The 13-valent pneumococcal conjugate vaccine for invasive pneumococcal disease in Alaska native children: results of a clinical trial.

BACKGROUND

During 1996 to 2000, Alaska Native children aged <5 years from Yukon Kuskokwim Delta (YKD) had invasive pneumococcal disease (IPD) rates 10-fold higher than non-Alaska Native children (547/100,000/yr versus 56/100,000/yr). After 7-valent pneumococcal conjugate vaccine (PCV7) introduction, IPD rates decreased to 148 per 100,000 during 2001 to 2004, increasing to 426 per 100,000 during 2005 to 2007 due to non-vaccine serotype disease. In 2009, we evaluated safety, immunogenicity and impact of 13-valent PCV (PCV13) in YKD children.

METHODS

In a prelicensure open-label clinical trial, eligible YKD children aged <5 years were offered PCV13 as appropriate for age and prior PCV7 history. PCV13 impact was assessed using existing Alaska-wide IPD surveillance. Serotype-specific anti-pneumococcal IgG levels were measured postinfant series and posttoddler dose in a subset of subjects. Adverse events and serious adverse events were collected in all; local reactions and systemic events were collected in toddlers. All YKD children were offered licensed PCV13 when it became available.

RESULTS

Three hundred seventy-two subjects received PCV13 during the clinical trial and 3342 postlicensure (April 2010 to August 2011). Adverse events were typically mild, or generally consistent with common childhood illnesses. IgG levels following PCV13 were similar to other populations. In YKD children aged <5 years, 52 IPD cases (31 PCV13-serotype) occurred during 2005 to 2008 (399.0/100,000/yr) versus 9 (7 PCV13-serotype) during January 2009 to August 2011 (106.7/100,000/yr; P < 0.001). No PCV13-serotype cases occurred among PCV13 recipients (3680 person follow-up years).

CONCLUSIONS

PCV13-serotype IPD incidence declined significantly after PCV13 introduction. Although non-PCV13-serotype IPD also declined significantly, absence of PCV13-serotype IPD in children who received PCV13 suggests a protective vaccine effect.