Immunogenicity and Safety Analysis of Inactivated Virus Vaccine against SARS-CoV-2: A Systematic Review of Phase 1/2 Clinical Trials

2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Muhammad Mikail Athif Zhafir Asyura ◽  
Angelina Patricia Chandra ◽  
Achmad Agussalim ◽  
Garry Soloan
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Virus Vaccine ◽  
Seroconversion Rate ◽  
Phase 1 ◽  
Safety Analysis ◽  
Inactivated Vaccine ◽  
Online Databases ◽  
Dependent Relation ◽  
Tract Infections

Introduction: The lingering Severe Acute Respiratory System-Coronavirus-2 (SARS-CoV-2) pandemic worldwide has called scientists to accelerate vaccine production and reduce the spread of the virus. The inactivated virus vaccine has been administered widely due to its potency. Following its recent public use, we aim to summarize the efficacy and safety of the inactivated vaccine, especially following Indonesia’s settlement on the SinoVac vaccine. Materials and Methods: A systematic review was performed, searching for randomized controlled trials, according to the PRISMA statement throughout four online databases with studies published up to 2 February 2021. Critical appraisal was further conducted utilizing the Cochrane Risk of Bias Tool 2.0. Results and Discussions: The search yielded six phase ½ clinical trials with a total of 3251 subjects. The outcome was obtained in seroconversion rates (%) after two doses of vaccine. Four studies administered the CoronaVac inactivated vaccine and resulted in a high seroconversion rate, ranging from 89—90%. The other two studies administered the BBV152 and BBIBP-CorV inactivated vaccine and showed similar results. Furthermore, a dose dependent relation is shown with higher doses showing higher seroconversion rates. The safety analysis reported injection site pain as an insignificant but most prevalent local adverse reaction, with other adverse reactions being mild to moderate respiratory tract infections Conclusion: The inactivated vaccine’s efficacy has been proven to stimulate antibody response regardless of dosage, period of administration, and age, with insignificant adverse effects. Further phase 3 clinical trials and widespread administration with the help of non-governmental and medical student organizations are recommended

scholarly journals Nervous and Muscular Adverse Events after COVID-19 Vaccination: A Systematic Review and Meta-Analysis of Clinical Trials

Vaccines ◽  
2021 ◽  
Vol 9 (8) ◽  
pp. 939
Author(s):  
Jiaxin Chen ◽  
Yuangui Cai ◽  
Yicong Chen ◽  
Anthony P. Williams ◽  
Yifang Gao ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Adverse Events ◽  
Fixed Effects ◽  
Meta Analysis ◽  
Phase 1 ◽  
Cochrane Library ◽  
Categorical Variables ◽  
Control Group ◽  
Open Label

Background: Nervous and muscular adverse events (NMAEs) have garnered considerable attention after the vaccination against coronavirus disease (COVID-19). However, the incidences of NMAEs remain unclear. We aimed to calculate the pooled event rate of NMAEs after COVID-19 vaccination. Methods: A systematic review and meta-analysis of clinical trials on the incidences of NMAEs after COVID-19 vaccination was conducted. The PubMed, Medline, Embase, Cochrane Library, and Chinese National Knowledge Infrastructure databases were searched from inception to 2 June 2021. Two independent reviewers selected the study and extracted the data. Categorical variables were analyzed using Pearson’s chi-square test. The pooled odds ratio (OR) with the corresponding 95% confidence intervals (CIs) were estimated and generated with random or fixed effects models. The protocol of the present study was registered on PROSPERO (CRD42021240450). Results: In 15 phase 1/2 trials, NMAEs occurred in 29.2% vs. 21.6% (p < 0.001) vaccinated participants and controls. Headache and myalgia accounted for 98.2% and 97.7%, and their incidences were 16.4% vs. 13.9% (OR = 1.97, 95% CI = 1.28–3.06, p = 0.002) and 16.0% vs. 7.9% (OR = 3.31, 95% CI = 2.05–5.35, p < 0.001) in the vaccine and control groups, respectively. Headache and myalgia were more frequent in the newly licensed vaccines (OR = 1.97, 95% CI = 1.28–3.06, p = 0.02 and OR = 3.31, 95% CI = 2.05–5.35, p < 0.001) and younger adults (OR = 1.40, 95% CI = 1.12–1.75, p = 0.003 and OR = 1.54, 95% CI = 1.20–1.96, p < 0.001). In four open-label trials, the incidences of headache, myalgia, and unsolicited NMAEs were 38.7%, 27.4%, and 1.5%. Following vaccination in phase 3 trials, headache and myalgia were still common with a rate of 29.5% and 19.2%, although the unsolicited NMAEs with incidence rates of ≤ 0.7% were not different from the control group in each study. Conclusions: Following the vaccination, NMAEs are common of which headache and myalgia comprised a considerable measure, although life-threatening unsolicited events are rare. NMAEs should be continuously monitored during the ongoing global COVID-19 vaccination program.

Effect of aerobic exercise on post-stroke cognitive function: a systematic review

2020 ◽  
Vol 27 (9) ◽  
pp. 1-15
Author(s):  
Muhammad Aliyu Abba ◽  
Olubukola Adebisi Olaleye ◽  
Talhatu Kolapo Hamzat
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Cognitive Function ◽  
Aerobic Exercise ◽  
Mini Mental State Examination ◽  
Cognitive Impairments ◽  
Inclusion Criteria ◽  
Post Stroke ◽  
Online Databases ◽  
State Examination

Background/Aims Literature suggests that aerobic exercise improves cognitive impairments post stroke. This systematic review was conducted to analyse evidence on the effectiveness of aerobic exercise in improving post-stroke cognitive impairments. Methods Online databases (PubMed, EMBASE and Web of Science) were systematically searched from inception until 13 July 2017 using the keywords stroke/exercise/cognition. Clinical trials that met the inclusion criteria were assessed for methodological quality using the PEDro scale. Extracted data were synthesised for evidence. Results A total of seven studies met the inclusion criteria. Participants in most of the studies were aged over 60 years and the majority had ischaemic stroke. The most commonly used measure for assessing cognition was the Mini Mental State Examination. The majority of studies included moderate to high intensity exercise (50–70% of VO2max) for 30–60 minutes three to five times per week. There is moderate evidence that aerobic exercise enhances global cognitive function, attention and working memory. Evidence that aerobic exercise improves memory, levels of brain-derived neurotrophic factor and executive function is conflicting and limited. Conclusions Aerobic exercise is moderately effective in improving post-stroke cognitive impairments. More clinical trials are needed in view of the methodological limitations and paucity of existing studies.

The effects of garlic supplementation on weight loss: A systematic review and meta-analysis of randomized controlled trials

2019 ◽  
pp. 1-13 ◽  
Author(s):  
Manije Darooghegi Mofrad ◽  
Jamal Rahmani ◽  
Hamed Kord Varkaneh ◽  
Alireza Teymouri ◽  
Seyed Mohammad Mousavi
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Body Weight ◽  
Waist Circumference ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Pooled Analysis ◽  
Cochrane Library ◽  
Random Effects Models ◽  
Online Databases

Abstract. Obesity is related to increase in the incidence of morbidity and mortality. Studies have suggested anti-obesity properties of garlic; however, results are inconsistent. This systematic review and meta-analysis is done to summarize the data obtained from available randomized clinical trials on the effect of garlic supplementation on body weight, Body Mass Index (BMI), and Waist Circumference (WC). The online databases of Scopus, PubMed, Google Scholar and Cochrane library were searched until March 2018 for related publications using relevant keywords. Effect sizes of eligible studies were pooled using random-effects models. Cochran’s Q-test and I2 index were used for assessing heterogeneity. We found 1241 records in our initial search, of which 13 randomized clinical trials (RCTs) with 15 treatment arms were included. Pooled analysis showed that garlic administration might significantly decrease WC (Weighed Mean Difference (WMD): −1.10 cm, 95% CI: −2.13, −0.07, P = 0.03, I2 = 0%). However, garlic intervention had no significant effect on body weight (WMD): −0.17 kg, 95% CI: −0.75 to 0.39, P = 0.54, I2 = 0%) and BMI (WMD: −0.17 kg/m2, 95% CI: −0.52, 0.16, P = 0.30, I2 = 44.5%) as compared to controls. From Subgroup analysis, it was ascertained that the effect of garlic supplementation on BMI was significant in trials with duration < 12 weeks (WMD: −0.58 kg/m2, 95% CI: −1.08, −0.08, I2 = 19.8%, P = 0.02) compared to those with higher duration (>12 weeks). The current meta-analysis results suggest that garlic supplementation seems to reduce waist circumference unlike body weight and BMI.

Abstract P1-19-29: An integrated safety analysis of talazoparib monotherapy from five clinical trials (phase 1-3) in advanced cancers

2020 ◽  
Author(s):  
Joannes Ettl ◽  
Jennifer Litton ◽  
Hope S. Rugo ◽  
Lida Mina ◽  
Miguel Martin ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Phase 1 ◽  
Safety Analysis

Systematic review of Marburg virus vaccine nonhuman primate studies and human clinical trials

Vaccine ◽  
2021 ◽  
Vol 39 (2) ◽  
pp. 202-208
Author(s):  
Nicholas Dulin ◽  
Adam Spanier ◽  
Kristen Merino ◽  
Jack N Hutter ◽  
Paige E Waterman ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Virus Vaccine ◽  
Nonhuman Primate ◽  
Marburg Virus
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