Pfizer Inc. (NYSE:PFE) presented today the results from a Phase 3 study demonstrating the immunogenicity, tolerability and safety of Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein])in adults infected with human immunodeficiency virus (HIV). The results were presented at the 20th Conference on Retroviruses and Opportunistic Infections (CROI) in Atlanta, Ga.
These data support planned regulatory submissions seeking to include data on HIV-infected immunocompromised adults in the Prevnar 13 label in the United States, the European Union, and other countries around the world.
In this study, HIV-infected individuals aged 18 years and older who had been previously vaccinated with at least one dose of the conventional pneumococcal polysaccharide vaccine (PPSV) received three doses of Prevnar 13 given six months apart. An immune response to the serotypes in the vaccine was observed after the first dose of Prevnar 13, and each of the two subsequent doses. The clinical relevance of the level of response is not known. The most common local reaction at the injection site was pain and the most common adverse event after vaccination was headache. Adverse events were generally consistent with those expected in this study population.
"Modern advances in medicine have significantly improved HIV case management, but the threat of infectious diseases to those with weakened immune systems is still prevalent," said Dr. Raul Isturiz, Pfizer Medicine Development Group and Scientific Affairs, Vaccines. "In fact, people living with HIV are more susceptible to the potentially devastating effects of pneumococcal diseases."
For adults with HIV, the incidence of invasive pneumococcal disease is significantly higher and the potential of recurrent disease, most of which represents re-infection, is more likely to occur in these individuals.
"These data add to the compelling body of research for Prevnar 13," said Dr. William Gruber, senior vice president, Pfizer Vaccine Clinical Research and Development. "Pfizer is committed to providing information about this important vaccine across all age groups, especially those with conditions that put them at higher risk of pneumococcal infections, such as those with HIV infection."