Pfizer have unveiled the results from a Phase 3 study that trialled pneumococcal vaccine Prevnar 13 in adults infected with human immunodeficiency virus (HIV).
In the Phase 3, open-label, single-arm trial, 331 HIV-infected individuals aged 18 years and older who had previously received at least one dose of pneumococcal polysaccharide vaccine (PSSV) were given three doses of Prevnar 13 at six month intervals. The investigators observed for vaccine safety, tolerability and immunogenicity.
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 adverse events experienced were generally consistent with those expected in the study population, with the most common local reaction at the injection site being pain, and the most common adverse event after vaccination being headache.
Vaccination against invasive pneumococcal disease is especially important for adults with HIV because the incidence and potential for recurrent diseases such as bacteraemia and meningitis are significantly higher in immunocompromised individuals.
"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."
Prevnar 13 protects against 13 serotypes of Streptococcus pneumonia. It is indicated in the US for the prevention of invasive disease caused by S. pneumoniae strains 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F in children 6 weeks through 17 years of age, and in children 6 weeks through 5 years for the prevention of otitis media caused by 7 of the 13 strains (4, 6B, 9V, 14, 18C, 19F, and 23F). It's also indicated for the prevention of pneumonia and invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F in persons 50 years of age or older.
"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."
Dr. Gruber will be speaking about pneumococcal conjugate vaccines at the World Vaccine Congress, Washington DC. His talk is entitled "Pneumococcal conjugate vaccine for adults: A new paradigm."
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If you'd like to know more about strategy and innovation in vaccines, you might like to consider attending the World Vaccine Congress and Expo 2013 on the 16-18 April 2013, Gaylord National Hotel and Convention Center, Washington DC. You can download the brochure here.