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Vaccines Nov 2023Aluminium adjuvants are commonly used in vaccines to boost the effects of vaccination. Here, we assessed the benefits and harms of different aluminium adjuvants vs.... (Review)
Review
Concentrations, Number of Doses, and Formulations of Aluminium Adjuvants in Vaccines: A Systematic Review with Meta-Analysis and Trial Sequential Analysis of Randomized Clinical Trials.
Aluminium adjuvants are commonly used in vaccines to boost the effects of vaccination. Here, we assessed the benefits and harms of different aluminium adjuvants vs. other aluminium adjuvants or vs. the same aluminium adjuvant at other concentrations, administered a different number of doses, or at different particle sizes used in vaccines or vaccine excipients. We conducted a systematic review with meta-analysis and Trial Sequential Analysis to assess the certainty of evidence with Grading of Recommendations Assessment, Development and Evaluation (GRADE). We obtained data from major medical databases until 20 January 2023 and included 10 randomized clinical trials of healthy volunteers. The comparisons assessed higher vs. lower aluminium adjuvant concentrations; higher vs. lower number of doses of aluminium adjuvant; and aluminium phosphate adjuvant vs. aluminium hydroxide adjuvant. For all three comparisons, meta-analyses showed no evidence of a difference on all-cause mortality, serious adverse events, and adverse events considered non-serious. The certainty of evidence was low to very low. None of the included trials reported on quality of life or proportion of participants who developed the disease being vaccinated against. The benefits and harms of different types of aluminium adjuvants, different aluminium concentrations, different number of doses, or different particle sizes, therefore, remain uncertain.
PubMed: 38140168
DOI: 10.3390/vaccines11121763 -
Clinical and Experimental Dental... Dec 2023Different materials have been used for capping the pulp after exposure during caries removal in permanent teeth. The purpose of this study was to collate and analyze all... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVES
Different materials have been used for capping the pulp after exposure during caries removal in permanent teeth. The purpose of this study was to collate and analyze all pertinent evidence from randomized controlled trials (RCTs) on different materials used in patients undergoing pulpotomy or direct pulp capping in carious teeth.
MATERIALS AND METHODS
Trials comparing two or more capping agents used for direct pulp capping (DPC) or pulpotomy were considered eligible. An electronic search of four databases and two clinical trial registries was carried out up to February 28, 2021 using a search strategy properly adapted to the PICO framework. Screening, data extraction, and risk of bias (RoB) assessment of primary studies were performed in duplicate and independently. The primary outcome was clinical and radiological success; secondary outcomes included continued root formation, tooth discoloration, and dentin bridge formation.
RESULTS
21 RCTs were included in the study. The RoB assessment indicated a moderate risk among the studies. Due to significant clinical and statistical heterogeneity among the studies, performing network meta-analysis (NMA) was not possible. An ad hoc subgroup analysis revealed strong evidence of a higher success of DPC with Mineral Trioxide Aggregate (MTA) compared to calcium hydroxide (CH) (odds ratio [OR] = 3.10, 95% confidence interval [CI]: 1.66-5.79). MTA performed better than CH in pulp capping (both DPC and pulpotomy) of mature compared to immature teeth (OR = 3.34, 95% CI: 1.81-6.17). The GRADE assessment revealed moderate strength of evidence for DPC and mature teeth, and low to very low strength of evidence for the remaining subgroups.
CONCLUSIONS
Considerable clinical and statistical heterogeneity among the trials did not allow NMA. The ad hoc subgroup analysis indicated that the clinical and radiographic success of MTA was higher than that of CH but only in mature teeth and DPC cases where the strength of evidence was moderate. PROSPERO Registration: number CRD42020127239.
Topics: Humans; Dental Pulp Capping; Pulpotomy; Calcium Compounds; Aluminum Compounds; Oxides; Silicates; Drug Combinations; Calcium Hydroxide; Dental Caries; Randomized Controlled Trials as Topic
PubMed: 37710421
DOI: 10.1002/cre2.767 -
Frontiers in Medicine 2022Inactivated vaccine is one of the primary technology types of Coronavirus Disease 2019 (COVID-19) vaccines, which has wide application in many countries, including...
BACKGROUND
Inactivated vaccine is one of the primary technology types of Coronavirus Disease 2019 (COVID-19) vaccines, which has wide application in many countries, including mainland China. However, systematic evaluation of the efficacy and safety of COVID-19 inactivated vaccines remains limited. And trust in the vaccine is the key to solving vaccine hesitancy.
METHODS
Various academic databases were searched comprehensively for randomized controlled trials (RCTs) related to COVID-19 inactivated vaccines. The deadline for retrieval was December 2021. Study screening and data extraction were according to inclusive and exclusive criteria. Statistical analyses were performed using RevMan software 5.3 version and STATA software 16.0 version.
RESULTS
Eight studies with 79,334 subjects were included of which 48,123 had received two doses of COVID-19 inactivated vaccines, and 31,211 had received two doses of placebo. The results of the meta-analysis showed that: in terms of effectiveness evaluation, two doses of COVID-19 inactivated vaccines decreased the symptomatic infection [relative risk (RR) = 0.23, 95% confidence interval (CI) (0.18,0.30), < 0.00001], asymptomatic infection [RR = 0.48, 95%CI (0.32, 0.74), = 0.0008], total infection [RR = 0.32, 95%CI (0.24, 0.41), < 0.00001] and hospitalization [RR = 0.06, 95%CI (0.01, 0.27), = 0.0002] for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) significantly. In terms of safety assessment, two doses of COVID-19 inactivated vaccines also caused more adverse events. After two inoculations, total adverse events and systemic adverse events increased significantly [total adverse events RR = 1.14, 95%CI (1.08, 1.21), < 0.00001; systemic adverse events RR = 1.22, 95%CI (1.09, 1.35), = 0.0002]. The most common adverse event was pain at the injection site. Almost all local adverse reactions consisted of these events. The incidence of pain at the injection site was related to adjuvants. Using aluminum hydroxide as an adjuvant increased local pain significantly [RR = 1.97, 95%CI (1.52, 2.55), < 0.00001]. Two doses COVID-19 inactivated vaccines did not increase serious adverse events [RR = 0.71, 95%CI (0.57, 0.90), = 0.004].
CONCLUSION
Two doses of inactivated COVID-19 vaccines in people over 18 years of age effectively prevented SARS-CoV-2 infection and its associated hospitalizations. Short-term, mild to moderate adverse reactions had occurred, but serious adverse events were rare. No placebo or vaccine-related deaths had been reported.
SYSTEMATIC REVIEW REGISTRATION
https://www.crd.york.ac.uk/prospero/, identifier: 42021291250.
PubMed: 36419789
DOI: 10.3389/fmed.2022.1015184 -
Frontiers in Immunology 2022We systematically reviewed and summarized studies focusing on Bharat Biotech's Whole Virion Inactivated Corona Virus Antigen BBV152 (Covaxin), which is India's...
We systematically reviewed and summarized studies focusing on Bharat Biotech's Whole Virion Inactivated Corona Virus Antigen BBV152 (Covaxin), which is India's indigenous response to fighting the SARS-CoV-2 pandemic. Studies were searched for data on the efficacy, immunogenicity, and safety profile of BBV152. All relevant studies published up to March 22, 2022, were screened from major databases, and 25 studies were eventually inducted into the systematic review. The studies focused on the virus antigen (6 μg) adjuvanted with aluminium hydroxide gel and/or Imidazo quinolin gallamide (IMDG), aTLR7/8 agonist. Pre-clinical, phase I, and II clinical trials showed appreciable immunogenicity. Both neutralizing and binding antibody titers were significant and T cell responses were Th1-biased. Phase III trials on the 6 μg +Algel-IMDG formulation showed a 93.4% efficacy against severe COVID-19. Data from the trials revealed an acceptable safety profile with mostly mild-moderate local and systemic adverse events. No serious adverse events or fatalities were seen, and most studies reported milder and lesser adverse events with Covaxin when compared with other vaccines, especially Oxford-Astra Zeneca's AZD1222 (Covishield). The immunogenicity performance of Covaxin, which provided significant protection only after the second dose, was mediocre and it was consistently surpassed by Covishield. One study reported adjusted effectiveness against symptomatic infection to be just 50% at 2 weeks after the second dose. Nonetheless, appreciable results were seen in previously infected individuals administered both doses. There was some evidence of coverage against the Alpha, Beta, and Delta variants. However, neither Covaxin nor Covishield showed sufficient protection against the Omicron variant. Two studies reported super-additive results on mixing Covaxin with Covishield. Further exploration of heterologous prime-boost vaccination with a combination of an inactivated vaccine and an adenoviral vector-based vaccine for tackling future variants may be beneficial.
Topics: COVID-19; COVID-19 Vaccines; ChAdOx1 nCoV-19; Humans; SARS-CoV-2; Vaccines, Inactivated; Viral Vaccines
PubMed: 36016940
DOI: 10.3389/fimmu.2022.863162 -
BMC Oral Health Oct 2019Pulpotomy is one of the most widely used methods in preserving vital pulp in teeth, which is of great significance in achieving continue root formation in immature... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Pulpotomy is one of the most widely used methods in preserving vital pulp in teeth, which is of great significance in achieving continue root formation in immature permanent teeth suffering from dental caries or trauma. The aim of this meta-analysis and systemic review is to synthesize the available evidences to compare different pulpotomy dressing agents for pulpotomy treatment in immature permanent teeth.
METHODS
Electronic databases including MEDLINE (via Pubmed), EMBASE, the Cochrane library (CENTRAL) and the clinicaltrials.gov database were searched. The references of all included articles or relevant reviews were cross-checked. Only randomized controlled trials (RCTs) comparing two or more pulp dressing agent in permanent teeth with open apex would be included. Also, the studies should have at least 6 months of follow-up, report clinical and radiographic success in detail and publish in English.
RESULTS
Five RCTs were included for a systematic review, and all of them had a high risk of bias. There is little difference in success rate between mineral trioxide aggregate (MTA) and calcium hydroxide (CH) at 6-month follow-up (risk ratio (RR) 1; 95% confidence interval (CI) 0.94 to 1.06) and 12-month follow-up (RR 1.04; 95% CI 0.96 to 1.13). There is no difference between MTA versus platelet-rich fibrin and MTA versus calcium-enriched mixture (CEM). There is only weak evidence of increased success rate in using MTA and triple antibiotic paste (TAP) rather than abscess remedy.
CONCLUSIONS
Based on the present evidence, similar success rates with MTA were found between the dressing agents CH, CEM, RPF and TAP as pulpotomy-dressing agents in the treatment of immature permanent teeth. More high-quality RCTs are needed in this field in future studies.
Topics: Aluminum Compounds; Calcium Compounds; Calcium Hydroxide; Dental Caries; Dental Pulp Capping; Dental Pulp Exposure; Dentition, Permanent; Drug Combinations; Humans; Oxides; Pulpotomy; Randomized Controlled Trials as Topic; Silicates; Treatment Outcome
PubMed: 31647004
DOI: 10.1186/s12903-019-0917-z