Life Sciences Commons^™

Evaluation Of The Efficacy Of Synthetic Glycovaccines Against Both Murine Acute Chagas Disease And Cutaneous Leishmaniasis, Colin D. Knight

Open Access Theses & Dissertations

Chagas disease (CD) and cutaneous leishmaniasis (CL) are neglected tropical diseases caused by the protozoan trypanosomatids, Trypanosoma cruzi and Leishmania spp., respectively. There are approximately 6-8 million people infected with T. cruzi worldwide and ~300,000 people in the US. Between 700,000 and 1.2 million new cases of CL occur worldwide yearly. The approved chemotherapies for both diseases are partially effective and may cause serious adverse events, resulting in premature treatment interruption. Moreover, no effective vaccine for either disease is available. Therefore, developing a vaccine that would provide effective cross-protection against both diseases would provide a cost-effective alternative to the existing …

Determining The Protective Effect Of A Boron Adjuvanted Vaccine With An Experimental Infection Model In Mice, Zafer Sayin, Ali̇ Uslu, Özgür Özdemi̇r, Abdullah Başoğlu, Asli Balevi̇, Uçkun Sai̇t Uçan, Zeki̇ Aras, Osman Ergani̇ş

Turkish Journal of Veterinary & Animal Sciences

Boron is a required trace element for plants, humans, and animals and it has significant influence over biological functions and the immune system. Vaccines have aided humans in the control of many contagious diseases around the world. The success of global immunization campaigns may be possible with the development of effective and low-cost vaccines and adjuvants. For this reason, the present study aimed to determine the adjuvant activity of easily accessible boron compounds. In this study, six different vaccines were prepared, including inactive Staphylococcus aureus bacteria, boric acid, aluminum hydroxide, montanide ISA 50, and ISA 206, ISA 50 + boric …

Sars-Cov-2: Tale Of A Microscopic Murderer, Josiah P. Garner

Quest

Independent Study

Research in progress for BIOL1406: Biology for Science Majors I

Faculty Mentor: Amina Tassa, Ph.D.

I am delighted to introduce Josiah Garner’s “SARS-CoV-2: Tale of a Microscopic Murderer.” This independent study assignment explores the impact of a novel, deadly, and worldwide virus. The assignment also examines the fast development of vaccines to control the spread and reduce the symptoms of the virus.

Josiah’s paper focuses on the early history of the emergence of COVID-19, the world response, and vaccine development. He demonstrates critical thinking skills and effectively utilizes various research methods to obtain and communicate his information. Josiah …

Neutralizing Anti-Rbd Fraction For Sars-Cov-2 Is Associated With The Interaction Waist Circumference And Sex. An Esfuerso Preliminary Report On University Students, Juan C. Lopez-Alvarenga, Esperanza M. Garcia-Oropeza, Adriana L. Perales-Torres, Alvaro Diaz-Badillo, Lucia M. Perez-Navarro, Estrella Martinez-Lopez, Marisol Rosas-Diaz, Octelina Castillo-Ruiz, Laura Yanneth Ramirez-Quintanilla, Jacquelynne Cervantes, Edda Sciutto, Beatriz Tapia, Leonel Vela, Claudia Munguia-Cisneros, Carlos Ramirez-Pfeiffer

Research Symposium

In a previous study we reported that 25% of college students had a family history of type 2 diabetes (T2D), and 39% of hypertension. Interestingly, between 17 to 47% reported not knowing about T2D or hypertension, neither the existing obesity-metabolic problems (ESFUERSO study). The COVID-19 pandemic forced confinement and modifications in food intake, physical activity, and psychological stress. This study aimed to analyze if the immune Ig-G anti-RBD (protective epitope in S protein) response associated with type of vaccination, metabolic risk, perceived stress, and history of COVID-19 contacts.

We included 116 students at the 3th year of follow up in …

Mycobacterium Avium Subsp. Paratuberculosis Candidate Vaccine Strains Are Pro-Apoptotic In Raw264.7murinemacrophages, Raul G. Barletta, John P. Bannantine, Judith R. Stabel, Ezhumalai Muthukrishnan, Dirk Anderson, Enakshy Dutta, Vamsi Manthena, Mostafa Hanafy, Denise K. Zinniel

School of Veterinary and Biomedical Sciences: Faculty Publications

Mycobacterium avium subsp. paratuberculosis (MAP) is the etiological agent of Johne’s disease, a severe gastroenteritis of ruminants. This study developed a model cell culture system to rapidly screen MAP mutants with vaccine potential for apoptosis. Two wild-type strains, a transposon mutant, and two deletion mutant MAP strains (MOI of 10 with 1.2 × 10⁶ CFU) were tested in murine RAW 264.7 macrophages to determine if they induce apoptosis and/or necrosis. Both deletion mutants were previously shown to be attenuated and immunogenic in primary bovine macrophages. All strains had similar growth rates, but cell morphology indicated that both deletion mutants …

Adenoviral-Vectored Epigraph Vaccine Elicits Robust, Durable, And Protective Immunity Against H3 Influenza A Virus In Swine, Erika M. Petro-Turnquist, Matthew J. Pekarek, Nicholas Jeanjaquet, Cedric Wooledge, David J. Steffen, Hiep Vu, Eric A. Weaver

Nebraska Center for Virology: Faculty Publications

Current methods of vaccination against swine Influenza A Virus (IAV-S) in pigs are infrequently updated, induce strain-specific responses, and have a limited duration of protection. Here, we characterize the onset and duration of adaptive immune responses after vaccination with an adenoviral-vectored Epigraph vaccine. In this longitudinal study we observed robust and durable antibody responses that remained above protective titers six months after vaccination. We further identified stable levels of antigen-specific T cell responses that remained detectable in the absence of antigen stimulation. Antibody isotyping revealed robust class switching from IgM to IgG induced by Epigraph vaccination, while the commercial comparator …

Prevalence Of Sars-Cov-2 Antibodies In Liberty University Student Population, Emily Bonus

Senior Honors Theses

In 2020, the virus SARS-CoV-2 gained attention as it spread around the world. Its antibodies are poorly understood, and little research focuses on those with few COVID-19 complications yet large numbers of close contacts: university students. This longitudinal study recorded SARS-CoV-2 antibody presence in 107 undergraduate Liberty University students twice during early 2021. After extensive data cleaning and the application of various statistical tests and ANOVAs, the data seems to show that in the case of COVID-19 infections, SARS-CoV-2 IgM antibodies are immediately produced, and then IgG antibodies follow later. However, the COVID-19 vaccine causes the production of both IgM …

Antibody-Dependent Enhancement Activity Of A Plant-Made Vaccine Against West Nile Virus, Amber M. Paul, Haiyan Sun, Dhiraj Acharya, Huafang Lai, Junyun He, Fengwei Bai, Qiang Chen

Publications

West Nile virus (WNV) causes annual outbreaks globally and is the leading cause of mosquito-borne disease in Unite States. In the absence of licensed therapeutics, there is an urgent need to develop effective and safe human vaccines against WNV. One of the major safety concerns for WNV vaccine development is the risk of increasing infection by related flaviviruses in vaccinated subjects via antibody-dependent enhancement of infection (ADE). Herein, we report the development of a plant-based vaccine candidate that provides protective immunity against a lethal WNV challenge mice, while minimizes the risk of ADE for infection by Zika (ZIKV) and dengue …

Generation Of Chimeric Rhinoviruses Presenting Sars-Cov-2 Broadly Neutralizing Epitopes And Their Antigenicity Characterization, Danish Ansari

Biotechnology Theses

The global COVID pandemic is not yet fully under control as there were over 21 million new cases of SARS-CoV-2 infections and over 50,000 deaths globally as of January of 2022. A heavily mutated variant of concern, Omicron is responsible for most of these cases which demands an urgency for a new vaccine. NIH reports over 180 vaccine candidates that use various strategies currently in development. However, a recurring concern with these vaccines is that the continuous viral mutations decrease the efficacy of vaccines. Therefore, we proposed to construct a human rhinovirus (HRV) based chimeric virus containing highly conserved, broadly …

The Psychology Of Science Denialism And Lessons For Public Health Authorities, Brenna Moreno, Molly J. Walker Wilson

All Faculty Scholarship

As it wreaked tragedy on the world, the outbreak of COVID-19 helped expose a pandemic of a different kind, one steeped in distrust and contrarianism. This movement, termed science denialism, has been lurking and undermining public health efforts for decades. Specifically, it is “the employment of rhetorical arguments to give the appearance of legitimate debate where there is none, an approach that has the ultimate goal of rejecting a proposition on which a scientific consensus exists.” Unlike skepticism, which is “doubt as to the truth of something” and works to progress both science and society, denialism is characterized by individuals’ …

A Monovalent Mt10-Cvb3 Vaccine Prevents Cvb4-Accelerated Type 1 Diabetes In Nod Mice, Mahima T. Rasquinha, Ninaad Lasrado, Meghna Sur, Kiruthiga Mone, Haowen Qiu, Jean-Jack Riethoven, Raymond A. Sobel, Jay Reddy

Nebraska Center for Virology: Faculty Publications

Enteroviruses, which include Coxsackieviruses, are a common cause of virus infections in humans, and multiple serotypes of the group B Coxsackievirus (CVB) can induce similar diseases. No vaccines are currently available to prevent CVB infections because developing serotype-specific vaccines is not practical. Thus, developing a vaccine that induces protective immune responses for multiple serotypes is desired. In that direction, we created a live-attenuated CVB3 vaccine virus, designated mutant (Mt)10, that offers protection against myocarditis and pancreatitis induced by CVB3 and CVB4 in disease-susceptible A/J mice. Here, we report that the Mt10 vaccine protected against CVB4-triggered type 1 diabetes (T1D) in …

Generation Of A More Immunogenic Fh Vlp Platform To Support Covid-19 Vaccine Development, Jewel E. Voyer, Xinyuan Chen Phd.

Senior Honors Projects

The SARS-CoV-2 based pandemic has seen almost a million deaths in just the United States according to the CDC. This number is due to the increase of variants of COVID-19, therefore calling a demand in vaccine production. Vaccine adjuvants and carriers have been studied to increase the immunogenicity and safety of a variety of immunizations. Flagellin fused Hepatitis B core (FH) virus like particles (VLP) has been studied to have beneficial effects of TLR5, IL6 levels, and lack of body temperature rise in murine study. The FH platform also provides an improvement from its predecessors FljB alone which is a …

The Determinants Of Covid-19 Vaccine Acceptance In Sumatra, Cindy Sidarta, Andree Kurniawan, Nata P H Lugito, Jeremia Imanuel Siregar, Veli Sungono, Rivaldo Steven Heriyanto, Novia Lauren Sieto, Devina Adella Halim, Claudia Jodhinata, Saraswati Anindita Rizki, Terry Devita Sinaga, Chintya Marcella, Felix Wijovi, Billy Susanto, Elizabeth Marcella, Johan Wibowo, Jonathan Juniard Anurantha, Michelle Imanuelly, Michele Indrawan, Nadia Khoirunnisa Heryadi

Kesmas

In light of the current coronavirus disease 2019 (COVID-19) vaccination programs being implemented worldwide, this study aimed to evaluate the COVID-19 vaccine acceptance survey in Indonesia conducted by the World Health Organization (WHO), the Ministry of Health of the Republic of Indonesia, the National Immunization Technical Advisory Group (NITAG), and the United Nations Children's Fund (UNICEF), published in November 2020. It was found that Sumatra Island having lower COVID-19 vaccine acceptance rates, with Aceh Province displaying the lowest level of vaccine acceptance. Thus, a cross-sectional study was conducted, and a logistic regression analysis was used to identify the factors affecting …

Immunogenicity And Protective Efficacy Of A Recombinant Pichinde Viral-Vectored Vaccine Expressing Influenza Virus Hemagglutinin Antigen In Pigs, Sushmita Kumari, Jayeshbhai Chaudhari, Qinfeng Huang, Phillip Gauger, Marcelo Nunes De Almeida, Yuying Liang, Hinh Ly, Hiep Vu

Nebraska Center for Virology: Faculty Publications

Influenza A virus of swine (IAV-S) is an economically important swine pathogen. The IAV-S hemagglutinin (HA) surface protein is the main target for vaccine development. In this study, we evaluated the feasibility of using the recombinant tri-segmented Pichinde virus (rPICV) as a viral vector to deliver HA antigen to protect pigs against IAV-S challenge. Four groups of weaned pigs (T01–T04) were included in the study. T01 was injected with PBS to serve as a non-vaccinated control. T02 was inoculated with rPICV expressing green fluorescence protein (rPICV-GFP). T03 was vaccinated with rPICV expressing the HA antigen of the IAV-S H3N2 strain …

Structural Analysis And Vaccine Efficacy Of Hla Mutants, Kelly Tomaszewski

Arts & Sciences Electronic Theses and Dissertations

Staphylococcus aureus is a commensal of the human skin and also a major human pathogen. Currently, there has been no successful vaccine despite many approaches over the last two decades. S. aureus α-hemolysin (Hla), a potent cytotoxin, plays an important role in the pathogenesis of S. aureus diseases, through the activation of its receptor, ADAM10. We utilized three distinct Hla mutants with differing structural and ADAM10 binding properties to examine for vaccine efficacy. Our studies have demonstrated immunization with each vaccine candidate antigens provided significant protection against S. aureus skin infection yet elicited distinguishable immune responses. We have also generated …

Investigation Of Histomoniasis Prevention In Poultry, Lesleigh Beer

Graduate Theses and Dissertations

Histomonas meleagridis is the etiological agent of histomoniasis, also commonly known as blackhead disease. This protozoal disease of poultry is detrimental to turkeys with flock mortalities often reaching 80-100%, although other gallinaceous birds are susceptible. Since the voluntary removal of nitarsone in 2015, the poultry industry is suffering with no approved prophylactics, therapeutics, or vaccines for this disease. The objectives of this dissertation were to evaluate multiple methods for prevention or control of histomoniasis, including dietary chemoprophylaxis and vaccination. Specifically, this research evaluated quinine as a chemoprophylactic candidate (Chapter 3) or live-attenuated H. meleagridis as vaccine candidates (Chapter 4) in …

Multi-Subunit Sars-Cov-2 Vaccine Design Using Evolutionarily Conserved T- And B- Cell Epitopes, Burkitkan Akbay, Syed Hani Abidi, Mahmoud A A. Ibrahim, Zhussipbek Mukhatayev, Syed Ali

Department of Biological & Biomedical Sciences

The SARS-CoV-2 pandemic has created a public health crisis worldwide. Although vaccines against the virus are efficiently being rolled out, they are proving to be ineffective against certain emerging SARS-CoV-2 variants. The high degree of sequence similarity between SARS-CoV-2 and other human coronaviruses (HCoV) presents the opportunity for designing vaccines that may offer protection against SARS-CoV-2 and its emerging variants, with cross-protection against other HCoVs. In this study, we performed bioinformatics analyses to identify T and B cell epitopes originating from spike, membrane, nucleocapsid, and envelope protein sequences found to be evolutionarily conserved among seven major HCoVs. Evolutionary conservation of …

Nih Funding For Vaccine Readiness Before The Covid-19 Pandemic, Anthony E. Kiszewski, Ekaterina Galkina Cleary, Matthew J. Jackson, Fred D. Ledley

Natural & Applied Sciences Faculty Publications

Rapid development of vaccines for COVID-19 has relied on the application of existing vaccine technologies. This work examines the maturity of ten technologies employed in candidate vaccines (as of July 2020) and NIH funding for published research on these technologies from 2000–2019. These technologies vary from established platforms, which have been used successfully in approved products, to emerging technologies with no prior clinical validation. A robust body of published research on vaccine technologies was supported by 16,358 fiscal years of NIH funding totaling $17.2 billion from 2000–2019. During this period, NIH funding for published vaccine research against specific pandemic threats …

Piglet Immunization With A Spike Subunit Vaccine Enhances Disease By Porcine Epidemic Diarrhea Virus, Jieshi Yu, Chithra Sreenivasan, Tirth Uprety, Rongyuan Gao, Chen Huang, Ella J. Lee, Steven Lawson, Julie Nelson, Jane Christopher-Hennings, Radhey S. Kaushik, Eric Nelson, Diego G. Diel, Ben M. Hause, Feng Li, Dan Wang

Maxwell H. Gluck Equine Research Center Faculty Publications

Immunization with an insect cell lysate/baculovirus mixture containing recombinant porcine epidemic diarrhea virus (PEDV) spike protein induced high levels of neutralizing antibodies in both mice and piglets. However, immunization of piglets with this vaccine resulted in enhancement of disease symptoms and virus replication in vaccine recipients exposed to PEDV challenge. Thus, these observations demonstrate a previously unrecognized challenge of PEDV vaccine research, which has important implications for coronavirus vaccine development.

Of Pigs And Men: The Best-Laid Plans For Prevention And Control Of Swine Fevers, Jishu Shi, Lihua Wang, David Scott Mcvey

School of Veterinary and Biomedical Sciences: Faculty Publications

John Steinbeck drew the title of his novel “Of Mice and Men” from a line in a Robert Burns poem “To a mouse”: “The best-laid plans of mice and men/Go often awry.” Unlike John Steinbeck who used the title to mirror the characters who were struggling during the Great Depression to the mouse whose nest was accidentally destroyed by the poet (Burns 1785), we chose this line to emphasize that the best-laid plan can go wrong in infectious disease control and prevention. Here, we will discuss the contributing factors behind the global successes and failures in the prevention and control …

Cervico-Vaginal Inflammatory Cytokine And Chemokine Responses To Two Different Siv Immunogens, Nikki P.L. Toledo, Hongzhao Li, Robert W. Omange, Tamara G. Dacoba, Jose Crecente-Campo, Dane Schalk, Mohammad A. Kashem, Eva Rakasz, Nancy Schultz-Darken, Qingsheng Li, James B. Whitney, Maria J. Alonso, Francis A. Plummer, Ma Luo

Nebraska Center for Virology: Faculty Publications

Studies have shown that vaccine vectors and route of immunization can differentially activate different arms of the immune system. However, the effects of different HIV vaccine immunogens on mucosal inflammation have not yet been studied. Because mucosal sites are the primary route of HIV infection, we evaluated the cervico-vaginal inflammatory cytokine and chemokine levels of Mauritian cynomolgus macaques following immunization and boost using two different SIV vaccine immunogens. The PCS vaccine delivers 12 20-amino acid peptides overlapping the 12 protease cleavage sites, and the Gag/Env vaccine delivers the full Gag and full Env proteins of simian immunodeficiency virus. We showed …

Immune Response To An Alum Precipitated Haemorrhagic Septicaemia Vaccine In Buffaloes At A Semiorganized Farm Of Madhya Pradesh In India, Sachin Audarya, Naresh Kakker, Rakesh Sharda, Daljeet Chhabra

Turkish Journal of Veterinary & Animal Sciences

Haemorrhagic septicaemia (HS) is one of the economically most important bacterial diseases of large ruminants. In the present investigation, a total of 156 buffaloes (Murrah, Jafarabadi, and Bhadawari breeds) at a semiorganized farm after administration of HS alum precipitated killed vaccine were screened serologically for the presence of anti-HS antibodies by single dilution indirect enzyme linked immunosorbent assay (iELISA). Out of 156 buffaloes tested for presence of anti-HS antibodies, a greater proportion of buffalo (67.94%) had protective level of anti-HS antibodies even after 90th day post vaccination.

Why The Government Shouldn't Pay People To Get Vaccinated Against Covid-19, Ana Santos Rutschman

All Faculty Scholarship

As several pharmaceutical companies approach the Food and Drug Administration (FDA) seeking authorization to bring COVID-19 vaccines to market, concerns about vaccine mistrust cloud the prospects of imminent vaccination efforts across the globe. These concerns have prompted some commentators to suggest that governments may nudge vaccine uptake by paying people to get vaccinated against COVID-19. This post argues that, even if potentially viable, this idea is undesirable against the backdrop of a pandemic marked by the intertwined phenomena of health misinformation and mistrust in public health authorities. Even beyond the context of COVID-19, paying for vaccination is likely to remain …

Evolutionary Dynamics Of Influenza Type B In The Presence Of Vaccination: An Ecological Study, Lindsey J. Fiedler

USF Tampa Graduate Theses and Dissertations

Understanding the evolutionary dynamics of influenza type B in human hosts is a public health concern as we strive to minimize the disease burden in seasonal epidemics. Vaccination is considered the best defense against contracting influenza, and everyone over the age of 6 months is advised to get vaccinated before each season. The effect that vaccine-acquired immunity has on the evolution of influenza B remains unclear. In the U.S., vaccine-uptake is irregular across the states, and the differing coverages present an opportunity to study how vaccination influences viral evolution. This thesis analyzes the evolutionary patterns of influenza B in the …

The Deadly Influenza Virus And Its Changing Forms, Kayce Boggess

D.U.Quark

The influenza virus has plagued humans for centuries. Recently antiviral medications, which shorten the duration of the flu, have been introduced into society. These medications along with vaccinations, which try to give the body immunity before the virus strikes, help to stop the flu before it attacks the host. The virus, however, replicates using host cells and can slightly change itself with each replication, which over time could lead to a strain immune to the current antiviral medication and vaccines. However, using more preventative measures could help slow the changing strains of the flu virus. Using vaccines to stop the …

Performance Differences Between Two Groups Of Commercial Pigs Following Experimental Infection With Prrs Virus 1-7-4, Erin Little

Electronic Theses and Dissertations

Porcine reproductive and respiratory syndrome virus (PRRSV) is the costliest swine disease in North America. Vaccines and management alone have not been effective in controlling this disease. Genetic selection for resilience may be a complimentary approach for controlling PRRSV. The objective of this study was to estimate performance differences between two groups of pigs from the same commercial line following infection with PRRSV 1-7-4: 1) pigs sired by boars selected based on a standard index (TN-S), which emphasized feed efficiency and carcass quality; and 2) pigs sired by boars selected based on an experimental index (TN-E), which emphasized feed intake, …

A Single-Cycle Adenovirus Type 7 Vaccine For Prevention Of Acute Respiratory Disease, Brianna L. Bullard, Brigette N. Corder, Eric A. Weaver

Nebraska Center for Virology: Faculty Publications

Adenovirus type 7 (Ad7) infection is associated with acute respiratory disease (ARD), especially in military recruits living in close quarters. Recently, several outbreaks of Ad7 infections have occurred in civilian populations, with some cases leading to death. However, the current Ad7 vaccine is licensed for use only in military recruits because it utilizes an orally delivered wild type virus which is shed in the stool for 28 days after immunization. This poses a safety risk due to the possibility of virus spread to vulnerable populations. To address the need for a safer Ad7 vaccine for use in civilian populations, we …

Trypanosoma Cruzi Trypomastigote Glycosylphosphatidylinositol-Anchored Mucins And A Synthetic Alpha-Gal-Containing Neoglycoprotein As Potential Biomarkers And Vaccines For Chagas Disease, Igor Leandro Estevao

Open Access Theses & Dissertations

Chagas disease (CD), caused by the protozoan Trypanosoma cruzi, is a neglected tropical disease that kills or permanently disable thousands of people annually. About 6-8 million people are estimated to be infected worldwide. Although many efforts have been made for the development of an effective immunotherapy, currently there is no vaccine to prevent or treat CD in humans. Despite their toxicity, the two current drugs for CD, benznidazole (BZN) and nifurtimox (NFX), have medium-to-high efficacy in the chronic stage of the disease and could save or improve the lives of thousands of patients. However, negative seroconversion in treated patients, as …

Nanosecond Pulsed Electric Fields Induce Endoplasmic Reticulum Stress Accompanied By Immunogenic Cell Death In Murine Models Of Lymphoma And Colorectal Cancer, Alessandra Rossi, Olga N. Pakhomova, Peter A. Mollica, Maura Casciola, Uma Mangalanathan, Andrei G. Pakhomov, Claudia Muratori

Bioelectrics Publications

Depending on the initiating stimulus, cancer cell death can be immunogenic or non-immunogenic. Inducers of immunogenic cell death (ICD) rely on endoplasmic reticulum (ER) stress for the trafficking of danger signals such as calreticulin (CRT) and ATP. We found that nanosecond pulsed electric fields (nsPEF), an emerging new modality for tumor ablation, cause the activation of the ER-resident stress sensor PERK in both CT-26 colon carcinoma and EL-4 lymphoma cells. PERK activation correlates with sustained CRT exposure on the cell plasma membrane and apoptosis induction in both nsPEF-treated cell lines. Our results show that, in CT-26 cells, the activity of …

First Results On Survival From A Large Phase 3 Clinical Trial Of An Autologous Dendritic Cell Vaccine In Newly Diagnosed Glioblastoma, Linda M. Liau, Keyoumars Ashkan, David D. Tran, Jian L. Campian, John E. Trusheim, Charles S. Cobbs, Jason A. Heth, Michael Salacz, Sarah Taylor, Stacy D. D'Andre, Fabio M. Iwamoto, Edward J. Dropcho, Yaron A. Moshel, Kevin A. Walter, Clement P. Pillainayagam, Robert Aiken, Rekha Chaudhary, Samuel A. Goldlust, Daniela A Bota, Paul Duic, Jai Grewal, Heinrich Elinzano, Steven A. Toms, Kevin O. Lillehei, Tom Mikkelsen, Tobias Walbert, Steven R. Abram, Andrew J. Brenner, Steven Brem, Matthew G. Ewend, John L. Villano

Internal Medicine Faculty Publications

Background: Standard therapy for glioblastoma includes surgery, radiotherapy, and temozolomide. This Phase 3 trial evaluates the addition of an autologous tumor lysate-pulsed dendritic cell vaccine (DCVax^®-L) to standard therapy for newly diagnosed glioblastoma.

Methods: After surgery and chemoradiotherapy, patients were randomized (2:1) to receive temozolomide plus DCVax-L (n = 232) or temozolomide and placebo (n = 99). Following recurrence, all patients were allowed to receive DCVax-L, without unblinding. The primary endpoint was progression free survival (PFS); the secondary endpoint was overall survival (OS).

Results: For the intent-to-treat (ITT) population (n = 331), median OS (mOS) was 23.1 months …