scholarly journals Current Vaccine Trials in Glioblastoma: A Review

2014 ◽  
Vol 2014 ◽  
pp. 1-10 ◽  
Author(s):  
Linda W. Xu ◽  
Kevin K. H. Chow ◽  
Michael Lim ◽  
Gordon Li
Keyword(s):  
Immune Responses ◽  
Primary Brain Tumor ◽  
Phase Iii ◽  
Tumor Vaccines ◽  
Vaccine Trials ◽  
Average Survival ◽  
Current Vaccine ◽  
Phase Iii Trials ◽  
Future Care ◽  
Potential Impact

Glioblastoma (GBM) is the most common primary brain tumor, and despite aggressive therapy with surgery, radiation, and chemotherapy, average survival remains at about 1.5 years. The highly infiltrative and invasive nature of GBM requires that alternative treatments for this disease be widespread and targeted to tumor cells. Immunotherapy in the form of tumor vaccines has the potential to meet this need. Vaccines against GBM hold the promise of triggering specific and systemic antitumor immune responses that may be the key to eradicating this unrelenting cancer. In this review, we will discuss past and present clinical trials of various GBM vaccines and their potential impact on the future care of GBM patients. There have been many promising phase I and phase II GBM vaccine studies that have led to ongoing and upcoming phase III trials. If the results of these randomized trials show a survival benefit, immunotherapy will become a standard part of the treatment of this devastating disease.

Prolongation of the average survival time in pancreatic cancer (a new measure of effect): Pooled analysis of adjuvant chemotherapy trials.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e16723-e16723
Author(s):  
Eduardo Ceballos Barbancho ◽  
Galo Sánchez Robles
Keyword(s):  
Pancreatic Cancer ◽  
Adjuvant Treatment ◽  
Area Under The Curve ◽  
Pooled Analysis ◽  
National Institutes Of Health ◽  
Phase Iii ◽  
Processing Application ◽  
Average Survival ◽  
Phase Iii Trials

e16723 Background: With the aim of improving the prognosis of the disease, in recent years attempts have been made to optimize the adjuvant treatment of pancreatic cancer, having demonstrated the usefulness of chemotherapy in several phase III trials: CONKO-001, JASPAC-01, ESPAC -4 and PRODIGE. Methods: The method to measure the Area Under the Curve (AUC) is universally known. When the curve is not homogeneous, the AUC is calculated using the traditional method of breaking down the total area into a sum of many polygons. We have calculated the AUC through pixel counting using Image J, which is an image processing application, programmed in Java, developed in the National Institutes of Health and free to access. To estimate the consistency between the pixels and the sum of polygons, we have performed several curves with linear edges to measure the AUC through the sums of the polygons, and then by counting pixels with the Image J application. We have verified that the results are similar, so the pixel count can be used to replace the sum of polygons, especially when the curves are not homogeneous. Entering the areas obtained with Image J in the worksheet, made for this purpose, and available for free at evalmed.es, the measures of the effect are automatically obtained: prolongation of the average surival time (PtS), prolongation of the average event free time (PtSLEv) and time lived without an event (PtvSEV). Results: The median follow-up in all studies was 60 months, with the exception of CONKO-001, for which we have data at an average follow-up time of 136 months, however for our comparative purpose we cite the results in the first 60 months. -CONKO-001: PtS was 5.1 months (24.2 observation vs 29.3 gemcitabine). PtSLEv was 9.6 months (13 observation vs 22.6 gemcitabine). PtvSEv was 22.57 months. -JASPAC-01: PtS was 9.04 months (32.4 gemcitabine vs 41.5 gemcitabine + S1). PtSLEv was 9.75 months (21.6 gemcitabine vs 31.4 gemcitabine + S1). PtvSEv was 31.38 months. -ESPAC-4: PtS was 3.2 months (34 gemcitabine vs 37.2 gemcitabine + capecitabine). PtSLEv was 2.7 months (25.6 gemcitabine + 28.3 gemcitabine + capecitabine). PtvSEv was 24.92 months. -PRODIGE: PtS was 6 months (37 gemcitabine vs 43 FOLFIRINOX). PtSLEv was 8.9 months (22.4 gemcitabine vs 31.2 FOLFIRINOX). PtvSEv was 31.23 months. Conclusions: In the adjuvant treatment with chemotherapy in pancreatic cancer, the transit from observation to gemcitabine, and from here to the most intensive schedules, has meant or contributed an important advance for patients in terms of PtS, PtSLEv and PtvSEv.

scholarly journals External validity of phase III trials on vaccines against SARS-CoV-2 to a middle-aged and elderly Western European population

2021 ◽  
Author(s):  
Natalie Terzikhan ◽  
Albert Hofman ◽  
Jaap Goudsmit ◽  
Mohammad Arfan Ikram
Keyword(s):  
High Risk ◽  
The Elderly ◽  
European Population ◽  
Phase Iii ◽  
Exclusion Criterion ◽  
Vaccination Programs ◽  
Vaccine Trials ◽  
Phase Iii Trials ◽  
Age Range ◽  
Ongoing Phase

AbstractInitial results from various phase-III trials on vaccines against SARS-CoV-2 are promising. For proper translation of these results to clinical guidelines, it is essential to determine how well the general population is reflected in the study populations of these trials. This study was conducted among 7162 participants (age-range: 51–106 years; 58% women) from the Rotterdam Study. We quantified the proportion of participants that would be eligible for the nine ongoing phase-III trials. We further quantified the eligibility among participants at high risk to develop severe COVID-19. Since many trials were not explicit in their exclusion criterion with respect to ‘acute’ or ‘unstable preexisting’ diseases, we performed two analyses. First, we included all participants irrespective of this criterion. Second, we excluded persons with acute or ‘unstable preexisting’ diseases. 97% of 7162 participants was eligible for any trial with eligibility for separate trials ranging between 11–97%. For high-risk individuals the corresponding numbers were 96% for any trial with separate trials ranging from 5–96%. Importantly, considering persons ineligible due to ‘acute’ or ‘unstable pre-existing’ disease drastically dropped the eligibilities for all trials below 43% for the total population and below 36% for high-risk individuals. The eligibility for ongoing vaccine trials against SARS-CoV-2 can reduce by half depending on interpretation and application of a single unspecified exclusion criterion. This exclusion criterion in our study would especially affect the elderly and those with pre-existing morbidities. These findings thus indicate the difficulty as well as importance of developing clinical recommendations for vaccination and applying these to the appropriate target populations. This becomes especially paramount considering the fact that many countries worldwide have initiated their vaccination programs by first targeting the elderly and most vulnerable persons.

Patient Assessment of Foam Attributes from the Tazarotene Foam, 0.1%, Phase III Trials and Potential Impact on Patient Compliance

2018 ◽  
Vol 2 ◽  
pp. S57
Author(s):  
Rhonda Schreiber ◽  
Caitlin Lewis ◽  
Kaytiana Crane
Keyword(s):  
Patient Compliance ◽  
Phase Iii ◽  
Patient Assessment ◽  
Phase Iii Trials ◽  
Potential Impact

Abstract not available. Disclosures: Study sponsored by Mayne Pharma.Copyright 2018 SKIN

scholarly journals Potential impact of dengue vaccination: Insights from two large-scale phase III trials with a tetravalent dengue vaccine

Vaccine ◽  
2016 ◽  
Vol 34 (50) ◽  
pp. 6426-6435 ◽  
Author(s):  
Laurent Coudeville ◽  
Nicolas Baurin ◽  
Maïna L’Azou ◽  
Bruno Guy
Keyword(s):  
Large Scale ◽  
Phase Iii ◽  
Dengue Vaccine ◽  
Phase Iii Trials ◽  
Potential Impact

scholarly journals Vaccine-induced immune responses against SARS-CoV-2 infections

2021 ◽  
Author(s):  
Mandeep Garg ◽  
Muniraju Maralakunte ◽  
Yashwant Kumar ◽  
Harish Bhujade ◽  
Inder Paul Sehgal ◽  
...  
Keyword(s):  
Immune Responses ◽  
South African ◽  
Phase Iii ◽  
Post Vaccination ◽  
Clinical Phase ◽  
Phase Iii Clinical Trials ◽  
New Variant ◽  
Phase Iii Trials ◽  
Global Concern ◽  
Cross Immunity

Vaccination against coronavirus disease 2019 (COVID-19) is one of the most effective tools to curb the pandemic. Multiple vaccine candidates based on different platforms are available for emergency use presently. However, in common all the vaccines target spike protein, which is a dominant immunogen of severe acute respiratory syndrome corona virus 2 (SARS-CoV-2). Adequate immunogenicity and efficacy are demonstrated by many of the vaccines in clinical phase III trials. The emergence of the new variant of concern is believed to be associated with less susceptibility to the post-infection or post-vaccination mounted immunity. It is a global concern currently threatening the progression of the vaccination drive. Nevertheless, the results of the presently available phase III clinical trials promote COVID-19 vaccination to prevent disease severity and COVID-19 related deaths. Cross-immunity towards the new variants of concern especially against the South African variant is yet to be explored and managed adequately.

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