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Advanced Drug Delivery Reviews 2020Vaccines are one of the most powerful technologies supporting public health. The adaptive immune response induced by immunization arises following appropriate activation...
Vaccines are one of the most powerful technologies supporting public health. The adaptive immune response induced by immunization arises following appropriate activation and differentiation of T and B cells in lymph nodes. Among many parameters impacting the resulting immune response, the presence of antigen and inflammatory cues for an appropriate temporal duration within the lymph nodes, and further within appropriate subcompartments of the lymph nodes- the right timing and location- play a critical role in shaping cellular and humoral immunity. Here we review recent advances in our understanding of how vaccine kinetics and biodistribution impact adaptive immunity, and the underlying immunological mechanisms that govern these responses. We discuss emerging approaches to engineer these properties for future vaccines, with a focus on subunit vaccines.
Topics: Adjuvants, Immunologic; B-Lymphocytes; Drug Carriers; Humans; Immunity, Humoral; Inflammation Mediators; Liposomes; Lymph Nodes; Nanoparticles; Plasmids; RNA, Messenger; T-Lymphocytes; Tissue Distribution; Vaccines
PubMed: 32598970
DOI: 10.1016/j.addr.2020.06.019 -
JCO Global Oncology Mar 2024Head and neck cancer accounts for about one third of the global burden in India. Mucosal high-risk human papillomavirus (HPV) has been hypothesized as a contributory... (Meta-Analysis)
Meta-Analysis Review
PURPOSE
Head and neck cancer accounts for about one third of the global burden in India. Mucosal high-risk human papillomavirus (HPV) has been hypothesized as a contributory risk factor for head and neck cancer (HNC) but its prevalence in Indian patients is not well established. Therefore, this systematic review and meta-analysis aimed to estimate the prevalence of HPV in HNC in India and their attributable fraction by considering the biomarkers of carcinogenesis, p16, and HPV mRNA.
METHODS
A systematic literature search was done in Medline via PubMed, Embase, Scopus, ScienceDirect, ProQuest, and Cochrane to identify studies on HPV and HNC in the Indian population, published between January 1990 and October 2022. Fifty-four eligible studies were identified and relevant clinical information was collected. Meta-analysis was conducted to estimate the pooled prevalence of HPV DNA, p16INK4a, and mRNA percent positivity by random-effect logistic regression model using Metapreg, STATA 18.
RESULTS
Thirty-four high-quality studies were taken for meta-analysis. The pooled prevalence of HPV in HNC was 20% (95% CI, 12 to 32) with a high level of heterogeneity ( = 90.79%). The proportion of HPV in oropharyngeal cancer (OPC; 22% [95% CI, 13 to 34]) and laryngeal cancer (LC; 29% [95% CI, 17 to 46]) was higher than in oral cancer (OC; 16% [95% CI, 8 to 30]). The HPV-attributable fraction of OPC, considering the mRNA and p16 positivity, was 12.54% and 9.68%, respectively, almost similar to LC (11.6% and 9.57%), while it was much lower in OC (3.36% and 4%).
CONCLUSION
The HPV-attributable fraction is considerably lower for OC, suggesting a negligible causative role of HPV in OC. A significant proportion of OPC and LC are attributed to HPV; however, their exact causative role is unclear because of the presence of other known risk factors.
Topics: Humans; Human Papillomavirus Viruses; Papillomavirus Infections; DNA, Viral; Head and Neck Neoplasms; India; RNA, Messenger
PubMed: 38513185
DOI: 10.1200/GO.23.00464 -
JAMA Otolaryngology-- Head & Neck... Jun 2023Bell palsy (BP) has been reported as an adverse event following the SARS-CoV-2 vaccination, but neither a causative relationship nor a higher prevalence than in the... (Meta-Analysis)
Meta-Analysis
IMPORTANCE
Bell palsy (BP) has been reported as an adverse event following the SARS-CoV-2 vaccination, but neither a causative relationship nor a higher prevalence than in the general population has been established.
OBJECTIVE
To compare the incidence of BP in SARS-CoV-2 vaccine recipients vs unvaccinated individuals or placebo recipients.
DATA SOURCES
A systematic search of MEDLINE (via PubMed), Web of Science, Scopus, Cochrane Library, and Google Scholar from the inception of the COVID-19 report (December 2019) to August 15, 2022.
STUDY SELECTION
Articles reporting BP incidence with SARS-CoV-2 vaccination were included.
DATA EXTRACTION AND SYNTHESIS
This study followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guideline and was conducted with the random- and fixed-effect models using the Mantel-Haenszel method. The quality of the studies was evaluated by the Newcastle-Ottawa Scale.
MAIN OUTCOMES AND MEASURES
The outcomes of interest were to compare BP incidence among (1) SARS-CoV-2 vaccine recipients, (2) nonrecipients in the placebo or unvaccinated cohorts, (3) different types of SARS-CoV-2 vaccines, and (4) SARS-CoV-2-infected vs SARS-CoV-2-vaccinated individuals.
RESULTS
Fifty studies were included, of which 17 entered the quantitative synthesis. Pooling 4 phase 3 randomized clinical trials showed significantly higher BP in recipients of SARS-CoV-2 vaccines (77 525 vaccine recipients vs 66 682 placebo recipients; odds ratio [OR], 3.00; 95% CI, 1.10-8.18; I2 = 0%). There was, however, no significant increase in BP after administration of the messenger RNA SARS-CoV-2 vaccine in pooling 8 observational studies (13 518 026 doses vs 13 510 701 unvaccinated; OR, 0.70; 95% CI, 0.42-1.16; I2 = 94%). No significant difference was found in BP among 22 978 880 first-dose recipients of the Pfizer/BioNTech vaccine compared with 22 978 880 first-dose recipients of the Oxford/AstraZeneca vaccine (OR, 0.97; 95% CI, 0.82-1.15; I2 = 0%). Bell palsy was significantly more common after SARS-CoV-2 infection (n = 2 822 072) than after SARS-CoV-2 vaccinations (n = 37 912 410) (relative risk, 3.23; 95% CI, 1.57-6.62; I2 = 95%).
CONCLUSIONS AND RELEVANCE
This systematic review and meta-analysis suggests a higher incidence of BP among SARS-CoV-2-vaccinated vs placebo groups. The occurrence of BP did not differ significantly between recipients of the Pfizer/BioNTech vs Oxford/AstraZeneca vaccines. SARS-CoV-2 infection posed a significantly greater risk for BP than SARS-CoV-2 vaccination.
Topics: Humans; Bell Palsy; COVID-19; COVID-19 Vaccines; SARS-CoV-2; Vaccination
PubMed: 37103913
DOI: 10.1001/jamaoto.2023.0160 -
Journal of the European Academy of... Nov 2022Although vaccination is widely accepted as an effective method of preventing and controlling the COVID-19 pandemic, many people are concerned about possible cutaneous... (Meta-Analysis)
Meta-Analysis Review
Although vaccination is widely accepted as an effective method of preventing and controlling the COVID-19 pandemic, many people are concerned about possible cutaneous side-effects, which can delay or prevent them from being vaccinated. The objectives of this systematic review were to assess the global prevalence and clinical manifestations of cutaneous adverse reactions following COVID-19 vaccination. PubMed and Scopus databases were searched for articles published from 1 January 2019 to 31 December 2021, and reference lists for each selected article were screened. Case reports, case series, observational studies and randomized controlled trials that provided information on cutaneous adverse reactions following COVID-19 vaccines were included. A total of 300 studies were included in a systematic review of which 32 studies with 946 366 participants were included in the meta-analysis. The pooled prevalence of cutaneous manifestations following COVID-19 vaccination was 3.8% (95% CI, 2.7%-5.3%). COVID-19 vaccines based on the mRNA platform had a higher prevalence than other platforms at 6.9% (95% CI, 3.8%-12.3%). Various cutaneous manifestations have been reported from injection site reactions, which were the most common (72.16%) to uncommon adverse reactions such as delayed inflammatory reactions to tissue filler (0.07%) and flares of pre-existing dermatoses (0.07%). Severe cutaneous reactions such as anaphylaxis have also been reported, but in rare cases (0.05%). In conclusion, cutaneous adverse reactions are common, especially in those receiving mRNA vaccines. Most reactions are mild and are not contraindications to subsequent vaccination except for anaphylaxis, which rarely occurs. COVID-19 vaccination may also be associated with flares of pre-existing dermatoses and delayed inflammatory reactions to tissue filler. Patients with a history of allergies, pre-existing skin conditions or scheduled for filler injections should receive additional precounselling and monitoring. A better understanding of potential side-effects may strengthen public confidence in those wary of new vaccine technologies.
Topics: Anaphylaxis; COVID-19; COVID-19 Vaccines; Humans; Pandemics; Prevalence; RNA, Messenger; Skin Diseases; Vaccination; Vaccines
PubMed: 35666609
DOI: 10.1111/jdv.18294 -
Future Journal of Pharmaceutical... 2022Vaccination against Coronavirus disease 2019 (COVID-19) is an important means of controlling the pandemic, however they are expected to stimulate immune responses when... (Review)
Review
Immunogenicity and clinical features relating to BNT162b2 messenger RNA COVID-19 vaccine, Ad26.COV2.S and ChAdOx1 adenoviral vector COVID-19 vaccines: a systematic review of non-interventional studies.
BACKGROUND
Vaccination against Coronavirus disease 2019 (COVID-19) is an important means of controlling the pandemic, however they are expected to stimulate immune responses when administered to confer immunity. In this review, we evaluated the clinical and laboratory features associated with BNT162b2 messenger RNA COVID-19 vaccine, Ad26.COV2.S and ChAdOx1 adenoviral vector COVID-19 vaccines, to determine their immunogenicity. Demographic distribution of pathogenic autoimmune response and time interval between vaccination and onset of symptoms were also assessed. This was to identify; persons at risk of developing auto-immune reactions and markers to enhanced occurrence of this event.
MAIN BODY
Using relevant keywords, search was conducted in the databases of PubMed, Scopus, Web of Science and Google scholar from November 2020 to May 31, 2021. Additional article was also identified through hand-searching of reference lists, and the review was conducted in line with Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines 2009. Study outcome measures were presence of antibodies after vaccination and evidence of autoimmune reactions, therefore studies relating these measures were considered eligible for this review. Studies showed stimulation of immune response with administration of BNT162b2 mRNA vaccine, ChAdOx1 and Ad26.COV2-S adenovirus vector-based vaccines. Aside SARS-CoV-2 spike protein antibodies, elevated D-dimers, presence of PF4 and low fibrinogen were most commonly seen laboratory features in persons with autoimmune reactions following vaccination. In addition, thrombotic thrombocytopenia was the commonest clinical features observed with ChAdOx1 and Ad26.COV2-S adenovirus vector-based vaccines. Findings from this study also suggest higher susceptibility of women of 22-60 years to the pathogenic immunogenicity that may particular result from exposure to ChAdOx1 and Ad26.COV2-S adenovirus vector-based vaccines. Time interval of 4-37 days was mostly observed between vaccination and occurrence of a symptom.
CONCLUSION
Immune thrombotic thrombocytopenia and other PF4 dependent syndrome are likely associated with ChAdOx1 and Ad26.COV2.S adenovirus vector vaccines, mostly occurring in women usually within 4-37 days of first dose of vaccine. Enhanced knowledge about vaccine adverse effects and its distribution is crucial for effective vaccination strategies.
PubMed: 35368622
DOI: 10.1186/s43094-022-00409-5 -
Cancer Cytopathology Feb 2022Cytology effusions are often the only material available for diagnosing malignant pleural mesothelioma (MPM). However, the cytomorphological features alone are not... (Meta-Analysis)
Meta-Analysis Review
Cytology effusions are often the only material available for diagnosing malignant pleural mesothelioma (MPM). However, the cytomorphological features alone are not always diagnostic, and cytology samples preclude an assessment for pleural tissue invasion. Accordingly, immunohistochemical, soluble, and molecular biomarkers have been developed. The aim of this study is to provide quantitative evidence regarding the diagnostic performance of novel biomarkers. To that end, a systematic literature review was performed of articles dealing with a loss of BRCA1-associated protein 1 (BAP1), methylthioadenosine (MTAP), 5-hydroxymethylcitosine (5-hmC), glucose transporter 1 (GLUT1), insulin like-growth factor II messenger RNA-binding protein 3 (IMP3), enhanced zeste homologue 2 (EZH2) staining, cyclin-dependent kinase inhibitor 2A (CDKN2A) homozygous deletion (HD) testing, soluble mesothelin, and microRNA quantification in cytological samples for the diagnosis of MPM versus reactive atypical mesothelial cells. Sensitivity and specificity were extracted, and a meta-analysis was performed. The quality of the studies was assessed with Quality Assessment of Diagnostic Accuracy Studies 2, and the quality of the evidence was evaluated with the Grading of Recommendations Assessment, Development, and Evaluation approach. Seventy-one studies were included. BAP1 loss showed a sensitivity of 0.65 (confidence interval [CI], 0.59-0.71) and a specificity of 0.99 (CI, 0.93-1.00). MTAP loss and p16 HD showed 100% specificity with sensitivities of 0.47 (CI, 0.38-0.57) and 0.62 (CI, 0.53-0.71), respectively. BAP1 loss and CDKN2A HD combined showed maximal specificity and a sensitivity of 0.83 (CI, 0.78-0.89). GLUT1 and IMP3 showed sensitivities of 0.82 (CI, 0.70-0.90) and 0.65 (CI, 0.41-0.90), respectively, with comparable specificity. Mesothelin showed a sensitivity of 0.73 (CI, 0.68-0.77) and a specificity of 0.90 (CI, 0.84-0.93). In conclusion, some of the recently emerging biomarkers are close to 1.00 specificity. Their moderate sensitivity on their own, however, can be significantly improved by the use of 2 biomarkers, such as a combination of BAP1 and CDKN2A with fluorescence in situ hybridization or a combination of BAP1 and MTAP immunohistochemistry.
Topics: Biomarkers, Tumor; Glucose Transporter Type 1; Homozygote; Humans; In Situ Hybridization, Fluorescence; Lung Neoplasms; Mesothelioma; Mesothelioma, Malignant; Pleural Neoplasms; Sequence Deletion
PubMed: 34478240
DOI: 10.1002/cncy.22509 -
Medicine Oct 2023Myasthenia Gravis (MG), a chronic neuromuscular junction disorder, emerged as one of the serious side effects of the Coronavirus Disease 2019 (COVID-19) vaccination. We...
BACKGROUNDS
Myasthenia Gravis (MG), a chronic neuromuscular junction disorder, emerged as one of the serious side effects of the Coronavirus Disease 2019 (COVID-19) vaccination. We aimed to summarize the findings of studies on the clinical features and outcomes of COVID-19 vaccination-associated MG.
METHODS
We performed a systematic search on 3 databases, Medline, Embase, and Scopus, using the query "COVID-19 vaccine" and "Myasthenia Gravis." Patients' data, including clinical data, MG subtype, vaccine type, and vaccine dose number, were extracted from the eligible studies.
RESULTS
A total of 20 COVID-19 vaccination-related MGs have been reported worldwide. The median (interquartile range) age was 64 (51, 75) years; 85% (17/20) of them were male, and 70% (14/20) of patients had received messenger RNA-based vaccines. The most common symptoms, in order of frequency, were binocular diplopia (8/11) and ptosis (4/11); the median (interquartile range) time from vaccine to MG symptoms was 6 (2, 7.5) days. Repetitive nerve stimulation showed abnormal decrement in 85% (11/13) of patients, and all 4 patients getting single-fiber electromyography showed an abnormal finding. Nine out of twelve patients with data on clinical outcomes experienced partial/complete improvement of symptoms within 1 month.
CONCLUSION
MG cases after the COVID-19 vaccine are more likely to occur among males and adults older than 50 years. Our pooled cohort data suggest MG symptoms appear within 2 weeks after receiving the vaccine. The presenting symptoms in MG cases associated with COVID-19 vaccine are possibly similar to non-vaccination related MGs. Most patients are expected to experience partial/complete improvement within 1 month.
Topics: Adult; Humans; Male; Female; COVID-19 Vaccines; COVID-19; Myasthenia Gravis; Diplopia; Vaccines; Vaccination
PubMed: 37800781
DOI: 10.1097/MD.0000000000034890 -
BMJ Open Jul 2022To determine whether spontaneous reporting rates of myocarditis and pericarditis differed in immunocompromised patients compared with the whole population overall, and...
OBJECTIVES
To determine whether spontaneous reporting rates of myocarditis and pericarditis differed in immunocompromised patients compared with the whole population overall, and in terms of demographics, vaccine dose and time-to-onset.
DESIGN
Systematic review of spontaneously reported data from the European Union/European Economic Area (EU/EEA), the USA and the UK.
DATA SOURCES
EudraVigilance (EU/EEA), Vaccine Adverse Event Reporting System (VAERS; USA) and the Medicines and Healthcare products Regulatory Agency (UK) spontaneous reporting databases were searched from date of vaccine launch to 1 December 2021.
ELIGIBILITY CRITERIA
Publicly available spontaneous reporting data for 'myocarditis' and 'pericarditis' from EU/EEA and USA following COVID-19 messenger RNA vaccines. Reports with comorbidities or concurrent medication indicative of transplantation, HIV infection or cancer ('immunocompromised' population) were compared with each overall database population.
DATA EXTRACTION AND SYNTHESIS
Two researchers extracted data. Spontaneously reported events of myocarditis and pericarditis were presented for immunocompromised populations for each data source, stratified by age, sex, dose and time-to-onset (where available). Seriousness of each event was determined according to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Guideline E2A definition. Proportional reporting ratio (PRR) was calculated.
RESULTS
There were 178 reports of myocarditis and pericarditis among immunocompromised individuals overall. Seriousness was comparable between the immunocompromised and overall populations in both databases. No trends in age or sex were observed among immunocompromised individuals. Most reports followed a second vaccine dose and occurred within 14 days. The frequency of reporting was similar to the wider population (PRR=1.36 (95% CI=0.89 to 1.82) for VAERS population).
CONCLUSIONS
Myocarditis and pericarditis following COVID-19 vaccination are very rare, and benefits of COVID-19 vaccination continue to outweigh any perceived risks. Reporting rates of myocarditis and pericarditis were similar in immunocompromised individuals, however defining characteristics differed compared with the whole population; therefore, continued monitoring of adverse events following vaccination remains vital to understand differences between population subgroups.
Topics: COVID-19; COVID-19 Vaccines; Humans; Immunocompromised Host; Myocarditis; Pericarditis; Transplant Recipients
PubMed: 35777878
DOI: 10.1136/bmjopen-2021-060425 -
International Journal of Infectious... Nov 2022Available data show that COVID-19 vaccines may be less effective in people living with HIV (PLWH) who are at increased risk for severe COVID-19. This meta-analysis aimed... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVES
Available data show that COVID-19 vaccines may be less effective in people living with HIV (PLWH) who are at increased risk for severe COVID-19. This meta-analysis aimed to compare the immunogenicity and efficacy of COVID-19 vaccines in PLWH with healthy individuals.
METHODS
Pubmed/Medline, EMBASE, and the Cochrane Library were searched. Risk ratios of seroconversion were separately pooled using random-effects meta-analysis, and a systematic review without meta-analysis of SARS-CoV-2 antibody titer levels was performed after the first and second doses of a COVID-19 vaccine.
RESULTS
A total of 22 studies with 6522 subjects met the inclusion criteria. After the first vaccine dose, seroconversion in PLWH was comparable to that in healthy individuals. After a second dose, seroconversion was slightly lower in PLWH compared with healthy controls, and antibody titers did not seem to be significantly affected or reduced among participants of both groups.
CONCLUSION
COVID-19 vaccines show favorable immunogenicity and efficacy in PLWH. A second dose is associated with consistently improved seroconversion, although it is slightly lower in PLWH than in healthy individuals. Additional strategies, such as a booster vaccination with messenger RNA COVID-19 vaccines, might improve seroprotection for these patients.
Topics: Humans; COVID-19 Vaccines; COVID-19; SARS-CoV-2; Seroconversion; Antibodies, Viral; HIV Infections; Vaccination
PubMed: 36241168
DOI: 10.1016/j.ijid.2022.10.005 -
Infectious Diseases of Poverty May 2022Heterologous prime-boost with ChAdOx1 nCoV-19 vector vaccine (ChAd) and a messenger RNA vaccine (BNT or mRNA-1273) has been widely facilitating mass coronavirus disease... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Heterologous prime-boost with ChAdOx1 nCoV-19 vector vaccine (ChAd) and a messenger RNA vaccine (BNT or mRNA-1273) has been widely facilitating mass coronavirus disease 2019 (COVID-19) immunisation. This review aimed to synthesize immunogenicity and reactogenicity of heterologous immunisations with ChAd and BNT (mRNA-1273) vaccine compared with homologous ChAd or BNT (mRNA-1273) immunisation.
METHODS
PubMed, Web of Science, and Embase databases were searched from inception to March 7, 2022. Immunogenicity involving serum antibodies against different SAS-CoV-2 fragments, neutralizing antibody, or spike-specific T cells response were compared. Any, local and systemic reactions were pooled by meta-analysis for comparison.
RESULTS
Of 14,571 records identified, 13 studies (3024 participants) were included for analysis. Compared with homologous BNT/BNT vaccination, heterologous ChAd/BNT schedule probably induced noninferior anti-spike protein while higher neutralizing antibody and better T cells response. Heterologous ChAd/BNT (mRNA-1273) immunisation induced superior anti-spike protein and higher neutralizing antibody and better T cells response compared with homologous ChAd/ChAd vaccination. Heterologous ChAd/BNT (mRNA-1273) had similar risk of any reaction (RR = 1.30, 95% CI: 0.86-1.96) while higher risk of local reactions (RR = 1.65, 95% CI: 1.27-2.15) and systemic reactions (RR = 1.49, 95% CI: 1.17-1.90) compared with homologous ChAd/ChAd vaccination. There was a higher risk of local reactions (RR = 1.16, 95% CI: 1.03-1.31) in heterologous ChAd/BNT (mRNA-1273) vaccination compare with homologous BNT/BNT but a similar risk of any reaction (RR = 1.03, 95% CI: 0.79-1.34) and systemic reactions (RR = 0.89, 95% CI: 0.60-1.30).
CONCLUSIONS
Heterologous ChAd/BNT schedule induced at least comparable immunogenicity compared with homologous BNT/BNT and better immunogenicity compared with homologous ChAd/ChAd vaccination. The synthetical evidence supported the general application of heterologous prime-boost vaccination using ChAd and BNT COVID-19 vaccines.
Topics: Antibodies, Neutralizing; Antibodies, Viral; BNT162 Vaccine; COVID-19; COVID-19 Vaccines; ChAdOx1 nCoV-19; Humans; RNA, Messenger; SARS-CoV-2; Vaccination; Vaccines, Synthetic; mRNA Vaccines
PubMed: 35562753
DOI: 10.1186/s40249-022-00977-x