Novavax announced forward momentum in its work to develop a vaccine to protect infants via maternal immunization. Their announcement of positive data in their Phase 2 clinical trial was combined with the news that they have been awarded a grant of up to $89 million by the Bill & Melinda Gates Foundation to support development of the RSV F Vaccine Phase 3 clinical trial in pregnant women, planned to initiate during the first quarter of 2016.
What is RSV?
Novavax, Inc. is a clinical-stage vaccine company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants. The vaccine at the center of the announcement is a RSV F-protein recombinant nanoparticle vaccine candidate (RSV F Vaccine). RSV stands for Respiratory syncytial virus, the most common cause of lower respiratory tract infections and the leading viral cause of severe lower respiratory tract disease in infants and young children worldwide, with estimated annual infection and mortality rates of 64 million and 160,000, respectively.
In the US, RSV is the leading cause of hospitalization of infants and can cause problems further down the line as repeat infection and lifelong susceptibility to RSV is common. Currently, there is no approved RSV vaccine available.
The goal of maternal immunization is to provide protection to the newborn through the transfer of vaccine-induced IgG antibodies across the placenta. The aim of maternal immunization is to enhance maternal antibody levels against particular infections, so that a protective level of antibody is transferred from the mother to the infant. Since direct immunization of infants is complicated by the immature immune system, which is unable to fight off infections when infants are most vulnerable, doctors are using the mother’s ability to have her immunity passed along to her baby during pregnancy to protect the baby from some diseases during the first few months of life until the baby can be effectively vaccinated.
The CDC already recommends pregnant women in their third trimester receive a tetanus, diptheria and pertussis (Tdap) vaccine every pregnancy to protect infants. To maximize the maternal antibody response and passive antibody transfer to the infant, optimal timing for Tdap administration is between 27 and 36 weeks gestation. The CDC also recommends pregnant women receive a seasonal influenza vaccine.
“Maternal immunization is an elegant and accepted approach to protect infants in the first few months of life, the time period when they are most vulnerable to RSV,” said Gregory Glenn, M.D., Senior Vice President, Research and Development. “These data are consistent with immune responses observed in our earlier trials of women of child-bearing age. As anticipated, infants received a significant bolus of all anti-RSV antibodies via transplacental transfer. Half of all hospitalizations due to RSV occur within the first three months of life and, based on these data, the RSV F Vaccine demonstrates the potential to protect infants when they are most at risk of infection.”
Progress of the RSV Vaccine
The purpose of Novavax Phase 2 trial was to evaluate the safety and immunogenicity of the RSV F Vaccine in healthy pregnant women. The trial also assessed the transplacental transfer of maternal antibodies induced by the vaccine, the impact of maternal immunization on infant safety during the first year of life and RSV-specific antibody levels through the infants’ first six months of life.
So what does passing Phase 2 mean? There are two more phases to go. According to the National Institute of Health, Clinical trials are conducted in a series of steps, called phases – each phase is designed to answer a separate research question.
• Phase I: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
• Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
• Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
• Phase IV: Studies are done after the drug or treatment has been marketed to gather information on the drug’s effect in various populations and any side effects associated with long-term use.
“These data illustrate the promise of our RSV F Vaccine to protect infants via maternal immunization, demonstrating robust immune responses in women with antibody transfer to infants. We look forward to advancing our maternal immunization program to a Phase 3 clinical trial with the support of the Bill & Melinda Gates Foundation,” said Stanley C. Erck, President and CEO. “We have now delivered positive top-line data from multiple clinical trials this quarter, including two from our RSV F Vaccine program. These announcements are not only significant achievements for our company, but important contributions to the field. We look forward to sustaining this momentum in the coming months, as we intend to initiate two pivotal Phase 3 trials.”
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