Dynavax Technologies Corp.

Data demonstrate superiority of HepB-CpG vaccination over conventional hepatitis B vaccines among people living with HIVLOS ANGELES, Dec. 03, 2024 (GLOBE NEWSWIRE) -- ACTG, a global clinical trials network focused on HIV and other infectious diseases, today announced the publication of “HepB-CpG vs HepB Vaccine in People with HIV and Prior Vaccine Nonresponse: The BEe-HIVe Randomized Clinical Trial” in JAMA. The publication reports that two- and three-dose regimens of HepB-CpG vaccine provided superior protection compared to three doses of the conventional hepatitis B vaccine among people living with HIV who had previously not responded to the conventional vaccines. Hepatitis B is a leading cause of liver-related mortality worldwide resulting in more than 1 million deaths in 2022. It is a major cause of liver injury, cirrhosis, and liver cancer among people living with HIV, who often do not develop protective antibodies after receiving conventional hepatitis B vaccines. The HepB-CpG (HEPLISAV-B® [Hepatitis B Vaccine (Recombinant) Adjuvanted]) vaccine includes a TLR-9 agonist adjuvant (CpG 1018® adjuvant) and is known to achieve high protection against hepatitis B among people living with HIV, but until now there have been limited data about its protection among people living with HIV who had not responded to conventional hepatitis B vaccines. “These findings are tremendous news for people living with HIV who have struggled to achieve protection against hepatitis B,” said ACTG Chair Joseph J. Eron, M.D., University of North Carolina. “As a result of this data, the U.S. Department of Health and Human Services’ ‘Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents With HIV’ have been updated and clinical practice is already changing. Ultimately, we expect them to have an important impact on people living with HIV.” BEe-HIVe (B-Enhancement of HBV Vaccination in Persons Living With HIV, also known as A5379) was an international study evaluating the HepB-CpG vaccine among people living with HIV who were on antiretroviral therapy (ART) and had not responded to prior conventional hepatitis B vaccination and thus remained vulnerable to hepatitis B infection. This phase 3 randomized, open-label clinical trial included 561 people from 41 sites in 10 countries in Africa, Asia, North America, and South America. Study participants were equally randomized to one of three groups, receiving either: Two doses of HepB-CpG intramuscularly at week 0 and week 4Three doses of HepB-CpG intramuscularly at week 0, week 4, and week 24Three doses of HepB-alum (conventional hepatitis B vaccine) intramuscularly at week 0, week 4, and week 24 The primary analysis published in JAMA demonstrates that 99 percent of those receiving three doses of the HepB-CpG vaccine and 93 percent of those receiving two doses of the HepB-CpG vaccine achieved protection against hepatitis B compared to 81 percent receiving three doses of the conventional hepatitis B vaccine. The study demonstrates that the three-dose regimen of the HepB-CpG vaccine led to higher levels of protective antibodies, which may have long-term implications related to vaccine durability. Long-term protection results will be available in 2025. There were no unexpected safety concerns. “This study provides strong evidence that people living with HIV for whom prior hepatitis B vaccination was not successful should be re-vaccinated with the HepB-CpG vaccine to reduce their risk of future hepatitis B infection," said lead author and Protocol Co-Chair Kristen Marks, M.D., Weill Cornell Medicine. BEe-HIVe is led by Kenneth Sherman, M.D., Ph.D., University of Cincinnati and Massachusetts General Hospital (Protocol Chair) and Dr. Marks. ACTG is led by Dr. Eron and Rajesh T. Gandhi, M.D., Massachusetts General Hospital and Harvard Medical School (ACTG Vice-Chair). It is sponsored by the National Institute of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID, which also funds ACTG) under award numbers UM1 AI068636, UM1 AI107716, and UM1 AI068634. HEPLISAV-B® was provided by Dynavax Technologies Corporation. For more information about BEe-HIVe, please visit clinicaltrials.gov. About ACTG ACTG is the world’s largest and longest running clinical trials network focused on HIV and other infectious diseases and the people living with them. It is funded by NIAID and collaborating NIH Institutes. Founded in 1987, ACTG conducts research to improve the management of HIV and its comorbidities; develop a cure for HIV; and innovate treatments for tuberculosis, hepatitis B, and emerging infectious diseases. It comprises thousands of dedicated researchers, staff, and community members who are pursuing research into novel treatments and cures for infectious diseases at 65 locations across four continents, with the ultimate goal of advancing science that meaningfully impacts the lives of the people we serve. Disclaimer: This content is solely the responsibility of ACTG and does not necessarily represent the official views of the NIH. Media Contact:Jenna Conley, ACTGjenna@conleycommunications.net

TUESDAY, Nov. 26, 2024 -- Exposures to fine particulate matter (PM 2.5 ) and specific PM 2.5 constituents during pregnancy is associated with increased odds of spontaneous preterm birth (sPTB), according to a study published online Nov. 13 in JAMA Network Open . Anqi Jiao, from the University of California Irvine, and colleagues examined whether exposure to PM 2.5 and its constituents are associated with sPTB. The analysis included 409,037 births in Southern California (2008 to 2018). The researchers found positive associations of PM 2.5 , black carbon, nitrate, and sulfate with sPTB. Per interquartile range increase, odds of sPTB were 15 percent higher for PM 2.5 , 15 percent higher for black carbon, 9 percent higher for nitrate, and 6 percent higher for sulfate during the entire pregnancy. The most susceptible window was exposure during the second trimester. Among individuals with lower educational attainment, risk was even higher. Additionally, environmental exposures increased risk (e.g., those who were exposed to limited green space, more wildfire smoke, or extreme heat). "Though the causes of spontaneous preterm birth are complex and not fully understood, our study identifies air pollution as a contributing factor, highlighting the need for targeted interventions," coauthor Jun Wu, Ph.D., also from the University of California Irvine, said in a statement. Two authors disclosed ties to Pfizer, Dynavax Technologies, and/or Hologic. Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

EMERYVILLE, Calif., Nov. 26, 2024 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, today announced that the Company will present at the 7th Annual Evercore HealthCONx Conference on Tuesday, December 3 at 2:35 p.m. ET. The presentation will be webcast and may be accessed through the "Events & Presentations" page on the "Investors" section of the Company's website at . About Dynavax Dynavax is a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines to help protect the world against infectious diseases. The Company has two commercial products, HEPLISAV-B® vaccine [Hepatitis B Vaccine (Recombinant), Adjuvanted], which is approved in the U.S., the European Union and Great Britain for the prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older, and CpG 1018® adjuvant, currently used in HEPLISAV-B and multiple adjuvanted COVID-19 vaccines. For more information about our marketed products and development pipeline, visit . For Investors/Media: Paul Cox [email protected] 510-665-0499 Nicole Arndt [email protected] 510-665-7264 SOURCE Dynavax Technologies WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED