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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 -
The Cochrane Database of Systematic... May 2017The common cold is a spontaneously remitting infection of the upper respiratory tract, characterised by a runny nose, nasal congestion, sneezing, cough, malaise, sore... (Review)
Review
BACKGROUND
The common cold is a spontaneously remitting infection of the upper respiratory tract, characterised by a runny nose, nasal congestion, sneezing, cough, malaise, sore throat, and fever (usually < 37.8º C). The widespread morbidity caused by the common cold worldwide is related to its ubiquitousness rather than its severity. The development of vaccines for the common cold has been difficult because of antigenic variability of the common cold virus and the indistinguishable multiple other viruses and even bacteria acting as infective agents. There is uncertainty regarding the efficacy and safety of interventions for preventing the common cold in healthy people. This is an update of a Cochrane review first published in 2011 and previously updated in 2013.
OBJECTIVES
To assess the clinical effectiveness and safety of vaccines for preventing the common cold in healthy people.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (September 2016), MEDLINE (1948 to September 2016), Embase (1974 to September 2016), CINAHL (1981 to September 2016), and LILACS (1982 to September 2016). We also searched three trials registers for ongoing studies and four websites for additional trials (February 2017). We included no language or date restrictions.
SELECTION CRITERIA
Randomised controlled trials (RCTs) of any virus vaccines compared with placebo to prevent the common cold in healthy people.
DATA COLLECTION AND ANALYSIS
Two review authors independently evaluated methodological quality and extracted trial data. We resolved disagreements by discussion or by consulting a third review author.
MAIN RESULTS
We found no additional RCTs for inclusion in this update. This review includes one RCT dating from the 1960s with an overall high risk of bias. The RCT included 2307 healthy participants, all of whom were included in analyses. This trial compared the effect of an adenovirus vaccine against placebo. No statistically significant difference in common cold incidence was found: there were 13 (1.14%) events in 1139 participants in the vaccines group and 14 (1.19%) events in 1168 participants in the placebo group (risk ratio 0.95, 95% confidence interval 0.45 to 2.02; P = 0.90). No adverse events related to the live vaccine were reported. The quality of the evidence was low due to limitations in methodological quality and a wide 95% confidence interval.
AUTHORS' CONCLUSIONS
This Cochrane Review was based on one study with low-quality evidence. We found no conclusive results to support the use of vaccines for preventing the common cold in healthy people compared with placebo. We identified a need for well-designed, adequately powered RCTs to investigate vaccines for the common cold in healthy people. Any future trials on medical treatments for preventing the common cold should assess a variety of virus vaccines for this condition. Outcome measures should include common cold incidence, vaccine safety, and mortality related to the vaccine.
Topics: Adenovirus Vaccines; Common Cold; Health Status; Humans; Randomized Controlled Trials as Topic; Vaccines, Attenuated
PubMed: 28516442
DOI: 10.1002/14651858.CD002190.pub5 -
Vaccines May 2021The current study systematically reviewed, summarized and meta-analyzed the clinical features of the vaccines in clinical trials to provide a better estimate of their... (Review)
Review
The current study systematically reviewed, summarized and meta-analyzed the clinical features of the vaccines in clinical trials to provide a better estimate of their efficacy, side effects and immunogenicity. All relevant publications were systematically searched and collected from major databases up to 12 March 2021. A total of 25 RCTs (123 datasets), 58,889 cases that received the COVID-19 vaccine and 46,638 controls who received placebo were included in the meta-analysis. In total, mRNA-based and adenovirus-vectored COVID-19 vaccines had 94.6% (95% CI 0.936-0.954) and 80.2% (95% CI 0.56-0.93) efficacy in phase II/III RCTs, respectively. Efficacy of the adenovirus-vectored vaccine after the first (97.6%; 95% CI 0.939-0.997) and second (98.2%; 95% CI 0.980-0.984) doses was the highest against receptor-binding domain (RBD) antigen after 3 weeks of injections. The mRNA-based vaccines had the highest level of side effects reported except for diarrhea and arthralgia. Aluminum-adjuvanted vaccines had the lowest systemic and local side effects between vaccines' adjuvant or without adjuvant, except for injection site redness. The adenovirus-vectored and mRNA-based vaccines for COVID-19 showed the highest efficacy after first and second doses, respectively. The mRNA-based vaccines had higher side effects. Remarkably few experienced extreme adverse effects and all stimulated robust immune responses.
PubMed: 34066475
DOI: 10.3390/vaccines9050467 -
Human Vaccines & Immunotherapeutics Nov 2016Antigenic drift of seasonal influenza viruses and the occasional introduction of influenza viruses of novel subtypes into the human population complicate the timely... (Review)
Review
Antigenic drift of seasonal influenza viruses and the occasional introduction of influenza viruses of novel subtypes into the human population complicate the timely production of effective vaccines that antigenically match the virus strains that cause epidemic or pandemic outbreaks. The development of game-changing vaccines that induce broadly protective immunity against a wide variety of influenza viruses is an unmet need, in which recombinant viral vectors may provide. Use of viral vectors allows the delivery of any influenza virus antigen, or derivative thereof, to the immune system, resulting in the optimal induction of virus-specific B- and T-cell responses against this antigen of choice. This systematic review discusses results obtained with vectored influenza virus vaccines and advantages and disadvantages of the currently available viral vectors.
Topics: Animals; Drug Carriers; Genetic Vectors; Humans; Influenza Vaccines; Vaccines, Attenuated; Vaccines, Synthetic; Viruses
PubMed: 27455345
DOI: 10.1080/21645515.2016.1210729 -
Infectious Disorders Drug Targets 2022Many potential vaccines for COVID-19 are being studied and developed. Several studies have reported on the safety and efficacy of these vaccines. This systematic review...
INTRODUCTION
Many potential vaccines for COVID-19 are being studied and developed. Several studies have reported on the safety and efficacy of these vaccines. This systematic review aimed to report on the current evidence concerning the feasibility and effectiveness of vaccines for COVID-19.
METHODS
A systematic search was carried out utilizing the keywords in the online databases, including Scopus, Web of Science, PubMed, Embase, and Cochrane. We included both human and non-human studies because of the vaccine novelty, limiting our ability to include sufficient human studies.
RESULTS
This review showed several SARS-CoV-2 vaccines to be currently under development using different platforms, including eight vaccines that are adenovirus-based vectors, six vaccines that are RNA-based formulations, one vaccine being DNA-based formulation, and other vaccines using other platforms, including lipid nanoparticles. Although the safety and efficacy profiles of these vaccines are still under debate, some countries have allowed for emergency use of some vaccines in at-risk populations, such as healthcare workers and the elderly.
CONCLUSION
It is crucial to gather as much clinically relevant evidence as possible regarding the immunogenicity, efficacy, and safety profiles of available vaccines and adhere wisely to CDC protocols and guidelines for vaccine production.
Topics: COVID-19; COVID-19 Vaccines; Feasibility Studies; Humans; Immunogenicity, Vaccine; Liposomes; Nanoparticles; SARS-CoV-2
PubMed: 34554905
DOI: 10.2174/1871526521666210923144837 -
The Lancet Regional Health. Europe Jan 2022For safety assessment in clinical trials, adverse events (AEs) are reported for the drug under evaluation and compared with AEs in the placebo group. Little is known...
BACKGROUND
For safety assessment in clinical trials, adverse events (AEs) are reported for the drug under evaluation and compared with AEs in the placebo group. Little is known about the nature of the AEs associated with clinical trials of SARS-CoV-2 vaccines and the extent to which these can be traced to nocebo effects, where negative treatment-related expectations favor their occurrence.
METHODS
In our systematic review, we compared the rates of solicited AEs in the active and placebo groups of SARS-CoV-2 vaccines approved by the Western pharmaceutical regulatory agencies.We implemented a search strategy to identify trial-III studies of SARS-CoV-2 vaccines through the PubMed database. We adopted the PRISMA Statement to perform the study selection and the data collection and identified three trial: two mRNA-based (38403 participants) and one adenovirus type (6736 participants).
FINDINGS
Relative risks showed that the occurrence of AEs reported in the vaccine groups was higher compared with the placebo groups. The most frequently AEs in both groups were fatigue, headache, local pain, as injection site reactions, and myalgia. In particular, for first doses in placebo recipients, fatigue was reported in 29% and 27% in BNT162b2 and mRNA-1273 groups, respectively, and in 21% of Ad26.COV2.S participants. Headache was reported in 27% in both mRNA groups and in 24% of Ad26.COV2.S recipients. Myalgia was reported in 10% and 14% in mRNA groups (BNT162b2 and mRNA-1273, respectively) and in 13% of Ad26.COV2.S participants. Local pain was reported in 12% and 17% in mRNA groups (BNT162b2 and mRNA-1273, respectively), and in 17% of Ad26.COV2.S recipients. These AEs are more common in the younger population and in the first dose of placebo recipients of the mRNA vaccines.
INTERPRETATION
Our results are in agreement with the expectancy theory of nocebo effects and suggest that the AEs associated with COVID-19 vaccines may be related to the nocebo effect.
FUNDING
Fondazione CRT - Cassa di Risparmio di Torino, IT (grant number 66346, "GAIA-MENTE" 2019).
PubMed: 34729549
DOI: 10.1016/j.lanepe.2021.100253 -
Vaccines Mar 2023Coronavirus disease 2019 (COVID-19) vaccine has effectively suppressed the spread of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and alleviated its... (Review)
Review
Coronavirus disease 2019 (COVID-19) vaccine has effectively suppressed the spread of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and alleviated its symptoms, but there are also many adverse events. Joint diseases caused by COVID-19 vaccine have been reported in many studies. Some are well-controlled arthritis patients who developed arthritis after COVID-19 vaccination, while others are new-onset joint pain and swelling problems after COVID-19 vaccination. The purpose of this systematic review is to examine the literature reports in existing databases and analyze the incidence of new-onset arthritis after COVID-19 vaccination. We included 31 eligible articles and described 45 patients, ranging in age from 17 to over 90, with more females than males. The majority (84.4%) of patients received the adenovirus vector vaccine (ChAdOx1) and the mRNA-based vaccine (BNT126b2 and mRNA-1273). Most (64.4%) patients developed joint-related symptoms after the first dose of vaccine, and 66.7% developed symptoms within the first week of vaccination. The joint symptoms involved were mainly joint swelling, joint pain, limited range of motion, and so on. A total of 71.1% of the patients involved multiple joints, both large and small; 28.9% of patients involved only a single joint. Some (33.3%) patients were confirmed by imaging, and the most common diagnoses were bursitis and synovitis. Two nonspecific inflammatory markers, erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP), were monitored in almost all cases, and all patients showed varying degrees of increase in these two markers. Most of the patients received the treatment of glucocorticoid drugs or nonsteroidal anti-inflammatory drugs (NSAIDs). Clinical symptoms markedly improved in most patients, with 26.7% making a full recovery and no relapse after a few months of follow-up. To determine whether there is a causal relationship between COVID-19 vaccination and the triggering of arthritis, large-scale and well-controlled research studies are needed in the future to verify this relationship and to further study its pathogenesis in detail. Clinicians should raise awareness of this complication with a view to early diagnosis and appropriate treatment.
PubMed: 36992249
DOI: 10.3390/vaccines11030665 -
Bulletin of the National Research Centre 2021High effectiveness of COVID-19 vaccines is essential for the pandemic control. This study systematically reviewed available evidence on effectiveness of ChAdOx1 and... (Review)
Review
BACKGROUND
High effectiveness of COVID-19 vaccines is essential for the pandemic control. This study systematically reviewed available evidence on effectiveness of ChAdOx1 and BNT162b2 vaccines in the general population, for improved vaccine policies and strategies.
MAIN BODY OF THE ABSTRACT
Using several keywords, a search of Scopus, PubMed, Google scholar and Hinari databases was conducted from December 1, 2020 to June 9, 2021. Eligible studies comprising original studies reporting effectiveness of the vaccines, were included following PRISMA guidelines. Individual studies were assessed for quality using National Heart, Lung and Blood Institute quality assessment tool. A total of 1766 titles were retrieved and 11 were included, out of which only 5 were peer-reviewed. Although data availability was limited, studies suggest equivalent effectiveness of BNT162b2 and ChAdOx1 COVID-19 vaccine against SARS-CoV-2 infection and COVID-19 related morbidity and mortality. Vaccine effectiveness increased steadily to about 35 days, with an enhanced effectiveness following the second dose.
SHORT CONCLUSION
BNT162 and ChAdOx1 vaccines were associated with equivalent and high effectiveness which increased with time and a second dose in the general population. This encourages continued practice of other preventive measures, particularly during the first week of vaccination, and reinforces the need for a second dose.
PubMed: 34456555
DOI: 10.1186/s42269-021-00607-w -
European Journal of Haematology Apr 2023This systematic review aimed to retrieve patients diagnosed with de novo immune thrombocytopenic purpura (ITP) after COVID-19 immunization to determine their... (Review)
Review
INTRODUCTION
This systematic review aimed to retrieve patients diagnosed with de novo immune thrombocytopenic purpura (ITP) after COVID-19 immunization to determine their epidemiological characteristics, clinical course, therapeutic strategies, and outcome.
MATERIALS AND METHODS
We conducted the review using four major databases, comprising PubMed, Scopus, Web of Science, and the Cochrane library, until April 2022. A systematic search was performed in duplicate to access eligible articles in English. Furthermore, a manual search was applied to the chosen papers' references to enhance the search sensitivity. Data were extracted and analyzed with the SPSS 20.1 software.
RESULTS
A total of 77 patients with de novo COVID-19 vaccine-associated ITP were identified from 41 studies, including 31 case reports and 10 case series. The median age of patients who developed COVID-19 vaccine-associated ITP was 54 years (IQR 36-72 years). The mRNA-based COVID-19 vaccines, including BNT16B2b2 and mRNA-1273, were most implicated (75.4%). Those were followed by the adenovirus vector-based vaccines, inclusive of ChAdOx1 nCoV-19 and vAd26.COV2.S. No report was found relating ITP to other COVID-19 vaccines. Most cases (79.2%) developed ITP after the first dose of COVID-19 vaccination. 75% of the patients developed ITP within 12 days of vaccination, indicating a shorter lag time compared to ITP after routine childhood vaccinations. Sixty-seven patients (87%) patients were hospitalized. The management pattern was similar to primary ITP, and systemic glucocorticoids, IVIg, or both were the basis of the treatment in most patients. Most patients achieved therapeutic goals; only two individuals required a secondary admission, and one patient who presented with intracranial hemorrhage died of the complication.
CONCLUSIONS
De novo ITP is a rare complication of COVID-19 vaccination, and corresponding reports belong to mRNA-based and adenovirus vector-based vaccines, in order of frequency. This frequency pattern may be related to the scale of administration of individual vaccines and their potency in inducing autoimmunity. The more the COVID-19 vaccine is potent to induce antigenic challenge, the shorter the lag time would be. Most patients had a benign course and responded to typical treatments of primary ITP.
Topics: Adult; Aged; Humans; Middle Aged; ChAdOx1 nCoV-19; COVID-19; COVID-19 Vaccines; Purpura, Thrombocytopenic, Idiopathic; Vaccination
PubMed: 36562217
DOI: 10.1111/ejh.13917 -
Frontiers in Immunology 2022Tuberculosis (TB), caused by respiratory infection with , remains a major global health threat. The only licensed TB vaccine, the one-hundred-year-old Bacille... (Review)
Review
Tuberculosis (TB), caused by respiratory infection with , remains a major global health threat. The only licensed TB vaccine, the one-hundred-year-old Bacille Calmette-Guérin has variable efficacy and often provides poor protection against adult pulmonary TB, the transmissible form of the disease. Thus, the lack of an optimal TB vaccine is one of the key barriers to TB control. Recently, the development of highly efficacious COVID-19 vaccines within one year accelerated the vaccine development process in human use, with the notable example of mRNA vaccines and adenovirus-vectored vaccines, and increased the public acceptance of the concept of the controlled human challenge model. In the TB vaccine field, recent progress also facilitated the deployment of an effective TB vaccine. In this review, we provide an update on the current virus-vectored TB vaccine pipeline and summarize the latest findings that might facilitate TB vaccine development. In detail, on the one hand, we provide a systematic literature review of the virus-vectored TB vaccines are in clinical trials, and other promising candidate vaccines at an earlier stage of development are being evaluated in preclinical animal models. These research sharply increase the likelihood of finding a more effective TB vaccine in the near future. On the other hand, we provide an update on the latest tools and concept that facilitating TB vaccine research development. We propose that a pre-requisite for successful development may be a better understanding of both the lung-resident memory T cell-mediated mucosal immunity and the trained immunity of phagocytic cells. Such knowledge could reveal novel targets and result in the innovative vaccine designs that may be needed for a quantum leap forward in vaccine efficacy. We also summarized the research on controlled human infection and ultra-low-dose aerosol infection murine models, which may provide more realistic assessments of vaccine utility at earlier stages. In addition, we believe that the success in the ongoing efforts to identify correlates of protection would be a game-changer for streamlining the triage of multiple next-generation TB vaccine candidates. Thus, with more advanced knowledge of TB vaccine research, we remain hopeful that a more effective TB vaccine will eventually be developed in the near future.
Topics: Animals; COVID-19; COVID-19 Vaccines; Humans; Mice; Tuberculosis; Tuberculosis Vaccines; Vaccine Development
PubMed: 35812383
DOI: 10.3389/fimmu.2022.895020