Hoping to boost its chances of FDA approval early next year, Pfizer has unveiled results from a Phase II clinical trial for its meningitis B vaccine, showing that the jab is safe and effective in adolescents when given alongside a licensed vaccine for human papillomavirus.
In a set of new data, Pfizer ($PFE) says its investigational bivalent rLP2086, meant to prevent serogroup B meningococcal disease, was well tolerated and showed immune responses when coadministered with Gardasil, a quadrivalent HPV (HPV4) vaccine, in healthy volunteers aged 11 to 17 years.
Subjects were divided into three groups--the first received both the HPV4 and bivalent rLP2086; the second received bivalent rLP2086 plus saline; and the third received saline and HPV4. The shots were given in three doses over a 6-month vaccination schedule. After the third dose, antibodies against all four HPV antigens were detectable in the blood of 99% of the subjects that received HPV4 along with bivalent rLP2086 or with saline. The bivalent rLP2086 in the first two groups also elicited intended immune responses.
Pfizer has primarily tested its bivalent rLP2086 in adolescents who, along with young adults, are the primary carriers of the meningococcal bacteria. This age group is also the same population that the HPV vaccine is targeted at. The noninferiority trial was designed to show that the effect of its experimental meningitis B vaccine would not lessen the effectiveness of Gardasil in adolescents or produce side effects in those patients receiving the HPV vaccines.
The results are favorable for Pfizer, which is racing Novartis ($NVS) to become the first vaccinemaker to roll out a meningitis B vaccine for the U.S. market. In August, the FDA granted priority review designation along with an anticipated Prescription Drug User Fee Act (PDUFA) action date of Feb. 14, 2015.
In 2012, about 40% of all meningitis cases in the U.S. were caused by serogroup B meningococcal disease. Meningitis B was responsible for an outbreak at Princeton University earlier this year that infected 8 students.
- read the press release