Pfizer has presented detailed results of the CAPiTA ( Community-Acquired Pneumonia Immunization Trial in Adults ), the landmark study of approximately 85,000 subjects, demonstrating that Prevenar 13 ( pneumococcal polysaccharide conjugate vaccine [ 13-valent, adsorbed ] ) prevented a first episode of vaccine-type community-acquired pneumonia ( CAP ) in adults 65 years of age and older, the study’s primary objective.
This trial is the first in adults to clearly demonstrate a significant reduction in vaccine-type pneumococcal community-acquired pneumonia, and importantly, non-bacteremic / non-invasive vaccine-type pneumococcal community-acquired pneumonia.
Results were presented at the 9th International Symposium on Pneumococci and Pneumococcal Diseases ( ISPPD ) in Hyderabad, India.
CAPiTA also met both of its secondary study objectives: significant reduction in (i) non-bacteremic/non-invasive vaccine-type pneumococcal community-acquired pneumonia and (ii) vaccine-type invasive pneumococcal disease ( IPD ).
Regarding the study’s primary objective, there were 45.56% fewer first episodes of vaccine-type community-acquired pneumonia among Prevenar 13-vaccinated subjects than in subjects who received placebo ( P=0.0006 ).
Regarding the study’s secondary objectives, the Prevenar 13 group experienced 45.00% fewer first episodes of non-bacteremic / non-invasive vaccine-type community-acquired pneumonia ( P=0.0067 ) and 75.00% fewer first episodes of vaccine-type IPD ( P=0.0005 ) compared with the placebo group.
The safety profile of Prevenar 13 in this study was consistent with studies previously conducted in adults.
Additional data showed reductions in vaccine-type community-acquired pneumonia, non-bacteremic / non-invasive vaccine-type community-acquired pneumonia, and vaccine-type IPD for up to four years after vaccination among subjects who received Prevenar 13.
Vaccine-type CAP (VT-CAP) was defined as CAP caused by any Streptococcus pneumoniae serotype included in the vaccine. Non-bacteremic/noninvasive VT-CAP was defined as CAP in which vaccine-type S. pneumoniae caused the pneumonia, but was not detected concurrently in the bloodstream or any other normally sterile site. Vaccine-type IPD was defined as a case in which vaccine-type S. pneumoniae was present in the bloodstream or any other normally sterile site, with or without pneumonia.
This study has demonstrated that vaccination with Prevenar 13 can prevent a significant portion of pneumococcal community-acquired pneumonia in adults aged 65 and older, which is an important global public health goal. ( Xagena )
Source: Pfizer, 2014