PATH [to 11 July 2015]
http://www.path.org/news/index.php
Announcement | July 09, 2015
Clinical study results pave the way for a promising new approach to rotavirus vaccines
Injected, non-replicating vaccines hold potential for expanded impact in developing countries
Data published this week in Vaccine reveal a promising immune response among adults who received a novel non-replicating rotavirus vaccine candidate. Rotavirus accounts for more than one-third of all childhood diarrhea deaths worldwide, and PATH is evaluating the potential of non-replicating rotavirus vaccines, or NRRVs, as valuable additions to the global vaccine portfolio.
Live, orally administered rotavirus vaccines have made a major public health impact since they were first licensed nearly a decade ago. However, as with other oral vaccines, their efficacy is lower in developing countries in comparison to high- and middle-income nations, highlighting the need to consider new approaches. Reduced efficacy may be due to elevated maternal antibodies, potential interference from other oral vaccines, malnutrition, and co-infections in a child’s gut, among other issues. Inactivated vaccines like NRRVs, which are injected rather than orally administered, may circumvent some of these factors.
The Phase 1 clinical study, conducted at the Center for Immunization Research at the Johns Hopkins School of Public Health, evaluated the safety, reactogenicity, and tolerability of the P2-VP8 rotavirus vaccine candidate among healthy US adults not previously immunized against rotavirus. The study found the vaccine to be safe and to evoke a strong immune response. Study participants developed high levels of antibodies after immunization and also produced neutralizing antibodies against strains not included in the vaccine.
“Non-replicating rotavirus vaccines offer an exciting approach to preventing the most common cause of severe and deadly childhood diarrhea,” said Dr. Stan Cryz, director of PATH’s NRRV project. “These data are very promising, and further studies will help us investigate their potential to protect children worldwide.”…
NIH [to 11 July 2015]
http://www.nih.gov/news/releases.htm
NIH-funded vaccine for West Nile virus enters human clinical trials
July 6, 2015 — A clinical trial of a new investigational vaccine designed to protect against West Nile Virus infection will be sponsored by the National Institute of Allergy and Infectious Diseases (NIAID).
European Vaccine Initiative [to 11 July 2015]
http://www.euvaccine.eu/news-events
Improving safety of medicines across Europe
06/07/2015
EMA publication of safety reports for nationally authorised medicines will support timely and harmonised implementation of safety measures in EU Member States …