Vaccine Update

Immune Response BioPharma Inc.’s flagship HIV/AIDS vaccine Remune has been granted orphan designation for pediatric HIV/AIDS by the U.S. Food and Drug Administration. Previous clinical studies of Remune have demonstrated distinct benefits in both immunologic and virologic parameters in HIV-1- infected individuals undergoing treatment. Data from clinical trials suggest that the vaccine may induce an HIV-specific T-cell response; induce cytokines and chemokines, substances that interfere with the virus attaching to and infecting normal cells; work with antiretroviral drugs as a complementary treatment for HIV infection; work in drug-naive patients to delay the need for initiation of highly active antiretroviral therapy; and be safe with no adverse side effects.

Novartis has received a breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) for Bexsero (Meningococcal Group B Vaccine [rDNA, component, adsorbed]). Bexsero is already approved in Europe, Canada and Australia to help protect against invasive meningococcal disease caused by serogroup B (meningitis B). Novartis planned to file for U.S. licensure of Bexsero in the second quarter of 2014. In the last four months, Novartis has provided nearly 30,000 doses of Bexsero to students and staff at Princeton University and the University of California Santa Barbara following meningitis B outbreaks on their campuses under an Investigational New Drug (IND) designation from FDA. Further, the U.S. Centers for Disease Control and Prevention has recommended including the incoming freshman class at Princeton University in the at-risk group to receive Bexsero.

The U.S. Food and Drug Administration has expanded the approved age range for Sanofi Pasteur’s Adacel active booster immunization for tetanus, diphtheria and pertussis to ages 10 years to 64 years. An open-label, multicenter Phase IV trial found that a single dose of the drug — which was approved for people ages 11 through 64 in 2005 — had similar antibody responses and rates of adverse reactions in 10-year-olds as it does in 11-year-olds.

The University of Pittsburgh and Sanofi-Pasteur are partnering to assess the efficacy of Sanofi-Pasteur’s investigational dengue vaccine. Researchers from Pitt’s Center for Vaccine Research are developing a test to determine whether a person’s immunity to dengue virus is the result of vaccination or a previous infection. The recombinant, live-attenuated quadrivalent vaccine was tested in more than 4,000 healthy Thai schoolchildren in a 2009-2010 randomized trial. Results indicated that vaccine efficacy was 61.2 percent against dengue virus type 1, 81.9 percent against type 3 and 90 percent against type 4. However, the vaccine was unable to protect against serotype 2, according to researchers. The vaccine was safe and well-tolerated. Sanofi-Pasteur is expected to release data from its Phase III studies of the vaccine’s efficacy later this year.