Safety and Immunogenicity of Nanocovax, a SARS-CoV-2 Recombinant Spike Protein Vaccine

ImportanceRandomized clinical trials (RCTs) on COVID-19 are increasingly being posted as preprints before publication in a scientific, peer-reviewed journal.ObjectiveTo assess time to journal publication for COVID-19 RCT preprints and to compare differences between pairs of preprints and corresponding journal articles.Evidence ReviewThis systematic review used a meta-epidemiologic approach to conduct a literature search using the World Health Organization COVID-19 database and Embase to identify preprints published between January 1 and December 31, 2021. This review included RCTs with human participants and research questions regarding the treatment or prevention of COVID-19. For each preprint, a literature search was done to locate the corresponding journal article. Two independent reviewers read the full text, extracted data, and assessed risk of bias using the Cochrane Risk of Bias 2 tool. Time to publication was analyzed using a Cox proportional hazards regression model. Differences between preprint and journal article pairs in terms of outcomes, analyses, results, or conclusions were described. Statistical analysis was performed on October 17, 2022.FindingsThis study included 152 preprints. As of October 1, 2022, 119 of 152 preprints (78.3%) had been published in journals. The median time to publication was 186 days (range, 17-407 days). In a multivariable model, larger sample size and low risk of bias were associated with journal publication. With a sample size of less than 200 as the reference, sample sizes of 201 to 1000 and greater than 1000 had hazard ratios (HRs) of 1.23 (95% CI, 0.80-1.91) and 2.19 (95% CI, 1.36-3.53) for publication, respectively. With high risk of bias as the reference, medium-risk articles with some concerns for bias had an HR of 1.77 (95% CI, 1.02-3.09); those with a low risk of bias had an HR of 3.01 (95% CI, 1.71-5.30). Of the 119 published preprints, there were differences in terms of outcomes, analyses, results, or conclusions in 65 studies (54.6%). The main conclusion in the preprint contradicted the conclusion in the journal article for 2 studies (1.7%).Conclusions and RelevanceThese findings suggest that there is a substantial time lag from preprint posting to journal publication. Preprints with smaller sample sizes and high risk of bias were less likely to be published. Finally, although differences in terms of outcomes, analyses, results, or conclusions were observed for preprint and journal article pairs in most studies, the main conclusion remained consistent for the majority of studies.

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“…After abstract screening and full-text reading, 152 RCTs were included in the analysis. All 152 RCTs were posted on the medRxiv server …”

Section: Resultsmentioning

confidence: 99%

Comparison of Preprint Postings of Randomized Clinical Trials on COVID-19 and Corresponding Published Journal Articles

et al. 2023

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“…Subsequently, correlations between D-dimer levels and diferent types of pancreatitis were assessed.In diferent types of pancreatitis, D-dimer levels in AP patients and RAP patients were signifcantly higher than those in control group (p < 0.05), and there was no signifcant diference in D-dimer levels between CP group and control group [24]. Clinical studies revealed that the levels of plasma brinogen degradation products (FDP) are signi cantly higher in AP patients compared to healthy individuals, and higher levels of FDP are related to severity,and portosplenomesenteric venous thrombosis occurs in about 17.86% of patients with early-stage SAP.These phenomena indicated that the hypercoagulable state during AP and the therapeutic strategies aimed at enhancing microcirculation by anticoagulant therapy might improve the outcomes in AP [25]. Acute pancreatitis is a procoagulant state.…”

Section: Discussionmentioning

confidence: 99%

Analysis of clinical features, biochemical and inflammatory indexes in patients with acute pancreatitis

Han,

Jiang,

Huang

2024

Preprint

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Background: Acute pancreatitis (AP) is an inflammatory process unpredictability occurring in the pancreas, imposing a substantial burden on healthcare systems. Herein,Exploring the clinical characteristics of patients with acute pancreatitis, biochemical tests and the role of inflammatory indexes in the disease, to predict the prognosis of acute pancreatitis. Methods: We retrospectively analyzed the clinical data, biochemical and inflammatory indexes of 116 patients with acute pancreatitis diagnosed in Puren Hospital affiliated to Wuhan University of Science and Technology. They were divided into non-severe group and severe group. Counting data were expressed as rate (%), X2 test was used, and measurement data were expressed as mean±standard deviation. Comparison between the two groups was performed by t test, and comparison between the mean of more than two samples was performed by a one-way analysis of variance (ANOVA).P<0.05 was considered to be statistically significant.Receiver operating characteristic curve (ROC) analysis was performed according to the inflammatory indexes of the two groups, and the area under the curve (AUC) and the cut-off value (CUT-OFF) are calculated respectively. Results: The mean age of patients in the severe group was older, and the proportion of underlying diseases was higher. The biochemical and inflammatory indexes in the severe group were higher than those in the non-severe group (P < 0.05). The area under the curve (AUC) and CUT-OFF value (cut-off) were obtained by ROC curve analysis of the inflammatory indexes of white blood cell count (WBC), neutrophil count (NEUT), hypersensitive C-reactive protein (hs-CRP), procalcitonin (PCT) and interleukin-6 (IL-6). Conclusion: Elderly patients with acute pancreatitis accompanied by underlying diseases are more likely to develop into severe disease. In severe patients, biochemical tests are obviously abnormal and inflammatory indexes are increased or even excessive, which is helpful to judge the condition and prognosis of patients with acute pancreatitis.

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“…It contains the full-length pre-fusion stabilized recombinant S glycoprotein of SARS-CoV-2 virus and aluminum hydroxide adjuvant. 148 The vaccine candidate is under investigation in Phase 3 clinical trials. 149…”

Section: Vaccine Platforms and Currently Available Vaccinesmentioning

confidence: 99%

An Update on the Status of Vaccine Development for SARS-CoV-2 Including Variants. Practical Considerations for COVID-19 Special Populations

Kantarcıoğlu

Iqbal

Lewis

et al. 2022

Clin Appl Thromb Hemost

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The progress in the development of various vaccine platforms against SARS-CoV-2 have been rather remarkable owing to advancement in molecular and biologic sciences. Most of the current vaccines and those in development focus on targeting the viral spike proteins by generating antibodies of varying spectrum. These vaccines represent a variety of platforms including whole virus vaccines, viral vector vaccines, nucleic acid vaccines representing RNA, DNA, and their hybrid forms. The therapeutic efficacy of these vaccines varies owing to their pharmacodynamic individualities. COVID-19 variants are capable of inducing different pathologic responses and some of which may be resistant to antibodies generated by current vaccines. The current clinical use of these vaccines has been through emergency use authorization until recently. Moreover, the efficacy and safety of these vaccines have been tested in substantial numbers of individuals but studies in special populations that better reflect the global population are pending results. These specialized populations include young children, immunocompromised patients, pregnant individuals, and other specialized groups. Combination approaches, molecularly modified vaccination approaches, and vaccines conferring longer periods of immunity are being currently being investigated, as well as pharmacovigilance studies. The continual transformation of SARS-CoV-2 and its variants are of concern along with the breakthrough infections. These considerations pose new challenges for the development of vaccination platforms. For this purpose, booster doses, combination vaccine approaches, and other modalities are being discussed. This review provides an updated account of currently available vaccines and those in advanced development with reference to their composition and mechanisms of action. A discussion on the use of vaccines in special populations including immunocompromised patients, pregnant women and other specialized populations are also included.

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Safety and Immunogenicity of Nanocovax, a SARS-CoV-2 Recombinant Spike Protein Vaccine

Cited by 5 publications

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Comparison of Preprint Postings of Randomized Clinical Trials on COVID-19 and Corresponding Published Journal Articles

Comparison of Preprint Postings of Randomized Clinical Trials on COVID-19 and Corresponding Published Journal Articles

Analysis of clinical features, biochemical and inflammatory indexes in patients with acute pancreatitis

An Update on the Status of Vaccine Development for SARS-CoV-2 Including Variants. Practical Considerations for COVID-19 Special Populations

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