![Sample our Medicine, Dentistry, Nursing & Allied Health journals, sign in here to start your FREE access for 14 days]({"type":"image" , "src" : "/sda/5944/TOC-Subject-Sample-2021-Medicine-Dentistry-Nursing-Allied-Health.jpg"})
ABSTRACT
To investigate long-term antibody persistence following the administration of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV), we present results of 2 follow-up studies assessing antibody persistence following 2 3+1 schedules up to 4 (NCT00624819 – Study A) and 5 years (NCT00891176 – Study B) post-booster vaccination. In Study A, antibody persistence was measured one, 2 and 4 years post-booster in children previously primed and boosted with PHiD-CV, or primed with the 7-valent pneumococcal conjugate vaccine (7vCRM) and boosted with either PHiD-CV or 7vCRM. In Study B, PHiD-CV was co-administered with meningococcal vaccines, and pneumococcal antibody persistence was measured 2, 3 and 5 years post-booster. An age-matched control group, unvaccinated against Streptococcus pneumoniae, was enrolled in Study A, allowing assessment of immunologic memory by administration of one dose of PHiD-CV to both primed (4 years post-booster) and unprimed 6-year-old children. Four years post-booster (Study A), antibody concentrations and opsonophagocytic activity (OPA) titers remained higher compared to the pre-booster timepoint, with no major differences between the 3 primed groups. Antibody persistence was also observed in Study B, with minimal differences between groups. The additional PHiD-CV dose administered 4 years post-booster in Study A elicited more robust immune responses in primed children than in unprimed children. Long-term serotype-specific antibody persistence and robust immunologic memory responses observed in these 2 studies suggest induction of long-term protection against pneumococcal disease after PHiD-CV vaccination.
Abbreviations
| 7vCRM | = | 7-valent pneumococcal conjugate vaccine |
| AE | = | adverse event |
| ATP | = | according-to-protocol |
| CI | = | confidence interval |
| DTPa-HBV-IPV/Hib | = | diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliomyelitis and Haemophilus influenzae type b vaccine |
| ELISA | = | enzyme-linked immunosorbent assay |
| EL.U | = | ELISA units |
| GCP | = | Good Clinical Practice |
| GMC | = | geometric mean concentration |
| GMT | = | geometric mean titer |
| MenC-CV | = | meningococcal serogroup C conjugate vaccine |
| OPA | = | opsonophagocytic activity |
| PCV | = | pneumococcal conjugate vaccine |
| PD | = | protein D |
| PHiD-CV | = | pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine |
| SAE | = | serious adverse event |
| TVC | = | total vaccinated cohort |
Disclosure of potential conflict of interest
JW declares receiving travel grants to participate in international scientific congresses and fees for lecturers from the GSK groups of companies; YS works as a consultant in XPE Pharma & Science for the GSK group of companies; NF, DK, ID, LS and DB are employed by the GSK group of companies; ID, LS and DB own stock options and restricted shares; SR was employed by the GSK group of companies and declares no conflict of interest. Other authors declare no conflict of interest.
Acknowledgments
The authors would like to thank investigators Hanna Czajka, Knecht Roland, Mathias H. Wagner and GSK team member Jacqueline Miller. The authors also acknowledge Mihai Surducan and Ioana Cristina Ilea (XPE Pharma & Science) for medical writing support and Marie-Line Seret and Bram Blomme (XPE Pharma & Science on behalf of GSK) for manuscript coordination.
Funding
GlaxoSmithKline Biologicals SA was the funding source and was involved in all stages of the conduct and analysis for both studies. GlaxoSmithKline Biologicals SA also took responsibility for all costs associated with the development and publishing of the present manuscript.
Contributorship section
LS, DB, ID and NF designed the study. ID, JW, JB, RK and FP acquired the data. NF, DK, SR, ID, DB, JW and YS performed or supervised the analysis. JW, JB, RK and FP contributed to the conduct of the study (monitoring of study participants). All authors participated in the interpretation of the data and all reviewed and approved the final version of the report.