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Immunogenicity in Medical News

DIA/AAPS Co-Sponsored Conference to Examine the Immunogenicity of Therapeutic Proteins

The Drug Information Association (DIA) and the American Association of Pharmaceutical Scientists (AAPS) will co-sponsor Immunogenicity of Therapeutic Proteins (September 10 -12; Bethesda, MD). Horsham, PA (Vocus) July 30, 2008 -- The Drug Information Association (DIA) a...

GeoVax Labs, Inc. Announces Six Month 2009 Financial Results and Provides Operational Update

...etwork dedicated to the development and testing of HIV/AIDS vaccines and has sponsored over 80 Phase 1 trials for the initial evaluation of safety and immunogenicity of candidate HIV/AIDS vaccines; of these, only five have progressed to Phase 2 trials since 1992. Achieving the Phase 2 milestone is a significant st...

PATH Malaria Vaccine Initiative and Crucell to test new malaria vaccine approach

...rotypes Ad35 and Ad26 as delivery mechanisms, this approach seeks to elicit a protective immune response obtained from delivering the CSP. The safety, immunogenicity and efficacy data from these studies will further advance the research forward development of a safe and highly efficacious malaria vaccine. "Adeno...

Intercell Supports the Japanese Encephalitis Vaccination Recommendations of CDC's Advisory Committee on Immunization Practices

...Intercell's Phase III trials for IXIARO found that the vaccine demonstrated immunogenicity against Japanese Encephalitis and an overall clinical safety profile simila...ese data were published in The Lancet in December 2007: The immunogenicity was comparable to that of the U.S. licensed product, JE-VAX(R). Int...

Intercell Executes Multi-Year Contract for Supply of IXIARO(R) to the United States Military

...se III trials for the vaccine found that the vaccine demonstrated excellent immunogenicity against Japanese Encephalitis and an overall clinical safety profile simila...ata were published in The Lancet in December 2007: The immunogenicity was comparable to that of the U.S. licensed product, JE-VAX(R). Int...

Novavax Reports Fourth Quarter and 2008 Year-End Financial Results

... The Company announced favorable safety and immunogenicity results in December 2008 from its Phase IIa season...controlled clinical trial evaluated the safety and immunogenicity of different doses of its trivalent seasonal flu V... the University of Massachusetts , evaluating the immunogenicity and efficacy of a Respiratory Syncitial Virus ("RS...

Intercell Announces FDA Approval of IXIARO(R), a Vaccine Against Japanese Encephalitis

...se III trials for the vaccine found that the vaccine demonstrated excellent immunogenicity against Japanese Encephalitis and an overall clinical safety profile simila...ata were published in The Lancet in December 2007: The immunogenicity was comparable to that of the U.S. licensed product, JE-VAX(R). Int...

WuXi AppTec Bioanalytical Services Unit Passes FDA Inspection

...GLP)-compliant services to analyze small-molecule drugs using liquid chromatography/mass spectroscopy, and to measure biomarker/biologics and antibody immunogenicity using immunochemistry. In the FDA review, which took place between March 23 and March 27, the entire BAS facility was inspected and two bioequi...

Pitt vaccine to prevent colon cancer being tested in patients

...r Olivera Finn, Ph.D., professor and chair of the Department of Immunology at Pitt's School of Medicine, MUC1 vaccines have been tested for safety and immunogenicity in patients with late-stage colon cancer and pancreatic cancer. "Patients were able to generate an immune response despite their cancer-weakened im...

InNexus Biotechnology Completes Preclinical Study Confirming in Vivo Effectiveness and Safety of Lead Candidate DXL625, Schedules Meeting With FDA

...clinical study was conducted with a single injection, which confirms the remarkable potency of DXL625. In addition, the study showed no difference in immunogenicity as compared to Rituxan(R). Prior assessment of potential cross-reactivity using a limited panel of human tissue slices has revealed no off-target rea...
Immunogenicity in Medical Technology

Dynavax's HEPLISAV(TM) Hepatitis B Vaccine Maintains Full Immunogenicity at 50 Weeks in Phase 3 Trial

In Difficult-to-Immunize Population, Demonstrates Superior Long-Term Seroprotection Compared to Conventional Vaccine BERKELEY, Calif., Sept. 19 /PRNewswire-FirstCall/ -- Dynavax Technologies Corporation (Nasdaq: DVAX ) announced today that the seroprotection of HEPLISAV at 50 wee...

GlaxoSmithKline’s Hib-MenCY-TT Combination Vaccine Meets Phase II Study Endpoints of Immunogenicity and Safety Compared to Licensed Vaccines

Investigational vaccine could offer protection for infants against Haemophilus influenzae type b and meningococcal disease TORONTO, Canada, May 11, 2007 — GlaxoSmithKline (GSK) announced results from a Phase II vaccine clinical study presented this week at the Pediatric Ac...

Sanofi Pasteur Submits Supplemental Application for A(H1N1) Pandemic Vaccine to U.S. FDA

...n change supplements are not required to be supported by new clinical data, immunogenicity and safety data will be made available through clinical studies. Sanofi Pasteur will test the immunogenicity and safety of its influenza A(H1N1) 2009 monovalent vaccine through clinica...

AlphaVax Announces Results from Initial Testing of Its H1N1 (Swine) Influenza Vaccine

... RESEARCH TRIANGLE PARK, N.C., July 17 /PRNewswire/ -- AlphaVax, Inc. announced today that it has completed process development and preclinical immunogenicity studies of its H1N1 (swine) influenza vaccine and will manufacture clinical trial material by the end of the month. This vaccine has shown good produ...

Novavax Completes Enrollment of Its Second Phase II Seasonal Influenza VLP Vaccine Clinical Trial

...vaccine, allowing further evaluation of safety and immunogenicity of a broad range of vaccine doses against a new se...cally, this new study is evaluating the safety and immunogenicity of the 2008-2009 influenza vaccine in approximatel...rovides the opportunity to evaluate the safety and immunogenicity of our VLP vaccine against a new set of influenza ...

Intercell Starts a Phase I Clinical Trial for a New Streptococcus pneumoniae Vaccine

...I clinical trial in healthy subjects - Study aims to obtain safety and immunogenicity data of this new vaccine candidate - Initial results expected in Q4 20...his Phase I trial is a first-in-man study with a focus to obtain safety and immunogenicity data in a small population of healthy adults. Thirty-two subjects will be e...

Nobilon Advances First Vaccine Into Human Trials - Intranasal Influenza Vaccine Begins Phase I Clinical Development

...sign and will include a total of 120 healthy volunteers. The primary objective of the Phase I program is to investigate the safety, tolerability and immunogenicity of escalating doses of SCH 900795 in adult men and women. "I am pleased to announce the start of the first clinical development program of Nobilo...

IBT Laboratories to Launch New Pneumococcal Antibody Avidity Test at AAAAI Meeting, Booth 729

...gy and allergy testing, IBT tests patient samples for physicians, hospitals, and commercial reference labs nationwide. IBT also provides biomarker and immunogenicity testing services to pharmaceutical and biotechnology companies and life-science researchers. Founded in 1983, IBT is privately held and centrally loca...

BN ImmunoTherapeutics Updates on Phase I/II Studies With Breast Cancer Vaccine

...of BN ImmunoTherapeutics, said: "I am pleased that we once again can confirm the unique safety profile of MVA-BN(R) and that we have been able to show immunogenicity in this patient group suffering from this severe disease. We are committed to bring this new and improved version of the HER2 vaccine further through ...

GeoVax Starts Injections for Phase 2a Human HIV/AIDS Vaccine Trial in USA

... 1 trials for the initial evaluation of safety and immunogenicity of candidate HIV/AIDS vaccines. The results of th...rial will build upon this foundation of safety and immunogenicity to support a Phase 2b efficacy trial." In a...le who are already on drugs to test the safety and immunogenicity of the vaccine in infected people. Therapeutic tr...
Immunogenicity in Biological News

Government of Canada announces funding for research on the H1N1 flu virus

...espond to an influenza pandemic. Network scientists will: test methodologies for the performance of rapid clinical trials assess the safety and immunogenicity of a novel pandemic influenza vaccine provide population-based estimates of vaccine safety and effectiveness measure vaccine coverage facilitate...

FSU researcher using computers to hone cancer-fighting strategies

...nant cells, too few cells will be killed with each dose. "Because the level of anticancer drug doses that can be given to any patient is limited by immunogenicity -- the immune response that results -- it is essential to explore how the efficacy of recombinant immunotoxins can be enhanced without resorting to es...

Penn researchers find monkeys able to fend off AIDS-like symptoms with enhanced HIV vaccine

... protection, and seek out any pockets of the virus that may be hiding in specific immune compartments. The approach will also be tested for safety and immunogenicity in humans through the HIV Vaccine Trials Network. ...

AIBS to cohost symposium on evolution, disease and human health

... assays for the measurement of functional antibody activity specific for pneumococci and Haemophilus species. Romero-Steiner has also been involved in immunogenicity studies of people who have undergone bone marrow transplants and splenectomies, have sickle cell anemia, or are HIV positive. George Armelagos...

Tips from the Journals of the American Society for Microbiology

...fter vaccination. The second candidate MVA IL-15 also demonstrated greater immunogenicity and efficacy than Dryvax. By integrating IL-15 cytokine into Wyeth and...MVA strains, we have developed two smallpox vaccine candidates with greater immunogenicity and efficacy yet with more-attenuated virulence than the currently licensed...

30+ AIDS vaccine clinical trials in 24 countries, research occurring on every continent

... Institute of Immunology. All of the new trials that began last year were either Phase I or Phase I/II trials designed to evaluate the safety and immunogenicity of the candidate vaccines. "Although these new trials are early-stage, they will provide critical information over the coming years that will help dri...

Africa's first large-scale HIV vaccine study launches

...ed with HIV. The studies already completed with this vaccine suggest that it is generally well tolerated and that the response of the immune system or immunogenicity is high. In South Africa, the vaccine trial is called "Phambili," which means "moving forward" in the Xhosa language. Volunteers will be health...

Combating anthrax: Results of study published this month as researchers look for a better vaccine

...clear relationship between the amount of vaccine administered and the subsequent immune response. The study was designed to evaluate the safety and immunogenicity of escalating doses of the new vaccine. A total of 100 healthy adults were randomized to receive either one of four different vaccine formulations, or...

High-dose flu vaccines appear to safely boost immunity in elderly

...h influenza in these vulnerable populations," they write. "Increasing the dose of inactivated influenza vaccine consistently and safely increases the immunogenicity [immune response] of inactivated influenza virus vaccines; moreover, vaccines that contain higher doses have conferred significantly enhanced protecti...

Avian flu modeled on supercomputer, explores vaccine and isolation options for thwarting a pandemic

... H5N1 influenza virus is most likely to adapt to human transmission, studies of broadly cross-reactive avian-influenza based vaccines with even modest immunogenicity in humans are important," said Macken, an influenza researcher in the Los Alamos Theoretical Division. Ideally, both vaccine strategies would be done ...
Immunogenicity in Biological Technology

Novavax Reports Second Quarter 2009 Financial Results

... second Phase II study of its trivalent season influenza virus-like-particle ("VLP") vaccine candidate. The company is planning on reporting top-line immunogenicity and safety results from this study by the fourth quarter of this year. Improved the company's balance sheet by retiring 100% of its $22.0 millio...

GeoVax Labs, Inc. Provides Clinical Studies Update

...s sponsored over 80 Phase 1 trials for the initial evaluation of safety and immunogenicity of candidate HIV/AIDS vaccines. The results of these trials have merited on...eed for anti-viral drugs. This initial trial will determine the safety and immunogenicity of the vaccine in patients with well controlled infections who started on d...

ImmunoVaccine Technologies Partners With Scancell to Advance DNA Vaccine Delivery

...livering DNA vaccines DepoVax(TM) is a vaccine-enhancement and delivery platform comprised of liposomes, adjuvants and oil. DepoVax(TM) enhances the immunogenicity of antigens in general, and can be used to dramatically enhance the delivery of polynucleotide-based antigens and SiRNA to lymph nodes. IVT has proven...

New Phase 3 Data Continue to Indicate that Wyeth's Investigational 13-valent Vaccine Has the Potential to Broaden Coverage Against Pneumococcal Disease

...ncomitantly administered vaccine and showed a safety profile comparable to Prevenar. A study of 352 children in Poland assessed the safety and immunogenicity of Prevenar 13 in older children not previously immunized with Prevenar. Children were vaccinated with one of three different catch-up schedules curr...

PharmaNet Development Group Clinical Research Experts to Present at Global Professional Meetings in June

... Manager, will be presenting their poster: "Development and Implementation of an Information Management System for Tiered immunogenicity Sample Testing and Reporting." Robert Dodge, PhD, Marisa Castellana, Research Scientist and Dania Yaskanin, Associate Dir...

PAREXEL Experts to Present Leading Insights at Drug Information Association 45th Annual Meeting

...ng pharmacovigilance documents, and securing venture funding for drug development plans. PAREXEL experts will also discuss best practices for creating immunogenicity strategies, developing safe and effective biological medicines, and addressing regulatory challenges related to second generation therapeutic proteins...

Medicago succesfully expresses VLP antigen for A H1N1 strain

...equires the genetic sequence of the virus, limiting delays that may happen with traditional systems. The H1 VLP will be purified in preparation for an immunogenicity study in mice. The Company expects results from this study in June, with the goal of confirming the immunogenic potential of this H1 VLP. "We are th...

Novavax Reports First Quarter 2009 Financial Results

...ccine candidate. This clinical trial is designed to evaluate the safety and immunogenicity of a broader range of vaccine doses and to provide data to help select dose...dults and a Phase III efficacy study. The Company plans to report top-line immunogenicity and safety results from this study by the fourth quarter of this year. ...

GeoVax Labs, Inc. Announces First Quarter Financial Results

...dedicated to the development and testing of HIV/AIDS vaccines. The HVTN has sponsored over 80 Phase 1 trials for the initial evaluation of safety and immunogenicity of candidate HIV/AIDS vaccines. Of these, only five have progressed to Phase 2 trials since 1992. Progressing to Phase 2 was a significant achieveme...

Novavax Announces Enrollment in the Second Phase II Study of its Seasonal Influenza VLP Vaccine Candidate

...cebo controlled clinical trial has been designed to evaluate the safety and immunogenicity of a broader range of vaccine doses. The purpose of this study is to provi...ns. Including this study, we now have created and evaluated the safety and immunogenicity of VLPs against seven different strains of influenza in clinical trials. T...
Immunogenicity in Biological Dictionary

Monoclonal Antibody

... is susceptible to such degradation, it is useless. ... The process of producing monoclonal antibodies described above was invented by ... The immunogenicity of the monoclonal antibody itself is a concern because of how ... Rituximab is an IgG monoclonal antibody , and has an Fc receptor. ... Mon...
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