POS1248 SAFETY PROFILE OF PFIZER-BIONTECH COVID-19 VACCINE IN PATIENTS WITH RHEUMATIC DISEASES: PRELIMINARY ASSESSMENT

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 907.2-908
Author(s):  
G. Cuomo ◽  
M. Atteno ◽  
C. Naclerio ◽  
L. E. Adinolfi ◽  
C. Romano
Keyword(s):  
Adverse Events ◽  
Injection Site ◽  
Rheumatic Diseases ◽  
Healthy Subjects ◽  
Vaccine Dose ◽  
Injection Site Pain ◽  
Multicenter Observational Study ◽  
Lymph Node Enlargement ◽  
Preliminary Study ◽  
Site Pain

Background:Efficacious vaccines are urgently needed to contain the ongoing coronavirus disease 2019 (Covid-19) pandemic of infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). On December 11, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Pfizer-BioNTech COVID-19 vaccine to prevent COVID-19, administered as 2 doses separated by 21 days (1)On December 27, 2020, Italy started use of Pfizer-BioNTech COVID-19 vaccine and initial doses were reserved for health care personnelObjectives:The primary end points were the safety of each administered dose in patients with Rheumatic diseases (RD’s)Methods:In this multicenter, observational study, we interviewed by phone 27 patients with rheumatic diseases (RDs) and 30 healthy subjects receiving the Pfizer-BioNTech vaccine (0.3 ml i.m. in two doses 21 days apart, time 0 and 3 weeks).Results:As of 30 January 2021, 57 subjects (27 patients and 30 healthy subjects) were interviewed. The epidemiological and clinical features of the 27 patients are reported in Table 1. Among the whole population, 35 subjects (16 patients and 19 healthy subjects) complained of an adverse event after the first vaccine dose, with symptom onset occurring within 1 day of vaccination. All adverse events (100%) were classified as nonserious and included: injection site pain (17), fatigue (5), headache (16), fever (3), tachycardia (2), and paresthesia (2).After 21 days, 6 patients and 11 healthy subjects received the second vaccine dose. Fifteen (5 patients and 10 healthy subjects) of them (88%) reported adverse events, again categorized as nonserious. Specifically, injection site pain (7), fatigue (10), headache (10), fever (10), paresthesia (1), cutaneous vasculitis (1), itchy and scratchy throat (1), diarrhea (4), lymph node enlargement (1) were recorded. No differences were noted between patients with RDs and healthy subjects in terms of adverse events.Conclusion:This preliminary study shows that the Pfizer-BioNTech COVID-19 vaccine is as safe in patients with RDs as in healthy subjects. Whether patients with RDs will develop protective titers of anti-SARS-CoV-2 antibodies as compared to healthy subjects will be evaluated in further, ongoing studies.References:[1]Dooling K et al. MMWR Morb Mortal Wkly Rep 2020; 69:1857Table 1.Acknowledgements:I thank the Italian League of Systemic Sclerosis for launching a survey for ssc patients.Disclosure of Interests:None declared

scholarly journals 1045. Safety of the Synthetic Saponin Adjuvant TQL1055: Preliminary Results from a First-in-humans Trial

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S614-S614
Author(s):  
Sean R Bennett ◽  
Tyler Martin
Keyword(s):  
Adverse Events ◽  
Injection Site ◽  
Dose Escalation ◽  
Large Scale ◽  
Phase 1 ◽  
Safety Data ◽  
Synthetic Analog ◽  
Injection Site Pain ◽  
The Mean ◽  
Site Pain

Abstract Background Saponin adjuvants reliably enhance immune response to a variety of antigens, but their use is hindered by dose-limiting toxicities and supply constraints. TQL1055 is a semi-synthetic analog of the natural saponin adjuvant QS-21, rationally modified to improve tolerability and enable large-scale manufacturing. We previously showed that the combination of acellular pertussis vaccine (aP) and TQL1055 was well-tolerated and increased anti-pertussis toxin (PT) antibody responses in mice and rabbits, with a no observed adverse effect level (NOAEL) > 2000 mcg/dose. Methods Here we report interim results from a Phase 1 first-in-humans dose-escalation study of TQL1055. Healthy adults 18 to 50 years of age were sequentially enrolled into 6 groups (n=12/group) and randomized 10:2 to receive one intramuscular dose of aP + TQL1055 or aP alone on Day 1. TQL1055 dose increased by group from 25 to 800 mcg (Figure 1). Local adverse events (AEs) (injection site pain, redness, swelling) and systemic AEs (fever, chills, headache, fatigue, myalgia, arthralgia, nausea, vomiting, diarrhea) were solicited through Day 8. Clinical laboratory panels (chemistry, hematology, coagulation) were performed on Days 1 (pre-dose), 8, and 29. Serious AEs were collected through Day 365. Antibodies to PT were assessed at all visits. Figure 1. Study Design Results Blinded safety data from the first four groups (n=48) through Day 8 were analyzed, including 2 subjects/group receiving aP alone. All solicited AEs were mild or moderate (Figure 2). Local AEs, mainly injection site pain, occurred in 75% of subjects (mild 65%, moderate 10%). The incidence of total local AEs increased with TQL1055 dose, from 50% at 25 mcg to 92% at 200 mcg. The mean duration of local AEs was 1.8 days and also increased with TQL1055 dose, from 1.3 days at 25 mcg to 2.1 days at 200 mcg. Systemic AEs, mostly fatigue, headache, and nausea, occurred in 63% of subjects (mild 40%, moderate 23%), with no fevers. The mean duration of systemic AEs was 1.4 days, with no association with TQL1055 dose. No severe or serious adverse events were reported. Figure 2. Solicited Adverse Events by Severity and TQL1055 Dose Conclusion In this early analysis, the safety profile of aP + TQL1055 appears similar to that of licensed aP vaccines, without severe or prolonged injection site pain. These data support further dose escalation and assessment of immunogenicity. Disclosures Sean R. Bennett, MD PhD, Adjuvance Technologies (Employee) Tyler Martin, MD, Adjuvance Technologies (Employee, Shareholder)

scholarly journals Adverse events following immunization with Covi-shield tm vaccine: a descriptive cross-sectional study at a tertiary center, Nepal

2021 ◽  
pp. 163-163
Author(s):  
Gopal Lama ◽  
Runa Jha ◽  
Sagar K Rajbhandari ◽  
Jenish Neupane ◽  
Anup Bastola
Keyword(s):  
Adverse Events ◽  
Injection Site ◽  
Cross Sectional Study ◽  
Injection Site Pain ◽  
Sectional Study ◽  
Serious Adverse Events ◽  
Cross Sectional ◽  
Tertiary Center ◽  
National Public Health ◽  
Site Pain

Introduction: As the COVID-19 pandemic continues to unfold, rapid global efforts to develop and test vaccines against SARS-CoV-2 have started. Adverse events after immunization are a common issue seen in many vaccines. This study aims at finding the adverse events following the first dose of CovishieldTM vaccine administered to the staffs at two health institutions in Kathmandu. Methods: This was a descriptive cross sectional study conducted among the staffs at National Public Health Laboratory and Sukraraj Tropical and Infectious Disease Hospital, Kathmandu between February to April, 2021. It included 162 participants who had taken the first dose of CovishieldTM vaccine. Ethical approval was taken from Nepal Health Research Council. Statistical Package for the Social Sciences were used for analysis. Results: Various adverse events were seen in 139 (85.8%) participants which were all minor events. None of the participants developed serious adverse events. Very common adverse events experienced were Injection site pain 116 (71.6%), myalgia 76 (46.9%), chills 68 (42%), headache 65 (40.1%), fever 54 (33.3%), dizziness 43 (26.5%) and nausea 20 (12.4%). Similarly, the range of time period from onset to recovery of adverse event was different for different adverse reactions. Conclusions: The adverse events following first dose of CovishieldTM vaccine were all minor reactions with commonest being injection site pain followed by myalgia, chills, headache and fever.

A Stromal Cell Derived Factor 1 (SDF-1) Agonist Stimulates Neutrophil Mobilization in Normal Humans after Subcutaneous Injection.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 4262-4262
Author(s):  
Donald Wong ◽  
Walter Korz ◽  
Ahmed Merzouk ◽  
Hassan Salari ◽  
Bensinger I. William
Keyword(s):  
Stem Cells ◽  
Adverse Events ◽  
Injection Site ◽  
Neutrophil Count ◽  
Dose Escalation ◽  
Blood Cells ◽  
Stromal Cell ◽  
Injection Site Pain ◽  
Stromal Cell Derived Factor ◽  
Site Pain

Abstract Stromal cell-derived factor-1 (SDF-1) is a well known key signaling molecule in the proliferation, homing, engraftment and expansion of hematopoietic stem cells and leukocytes. CTCE-0214, a peptide produced by rational drug design, is an analog of SDF-1 and agonist of the SDF-1 receptor, CXCR4. In vitro and in vivo models have shown that CTCE-0214 mobilized blood and progenitor cells and enhanced the survival and expansion of cord blood cells (Letters in Drug Design and Discovery.1:126, 2004; Exp Hematol.32:470, 2004; Exp Hematol.32:300, 2004; Stem Cells. In press). In this first phase I clinical trial of CTCE-0214, the safety and tolerability of single doses of CTCE-0214 given subcutaneously to healthy subjects as well as the pharmacokinetic profile and the pharmacodynamic effects were studied. The randomized, double-blinded, placebo-controlled dose-escalation trial enrolled 24 subjects in six dose-escalation groups. Four healthy human subjects in each cohort received either CTCE-0214 or Placebo, randomized in a 3:1 ratio. The starting dose for CTCE-0214 was 0.2 mg/kg. Successive dose cohorts received 0.5 mg/kg, 0.8 mg/kg, 1.5 mg/kg, 2.0 mg/kg, and 3.0 mg/kg. CTCE-0214 was shown to be safe with no serious adverse events reported in any of the dose levels studied. The most common drug related adverse events were injection site pain and erythema which were transient and resolved without intervention. The severity of injection site pain appeared to have an association with the overall quantity of study drug administered. Moderate or severe pain was reported only in subjects who received at least 80 mg of CTCE-0214 per syringe. Dilution across more than one syringe appeared to be effective in reducing injection site pain. Pharmacokinetic analysis of CTCE-0214 plasma concentrations showed that Tmax was reached at 0.25 hours post-administration for all CTCE-0214 treated cohorts. The apparent terminal elimination half-life (t1/2) values were estimated to be 0.41 to 0.32 hours. CTCE-0214 administration was associated with significant dose-dependent increases in total white blood cell and neutrophil counts in treated subjects, peaking at around 6 hours post-injection. In the 3.0 mg/kg arm, the mean difference in neutrophil count from baseline was more than three times the corresponding figure in the Placebo arm. The same trend was apparent in the 2.0 and 1.5 mg/kg arms with a greater than two times and two times increases, respectively. These results suggest that SDF-1 agonists may potentially be used in patients with low neutrophil count receiving chemotherapy with or without the use of G-CSF. The potential for CTCE-0214 to mobilize neutrophils and other blood cells merits serious consideration.

scholarly journals AB1343-HPR A QUALITATIVE REVIEW ASSESSING THEMATIC OUTCOMES FROM THE PHARMACY-LED ADALIMUMAB BIOSIMILAR SWITCH PLAN ACROSS 3 SPECIALITIES; RHEUMATOLOGY, GASTROENTEROLOGY AND DERMATOLOGY AT UNIVERSITY HOSPITALS OF COVENTRY AND WARWICKSHIRE (UHCW)

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1959.1-1960
Author(s):  
S. Gohil
Keyword(s):  
Cost Saving ◽  
Injection Site ◽  
Cost Savings ◽  
Latex Allergy ◽  
Foot Drop ◽  
Injection Site Pain ◽  
Patient Counselling ◽  
Qualitative Review ◽  
Patient Reported ◽  
Site Pain

Background:The advent of biosimilars has heralded a new era for cost effective biologic prescribing in the NHS. As patents expire for originator biologics, less expensive versions are now widely available as biosimilars. Non-medical switches (for reasons unrelated to a patient’s health) ensure prescribing of best value medicines, and cost savings can be redirected to patient care.1This practice resonates with recommendations from Lord Carter’s 2016 report regarding reducing unwarranted variation in the NHS and adopting cost saving opportunities.2In 2018/19, following loss of patent exclusivity for the expensive adalimumab originator biologic, UHCW worked in accordance with national directives to drive forward one of the largest non-medical biosimilar switches.Objectives:This qualitative review aims to explore the success of the adalimumab biosimilar switch and key themes associated with switch backs/refusals across the Rheumatology (R), Gastroenterology (G) and Dermatology (D) specialities at UHCW.Methods:The switch plan occurred between April-December 2019. 403 patients (R;189, G;176, D; 38) were eligible for switch. Patients were informed of the plan in advance via a patient information leaflet/hospital clinic visits. Switch refusals, withheld treatments and cancellations were documented and patients were advised to contact the hospital pharmacy/clinical teams if they encountered any concerns, adverse effects or lack of efficacy post switch. The clinician would then advise on subsequent management.Results:During April-December 2019, 264/403 patients had been successfully switched (R;122, G;109, D;33). 33/403 patients switched back to the originator biologic (R;22, G;10; D;1). Of the 22 rheumatology switch back patients; 6 patients reported injection site pain and variably headache, fatigue, disease relapse, gastrointestinal (GI) upset, erythema; 10=reported lack of efficacy and variably influenza-type symptoms, relapse in associated psoriasis, difficulty in walking/sleeping, hair loss, excessive perspiration, facial cellulitis, foot drop and GI upset; 1=blepharitis;1=latex allergy before injection; 3=later declined switch; 1=damaged two devices and did not wish to continue biosimilar. Of the 10 gastroenterology switch back patients; 1=injection site pain; 2=lack of efficacy; 1=developed needle phobia; 1=latex allergy before injection; 1=switch detrimental to health; 2=unstable disease; 1=insomnia; 1=pregnancy. The 1 dermatology switch back patient reported injection site pain and bleeding.38/403 patients refused the switch and remained on the originator biologic (R;11, G;27, D;0). 29/403 patients had treatment cancellations and were switched to an alternative biologic (R;17, G;9, D;3). 32/403 patients stopped treatment (R;13, G;19, D;0). Treatment was withheld for 7/403 patients (R;4, G;2, D;1).Conclusion:The UHCW adalimumab biosimilar switch plan succeeded in switching a total of 66% of patients; thus an annual cost saving of £73,020. Injection site pain, most likely due to the biosimilar citrate content, and lack of efficacy according to patient perception and subsequent clinical review, were the most predominant causative themes for switch backs. Gastroenterology patients accounted for 71% (27/38) of the total switch refusals. Additional data regarding patient refusals, identifies future opportunities to improve patient counselling and drive further cost savings.References:[1]Azevedo V, et al. Biosimilars: considerations for clinical practice. Considerations in Medicine. 2017;1(1):13–8[2]Lord Carter of Coles. (2016) Operational productivity and performance in English NHS Acute Hospitals: Unwarranted variations [Online]Acknowledgments:Mark Easter, Chief Pharmacist, Hardeep Bagga, Deputy Chief Pharmacist, UHCW Pharmacy Homecare Team, UHCW Specialist Clinical Teams.Disclosure of Interests:None declared

scholarly journals A Retrospective Study of Injection Site Pain from Azithromycin Injection in Japanese Patient

2020 ◽  
Vol 32 (3) ◽  
pp. 207-213
Author(s):  
Hironori TANAKA ◽  
Makoto HAYASHI ◽  
Mariko AWAYA ◽  
Yumiko KUSUNOKI ◽  
Nao TANAKA ◽  
...  
Keyword(s):  
Retrospective Study ◽  
Injection Site ◽  
Japanese Patient ◽  
Injection Site Pain ◽  
Site Pain

Safety of Single-Dose Oral Cefixime, Intramuscular Ceftriaxone, or Intramuscular Gentamicin for the Treatment of Gonorrhea: A Systematic Review and Meta-analysis

2020 ◽  
pp. 106002802096633
Author(s):  
Jacob Dresser ◽  
Kyle John Wilby
Keyword(s):  
Adverse Effect ◽  
Single Dose ◽  
Adverse Effects ◽  
Injection Site ◽  
Randomized Controlled Trials ◽  
Keyword Search ◽  
Controlled Trials ◽  
Injection Site Pain ◽  
Randomized Controlled ◽  
Site Pain

Objective: To compare the incidence and types of adverse effects between 3 recommended treatment options for gonorrhea and to compare the incidence of injection site pain between single-dose intramuscular ceftriaxone and gentamicin. Data Sources: A keyword search of MEDLINE (1966 to September 2020), EMBASE (1947 to September 2020), and International Pharmaceutical Abstracts (1970 to September 2020) was conducted. The electronic search was supplemented with manual screening of references. Study Selection and Data Extraction: Comparator studies reporting adverse effect outcomes of treatment with cefixime, ceftriaxone, or gentamicin for gonorrhea in humans were included. Data extracted included study year, authors, aim, setting, population, dosing protocols, and outcome results. Data Synthesis: A total of 298 articles were identified, of which 6 met inclusion criteria. Two randomized controlled trials compared ceftriaxone and gentamicin. Four randomized controlled trials compared cefixime and ceftriaxone. No differences were noted for the occurrence of at least 1 adverse effect between gentamicin and ceftriaxone (odds ratio [OR] = 0.81; 95% CI = 0.56-1.18) or between cefixime and ceftriaxone (OR = 1.11; 95% CI = 0.21-5.93). Injection site pain (ceftriaxone and gentamicin) and other adverse effects (all drugs) were common but occurred at similar rates between groups. Relevance to Patient Care and Clinical Practice: Results of this review show a lack of signal for safety concerns with gentamicin-based regimens for the treatment of gonorrhea. Future research should investigate patient acceptability, especially for intramuscular injections. Conclusions: The use of single-dose cefixime, ceftriaxone, and gentamicin-based regimens for treatment of gonorrhea appears to be safe and acceptable for use in practice.

scholarly journals 167 Randomized, Double-Blind, Active-Controlled Study of Starting Aripiprazole Lauroxil with 1-Day Initiation in Acutely Ill Patients with Schizophrenia

CNS Spectrums ◽  
2020 ◽  
Vol 25 (2) ◽  
pp. 306-307
Author(s):  
Peter J. Weiden ◽  
Amy Claxton ◽  
Yangchun Du ◽  
Sergey Yagoda ◽  
David Walling ◽  
...  
Keyword(s):  
Adverse Events ◽  
Outpatient Setting ◽  
Controlled Study ◽  
Injection Site Pain ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Secondary Analyses ◽  
Site Pain ◽  
Over Time ◽  
Funding Acknowledgements

Abstract:Objective:Evaluate efficacy and safety of a 2-month dose of aripiprazole lauroxil (AL) with a 1-day initiation regimen during hospitalization for an acute exacerbation of schizophrenia.Methods:In the phase 3b double-blind ALPINE study, adults with schizophrenia were randomized to AL (AL NanoCrystal® Dispersion + oral aripiprazole 30 mg day 1; AL 1064 mg day 8 and every 8 weeks) or paliperidone palmitate (PP 234 mg day 1; PP 156 mg day 8 and every 4 weeks). Patients were discharged after 2 weeks of hospitalization and followed through week 25. Primary endpoint was within-group changes in PANSS total score from baseline to week 4 (observed cases). Secondary analyses included within-group changes at weeks 9 and 25 (observed) and between-group comparisons at weeks 4, 9, and 25 (MMRM). Adverse events (AEs) were monitored throughout the study.Results:200 patients were randomized (AL, n=99; PP, n=101); 56.6% and 42.6%, respectively, completed the study. Within-group changes from baseline in PANSS were −17.4 for AL and −20.1 for PP at week 4 (both groups, P<0.001) and continued to decline at weeks 9 (AL, −19.8; PP, −22.5) and 25 (AL, −23.3; PP, −21.7). The change in PANSS over time was similar between groups. AEs occurring in ≥10% of patients in either group were injection site pain (AL, 17.2%; PP, 24.8%), akathisia (AL, 9.1%; PP, 10.9%), and weight increased (AL, 9.1%; PP, 16.8%).Conclusions:AL and PP were effective and well-tolerated for initiating treatment of schizophrenia in the hospital and continuing in the outpatient setting.Funding Acknowledgements:This study was funded by Alkermes, Inc.

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