Immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine compared to the 23-valent pneumococcal polysaccharide vaccine in elderly Japanese adults

Abstract

sive pneumococcal disease; LLOQ, lower limit of quantitation; OPA, opsonophagocytic activity; PCV13, 13-valent pneumococcal conjugate vaccine; PPSV23, 23-valent pneumococcal polysaccharide vaccineStreptococcus pneumoniae is a major cause of severe disease worldwide, particularly in the elderly population. Due to increasing life expectancy in Japan and elsewhere, an effective vaccine which offers the possibility of prolonged protection is required. Protein conjugated pneumococcal vaccines, which have the ability to boost immunity (immunologic memory) on natural exposure or revaccination, may meet these requirements. An unconjugated 23-valent pneumococcal polysaccharide vaccine (PPSV23) has been available for decades; however data on protection against pneumonia are inconsistent. For the first time, a randomized, modified double-blind trial comparing the 13-valent pneumococcal conjugate vaccine (PCV13) with PPSV23 was conducted in PPSV23-naive adults 65 years of age in Japan. This study showed that statistically significantly greater functional antibody responses as measured by opsonophagocytic assays 1 month after vaccination were elicited in the PCV13 group (n D 366) compared with the PPSV23 group (n D 367) for 9 of the 12 serotypes in common with both vaccines and for serotype 6A, unique to PCV13. Local reactions collected within 14 days of vaccination were more frequent in the PCV13 (57.5%, 211/367) than PPSV23 (44.9%, 166/370) group, although severity was generally mild to moderate; systemic and adverse events were similar across groups. There were no treatment-related serious adverse events. Consistent with global studies comparing PCV13 with PPSV23, PCV13 use in Japanese subjects was safe and well-tolerated and elicited greater functional immune responses than PPSV23 for the majority of PCV13-serotypes. PCV13 has the potential to protect against pneumococcal disease in Japanese elderly adults.

Invasive pneumococcal disease among adults in Japan, April 2013 to March 2015: disease characteristics and serotype distribution

“…Although a 44% reduction of IPD incidence caused by serotype 3 was reported in the UK among individuals who were aged 65 years or older after the introduction of PCV13 for children, a herd immunity effect against serotype 3 is unclear worldwide [15, 16]. In addition, the immunogenicity of PCV13 against serotype 3 remains controversial in children and was reported to be lower than that of PCV13 serotypes other than serotype 3 in the elderly [17–20]. …”

Invasive pneumococcal disease caused by mucoid serotype 3 Streptococcus pneumoniae: a case report and literature review

“…All pneumonia patients were hospitalized and none had been vaccinated with PPSV23. Shiramoto et al reported that the immunogenicity of PCV13 and PPSV23, measured as opsonophagocytic activity titer, for serotype 3 were both lower than that for the other serotypes, suggesting lower vaccination efficacy [12]. Another study reported that the effectiveness of the PCV13 vaccine for serotype 3 was not significant [13].…”

Recommendations for influenza and Streptococcus pneumoniae vaccination in elderly people in China

“…Pneumococcal conjugate vaccine can elicit interaction between T‐helper lymphocytes and B lymphocytes, and induce strong immune responses and immunological memory. PCV13 can reportedly induce higher levels of antibody in elderly people than PPSV23 60,64 . Jackson et al 65 reported that in a randomized double‐blind study involving 936 adults aged ≥ 70 years, the opsonophagocytic activity titers were significantly greater in a PCV13 inoculation group than in a PPSV23 group for 10 of the 12 serotypes common to both vaccines and serotype 6A, which is unique to PCV13.…”

“…PCV13 can reportedly induce higher levels of antibody in elderly people than PPSV23. 60,64 Jackson et al 65 reported that in a randomized double-blind study involving 936 adults aged ≥ 70 years, the opsonophagocytic activity titers were significantly greater in a PCV13 inoculation group than in a PPSV23 group for 10 of the 12 serotypes common to both vaccines and serotype 6A, which is unique to PCV13. Opsonophagocytic activity responses after a follow-on dose of PCV13 a year later demonstrated that a prior dose of PPSV23, but not PCV13, diminished the response to a subsequent administration of PCV13, which indicates better immunogenicity of PCV13.…”