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A dose ranging study of 2 different formulations of 15-valent pneumococcal conjugate vaccine (PCV15) in healthy infants.
Hum Vaccin Immunother. 2019; 15(3):549-559.HV

Abstract

BACKGROUND

Two new formulations of an investigational 15-valent pneumococcal conjugate vaccine (PCV15-A and PCV15-B) were developed using 2 different protein-polysaccharide conjugation processes and evaluated in separate phase I/II studies (NCT02037984 [V114-004] and NCT02531373 [V114-005]) to assess optimal concentrations of pneumococcal polysaccharide (PnPs) and Aluminum Phosphate Adjuvant.

METHODS

Various lots of PCV15-A and PCV15-B containing different concentrations of PnPs and/or adjuvant were compared to PCV13 in young adults and infants. Adults received single dose and infants received 4 doses at 2, 4, 6, and 12-15 months of age. Adverse events (AEs) were collected after each dose. Serotype-specific immunoglobulin G (IgG) concentrations and opsonophagocytic activity (OPA) were measured prior and 30 days postvaccination in adults, at 1 month postdose 3 (PD3), pre-dose4, and postdose 4 (PD4) in infants.

RESULTS

Safety profiles were comparable across vaccination groups. At PD3, serotype-specific IgG GMCs were generally lower for either PCV15 formulation than PCV13 for most shared serotypes. PCV15 consistently elicited higher antibody responses to the 2 serotypes unique to the vaccine (22F and 33F) and serotype 3 for which PCV13 was shown to be ineffective. Except for serotypes 6A and 6B, no dose-response effect was observed with increasing concentrations of PnPs and/or adjuvant.

CONCLUSION

PCV15 is safe and induces IgG and OPA responses to all 15 serotypes in the vaccine. No significant differences in antibody responses were observed with increases in PnPs and/or Aluminum Phosphate Adjuvant.

Authors+Show Affiliations

a University of Texas Medical Branch , Galveston , TX , USA.b Wasatch Pediatrics, Cottonwood Office , Murray , UT , USA.c Merck & Co., Inc ., Kenilworth , NJ , USA.c Merck & Co., Inc ., Kenilworth , NJ , USA.c Merck & Co., Inc ., Kenilworth , NJ , USA.c Merck & Co., Inc ., Kenilworth , NJ , USA.c Merck & Co., Inc ., Kenilworth , NJ , USA.c Merck & Co., Inc ., Kenilworth , NJ , USA.c Merck & Co., Inc ., Kenilworth , NJ , USA.c Merck & Co., Inc ., Kenilworth , NJ , USA.c Merck & Co., Inc ., Kenilworth , NJ , USA.c Merck & Co., Inc ., Kenilworth , NJ , USA.

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

30689507

Citation

Rupp, R, et al. "A Dose Ranging Study of 2 Different Formulations of 15-valent Pneumococcal Conjugate Vaccine (PCV15) in Healthy Infants." Human Vaccines & Immunotherapeutics, vol. 15, no. 3, 2019, pp. 549-559.
Rupp R, Hurley D, Grayson S, et al. A dose ranging study of 2 different formulations of 15-valent pneumococcal conjugate vaccine (PCV15) in healthy infants. Hum Vaccin Immunother. 2019;15(3):549-559.
Rupp, R., Hurley, D., Grayson, S., Li, J., Nolan, K., McFetridge, R. D., Hartzel, J., Abeygunawardana, C., Winters, M., Pujar, H., Benner, P., & Musey, L. (2019). A dose ranging study of 2 different formulations of 15-valent pneumococcal conjugate vaccine (PCV15) in healthy infants. Human Vaccines & Immunotherapeutics, 15(3), 549-559. https://doi.org/10.1080/21645515.2019.1568159
Rupp R, et al. A Dose Ranging Study of 2 Different Formulations of 15-valent Pneumococcal Conjugate Vaccine (PCV15) in Healthy Infants. Hum Vaccin Immunother. 2019;15(3):549-559. PubMed PMID: 30689507.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A dose ranging study of 2 different formulations of 15-valent pneumococcal conjugate vaccine (PCV15) in healthy infants. AU - Rupp,R, AU - Hurley,D, AU - Grayson,S, AU - Li,J, AU - Nolan,K, AU - McFetridge,R D, AU - Hartzel,J, AU - Abeygunawardana,C, AU - Winters,M, AU - Pujar,H, AU - Benner,P, AU - Musey,L, Y1 - 2019/02/15/ PY - 2019/1/29/pubmed PY - 2020/2/27/medline PY - 2019/1/29/entrez KW - Pneumococcal conjugate vaccine KW - immunogenicity KW - safety SP - 549 EP - 559 JF - Human vaccines & immunotherapeutics JO - Hum Vaccin Immunother VL - 15 IS - 3 N2 - BACKGROUND: Two new formulations of an investigational 15-valent pneumococcal conjugate vaccine (PCV15-A and PCV15-B) were developed using 2 different protein-polysaccharide conjugation processes and evaluated in separate phase I/II studies (NCT02037984 [V114-004] and NCT02531373 [V114-005]) to assess optimal concentrations of pneumococcal polysaccharide (PnPs) and Aluminum Phosphate Adjuvant. METHODS: Various lots of PCV15-A and PCV15-B containing different concentrations of PnPs and/or adjuvant were compared to PCV13 in young adults and infants. Adults received single dose and infants received 4 doses at 2, 4, 6, and 12-15 months of age. Adverse events (AEs) were collected after each dose. Serotype-specific immunoglobulin G (IgG) concentrations and opsonophagocytic activity (OPA) were measured prior and 30 days postvaccination in adults, at 1 month postdose 3 (PD3), pre-dose4, and postdose 4 (PD4) in infants. RESULTS: Safety profiles were comparable across vaccination groups. At PD3, serotype-specific IgG GMCs were generally lower for either PCV15 formulation than PCV13 for most shared serotypes. PCV15 consistently elicited higher antibody responses to the 2 serotypes unique to the vaccine (22F and 33F) and serotype 3 for which PCV13 was shown to be ineffective. Except for serotypes 6A and 6B, no dose-response effect was observed with increasing concentrations of PnPs and/or adjuvant. CONCLUSION: PCV15 is safe and induces IgG and OPA responses to all 15 serotypes in the vaccine. No significant differences in antibody responses were observed with increases in PnPs and/or Aluminum Phosphate Adjuvant. SN - 2164-554X UR - https://www.unboundmedicine.com/medline/citation/30689507/A_dose_ranging_study_of_2_different_formulations_of_15_valent_pneumococcal_conjugate_vaccine__PCV15__in_healthy_infants_ L2 - https://www.tandfonline.com/doi/full/10.1080/21645515.2019.1568159 DB - PRIME DP - Unbound Medicine ER -