Immunogenicity and safety of the 10-valent pneumococcal nontypeableHaemophilus influenzaeprotein D conjugate vaccine (PHiD-CV) co-administered with DTPa vaccine in Japanese children: A randomized, controlled study

Abstract

This phase III, randomized, open-label, multicenter study (NCT01027845) conducted in Japan assessed the immunogenicity, safety, and reactogenicity of 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV, given intramuscularly) co-administered with diphtheria-tetanus-acellular pertussis vaccine (DTPa, given subcutaneously). Infants (N=360 ) were randomized (2:1) to receive either PHiD-CV and DTPa (PHiD-CV group) or DTPa alone (control group) as 3-dose primary vaccination (3–4–5 months of age) and booster vaccination (17–19 months of age). Immune responses were measured before and one month after primary/booster vaccination and adverse events (AEs) were recorded. Post-primary immune responses were non-inferior to those in pivotal/efficacy European or Latin American pneumococcal protein D-conjugate vaccine studies. For each PHiD-CV serotype, at least 92.6% of infants post-primary vaccination and at least 97.7% of children post-booster had pneumococcal antibody concentrations ≥0.2 μg/ml, and at least 95.4% post-primary and at least 98.1% post-booster had opsonophagocytic activity (OPA) titers ≥8 . Geometric mean antibody concentrations and OPA titers (except OPA titer for 6B) were higher post-booster than post-priming for each serotype. All PHiD-CV-vaccinated children had anti-protein D antibody concentrations ≥100 EL.U/ml one month post-primary/booster vaccination and all were seroprotected/seropositive against each DTPa antigen. Redness and irritability were the most common solicited AEs in both groups. Incidences of unsolicited AEs were comparable between groups. Serious AEs were reported for 47 children (28 in PHiD-CV group); none were assessed as vaccine-related. In conclusion, PHiD-CV induced robust immune responses and was well tolerated when co-administered with DTPa in a 3-dose priming plus booster regimen to Japanese children.

Safety profile of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV)

“…In study 058, an 8-day post-vaccination observation period was used on the request of local authorities but the vast majority of solicited AEs were reported within the first 4 days after each PHiD-CV dose [16]. In study 022, fever was monitored during a 15-day period and screened during days 15-42 due to measles, mumps, rubella, and varicella (MMRV) vaccine co-administration [17].…”

Associations between geographic region and immune response variations to pneumococcal conjugate vaccines in clinical trials: A systematic review and meta-analysis

“…Korean and Taiwanese studies on PCV7 have suggested higher post-vaccination GMCs compared to the studies from Europe or the Americas (Kim et al, 2007, Shao et al, 2004. Studies on PCV10 from Singapore, Malaysia, Korea, and Japan have also found that post third dose GMCs to most serotypes were higher than those found in European or American studies (Iwata et al, 2015;Kim et al, 2011;Lin et al, 2012). Previous studies have suggested a decreased immune response in vaccinees identified as of White Caucasian descent, compared to people identified as Black African.…”

Revival of the heterologous prime‐boost technique in COVID‐19: An outlook from the history of outbreaks

“…16,18 immune response to monovalent influenza vaccine changes significantly after 35 years. 27 Conclusively, mix-and-match approaches generally have been successfully employed in addressing the majority of outbreaks to tackle many others, that is, seasonal influenza virus, [28][29][30] papillomavirus, 31 pneumococcus, 32,33 and rotavirus, 34 poliovirus, 7 and a few other examples. Furthermore, though the technique was unsuccessful in combating HIV, it is gaining favor.…”