PNEUMOVAX 23 Rx

Effectiveness

• 2 controlled studies in South Africa evaluated the efficacy of pneumococcal vaccines containing six (types 1, 2, 4, 8, 12F, and 25) or twelve (types 1, 2, 3, 4, 6A, 8, 9N, 12F, 25, 7F, 18C, and 46) capsular polysaccharides in male novice gold miners ranging in age from 16 to 58 years who had a high attack rate for pneumococcal pneumonia and bacteremia. In both studies, patients received either meningococcal polysaccharide serogroup A or placebo. The 6- and 12-valent vaccines achieved a protective efficacy of 76% and 92%, respectively, for the capsular types.

• 3 similar studies in South Africa evaluated the efficacy of pneumococcal vaccines containing 6 (types 1, 3, 4, 7, 8, and 12) or 13 (types 1, 2, 3, 4, 6, 7, 8, 9, 12, 14, 18, 19, and 25) capsular polysaccharides in young adult male novice gold miners. The vaccines achieved a 79% reduction in pneumococcal pneumonia caused by the capsular types and a 82% reduction in type-specific pneumococcal bacteremia.

• A prospective study in France evaluated the efficacy of a pneumococcal vaccine containing 14 (types 1, 2, 3, 4, 6A, 7F, 8, 9N, 12F, 14, 18C, 19F, 23F, and 25) capsular polysaccharides in male and female nursing home residents with a mean age of 74. The vaccine achieved a 77% efficacy in reducing the incidence of pneumonia.

• A study evaluated a pneumococcal vaccine containing 8 (types 1, 3, 6, 7, 14, 18, 19, and 23) capsular polysaccharides in children and young adults aged 2 to 25 years with sickle cell disease, congenital asplenia, or undergone a splenectomy. Vaccinated patients had a significantly lower incidence of bacteremic pneumococcal disease compared with unvaccinated patients.

• In a retrospective cohort analysis study based on the US CDC pneumococcal surveillance system, the overall protective efficacy was 57% against invasive infections caused by serotypes included in Pneumovax 23 in persons 6 years of age and older. The overall efficacy was 65–84% among specific patients groups (eg, diabetes mellitus, coronary vascular disease, congestive heart failure, chronic pulmonary disease, and anatomic asplenia). The overall efficacy was 75% in immunocompetent persons aged 65 years and older.

Immunogenicity

Sequential Administration of Prevnar 13 and Pneumovax 23

• A randomized, double-blind, placebo-controlled, multicenter study evaluated the sequential administration of Prevnar 13 and Pneumovax 23 in 400 healthy adults 50 years of age and older. Patients received Prevnar 13 followed by Pneumovax 23 or placebo either 8 weeks later (Group 1) or 26 weeks later (Group 2). Of these, 188 subjects received Pneumovax 23 (Group 1) and 185 subjects received placebo (Group 2) at Week 8, and 172 subjects received placebo (Group 1) and 164 subjects received Pneumovax 23 (Group 2) at Week 26.

• For each of the shared serotypes, Week 12 OPA geometric mean titers (GMTs) in Group 1 were noninferior to those of Group 2, as the lower bounds of the 95% CIs for the OPA GMT ratios were >0.5 for all 12 shared serotypes. 

• For serotypes 22F and 33F, OPA GMTs in Group 1 at Week 12 were superior to those of Group 2 at Week 12, as the lower bounds of the 95% CIs for the OPA GMT ratios were >2.0 for both serotypes. The OPA GMTs to the 12 shared serotypes and 2 unique serotypes (22F and 33F) when measured 4 weeks after dosing with Pneumovax 23 were generally similar between Group 1 (Week 12) and Group 2 (Week 30 subset).