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Positive Phase III Results for Pneumococcal Vaccine in Adults With HIV Infection
A new phase III study has evaluated the immunogenicity, tolerability, and safety of Prevnar 13 (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]; Pfizer) in adults with human immunodeficiency virus (HIV) infection. The results were presented at the 20th Conference on Retroviruses and Opportunistic Infections (CROI), held in Atlanta, Georgia.
A planned regulatory submission will seek to include data on HIV-infected, immunocompromised adults in the U.S. labeling for Prevnar 13.
In the new 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 6 months apart. An immune response to the serotypes in the vaccine was observed after the first dose of Prevnar 13 and after each of the two subsequent doses. However, the clinical relevance of the level of these responses is not known. The most common local reaction at the injection site was pain, and the most common adverse event after vaccination was headache.
For adults with HIV, the incidence of invasive pneumococcal disease is significantly higher than in uninfected adults, and recurrent disease — most of which represents re-infection — is more likely to occur in these individuals.
The vaccine’s immunogenicity, tolerability, and safety were evaluated in a phase III, open-label, single-arm trial of 331 adults aged 18 years or older with HIV infection. All of the participants had CD4 cell counts of 200 cells/mm3 or higher and had previously received one or more doses of PPSV.
Prevnar 13 is a vaccine approved for the prevention of invasive disease caused by 13 Streptococcus 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 of age for the prevention of otitis media caused by seven of the 13 strains (4, 6B, 9V, 14, 18C, 19F, and 23F). Based on immune responses to the vaccine, Prevnar 13 is also approved for adults 50 years of age and older for the prevention of pneumococcal pneumonia and invasive disease caused by the 13 vaccine strains.
Source: Pfizer; March 4, 2013.