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A Phase II Trial of Safety, Tolerability and Immunogenicity of V114, a 15-Valent Pneumococcal Conjugate Vaccine, Compared With 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants.
Pediatr Infect Dis J. 2020 08; 39(8):763-770.PI

Abstract

BACKGROUND

Pneumococcal disease remains a public health priority worldwide. This phase 2 study (V114-008; NCT02987972; EudraCT 2016-001117-25) compared safety and immunogenicity of 2 clinical lots of V114 (investigational 15-valent pneumococcal vaccine: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19F, 19A, 22F*, 23F, 33F*) to 13-valent pneumococcal conjugate vaccine (PCV13) in healthy infants (*serotypes unique to V114).

METHODS

Healthy infants 6-12 weeks old were randomized to receive a 4-dose regimen of V114 Lot 1, V114 Lot 2 or PCV13 at 2, 4, 6 and 12-15 months old. Adverse events were evaluated after each dose. Primary immunogenicity endpoint was to demonstrate noninferiority of V114 Lot 1 and V114 Lot 2 relative to PCV13 based on proportion of infants achieving serotype-specific IgG concentration ≥0.35 µg/mL for 13 serotypes shared with PCV13 at 1 month postdose 3 (PD3). Serotype-specific IgG geometric mean concentrations (GMCs) for all 15 V114 serotypes were measured at PD3, predose 4 and 1 month postdose 4 (PD4).

RESULTS

Overall, 1044 of 1051 randomized infants received ≥1 dose of vaccine (V114 Lot 1 [n = 350], V114 Lot 2 [n = 347] or PCV13 [n = 347]). Adverse events were generally comparable across groups. At PD3, both V114 lots met noninferiority criteria for all 13 serotypes shared with PCV13. IgG GMCs were comparable among V114 and PCV13 recipients at PD3 and PD4. Serotype 3 responses were higher following receipt of V114 than PCV13. Both V114 lots induced higher GMCs than PCV13 to the 2 unique V114 serotypes.

CONCLUSIONS

Immunogenicity of both V114 lots was noninferior to PCV13 for all 13 shared serotypes between the 2 vaccines and displayed comparable safety and tolerability profiles to PCV13.

Authors+Show Affiliations

From the Merck & Co., Inc., Kenilworth, New Jersey.Soroka Medical Center, Research, Beersheba, Israel.CHU Sainte-Justine, Université de Montréal, Montréal, Québec, Canada.Coastal Pediatric Research, Charleston, South Carolina.Kaiser Permanente Vaccine Study Center, Oakland, California.Cottonwood Pediatrics, Research, Murray, Utah.From the Merck & Co., Inc., Kenilworth, New Jersey.From the Merck & Co., Inc., Kenilworth, New Jersey.From the Merck & Co., Inc., Kenilworth, New Jersey.From the Merck & Co., Inc., Kenilworth, New Jersey.From the Merck & Co., Inc., Kenilworth, New Jersey.From the Merck & Co., Inc., Kenilworth, New Jersey.From the Merck & Co., Inc., Kenilworth, New Jersey.From the Merck & Co., Inc., Kenilworth, New Jersey.From the Merck & Co., Inc., Kenilworth, New Jersey.No affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

32639460

Citation

Platt, Heather L., et al. "A Phase II Trial of Safety, Tolerability and Immunogenicity of V114, a 15-Valent Pneumococcal Conjugate Vaccine, Compared With 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants." The Pediatric Infectious Disease Journal, vol. 39, no. 8, 2020, pp. 763-770.
Platt HL, Greenberg D, Tapiero B, et al. A Phase II Trial of Safety, Tolerability and Immunogenicity of V114, a 15-Valent Pneumococcal Conjugate Vaccine, Compared With 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants. Pediatr Infect Dis J. 2020;39(8):763-770.
Platt, H. L., Greenberg, D., Tapiero, B., Clifford, R. A., Klein, N. P., Hurley, D. C., Shekar, T., Li, J., Hurtado, K., Su, S. C., Nolan, K. M., Acosta, C. J., McFetridge, R. D., Bickham, K., & Musey, L. K. (2020). A Phase II Trial of Safety, Tolerability and Immunogenicity of V114, a 15-Valent Pneumococcal Conjugate Vaccine, Compared With 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants. The Pediatric Infectious Disease Journal, 39(8), 763-770. https://doi.org/10.1097/INF.0000000000002765
Platt HL, et al. A Phase II Trial of Safety, Tolerability and Immunogenicity of V114, a 15-Valent Pneumococcal Conjugate Vaccine, Compared With 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants. Pediatr Infect Dis J. 2020;39(8):763-770. PubMed PMID: 32639460.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A Phase II Trial of Safety, Tolerability and Immunogenicity of V114, a 15-Valent Pneumococcal Conjugate Vaccine, Compared With 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants. AU - Platt,Heather L, AU - Greenberg,David, AU - Tapiero,Bruce, AU - Clifford,Robert A, AU - Klein,Nicola P, AU - Hurley,David C, AU - Shekar,Tulin, AU - Li,Jianing, AU - Hurtado,Kim, AU - Su,Shu-Chih, AU - Nolan,Katrina M, AU - Acosta,Camilo J, AU - McFetridge,Richard D, AU - Bickham,Kara, AU - Musey,Luwy K, AU - ,, PY - 2020/7/9/pubmed PY - 2021/7/16/medline PY - 2020/7/9/entrez SP - 763 EP - 770 JF - The Pediatric infectious disease journal JO - Pediatr Infect Dis J VL - 39 IS - 8 N2 - BACKGROUND: Pneumococcal disease remains a public health priority worldwide. This phase 2 study (V114-008; NCT02987972; EudraCT 2016-001117-25) compared safety and immunogenicity of 2 clinical lots of V114 (investigational 15-valent pneumococcal vaccine: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19F, 19A, 22F*, 23F, 33F*) to 13-valent pneumococcal conjugate vaccine (PCV13) in healthy infants (*serotypes unique to V114). METHODS: Healthy infants 6-12 weeks old were randomized to receive a 4-dose regimen of V114 Lot 1, V114 Lot 2 or PCV13 at 2, 4, 6 and 12-15 months old. Adverse events were evaluated after each dose. Primary immunogenicity endpoint was to demonstrate noninferiority of V114 Lot 1 and V114 Lot 2 relative to PCV13 based on proportion of infants achieving serotype-specific IgG concentration ≥0.35 µg/mL for 13 serotypes shared with PCV13 at 1 month postdose 3 (PD3). Serotype-specific IgG geometric mean concentrations (GMCs) for all 15 V114 serotypes were measured at PD3, predose 4 and 1 month postdose 4 (PD4). RESULTS: Overall, 1044 of 1051 randomized infants received ≥1 dose of vaccine (V114 Lot 1 [n = 350], V114 Lot 2 [n = 347] or PCV13 [n = 347]). Adverse events were generally comparable across groups. At PD3, both V114 lots met noninferiority criteria for all 13 serotypes shared with PCV13. IgG GMCs were comparable among V114 and PCV13 recipients at PD3 and PD4. Serotype 3 responses were higher following receipt of V114 than PCV13. Both V114 lots induced higher GMCs than PCV13 to the 2 unique V114 serotypes. CONCLUSIONS: Immunogenicity of both V114 lots was noninferior to PCV13 for all 13 shared serotypes between the 2 vaccines and displayed comparable safety and tolerability profiles to PCV13. SN - 1532-0987 UR - https://www.unboundmedicine.com/medline/citation/32639460/A_Phase_II_Trial_of_Safety_Tolerability_and_Immunogenicity_of_V114_a_15_Valent_Pneumococcal_Conjugate_Vaccine_Compared_With_13_Valent_Pneumococcal_Conjugate_Vaccine_in_Healthy_Infants_ L2 - https://doi.org/10.1097/INF.0000000000002765 DB - PRIME DP - Unbound Medicine ER -