scholarly journals Assessment of Factors Affecting Inactivated COVID-19 (CORONAVAC) Vaccine Response and Antibody Response in Healthcare Professionals

2021 ◽  
Author(s):  
Hülya Özkan Özdemir ◽  
Selma Tosun ◽  
Seher Ayten COŞKUNER ◽  
Seval Demir
Keyword(s):  
Antibody Response ◽  
Healthcare Workers ◽  
Advanced Age ◽  
Phase Iii ◽  
Vaccine Response ◽  
H1n1 Vaccine ◽  
Phase Iii Trial ◽  
Factors Affecting ◽  
Weak Response ◽  
The Difference

Abstract BackgroundAlthough COVID-19 pandemic Phase III trial results of many vaccines were reported, the literature about community results is inadequate. This study aims to evaluate the experience gained during the vaccination process of healthcare workers (HCW), the measured antibody responses and the factors affecting the response, and to contribute to the literature in this field by presenting the data. MethodAnti-RBD anti-SARS Cov2 IgG antibodies were measured by the ELISA method in blood samples taken at least a month after the second vaccine from 264 HCW vaccinated twice with an interval of 28 days. Information from individuals were collected with an online participation form. Results264 HCW (166 females (63%), 98 males (37%)) were included in the study whose age are between 23-69 (mean 44.22 ± 11.58). After vaccination, 22 (8.3%) were unresponsive, 25 (9.5%) had weak response, and 217 (82.2%) had a response. The overall rate of weak response and the high response was 91.6%. In our study, that the antibody response was found to be statistically significantly lower in males (p: 0.022), there was a significant decrease in antibody response with advanced age (p <0.005), and the difference was highly significant (p: 0.0005) above the age of 60.ConclusionIn this study, 91.6% anti spike antibodies were detected with CoronaVac which an inactivated vaccine and the antibody response is was lower in cases of advanced age, male gender, not having COVID-19, not developing PVAE, and having pandemic H1N1 vaccine.

scholarly journals SUPR-3D: A randomized phase iii trial comparing simple unplanned palliative radiotherapy versus 3d conformal radiotherapy for patients with bone metastases: study protocol

BMC Cancer ◽  
2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Robert Olson ◽  
Roel Schlijper ◽  
Nick Chng ◽  
Quinn Matthews ◽  
Marco Arimare ◽  
...  
Keyword(s):  
Bone Metastases ◽  
Volumetric Modulated Arc Therapy ◽  
Palliative Radiotherapy ◽  
Conformal Radiotherapy ◽  
Phase Iii ◽  
Phase Iii Trial ◽  
Patient Reported ◽  
Radiation Induced ◽  
The Difference

Abstract Background Bone metastases in the lower spine and pelvis are effectively palliated with radiotherapy (RT), though this can come with side effects such as radiation induced nausea and vomiting (RINV). We hypothesize that high rates of RINV occur in part because of the widespread use of inexpensive simple unplanned palliative radiotherapy (SUPR), over more complex and resource intensive 3D conformal RT, such as volumetric modulated arc therapy (VMAT). Methods This is a randomized, multi-centre phase III trial of SUPR versus VMAT. We will accrue 250 patients to assess the difference in patient-reported RINV. This study is powered to detect a difference in quality of life between patients treated with VMAT vs. SUPR. Discussion This trial will determine if VMAT reduces early toxicity compared to SUPR and may provide justification for this more resource-intensive and costly form of RT. Trial registration Clinicaltrials.gov identifier: NCT03694015. Date of registration: October 3, 2018.

Update of a phase III trial of adjuvant vinorelbine plus cisplatin (NP) versus NP plus endostar (NPE) in patients with completely resected stage IB-IIIA non-small cell lung cancer (NSCLC).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e18013-e18013
Author(s):  
He Jie ◽  
Baohui Han ◽  
Yongyu Liu ◽  
Shi Xiu Wu ◽  
Yukang Kuang ◽  
...  
Keyword(s):  
Survival Time ◽  
Early Stage ◽  
Phase Iii ◽  
Phase Iii Trial ◽  
Stage Ib ◽  
Early Stage Nsclc ◽  
The Difference ◽  
Grade 3 ◽  
Resected Stage ◽  
Relapsed Disease

e18013 Background: Adjuvant chemotherapy demonstrated a 5-15% benefit in 5-year survival in early-stage NSCLC. Endostar,a recombinant human Endostatin, could inhibit tumor angiogenesis. In a phase III trial, the addition of Endostar to NP regimen resulted in higher response rate, clinical benefit rate and longer median time to progression compared with NP alone in advanced NSCLC patients. Methods: Completely resected patients (stage IB-IIIA) were randomized to receive adjuvant NP plus Endostar (arm A, Vinorelbine 25mg/m2 on d1 and d8 plus Cisplatin 80 mg/m2 intravenously plus Endostar 7.5mg/m2 per day, iv, for 14 consecutive days. 21 days as one cycle(arm A) or NP regimen alone (arm B) for four cycles. The randomization was stratified by gender, stage and histology. The primary endpoint was OS and the secondary endpoints were RFS and safety. Results: 1037 patients (arm A: 520; arm B: 517) from 43 centers in China were enrolled between 9/2007 and 12/2010. Two arms were well-balanced with regard to age, gender, histology, stage, and resection type. 184 patients in arm A and 202 patients in arm B had relapsed disease or died. The median RFS was 34.1 months in arm A and 30.3 months in arm B (p=0.1573). 79.0% of patients in arm A and 76.0% of patients in arm B received 4 cycles of chemotherapy. Median survival time was not available at this time. Grade 3/4 toxicities in arm A included leukopenia (57.4%), neutropenia (75.0%), anemia (12.9%), nausea (11.3%). Grade 3/4 toxicities in arm B included leukopenia (35.0%) neutropenia (60.5%), anemia (8.5%) and nausea (8.5%). It is worth noting that the incidence of cardiac toxicities in arm A (26.3%) was slightly higher than that in arm B (21.4%). Conclusions: The preliminary result showed that patients in arm A experienced a longer median relapse-free survival time than in arm B (34.1 months vs. 30.3 months), although the difference was not statistically significant by far. The toxicity profiles for both arms were tolerable in this study. The patient follow-up is still ongoing.

Impact of the trifunctional antibody catumaxomab followed by systemic chemotherapy (CTX) on overall survival (OS): Results of a subgroup analysis in patients (pts) with relapsed ovarian cancer (OC) and malignant ascites (MA).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e16547-e16547
Author(s):  
Radoslav Chekerov ◽  
Pauline Wimberger ◽  
Ignace Vergote ◽  
Per Rosenberg ◽  
Andreas Schneeweiss ◽  
...  
Keyword(s):  
Systemic Chemotherapy ◽  
Malignant Ascites ◽  
Phase Iii ◽  
Phase Iii Trial ◽  
Free Survival ◽  
Safety And Efficacy ◽  
Asco 2012 ◽  
The Difference ◽  
Efficacy Parameters ◽  
To Receive

e16547 Background: MA can compromise QoL in pts with OC. The safety and efficacy of catumaxomab in pts with MA due to EpCAM+ carcinomas where standard therapy was not available, not effective or no longer feasible was confirmed in a phase III trial comparing a 3-h intraperitoneal (i.p.) infusion with and without prednisolone premedication (Sehouli, ASCO 2012). Pts with OC who received subsequent CTX after treatment with catumaxomab (post-catumaxomab CTX) were analysed separately. Methods: OC pts in both treatment arms were pooled. The efficacy parameters time to next puncture (TTPu), puncture-free survival (PuFS) and OS were evaluated in relation to post-catumaxomab CTX. Results: 42/109 (39%) pts with MA due to OC received post-catumaxomab CTX, which included a platinum-containing regimen in 19 pts (17%). 21/109 (19%) received >1 post-catumaxomab CTX regimen. Pts with any post-catumaxomab CTX compared with those without CTX had significantly prolonged OS (median 273 vs 81 d, HR 0.24, p<0.0001) and PuFS (median 138 vs 43 d, HR 0.46, p = 0.0002). The difference in TTPu was not significant (223 vs 110 d, HR 0.68, p = 0.1788). Pts with >1 post-catumaxomab CTX compared with 1 post-catumaxomab CTX had significantly prolonged OS (480 vs 167 d, HR 0.20, p < 0.0001). The difference between the groups with 1 and >1 post-catumaxomab CTX in PuFS (153 vs 123 d, HR 0.64, p = 0.1804) and TTPu (153 vs 169 d, HR 1.52, p = 0.3600) was not significant. Pts who received platinum-containing post-catumaxomab CTX had significantly prolonged OS compared with those who received post-catumaxomab CTX without platinum (462 vs 169 d, HR 0.32, p = 0.0026). The difference between the groups with and without platinum in PuFS (153 vs 123 d, HR 0.76, p = 0.4448) and TTPu (153 vs 229 d, HR 1.68, p = 0.2373) was not significant. Conclusions: The data indicate that pts with MA due to OC who are able to receive CTX after catumaxomab treatment have significantly prolonged survival compared with pts who could not receive CTX. Further trials have been initiated to identify the best patient population to receive i.p. catumaxomab followed by subsequent CTX.

scholarly journals Factors Affecting Side Effects, Seroconversion Rates and Antibody Response After Inactivated SARS-CoV-2 Vaccination in Healthcare Workers

2021 ◽  
Vol 55 (4) ◽  
pp. 519-538
Author(s):  
Şebnem Şenol Akar ◽  
Sinem Akçalı ◽  
Yunus Özkaya ◽  
Fatma Merve Gezginci ◽  
Beyhan Cengiz Özyurt ◽  
...  
Keyword(s):  
Side Effects ◽  
Antibody Response ◽  
Healthcare Workers ◽  
Factors Affecting

Phase II Study of Anti–Gastrin-17 Antibodies, Raised to G17DT, in Advanced Pancreatic Cancer

2002 ◽  
Vol 20 (20) ◽  
pp. 4225-4231 ◽  
Author(s):  
B. T. Brett ◽  
S. C. Smith ◽  
C. V. Bouvier ◽  
D. Michaeli ◽  
D. Hochhauser ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Antibody Response ◽  
Median Survival ◽  
Response Rate ◽  
Phase Ii Study ◽  
Advanced Pancreatic Cancer ◽  
Preliminary Evidence ◽  
Phase Iii ◽  
The Difference ◽  
Phase Iii Studies

PURPOSE: The prognosis for advanced pancreatic cancer remains poor. Gastrin acts as a growth factor for pancreatic cancer. We describe the first study of the antigastrin immunogen G17DT in pancreatic cancer. Our aims were to determine the antibody response, safety, tolerability, and preliminary evidence of efficacy of G17DT in advanced pancreatic cancer. PATIENTS AND METHODS: Thirty patients with advanced pancreatic cancer were immunized with three doses of either 100 μg or 250 μg of G17DT. RESULTS: In the whole group, 20 (67%) of 30 patients produced an antibody response. The 250-μg dose resulted in a significantly greater response rate of 82% compared with 46% for the 100-μg group (P = .018). The most significant side effects, seen in three patients, were local abscess and/or fever. The median survival for the whole group from the date of the first immunization was 187 days; median survival was 217 days for the antibody responders and 121 days for the antibody nonresponders. The difference in survival between the antibody responders and nonresponders was significant (P = .0023). CONCLUSION: Patients with advanced pancreatic cancer are able to mount an adequate antibody response to G17DT. The 250-μg dose is superior to the 100-μg dose, and it appears to be generally well tolerated. Antibody responders demonstrate significantly greater survival than antibody nonresponders. Phase III studies are currently underway in order to determine efficacy.

Rapid Identification of Hematology-Associated Serious Adverse Drug Reactions (sADRS) with Small Datasets: Findings from the Research on Adverse Drug Events and Reports (RADAR) Project.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 3339-3339
Author(s):  
Nina Undevia ◽  
Cara C. Tigue ◽  
Dennis P. West ◽  
June M. McKoy ◽  
Beatrice J. Edwards ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Healthy Volunteers ◽  
Healthcare Workers ◽  
Case Reports ◽  
Case Series ◽  
Boxed Warning ◽  
Phase Iii ◽  
Phase Ii Trials ◽  
Phase Iii Trial ◽  
Fda Approval

Abstract Current FDA and pharmaceutical industry drug safety efforts rely on statistical review of large databases populated with voluntary reports of sADRs. These data are limited by low rates of complete reporting and high rates of underreporting. Improved post-marketing drug surveillance efforts are needed to improve patient safety. The RADAR project is an academic pharmacovigilance program that focuses on small numbers of thoroughly researched cases of sADRs. In the last decade, RADAR has utilized the resources of a comprehensive cancer center and a global network of collaborators to evaluate and disseminate information on sADRs, many of which are related to hematology. Between 1998 and 2007, RADAR investigated and reported 16 hematology-associated sADRs. RADAR disseminated information on over half of the sADRs within 2 years of FDA approval, compared to half of all new sADRs documented in the Physician’s Desk Reference within 7 years of FDA approval. RADAR’s novel pharmacovigilance methods identified previously undetected sADRs based on small numbers of completely described reports. The RADAR project’s experience shows that private sector programs that utilize small yet comprehensive datasets can significantly contribute to pharmacovigilance networks in hematology. As the FDA develops public-private networks to evaluate safety concerns associated with new drugs, focused independent efforts can assume increasing importance to address unmet needs. Summary of 16 hematology-associated sADRs reported by RADAR since 1998. Drug (FDA approval) sADR (# of reports) Clinical Setting (yr) Data Source Time to detection (yrs) FDA/Company alert PEG-rHuMGDF(unapproved) ITP (13) Healthy volunteers (2001) Phase I trials Preclinical detection NA PEG-rHuMGDF(unapproved) Lymphomas (3) Healthy volunteers (2003) Case reports Preclinical detection NA Ticlopidine (1991) TTP (13) CVA pts (1998) Case reports <1 DHP letter; boxed warning Gemtuzumab (2000) VOD (50) Leukemia or AML (2000) Phase II trials <1 Boxed warning Lenalidomide (2005) VTE (75) Multiple myeloma (2005) Phase III trial <1 Boxed warning Enoxaparin (1993) Hemorrhage (5) PTCA (2003) Case reports 1 NA Clopidogrel (1997) TTP (39) CAD pts (1998) Case reports 1 Company warning Thalidomide (1998) VTE (91) Multiple myeloma (2002) Phase II trials 1 Black box warning Nevirapine (1996) Stevens-Johnson syndrome (3) Healthcare workers (2002) Case series 2 Boxed warning Nevirapine (1996) Hepatotoxicity (5) Healthcare workers (2002) Case series 2 Boxed warning; DHP letter EPO (1993) PRCA (9) ESRD (2000) Referral hematologist 5 Boxed warning; DHP letter EPO (1993) Loss of efficacy (2) Counterfeit drug (2000) Case reports 7 NA EPO(1993)/ Darb (2001) VTE (52) Cancer (2004) Phase III trial 10(EPO)/3 (Darb) FDA alert; DHP letter; boxed warning EPO (1993)/ Darb(2001) Death (NA) Cancer (2006) Clinical trials 10(EPO)/3 (Darb) FDA alert; DHP letter; boxed warning G-CSF (1991) AML/MDS (16) Breast Ca (2007) SEER-Medicare 12 NA Piperacillin (1981) Neutropenia (1) Infection (2006) Case reports 25 Precaution

Iodixanol in Abdominal Digital Subtraction Angiography

1993 ◽  
Vol 34 (3) ◽  
pp. 242-245 ◽  
Author(s):  
K. Singh ◽  
R. Sundgren ◽  
B. Bolstad ◽  
L. Björk ◽  
M. Lie
Keyword(s):  
Adverse Events ◽  
Clinical Importance ◽  
Diagnostic Information ◽  
Phase Iii ◽  
Digital Subtraction ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Phase Iii Trial ◽  
The Mean ◽  
The Difference

The safety, tolerability and efficacy of iodixanol 270 mg I/ml were compared to those of iohexol 300 mg I/ml in a double-blind, randomized, parallel abdominal intra-arterial DSA phase III trial. Fifty-nine patients were included in the trial; 39 patients received iodixanol and 20 received iohexol. The mean volume of iodixanol administered was 235.8 ml (0.93 g I/kg b.w.) while the mean volume of iohexol was 254.7 ml (1.10 g I/kg b.w.). No differences in diagnostic information and radiographic density were apparent in spite of the difference in the concentration of iodine. No serious adverse events occurred. Four patients (10%) in the iodixanol group and 2 (10%) in the iohexol group experienced adverse events. Eight percent of the injections of iodixanol promoted discomfort, compared to 12%) of the injections of iohexol. An increase in S-urea and S-creatinine was seen with both agents the first day after injection, but appeared to be less pronounced with iodixanol than with iohexol. Other serum tests revealed no changes of clinical importance. Both iodixanol and iohexol were found to be effective, safe and well tolerated contrast media for abdominal intra-arterial DSA.

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