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FDA Rejects Heplisav Hepatitis B Vaccine Seeking More Safety Data

The U.S. Food and Drug Administration (FDA) has declined to approve Dynavax Technologies' experimental hepatitis B virus (HBV) vaccine candidate with a toll-like receptor 9 adjuvant, stating it wants to see further data on safety in adults including seniors, the company announced this week.

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HIV+ Less Likely to Respond to Hepatitis B Vaccine, but More Shots Increase Protection

Adults in Kenya responded as well overall to hepatitis B vaccination as people in high-income countries. People with HIV had poorer response, but this could be mostly overcome with repeated doses, according to a study described in the February 1, 2013, Journal of Infectious Diseases.

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ICAAC 2012: Hepatitis B Vaccine Effective Long-term, but Some Lose Protection after 15 Years

Nearly all children who received 3 doses of the Engerix-B hepatitis B vaccine achieved protective immunity, but about 20% fell below the protective antibody threshold by year 15 and could benefit from a booster shot, Canadian researchers reported at the 52nd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC 2012) this week in San Francisco. alt

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Teens Vaccinated Against Hepatitis B as Infants May Lose Immunity

Adolescents who received combined active-passive hepatitis B virus (HBV) immunization soon after birth may lose "immunological memory" that protects them from future infection, with the HBeAg status of the mother playing a key role, researchers reported in the January 2013 issue of Hepatology.

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Hepatitis B Rates Higher than Expected among Gay Men, Drug Users, Vaccinated Babies

altAn unexpectedly high proportion of gay/bisexual men and injection drug users develop chronic hepatitis B rather than clearing the infection, Amsterdam researchers reported in the September 2012 Journal of Hepatology. Other recent studies found that more than one-quarter of children born to mothers with hepatitis B showed evidence of "occult" HBV infection despite vaccination at birth, and that some individuals vaccinated as children may still show evidence of infection as adults.

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FDA Committee Says Heplisav Hepatitis B Vaccine Is Effective, but Safety Data Inadequate

A U.S. Food and Drug Administration (FDA) committee last month concurred that Dynavax's investigational hepatitis B virus (HBV) vaccine Heplisav was effective in preventing infection, but a majority thought there was not enough data to show whether the vaccine is safe.

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Lack of Sleep May Compromise Hepatitis B Vaccine Response

People who got less than 6 hours of sleep per night showed significantly reduced antibody responses after hepatitis B virus (HBV) vaccination, a finding that may shed light on the well-known association between poor sleep and increased susceptibility to infectious disease, researchers reported in the August 1, 2012, issue of Sleep.alt

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