PMID- 36383730
OWN - NLM
STAT- MEDLINE
DCOM- 20230208
LR  - 20230304
IS  - 2473-9537 (Electronic)
IS  - 2473-9529 (Print)
IS  - 2473-9529 (Linking)
VI  - 7
IP  - 3
DP  - 2023 Feb 14
TI  - Safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, in 
      children with SCD: a V114-023 (PNEU-SICKLE) study.
PG  - 414-421
LID - 10.1182/bloodadvances.2022008037 [doi]
AB  - Sickle 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.
CI  - (c) 2023 by The American Society of Hematology. Licensed under Creative Commons 
      Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0), 
      permitting only noncommercial, nonderivative use with attribution. All other 
      rights reserved.
FAU - Quinn, Charles T
AU  - Quinn CT
AUID- ORCID: 0000-0002-2372-2175
AD  - Cincinnati Children's Hospital Medical Center and University of Cincinnati 
      College of Medicine, Cincinnati, OH.
FAU - Wiedmann, Richard T
AU  - Wiedmann RT
AUID- ORCID: 0000-0003-1069-466X
AD  - Merck & Co, Inc, Rahway, NJ.
FAU - Jarovsky, Daniel
AU  - Jarovsky D
AUID- ORCID: 0000-0002-4825-7396
AD  - Santa Casa de Sao Paulo, Sao Paulo, Brazil.
FAU - Lopez-Medina, Eduardo
AU  - Lopez-Medina E
AUID- ORCID: 0000-0003-3066-5938
AD  - Centro de Estudios en Infectologia Pediatrica, Department of Pediatrics 
      Universidad del Valle and Clinica Imbanaco Grupo Quironsalud, Cali, Valle del 
      Cauca, Colombia.
FAU - Rodriguez, Hilze M
AU  - Rodriguez HM
AD  - Hospital del Nino Jose Renan Esquivel, Ciudad de Panama, Panama.
FAU - Papa, Melanie
AU  - Papa M
AD  - Merck & Co, Inc, Rahway, NJ.
FAU - Boggio, Gordana
AU  - Boggio G
AD  - Merck & Co, Inc, Rahway, NJ.
FAU - Shou, Qiong
AU  - Shou Q
AD  - Merck & Co, Inc, Rahway, NJ.
FAU - Dagan, Ron
AU  - Dagan R
AD  - The Shraga Segal Dept. of Microbiology, Immunology and Genetics, Faculty of 
      Health Sciences of the Ben-Gurion University of the Negev, Beer-Sheva, Israel.
FAU - Richmond, Peter
AU  - Richmond P
AUID- ORCID: 0000-0001-7562-7228
AD  - University of Western Australia School of Medicine, Perth, Australia.
FAU - Feemster, Kristen
AU  - Feemster K
AD  - Merck & Co, Inc, Rahway, NJ.
FAU - McFetridge, Richard
AU  - McFetridge R
AD  - Merck & Co, Inc, Rahway, NJ.
FAU - Tamms, Gretchen
AU  - Tamms G
AD  - Merck & Co, Inc, Rahway, NJ.
FAU - Lupinacci, Robert
AU  - Lupinacci R
AD  - Merck & Co, Inc, Rahway, NJ.
FAU - Musey, Luwy
AU  - Musey L
AD  - Merck & Co, Inc, Rahway, NJ.
FAU - Bickham, Kara
AU  - Bickham K
AD  - Merck & Co, Inc, Rahway, NJ.
LA  - eng
SI  - ClinicalTrials.gov/NCT03731182
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Blood Adv
JT  - Blood advances
JID - 101698425
RN  - 0 (Antibodies, Bacterial)
RN  - 0 (Immunoglobulin G)
RN  - 0 (Pneumococcal Vaccines)
RN  - 0 (Vaccines, Conjugate)
SB  - IM
MH  - Adult
MH  - Child
MH  - Humans
MH  - *Anemia, Sickle Cell
MH  - Antibodies, Bacterial
MH  - Immunoglobulin G
MH  - *Pneumococcal Infections/prevention & control/chemically induced
MH  - *Pneumococcal Vaccines/adverse effects
MH  - *Vaccines, Conjugate/adverse effects
MH  - Adolescent
PMC - PMC9979710
COIS- Conflict-of-interest disclosure: R.T.W., M.P., G.B., Q.S., K.F., R.M., G.T., 
      R.L., and L.M. are employees of Merck Sharp & Dohme LLC, a subsidiary of Merck & 
      Co, Inc, Rahway, NJ, and may hold stock in Merck & Co, Inc, Rahway, NJ. K.B. was 
      an employee of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, 
      NJ at the time of the study, may hold stock in Merck & Co, Inc, Rahway, NJ, and 
      is currently employed by Affinivax Inc. D.J. has received i) speaker honoraria 
      from Pfizer, GlaxoSmithKline, Janssen, Sanofi, Abbott, and Merck Sharp & Dohme 
      LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ, ii) honoraria as a clinical 
      trial investigator from Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, 
      Rahway, NJ, iii) honoraria as a clinical trial investigator from GlaxoSmithKline, 
      Takeda, and Janssen outside the submitted work, and iv) an institutional research 
      grant from Pfizer outside the submitted work. R.D. reports grants or contracts 
      from Pfizer, Medimmune, and Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, 
      Inc, Rahway, NJ; consulting fees from Pfizer, Biondvax, MeMed, and Merck Sharp & 
      Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ; serving on advisory 
      boards of Pfizer, Biondvax, and Merck Sharp & Dohme LLC, a subsidiary of Merck & 
      Co, Inc, Rahway, NJ; providing expert testimony for Pfizer; and participating on 
      an advisory board for Pfizer, Biondvax, and Merck Sharp & Dohme LLC, a subsidiary 
      of Merck & Co, Inc, Rahway, NJ. P.R. has served on vaccine advisory boards for 
      Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ, Pfizer, and 
      GlaxoSmithKline, and received institutional grant funding from GlaxoSmithKline 
      and Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ, outside 
      the submitted work. The remaining authors declare no competing financial 
      interests.
EDAT- 2022/11/17 06:00
MHDA- 2023/02/08 06:00
PMCR- 2022/11/21
CRDT- 2022/11/16 14:23
PHST- 2022/09/30 00:00 [accepted]
PHST- 2022/05/09 00:00 [received]
PHST- 2022/11/17 06:00 [pubmed]
PHST- 2023/02/08 06:00 [medline]
PHST- 2022/11/16 14:23 [entrez]
PHST- 2022/11/21 00:00 [pmc-release]
AID - 493243 [pii]
AID - 10.1182/bloodadvances.2022008037 [doi]
PST - ppublish
SO  - Blood Adv. 2023 Feb 14;7(3):414-421. doi: 10.1182/bloodadvances.2022008037.