Safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, in children with SCD: a V114-023 (PNEU-SICKLE) study

Blood Advances - Tập 7 - Trang 414-421 - 2023
Charles T. Quinn1, Richard T. Wiedmann2, Daniel Jarovsky3, Eduardo Lopez-Medina4, Hilze M. Rodriguez5, Melanie Papa2, Gordana Boggio2, Qiong Shou2, Ron Dagan6, Peter Richmond7, Kristen Feemster2, Richard McFetridge2, Gretchen Tamms2, Robert Lupinacci2, Luwy Musey2, Kara Bickham2
1Cincinnati Children's Hospital Medical Center and University of Cincinnati College of Medicine, Cincinnati, OH
2Merck & Co, Inc, Rahway, NJ
3Santa Casa de São Paulo, São Paulo, Brazil
4Centro de Estudios en Infectologia Pediatrica, Department of Pediatrics Universidad del Valle and Clinica Imbanaco Grupo Quironsalud, Cali, Valle del Cauca, Colombia
5Hospital del Niño Jose Renan Esquivel, Ciudad de Panama, Panama
6The Shraga Segal Dept. of Microbiology, Immunology and Genetics, Faculty of Health Sciences of the Ben-Gurion University of the Negev, Beer-Sheva, Israel
7University of Western Australia School of Medicine, Perth, Australia

Tóm tắt

AbstractSickle cell disease (SCD) is an inherited red blood cell disease that results in a multitude of medical complications, including an increased risk of invasive disease caused by encapsulated bacteria, such as Streptococcus pneumoniae. Pneumococcal vaccines have contributed to a significant reduction in pneumococcal disease (PD) in children and adults, including those with SCD. This phase 3 study evaluated the safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine (PCV), in children with SCD. A total of 103 children aged 5 to 17 years with SCD were randomized and received a single dose of V114 or Prevnar 13 (PCV13). Safety was evaluated as the proportion of participants with adverse events (AEs). Serotype-specific immunoglobulin G (IgG) levels and opsonophagocytic activity (OPA) were measured immediately before vaccination and 30 days after vaccination. Overall, the rates of injection-site and systemic AEs reported after vaccination were similar between the vaccination groups. Up to 6 months after vaccination, serious AEs were those expected for patients with SCD, and none were assessed to be vaccine related. IgG geometric mean concentrations (GMCs) and OPA geometric mean titers (GMTs) for the 13 shared serotypes were generally comparable between recipients of V114 and PCV13. Additionally, V114 induced immune responses to serotypes 22F and 33F, which are not included in PCV13. The safety and tolerability profiles of V114 were consistent with those reported for PCV13. Immune responses following vaccination with V114 were generally comparable to PCV13 for the shared serotypes and higher for unique serotypes 22F and 33F. These results support the use of V114 in children with SCD. This trial was registered at www.clinicaltrials.gov as #NCT03731182.

Tài liệu tham khảo

Rees, 2010, Sickle-cell disease, Lancet, 376, 2018, 10.1016/S0140-6736(10)61029-X Adamkiewicz, 2003, Invasive pneumococcal infections in children with sickle cell disease in the era of penicillin prophylaxis, antibiotic resistance, and 23-valent pneumococcal polysaccharide vaccination, J Pediatr, 143, 438, 10.1067/S0022-3476(03)00331-7 Al-Tawfiq, 2021, Frequency of bacteremia in patients with sickle cell disease: a longitudinal study, Ann Hematol, 100, 1411, 10.1007/s00277-021-04523-x Battersby, 2010, Susceptibility to invasive bacterial infections in children with sickle cell disease, Pediatr Blood Cancer, 55, 401, 10.1002/pbc.22461 Oligbu, 2019, Risk of invasive pneumococcal disease in children with sickle cell disease in the era of conjugate vaccines: a systematic review of the literature, Br J Haematol, 185, 743, 10.1111/bjh.15846 Pearson, 1977, Sickle cell anemia and severe infections due to encapsulated bacteria, J Infect Dis, 136, S25, 10.1093/infdis/136.Supplement.S25 Centers for Disease C, Prevention, 2013, Use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine among children aged 6-18 years with immunocompromising conditions: recommendations of the Advisory Committee on Immunization Practices (ACIP), MMWR Morb Mortal Wkly Rep, 62, 521 Centers for Disease Control and Prevention (CDC) . Complications and treatments of sickle cell disease. 2020. Available at:https://www.cdc.gov/ncbddd/sicklecell/treatments.html#Infection. Adamkiewicz, 2008, Effectiveness of the 7-valent pneumococcal conjugate vaccine in children with sickle cell disease in the first decade of life, Pediatrics, 121, 562, 10.1542/peds.2007-0018 De Montalembert, 2015, 13-valent pneumococcal conjugate vaccine (PCV13) is immunogenic and safe in children 6-17 years of age with sickle cell disease previously vaccinated with 23-valent pneumococcal polysaccharide vaccine (PPSV23): Results of a phase 3 study, Pediatr Blood Cancer, 62, 1427, 10.1002/pbc.25502 Nuorti, 2010, Prevention of pneumococcal disease among infants and children - use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine - recommendations of the advisory committee on immunization practices (ACIP), MMWR Recomm Rep, 59, 1 McCavit, 2012, Hospitalization for invasive pneumococcal disease in a national sample of children with sickle cell disease before and after PCV7 licensure, Pediatr Blood Cancer, 58, 945, 10.1002/pbc.23259 Yawn, 2014, Management of sickle cell disease: summary of the 2014 evidence-based report by expert panel members, JAMA, 312, 1033, 10.1001/jama.2014.10517 McCavit, 2011, Increase in invasive Streptococcus pneumoniae infections in children with sickle cell disease since pneumococcal conjugate vaccine licensure, J Pediatr, 158, 505, 10.1016/j.jpeds.2010.11.025 Balsells, 2017, Serotype distribution of Streptococcus pneumoniae causing invasive disease in children in the post-PCV era: A systematic review and meta-analysis, PLoS One, 12, e0177113, 10.1371/journal.pone.0177113 Moore, 2015, Effect of use of 13-valent pneumococcal conjugate vaccine in children on invasive pneumococcal disease in children and adults in the USA: analysis of multisite, population-based surveillance, Lancet Infect Dis, 15, 301, 10.1016/S1473-3099(14)71081-3 Tin Tin Htar, 2019, Serotype evolution in Western Europe: perspectives on invasive pneumococcal diseases (IPD), Expert Rev Vaccines, 18, 1145, 10.1080/14760584.2019.1688149 Waight, 2015, Effect of the 13-valent pneumococcal conjugate vaccine on invasive pneumococcal disease in England and Wales 4 years after its introduction: an observational cohort study, Lancet Infect Dis, 15, 535, 10.1016/S1473-3099(15)70044-7 Adamkiewicz, 2021, Population-based surveillance of pneumococcal infections in children with sickle cell disease before and after prevnar 7® and prevnar 13® licensure: implications for expanded vaccination, Blood, 138, 763, 10.1182/blood-2021-154474 Platt, 2022, A phase 3 trial of safety, tolerability, and immunogenicity of V114, 15-valent pneumococcal conjugate vaccine, compared with 13-valent pneumococcal conjugate vaccine in adults 50 years of age and older (PNEU-AGE), Vaccine, 40, 162, 10.1016/j.vaccine.2021.08.049 Platt, 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, Pediatr Infect Dis J, 39, 763, 10.1097/INF.0000000000002765 Rupp, 2019, A dose ranging study of 2 different formulations of 15-valent pneumococcal conjugate vaccine (PCV15) in healthy infants, Hum Vaccin Immunother, 15, 549, 10.1080/21645515.2019.1568159 Nolan, 2020, Optimization and validation of a microcolony multiplexed opsonophagocytic killing assay for 15 pneumococcal serotypes, Bioanalysis, 12, 1003, 10.4155/bio-2020-0024 Nolan, 2020, Enhanced antipneumococcal antibody electrochemiluminescence assay: validation and bridging to the WHO reference ELISA, Bioanalysis, 12, 1363, 10.4155/bio-2020-0023 Collett, 1999, Modelling Binary Data, 17 O'Brien, 2000, Safety and immunogenicity of heptavalent pneumococcal vaccine conjugated to CRM(197) among infants with sickle cell disease. Pneumococcal conjugate vaccine study group, Pediatrics, 106, 965, 10.1542/peds.106.5.965 Sirima, 2017, Immunogenicity and safety of 10-valent pneumococcal nontypeable haemophilus influenzae protein D conjugate vaccine (PHiD-CV) administered to children with sickle cell disease between 8 weeks and 2 years of age: a phase III, open, controlled study, Pediatr Infect Dis J, 36, e136, 10.1097/INF.0000000000001518 McFetridge, 2015, Safety, tolerability, and immunogenicity of 15-valent pneumococcal conjugate vaccine in healthy adults, Vaccine, 33, 2793, 10.1016/j.vaccine.2015.04.025 Yeh, 2010, Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in infants and toddlers, Pediatrics, 126, e493, 10.1542/peds.2009-3027 Rankine-Mullings, 2021, Prophylactic antibiotics for preventing pneumococcal infection in children with sickle cell disease, Cochrane Database Syst Rev, 3, CD003427 Mohapi, 2022, Safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, in adults living with HIV, AIDS, 36, 373, 10.1097/QAD.0000000000003126 Kobayashi, 2022, Use of 15-valent pneumococcal conjugate vaccine and 20-valent pneumococcal conjugate vaccine among U.S. adults: updated recommendations of the advisory committee on immunization practices - United States, 2022, MMWR Morb Mortal Wkly Rep, 71, 109, 10.15585/mmwr.mm7104a1
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Blood Advances

Tập 7

414-421

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