Sacro Cuore Roma/Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy (prot. no. 0013008/20). | PMC10049539 | |
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC10049539 | ||
Data Availability Statement | The data presented in this study are available from the corresponding author upon reasonable request pending approval by the Gemelli against COVID Scientific Committee. | PMC10049539 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC10049539 | ||
Abstract | PMC9924108 | |||
Purpose | This study aims to develop an algorithm to predict gamma passing rate (GPR) in the volumetric‐modulated arc therapy (VMAT) technique. | PMC9924108 | ||
Materials and methods | head and neck, 40 brains, prostate | REGRESSION, PROSTATE | A total of 118 clinical VMAT plans, including 28 mediastina, 25 head and neck, 40 brains intensity‐modulated radiosurgery, and 25 prostate cases, were created in RayStation treatment planning system for Edge and TrueBeam linacs. In‐house scripts were developed to compute Modulation indices such as plan‐averaged beam ar... | PMC9924108 |
Results | RMSEs at | PMC9924108 | ||
Conclusion | In terms of its prediction values and errors, SVR (linear) appeared to be comparable with RFR for this dataset. Based on our results, the PA, PI, and total MU calculations may be useful in guiding VMAT plan evaluation and ultimately reducing uncertainties in planning and radiation delivery.
[Corrections added on 26 Dec... | PMC9924108 | ||
INTRODUCTION | REGRESSION | Over the last two decades, the complexity of external beam radiation therapy has increased significantly. Volumetric‐modulated arc therapy (VMAT) often requires more beam intensity modulation, which typically results in a higher degree of complexity and larger dosimetric uncertainty. Consequently, pretreatment verifica... | PMC9924108 | |
MATERIALS AND METHODS | PMC9924108 | |||
Treatment planning | A mix of VMAT treatment sites consisting of a total of 118 clinical plans were randomly selected for this study. All treatment plans were created in RayStation version 10.A (RaySearch Medical Laboratories AB, Stockholm, Sweden) TPS with a grid size of 1 mm for intensity‐modulated radiosurgery (IMRS) cases and 2 mm for ... | PMC9924108 | ||
Second MU check and pretreatment verification | VMAT technique requires more beam intensity modulation, which usually results in a larger number of MUs. Moreover, uncertainties in using CT/MR/PET simulation, inhomogeneity corrections, and complex calculation algorithms such as convolution/superposition and Monte Carlo warrant the need of doing a second MU check to a... | PMC9924108 | ||
Modulation indices | REGRESSION | We developed several Python scripts to compute complexity metrics consisting of the following components for each segment: The aperture area was calculated as the total area of all MLC openings; the aperture perimeter (AP) is the length of the boundary of the total area of all MLC openings; and the aperture irregularit... | PMC9924108 | |
Statistical analysis | MIs | There may be complex and unknown relationships between the dependent and independent variables in the dataset. Discovering and quantifying the degree to which variables in the dataset are dependent upon each other is an important step in machine learning because this information can help us better prepare our data to m... | PMC9924108 | |
Trajectory log files analysis | It has been indicated that machine log file analysis is a robust and efficient way to detect errors originating from human mistakes, flawed planning, and data transfer problems.Therefore, a total of 262 and 214 trajectory log files for Edge and TrueBeam, respectively, were analyzed using Pylinac (Ver 3.0) to find any p... | PMC9924108 | ||
Machine‐learning models | The calculated features were shuffled and then randomly split into 70% (82 treatment plans) being fed into the training dataset and 30% (36 treatment plans) into the test dataset. In this study, the Scikit‐learn implementation of RFR and SVR with linear kernel was used, which gives the user an option for tuning the hyp... | PMC9924108 | ||
Random forest regression | REGRESSION | In recent years, one of the ML models that has been used to predict GPR is RFR.Hyperparameters used to train the random forest regression (RFR) model | PMC9924108 | |
Support vector regression | respiratory tumor | SVR is a powerful algorithm that has been used for radiotherapy outcome predictions such as the prediction of respiratory tumor motion,In this study, GridSearchCV from the Scikit‐learn package was used to tune hyperparameters, including kernels (linear, RBF, poly), epsilon, C, and gamma. In the case of this dataset, th... | PMC9924108 | |
RESULTS | PMC9924108 | |||
Second MU check and pretreatment verification | prostate | PROSTATE | All computed dose differences between the RadCalc and TPS were less than 3% for all treatment sites.Figure Boxplots for gamma passing rate (GPR) (3%/2 mm) based on treatment site. Intensity‐modulated radiosurgery (IMRS) has the lowest GPR, whereas the prostate has the highest GPR among all treatment sites. This chart s... | PMC9924108 |
Modulation indices | prostate | PROSTATE | Figure Boxplots of (a) total_MU, (b) plan‐averaged beam irregularity (PI), (c) plan‐averaged beam area (PA), (d) leaf travel per arc length (LT/AL), (e) mean dose rate (DR) variation, and (f) mean gantry speed (GS) variation for head and neck, intensity‐modulated radiosurgery (IMRS), mediastinum/lung, and prostate. Thi... | PMC9924108 |
Statistical analysis | In careful analysis of computed data, the following results were observed: a strong correlation among GPR and PA, PI, total MU, and GS (0.723, −0.672, −0.66, and 0.624, respectively, with | PMC9924108 | ||
Trajectory log files analysis | Table Maximum percentage difference between plan and delivery for each treatment siteAbbreviations: H&N, head and neck; IMRS, intensity‐modulated radiosurgery; MLC, multileaf collimator; MU, monitor unit. | PMC9924108 | ||
Machine‐learning models | ± | REGRESSION | Applying SVR (linear) directly to GPR did not result in good prediction values as some of the prediction values were greater than 100%, which is not acceptable for GPR.To avoid this issue, a logit transform was applied to GPRs. First, GPRs were divided by 100 to have data in the range between 0 and 1. However, as it is... | PMC9924108 |
DISCUSSION | MIs | REGRESSION | This study has investigated the impact of the combination of plan complexity features on GPR using four treatment sites with variable levels of complexity and on two linacs with different MLC designs. Additionally, we included two VMAT‐specific features GS and DR variations as independent variables to build our model. ... | PMC9924108 |
CONCLUSION | MIs | The relationship between GPR (3%/2 mm) and the complexity of VMAT plans was studied by analyzing different MIs. We found that PA, PI, and total MU have the highest level of impact on GPR. However, because MU is already included in PA and PI calculations these metrics may not be fully independent predictors of GPR. Acco... | PMC9924108 | |
AUTHOR CONTRIBUTIONS | Elahheh Salari: conceived and designed the analysis, collected the data, contributed data, performed the analysis, wrote the paper.Kevin Shuai Xu: conceived and designed the analysis, wrote the paper.Nicholas Niven Sperling: conceived and designed the analysis. E. Ishmael Parsai: conceived and designed the analysis, wr... | PMC9924108 | ||
CONFLICT OF INTEREST | The authors declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research reported. | PMC9924108 | ||
ACKNOWLEDGMENTS | None. | PMC9924108 | ||
REFERENCES | PMC9924108 | |||
Background | migraine, CM | MIGRAINE | No available studies demonstrate validity and meaningful change thresholds of Work Productivity and Activity Impairment (WPAI) questionnaire in patients with migraine. In this post-hoc analysis, we assessed reliability, validity, responsiveness, and meaningful within-patient change from baseline to Month 3 for Work Pro... | PMC10073392 |
Method | migraine headache, Migraine, CM | MIGRAINE HEADACHE, MIGRAINE | The Phase 3, multicenter, randomized, double-blind, placebo-controlled CONQUER study (NCT03559257, N = 462) enrolled patients with EM or CM who failed two to four categories of prior preventive medication in past ten years. The analyses were performed for WPAI domain scores (absenteeism, presenteeism, overall work prod... | PMC10073392 |
Results | migraine headache | MIGRAINE HEADACHE | Of 462 randomized patients, 444 who completed WPAI questionnaire were included in post-hoc analysis. Test–retest reliability over 3 months in a stable subgroup revealed moderate correlations for non-work-related Activity Impairment (ICC = 0.446) presenteeism (ICC = 0.438) and a fair correlation for overall work product... | PMC10073392 |
Conclusion | CM | In conclusion, WPAI has sufficient validity, reliability, responsiveness, and appropriate interpretation standards to assess the impact of EM or CM on presenteeism and overall work productivity loss and non-work-related activity impairment. | PMC10073392 | |
Supplementary Information | NCT number of CONQUER study, NCT03559257.The online version contains supplementary material available at 10.1186/s41687-023-00552-4. | PMC10073392 | ||
Keywords | PMC10073392 | |||
Introduction | migraine, Migraine, CM | MIGRAINE, MIGRAINE | The global prevalence of migraine varies among studies, a recent update provides a summary estimate of 14% and shows a prevalence peak in mid-life [A recent global survey, “My Migraine Voice”, evaluated the social and economic impact of migraine in patients with ≥ 4 monthly migraine days who were receiving preventive t... | PMC10073392 |
Methods | PMC10073392 | |||
Study design and patient population | CM, nonmigraine, headache, migraine, migraine headache, disability | MIGRAINE, MIGRAINE HEADACHE | CONQUER (NCT03559257, N = 462) was a Phase 3, multicenter, randomized, double-blind, placebo-controlled study. The details on the study design and patient population have been previously published [Subgroup analyses were conducted based on EM and CM status as defined in the clinical trial protocol based on the baseline... | PMC10073392 |
Study measures | migraine headache, pain, phonophobia, ICHD-3, headache, migraine, nausea and/or vomiting, Migraine, photophobia | MIGRAINE, DISEASE, MIGRAINE, MIGRAINE HEADACHE | The WPAI-Specific Health Problem version 2 is a six-item questionnaire, with a recall period of past seven days. The WPAI questionnaire was collected at the baseline and at the Month 3 visit during double-blind period to assess past one week WPAI score. The instrument includes questions on employment status, hours miss... | PMC10073392 |
Statistical analysis | migraine | MIGRAINE, HEAT | A statistical analysis plan was developed prior to the execution of this post-hoc analysis. In this post-hoc analysis, reliability, validity, responsiveness (ability to detect change), and meaningful within-patient change in WPAI score were assessed before the use of the 3 anchor-based responder definitions indicated a... | PMC10073392 |
Reliability | Test–retest reliability was assessed in a population considered to be stable. This group received placebo and had a change of one day or less in their number of migraine-headache days per month. WPAI domain scores at baseline and Months 3 were used to assess test–retest reliability. Intra-class correlation coefficients... | PMC10073392 | ||
Validity | Construct validity of WPAI domain scores with MSQ-RFR, MSQ-RFP, and monthly migraine-headache days was assessed using Spearman’s correlation analyses at baseline. The Spearman’s rank correlation coefficient measures the strength and direction of association between two variables using a non-parametric correlation stati... | PMC10073392 | ||
Responsiveness | non-work-related activity impairment | Anchor-based responder analyses were performed to assess the ability to detect change in WPAI domain scores by responder status for each of the three anchors (MSQ-RFR, MSQ-RFP, and monthly migraine-headache days). The least square mean changes from baseline to Month 3 for WPAI for both responders and non-responders for... | PMC10073392 | |
Meaningful within-patient change thresholds | migraine headache | REGRESSION, MIGRAINE HEADACHE | Anchor-based analyses were used to determine the meaningful within-patient change in WPAI domain scores. Monthly migraine headache days decreased by 50%, MSQ-RFR scores decreased by ≥ 25.71 points and MSQ-RFP scores decreased by ≤ 20 points were selected as anchors.WPAI change score threshold was estimated by logistic ... | PMC10073392 |
Results | PMC10073392 | |||
Reliability | CM | Test–retest reliability results, estimated in stable patients treated with placebo, showed moderate correlations for WPAI presenteeism (ICC: all patients = 0.438; EM patients = 0.227; CM patients = 0.893) and WPAI non-work-related Activity Impairment (ICC: all patients = 0.446; EM patients = 0.272; CM patients = 0.653)... | PMC10073392 | |
Validity | migraine headache, CM | MIGRAINE HEADACHE | At baseline, all the correlations between WPAI domain scores and continuous anchor variables exceeded the recommended threshold of ≥ 0.30, except for WPAI domain scores with the number of monthly migraine headache days in the overall population, and in patients with EM or CM. In patients with EM, the correlation betwee... | PMC10073392 |
Discussion | chronic pain disorders, pain, CM, headache, migraine, migraine headache, disability | MIGRAINE, MIGRAINE HEADACHE | This post-hoc analyses of the CONQUER study demonstrated the reliability, validity, responsiveness, and meaningful change of the WPAI questionnaire in patients with EM or CM. These results support the validity of the WPAI as a PRO to measure the impact of EM or CM on work productivity (overall and presenteeism) and non... | PMC10073392 |
Conclusions | migraine, CM | MIGRAINE | The results of this study demonstrated the validity of the WPAI PRO to measure the impact of EM or CM on work productivity (overall and presenteeism) and non-work-related activity impairment. The meaningful change thresholds for the WPAI domain scores may help in evaluating clinically meaningful treatment responses and... | PMC10073392 |
Acknowledgements | The authors would like to thank the investigators for conduct of CONQUER study. The author would also like to thank Rahul Nikam and Karan Sharma, employees of Eli Lilly and Company for providing writing assistance. | PMC10073392 | ||
Author contributions | J.H.F., D.W.A., and W.Y. conceived and designed the study. X.M. and W.Y. acquired the data. X.M., W.Y., D.W.A., J.H.F., S.B., D.C.B., and R.B.L. analyzed and interpreted the data. J.H.F., X.M., W.Y., D.W.A., D.C.B., and R.B.L. provided technical direction in the preparation of the manuscript. All authors critically rev... | PMC10073392 | ||
Funding | The study was sponsored by Eli Lilly and Company. | PMC10073392 | ||
Availability of data and materials | Eli Lilly and Company provides access to all individual participant data collected during the trial, after anonymization except for pharmacokinetic or genetic data. Data are available to request six months after the indication studied has been approved in the United States and European Union and after primary publicati... | PMC10073392 | ||
Declarations | PMC10073392 | |||
Ethics approval and consent to participate | The study protocol was approved by the Institutional Review Board, Medical Ethics Committee or Medical Research, and Ethics Committee of the participating study sites. The study was conducted in concordance with the Declaration of Helsinki guidelines. All patients provided written informed consent before study particip... | PMC10073392 | ||
Consent for publication | All the authors have provided their consent for publication. | PMC10073392 | ||
Competing interests | Headache, JHF, Pain, Stroke, Migraine, Wolff's Headache, Neurological Disorders | MINOR, MIGRAINE, STROKE, NEUROLOGICAL DISORDERS | WY, and DWA are employees and minor stockholders of Eli Lilly and Company. JHF is a former employee of Eli Lilly and Company and was associated with Eli Lilly till the time of manuscript submission. Her current affiliation is Agios. XM is an employee of Tech Data Services Company and performs contracted work for Eli Li... | PMC10073392 |
References | PMC10073392 | |||
Methods | CORONAVIRUS, SEVERE ACUTE RESPIRATORY SYNDROME | From 11-September-2020 to 05-May-2021, across six sites in the Russian Federation, 496 participants were injected with either placebo or Ad5-nCoV expressing the full-length spike (S) protein from the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). | PMC9994755 | |
Results | deaths, RBD | ADVERSE EVENTS, EVENTS, SECONDARY | Seroconversion (the primary endpoint) rates of 78.5% (95% CI: 73.9; 82.6) against receptor binding domain (RBD), 90.6% (95% CI: 87.2; 93.4) against S protein and 59.0% (95% CI: 53.3; 64.6) seroconversion of neutralising antibodies against SARS-CoV-2 at 28 days post-vaccination were observed. Geometric mean titres (GMTs... | PMC9994755 |
Conclusion | A single-dose of Ad5-nCoV vaccine induced a marked specific humoral and cellular immune response with a favourable safety profile. | PMC9994755 | ||
Data Availability | All relevant data are within the manuscript and its | PMC9994755 | ||
Introduction | RBD | CORONAVIRUS, ADENOVIRUS, SEVERE ACUTE RESPIRATORY SYNDROME, FLU | The ongoing COVID-19 pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has resulted in morbidity and mortality unseen since the Spanish flu outbreak more than a century ago [A candidate COVID-19 vaccine that initially showed a capacity to induce a significant antibody and cellular immune r... | PMC9994755 |
Materials and methods | The protocol for this trial and supporting CONSORT checklist are available as supporting information; see | PMC9994755 | ||
Ethical conduct of the study | The study proceeded in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice. The trial protocol was reviewed and approved by the Independent Ethics Committees of the involved sites and the Ethics Council of the Ministry of Health of the Russian Federation. The study design and method... | PMC9994755 | ||
Study design and participants | Prometheus | SARS-COV-2 INFECTION, RECRUITMENT | Prometheus is a multicentre, randomised, double-blind, placebo-controlled, clinical trial being conducted in six centres in the Russian Federation. The study seeks to evaluate the immunogenicity, efficacy, reactogenicity and safety of a single dose of the Ad5-nCoV COVID-19 vaccine compared with placebo in adults up to ... | PMC9994755 |
Randomisation and study populations | The investigational vaccine, Ad5-nCoV, and the placebo were provided by NPO Petrovax Pharm LLC (Moscow, Russia). Both vaccine and placebo were developed by CanSino Biologics Inc. (Tianjin, China) and the Beijing Institute of Biotechnology (Beijing, China). The vaccine was administered with the optimal dose of 5 × 10Eli... | PMC9994755 | ||
Procedures | allergic, RBD | VIRUS, ADVERSE EVENT, IMMUNISATION REACTION, INFLUENZA, ACUTE RESPIRATORY INFECTION | A single dose (0.5 mL) of Ad5-nCoV or placebo was administered by intramuscular (IM) injection to the upper arm on Day 0. Participants were requested to remain at the site for 2 h after vaccination for study staff to monitor for any systemic or local reactions to vaccination. Following the administration of the vaccine... | PMC9994755 |
Outcomes | COVID-19-related deaths | SECONDARY | The primary endpoint was the seroconversion rate, specifically the percentage of individuals with a four-fold or higher increase in antibody titres to the RBD of the SARS-CoV-2 S protein, 28 days after vaccination. Secondary endpoints included the assessment of four outcomes: 1) examining the seroconversion rates in re... | PMC9994755 |
Statistical methods | Statistical analysis was performed using SPSS Statistics, Version 26.0 (IBM Corp.). An in-depth description of the statistical analysis performed and sample size calculations used in this study is available in | PMC9994755 | ||
Patient and public involvement | Participants were fully informed about the study and informed consent was obtained. We thank them for their involvement in the study. | PMC9994755 | ||
Data sharing | The Authors commit to making the relevant anonymised participant level data available upon reasonable request for 3 years following publication of this study. Requests should be directed to the corresponding author. | PMC9994755 | ||
Results | PMC9994755 | |||
Participant population | Out of the 783 participants who were screened, this analysis included 500 eligible participants intended for vaccination at six locations in the Russian Federation between 11 September 2020 and 11 November 2020. Of these, 374 participants were randomised to the Ad5-nCoV group and 126 to the Placebo group ( | PMC9994755 | ||
Participant flow diagram. | ADVERSE EVENT | Populations used to evaluate the findings of this study are presented in bold text. AE, adverse event; FAS, Full Analysis Set; PPS, Per-Protocol Set.The mean age of participants was 41.2 years (range 18–79 years), with 300 (60.5%) participants aged 18–44 years, 161 (32.5%) aged 45–59 years, and 35 (7.1%) aged 60 years ... | PMC9994755 | |
Participant demographics (safety analysis set). | PMC9994755 | |||
Efficacy results | Out of those from the FAS for immunogenicity analysis population, a total of 31 participants were confirmed to have COVID-19 within 6 months post-vaccination (excluding the cases within 14 days post-vaccination). The PPS for efficacy analysis included a total of 481 participants ( | PMC9994755 | ||
Immunogenicity results | Antibody titres are shown in | PMC9994755 | ||
The Ad5-nCoV vaccine elicits a strong immunogenic response that lasts up to 6 months. | RBD | SARS-COV-2 INFECTION | Geometric mean titre (GMT) of serum antibodies against the RBD and SARS-CoV-2 S protein on Day 0, Day 14, Day 28 and Month 6 after vaccination measured from participants from the Ad5-nCoV (n = 371) or the Placebo group (n = 124; from the FAS for immunogenicity analysis). The GMTs with 95% CI are shown for serum antibod... | PMC9994755 |
High seroconversion rates persist up to 6 months post-vaccination. | Seroconversion rates were examined on Day 14, Day 28 and Month 6 post-vaccination measured from participants in the Ad5-nCoV (n = 371) or the Placebo group (n = 124; from the FAS for immunogenicity analysis). The seroconversion rates with 95% CI (calculated using the Clopper-Pearson method) are shown for serum antibodi... | PMC9994755 | ||
Titres to anti-Ad5 neutralising antibodies increase and persist up to 6 months post-vaccination. | Participants were from the FAS for immunogenicity analysis population (Ad5-nCoV, n = 371; Placebo group, n = 124). Based on the GMTs of anti-Ad5 on Day 0, Day 28 and Month 6, the number of participants with low (≤1:200) or high (>1:200) anti-Ad5 titres those from either the Ad5-nCoV (left panels) or Placebo groups (rig... | PMC9994755 | ||
Antibody responses to SARS-CoV-2 vaccine peak at Day 28 in those with low pre-existing immunity to Ad5. | Geometric mean titres in response to serum antibodies Pearson’s correlation coefficient was calculated to correlate serological responses to Ad5 load, that is, baseline GMTs to Ad5 (i.e., pre-existing Ad5 antibodies) were correlated against GMTs to RBD, S protein and NAbs post-vaccination ( | PMC9994755 | ||
Immunity to RBD of SARS-CoV-2 diminishes by 6 months post-vaccination in those with pre-existing Ad5 antibodies. | ADENOVIRUS, SEVERE ACUTE RESPIRATORY SYNDROME, CORONAVIRUS | Pearson’s correlation coefficient between GMTs versus anti-Ad5 antibodies (ADENOVAB) in response to anti-RBD and anti-S protein antibodies as well as neutralising SARS-CoV-2 antibodies (NAbs) on Day 0, Day 14, Day 28 and Month 6 after vaccination. Participants were from the FAS for immunogenicity analysis population th... | PMC9994755 | |
The Ad5-nCoV vaccine induces a durable cellular immune response. | The cellular immune response (IFN-γ-positive cells from isolated PBMCs) was evaluated following the SARS-CoV-2 vaccine using an enzyme-linked immunospot (ELISpot) assay. Peripheral blood mononuclear cells were isolated from blood samples taken from each participant in the Placebo (n = 19) and Ad5-nCoV (n = 50) groups. ... | PMC9994755 | ||
Summary of participants with IFN-γ-positive samples following vaccination. | ADENOVIRUS, CORONAVIRUS DISEASE 2019 | Ab, antibody; Ad5-nCoV, adenovirus type-5 vectored COVID-19 vaccine; CI, confidence interval; COVID-19, coronavirus disease 2019; FAS, full analysis set; N, total number of participants; n, number of participants with IFN-γ-positive samples; IFN-γNotes: Participants were a subset of the FAS for immunogenicity analysis ... | PMC9994755 | |
Safety evaluation | PMC9994755 | |||
Systemic (general) immunisation reactions | A total of 100 (26.9%) of the 372 participants who received the Ad5-nCoV vaccine reported systemic reactions ( | PMC9994755 |
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