scholarly journals Immunogenicity and safety of inactivated Influenza Split-Virion vaccine administered via a transdermal micro needle system

2021 ◽  
pp. 041-048
Author(s):  
Ameri Mahmoud ◽  
Lewis Hayley ◽  
Nguyen Joe
Keyword(s):  
Seroconversion Rate ◽  
Phase 1 ◽  
Controlled Study ◽  
Application Site ◽  
Treatment Groups ◽  
Randomized Controlled ◽  
Patch Removal ◽  
Antibody Titers ◽  
Antibody Levels ◽  
Hemagglutinin Inhibition

The purpose of the study was to evaluate the immunogenicity and safety of an inactivated influenza split virion vaccine administered via a transdermal microneedle system. In this Phase 1, single-center, randomized, controlled study, 90 subjects aged 18 to 40 years received influenza vaccine (strains (A/H1N1, A/H3N2, and B) either via a transdermal microneedle system (“patch”; 10 µg) for 5 or 15 minutes or by Intramuscular (IM) injection (15g). Influenza antibody titers were measured by the hemagglutinin inhibition method and compared to EMEA guidelines for influenza vaccines (seroconversion rate, mean increase in hemagglutinin inhibition titer, and percentage of seroprotected subjects). Safety was assessed through local and systemic adverse events, and specific application site events in the transdermal groups. At Day 21, the EMEA criteria were met in all treatment groups for all three influenza strains. The immunogenicity response was similar between all three groups and increased antibody levels persisted to Month 6. The transdermal microneedle system was generally well tolerated, although pinpoint red spots, edema, and erythema were noted after patch removal in most subjects. Influenza vaccination administered via a novel transdermal microneedle system was generally well tolerated and provided similar antibody response using a lower dose than IM injection.

scholarly journals Pharmacokinetics and Safety of Icotinib Hydrochloride Cream in Patients with Mild to Moderate Chronic Plaque Psoriasis: A Randomized Double-Blind Vehicle-Controlled Phase 1 Study

2019 ◽  
Vol 2019 ◽  
pp. 1-8
Author(s):  
Lunfei Liu ◽  
Honggang Lou ◽  
Jiong Zhou ◽  
Ying Shen ◽  
Min Zheng ◽  
...  
Keyword(s):  
Plaque Psoriasis ◽  
Phase 1 ◽  
Vehicle Group ◽  
Controlled Study ◽  
Application Site ◽  
Dependent Manner ◽  
Local Tolerability ◽  
Phase 1 Study ◽  
Double Blind ◽  
Quality Life

Objective.This phase I study aimed to systematically assess the safety, local tolerability, pharmacokinetics, and preliminary efficacy of topical icotinib hydrochloride cream in patients with mild to moderate plaque psoriasis.Materials and Methods.Eligible Chinese adult patients with mild to moderate psoriasis were assigned to the icotinib cream or vehicle group. Icotinib cream with increasing concentrations (0.5%, 1.0%, 2.0%, and 4.0%) or vehicle were administered by the fingertip unit method to the skin lesions twice a day for 4 weeks. Safety assessments included the incidence and severity of adverse events (AEs), local tolerability at the treatment area, vital signs, and laboratory examinations. Plasma levels of icotinib were also measured for the pharmacokinetics calculation. The efficacy was preliminarily explored by assessing the improvement in the severity level using Target Plaque Severity Score (TPSS) and overall improvement using the Psoriasis Area Severity Index (PASI) and Dermatological Quality Life Index.Results.Forty-one patients were enrolled and qualified for safety analysis. 27 (65.9%) patients experienced at least one AE, of which application-site adverse drug reactions (ADRs) were reported in 6 (14.6%) patients. All ADRs were of grade 1 or 2, most common irritation (4.5%), itching (3.1%), and erythema (2.4%), and resolved during follow-up. The systemic exposure to icotinib was very low; the highest plasma concentration was 0.214 ng/mL, while the area under the curve from 0 to 12 hours was 1.626 h·ng/mL. The TPSS improved for all icotinib groups after treatment in a dose- and time-dependent manner.Conclusion.This phase 1 study demonstrated favorable safety, tolerable toxicity, and preliminary efficacy of icotinib cream in patients with mild to moderate psoriasis. The dose concentration of 2.0% (twice daily based on the fingertip unit method) is recommended for further study.Study Design.This is a single-center, randomized, double-blind, and vehicle-controlled study.

Roflumilast Cream Improves Signs and Symptoms of Plaque Psoriasis: Results from a Phase 1/2a Randomized, Controlled Study

2020 ◽  
Vol 19 (8) ◽  
pp. 734-740
Author(s):  
Kim Papp ◽  
Melinda Gooderham ◽  
Michael Droege ◽  
Charlotte Merritt ◽  
David Osborne ◽  
...  
Keyword(s):  
Plaque Psoriasis ◽  
Phase 1 ◽  
Signs And Symptoms ◽  
Randomized Controlled Study ◽  
Controlled Study ◽  
Randomized Controlled

scholarly journals Comparison of the 3 Different Injection Techniques Used in a Randomized Controlled Study Evaluating a Cross-Linked Sodium Hyaluronate Combined With Triamcinolone Hexacetonide (Cingal) for Osteoarthritis of the Knee: A Subgroup Analysis

2017 ◽  
Vol 10 ◽  
pp. 117954411772502 ◽  
Author(s):  
Robert McCormack ◽  
Martin Lamontagne ◽  
Christopher Vannabouathong ◽  
Robert T Deakon ◽  
Etienne L Belzile
Keyword(s):  
Sodium Hyaluronate ◽  
Controlled Study ◽  
Injection Technique ◽  
Osteoarthritis Of The Knee ◽  
Previous Trial ◽  
Additional Insight ◽  
Recent Trial ◽  
Treatment Groups ◽  
Randomized Controlled ◽  
Injection Techniques

A recent trial demonstrated that patients with knee osteoarthritis treated with a sodium hyaluronate and corticosteroid combination (Cingal) experienced greater pain reductions compared with those treated with sodium hyaluronate alone (Monovisc) or saline up to 3 weeks postinjection. In this study, injections were administered by 1 of 3 approaches; however, there is currently no consensus on which, if any, of these techniques produce a more favorable outcome. To provide additional insight on this topic, the results of the previous trial were reanalyzed to determine whether (1) the effect of Cingal was significant within each injection technique and (2) pain reductions were similar between injection techniques across all treatment groups. Greater pain reductions with Cingal up to 3 weeks were only significant in the anteromedial subgroup. Across all therapies, both the anteromedial and anterolateral techniques demonstrated significantly greater pain reductions than the lateral midpatellar approach at 18 and 26 weeks.

Efficacy of EGF and Gelatin Sponge for Traumatic Tympanic Membrane Perforations: A Randomized Controlled Study

2018 ◽  
Vol 159 (6) ◽  
pp. 1028-1036 ◽  
Author(s):  
Zheng Cai Lou ◽  
Zihan Lou
Keyword(s):  
Tympanic Membrane ◽  
Gelatin Sponge ◽  
Controlled Study ◽  
Spontaneous Healing ◽  
Related Factors ◽  
Closure Rate ◽  
Randomized Controlled ◽  
Tympanic Membrane Perforations ◽  
Closure Time ◽  
Patch Removal

Objective To compare the outcomes of epidermal growth factor (EGF) and gelatin sponge patch treatments for traumatic tympanic membrane perforations. Study Design Prospective, randomized, controlled. Setting University-affiliated teaching hospital. Subjects and Methods In total, 141 perforations encompassing >50% of the eardrum were randomly divided into 3 groups: EGF (n = 47), gelatin sponge patch (n = 47), and observation (n = 47). The edges of the perforations were not approximated. The closure rate, mean closure time, and infection rate were evaluated at 6 months and the related factors analyzed. Results A total of 135 perforations were analyzed. At 6 months, the closure rates were 97.8%, 86.7%, and 82.2% in the EGF, gelatin sponge patch, and spontaneous healing groups, respectively ( P = .054). The mean ± SD closure time was 11.12 ± 4.60, 13.67 ± 5.37, and 25.65 ± 13.32 days in the EGF, gelatin sponge patch, and spontaneous healing groups, respectively ( P < .001). In addition, the presence of infection was not significantly associated with rate of closure in any group. Conclusions As compared with spontaneous healing, daily application of EGF and gelatin sponge patching reduced the closure time of traumatic tympanic membrane perforations. EGF treatment had a higher closure rate and shorter closure time but resulted in otorrhea. By contrast, gelatin sponge patches did not improve the closure rate or cause otorrhea but required repeated patch removal and reapplication. Thus, the appropriate treatment should be selected according to patient need.

Serologic Response of 2 Versus 3 Doses and Intradermal Versus Intramuscular Administration of a Licensed Rabies Vaccine for Preexposure Prophylaxis

2019 ◽  
Vol 221 (9) ◽  
pp. 1494-1498 ◽  
Author(s):  
Timothy P Endy ◽  
Paul B Keiser ◽  
Dongliang Wang ◽  
Richard G Jarman ◽  
Don Cibula ◽  
...  
Keyword(s):  
Neutralizing Antibody ◽  
Dose Schedule ◽  
Rabies Vaccine ◽  
World Health ◽  
Treatment Groups ◽  
Preexposure Prophylaxis ◽  
Antibody Titers ◽  
Health Organization ◽  
Antibody Levels ◽  
Rabies Vaccination

Abstract Background The World Health Organization recommends intradermal (ID) administration of rabies vaccine for preexposure prophylaxis. Methods In a randomized trial in adults assigned to 1 of 6 treatment groups (ID vs intramuscular [IM], 2 vs 3 doses, and controls), rabies neutralizing antibody titers were measured to 1 year postvaccination. Results ID vaccination produced acceptable antibody levels in all subjects (2- and 3-dose groups). At day 365, acceptable levels were 40% for IM and 50% for ID 2-dose schedule, and 70% for IM and 60% for ID 3-dose schedule. Conclusions ID rabies vaccination induces acceptable antibody titers at a fraction of the dose. Clinical Trials Registration NCT02374814.

scholarly journals Antibody Response and Safety After mRNA-1273 SARS-CoV-2 Vaccination in Peritoneal Dialysis Patients – the Vienna Cohort

2021 ◽  
Vol 12 ◽  
Author(s):  
Georg Beilhack ◽  
Rossella Monteforte ◽  
Florian Frommlet ◽  
Martina Gaggl ◽  
Robert Strassl ◽  
...  
Keyword(s):  
Peritoneal Dialysis ◽  
Seroconversion Rate ◽  
Dialysis Patients ◽  
Serious Adverse Events ◽  
Quantile Regression Model ◽  
Local Adverse Event ◽  
Dialysis Vintage ◽  
Antibody Titers ◽  
Systemic Side Effects ◽  
Antibody Levels

BackgroundDialysis patients are at high risk for a severe clinical course after infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Safety and early immune responses after mRNA-based vaccination have been reported mostly in patients on hemodialysis (HD), whereas reports of peritoneal dialysis (PD) patients remain rare.MethodsIn this retrospective observational study, 39 PD patients had received two doses of the mRNA-1273 Moderna® vaccine. We analyzed SARS-CoV-2 Spike (S) antibody titers 4 weeks after each dose of mRNA-1273 and report local and systemic side effects in PD patients that occurred within one week after each mRNA-1273 dose. Using a quantile regression model we examined factors that might influence SARS-CoV-2 S antibody levels in PD patients.ResultsFour weeks after the first dose of mRNA-1273 vaccine 33 of 39 (84.6%) PD patients seroconverted and presented with 6.62 U/mL (median; IQR 1.57-22.5) anti-SARS-CoV-2 S antibody titers. After the second dose, 38 of 39 (97.4%) PD patients developed anti-SARS-CoV-2 S antibodies and titers increased significantly (median 968 U/mL; IQR 422.5-2500). Pain at the injection site was the most common local adverse event (AE) (71%). Systemic AEs occurring after the first dose were mostly fatigue (33%) and headache (20%). No severe systemic AEs were reported after the first injection. After the second dose the incidence and the severity of the systemic AEs increased. The most common systemic AEs were: fatigue (40.5%), headache (22.5%), joint pain (20%), myalgia (17.5%) and fever (13%). Lower Davies Comorbidity Score (p=0.04) and shorter dialysis vintage (p=0.017) were associated with higher antibody titers after the first dose. Patients with higher antibody titers after the first dose tended to have higher antibody titers after the second dose (p=1.53x10-05).ConclusionsPeritoneal dialysis patients in this cohort had a high seroconversion rate of 97.4%, showed high antibody titers after full vaccination and tolerated the anti-SARS-CoV-2 mRNA-1273 vaccine well without serious adverse events.

scholarly journals Safety, tolerability, and pharmacokinetics of pregabalin in children with refractory partial seizures: A phase 1, randomized controlled study

Epilepsia ◽  
2014 ◽  
Vol 55 (12) ◽  
pp. 1934-1943 ◽  
Author(s):  
Donald Mann ◽  
Jing Liu ◽  
Marci L. Chew ◽  
Howard Bockbrader ◽  
Christine W. Alvey ◽  
...  
Keyword(s):  
Phase 1 ◽  
Randomized Controlled Study ◽  
Controlled Study ◽  
Partial Seizures ◽  
Randomized Controlled

scholarly journals Randomized Controlled Study to Evaluate Prophylactic Properties of Ayurvedic Treatment Protocol in Refractory and Chronic Migraine Patients

2021 ◽  
Vol 6 (04) ◽  
pp. 259-263
Author(s):  
Vaidya Balendu Prakash ◽  
Nitin Chandurkar ◽  
Vaidya Shikha Prakash ◽  
Shakshi Sharma ◽  
Sneha Tiwari
Keyword(s):  
Treatment Protocol ◽  
Controlled Study ◽  
Controlled Clinical Trial ◽  
Open Label ◽  
Treatment Groups ◽  
Randomized Controlled ◽  
Vas Score ◽  
Ayurvedic Treatment ◽  
Refractory Migraine

Background: Migraine is a disorder marked by recurrent episodes of headache. There is a subset of migraine patients who remain refractory to the conventional prophylactic and abortive therapies. This study aimed to assess the therapeutic role of an ayurvedic treatment protocol in patients who had chronic/ refractory migraine. Methods: This single-center, open label, randomized, controlled clinical trial compared the efficacy of ayurvedic treatment protocol to conventional treatment. Included patients were 18-65 years of age and met the diagnostic criteria for chronic/ refractory migraine. The patients were randomized in a 1:1 ratio to the ayurvedic treatment or conventional therapy at the baseline and were followed at regular intervals for 360 days. The primary outcome was reduction in the number of headache days in the last 3 months and the secondary outcomes were a reduction in the visual analog scale (VAS) score and migraine disability assessment score (MIDAS) as compared to the baseline. Results: Patients (n=154) were randomized to the two treatment groups with similar baseline demographic and clinical characteristics. The patients in ayurvedic treatment group had a greater reduction in the number of headache days, VAS score and MIDAS score at day 360 (p<0.05). Further, there were no reported medication-related adverse effects in either group. Conclusion: Ayurvedic treatment protocol is well tolerated and is associated with significant improvement in symptoms of chronic refractory migraine.

scholarly journals Cognitive Effects of the BET Protein Inhibitor Apabetalone: A Prespecified Montreal Cognitive Assessment Analysis Nested in the BETonMACE Randomized Controlled Trial

2021 ◽  
Vol 83 (4) ◽  
pp. 1703-1715
Author(s):  
Jeffrey Cummings ◽  
Gregory G. Schwartz ◽  
Stephen J. Nicholls ◽  
Aziz Khan ◽  
Chris Halliday ◽  
...  
Keyword(s):  
Cognitive Assessment ◽  
Late Life ◽  
Montreal Cognitive Assessment ◽  
Controlled Study ◽  
Protein Inhibitor ◽  
Treatment Groups ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Bet Protein ◽  
Moca Score

Background: Epigenetic changes may contribute importantly to cognitive decline in late life including Alzheimer’s disease (AD) and vascular dementia (VaD). Bromodomain and extra-terminal (BET) proteins are epigenetic “readers” that may distort normal gene expression and contribute to chronic disorders. Objective: To assess the effects of apabetalone, a small molecule BET protein inhibitor, on cognitive performance of patients 70 years or older participating in a randomized trial of patients at high risk for major cardiovascular events (MACE). Methods: The Montreal Cognitive Assessment (MoCA) was performed on all patients 70 years or older at the time of randomization. 464 participants were randomized to apabetalone or placebo in the cognition sub-study. In a prespecified analysis, participants were assigned to one of three groups: MoCA score≥26 (normal performance), MoCA score 25–22 (mild cognitive impairment), and MoCA score≤21 (dementia). Exposure to apabetalone was equivalent in the treatment groups in each MoCA-defined group. Results: Apabetalone was associated with an increased total MoCA score in participants with baseline MoCA score of≤21 (p = 0.02). There was no significant difference in change from baseline in the treatment groups with higher MoCA scores. In the cognition study, more patients randomized to apabetalone discontinued study drug for adverse effects (11.3% versus 7.9%). Conclusion: In this randomized controlled study, apabetalone was associated with improved cognition as measured by MoCA scores in those with baseline scores of 21 or less. BET protein inhibitors warrant further investigation for late life cognitive disorders.

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