PMID- 35344464
OWN - NLM
STAT- MEDLINE
DCOM- 20220614
LR  - 20221003
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 18
IP  - 5
DP  - 2022 Nov 30
TI  - Safety and immunogenicity of 3 formulations of a Sabin inactivated poliovirus 
      vaccine produced on the PER.C6(R) cell line: A phase 2, double-blind, randomized, 
      controlled study in infants vaccinated at 6, 10 and 14 weeks of age.
PG  - 2044255
LID - 10.1080/21645515.2022.2044255 [doi]
LID - 2044255
AB  - An inactivated poliovirus vaccine candidate using Sabin strains (sIPV) grown on 
      the PER.C6(R) cell line was assessed in infants after demonstrated immunogenicity 
      and safety in adults. The study recruited 300 infants who were randomized 
      (1:1:1:1) to receive one of 3 dose levels of sIPV or a conventional IPV based on 
      Salk strains (cIPV). Poliovirus-neutralizing antibodies were measured before the 
      first dose and 28 days after the third dose. Reactogenicity was assessed for 7 
      days and unsolicited adverse events (AEs) for 28 days after each vaccination. 
      Serious AEs (SAEs) were recorded throughout the study. Solicited AEs were mostly 
      mild to moderate. None of the SAEs reported in the study were judged vaccine 
      related, including one fatal SAE due to aspiration of vomitus that occurred 26 
      days after the third dose of low-dose sIPV. After 3 sIPV vaccinations and across 
      all dose levels, seroconversion (SC) rates were at least 92% against Sabin 
      poliovirus types and at least 80% against Salk types, with a dose-response in 
      neutralizing antibody geometric mean titers (GMTs) observed across the 3 sIPV 
      groups. Compared to cIPV, the 3 sIPV groups displayed similar or higher SC rates 
      and GMTs against the 3 Sabin types but showed a lower response against Salk types 
      1 and 2; this was most visible for Salk type 1. While the PER.C6(R) cell line-based 
      sIPV showed an acceptable safety profile and immunogenicity in infants, lower 
      seroprotection against type 1 warrants optimization of dose level and additional 
      clinical evaluation.
FAU - Ong-Lim, Anna Lisa
AU  - Ong-Lim AL
AD  - Philippine General Hospital, University of the Philippines Manila, Manila, 
      Philippines.
FAU - Shukarev, Georgi
AU  - Shukarev G
AD  - Janssen Vaccines AG, Bern, Switzerland.
FAU - Trinidad-Aseron, Mitzi
AU  - Trinidad-Aseron M
AD  - De La Salle University Medical Center, Cavite, Philippines.
FAU - Caparas-Yu, Delia
AU  - Caparas-Yu D
AD  - De La Salle Medical and Health Sciences Institute, Cavite, Philippines.
FAU - Greijer, Astrid
AU  - Greijer A
AD  - Janssen Vaccines & Prevention B.V., Leiden, The Netherlands.
FAU - Duchene, Michel
AU  - Duchene M
AD  - Janssen Vaccines & Prevention B.V., Leiden, The Netherlands.
FAU - Scheper, Gert
AU  - Scheper G
AD  - Janssen Vaccines & Prevention B.V., Leiden, The Netherlands.
FAU - van Paassen, Vitalija
AU  - van Paassen V
AD  - Janssen Vaccines & Prevention B.V., Leiden, The Netherlands.
FAU - Le Gars, Mathieu
AU  - Le Gars M
AD  - Janssen Vaccines & Prevention B.V., Leiden, The Netherlands.
FAU - Cahill, Conor P
AU  - Cahill CP
AUID- ORCID: 0000-0001-7108-1168
AD  - Janssen Vaccines & Prevention B.V., Leiden, The Netherlands.
FAU - Schuitemaker, Hanneke
AU  - Schuitemaker H
AUID- ORCID: 0000-0001-8563-2266
AD  - Janssen Vaccines & Prevention B.V., Leiden, The Netherlands.
FAU - Douoguih, Macaya
AU  - Douoguih M
AD  - Janssen Vaccines & Prevention B.V., Leiden, The Netherlands.
FAU - Jacquet, Jeanne-Marie
AU  - Jacquet JM
AUID- ORCID: 0000-0001-7081-7022
AD  - Janssen Vaccines & Prevention B.V., Leiden, The Netherlands.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20220328
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (Antibodies, Neutralizing)
RN  - 0 (Antibodies, Viral)
RN  - 0 (Poliovirus Vaccine, Inactivated)
RN  - 0 (Poliovirus Vaccine, Oral)
SB  - IM
MH  - Adult
MH  - Antibodies, Neutralizing
MH  - Antibodies, Viral
MH  - Cell Line
MH  - Humans
MH  - Immunogenicity, Vaccine
MH  - Infant
MH  - *Poliomyelitis/prevention & control
MH  - *Poliovirus
MH  - Poliovirus Vaccine, Inactivated
MH  - Poliovirus Vaccine, Oral/adverse effects
PMC - PMC9196784
OTO - NOTNLM
OT  - IPV
OT  - Inactivated
OT  - PER.C6(R) cell line
OT  - Sabin
OT  - infants
OT  - poliovirus
OT  - vaccine
COIS- G.Sh., A.G., M.Du., G.Sc., V.v.P., M.L.G., H.S. and M.Do. are full-time employees 
      of the study sponsor. C.P.C. was a full-time employee of the sponsor at the time 
      of the trial, J.-M. J. is an independent consultant under contract with the study 
      sponsor. A.L.O.-L, M.T.-A., and D.C.-Y. have received grants from Janssen 
      Vaccines to finance the conduct of this study in their institution. G.Sh, G.Sc, 
      M.L.G., H.S., and A.G hold shares in Johnson & Johnson.
EDAT- 2022/03/29 06:00
MHDA- 2022/06/15 06:00
PMCR- 2022/03/28
CRDT- 2022/03/28 17:09
PHST- 2022/03/29 06:00 [pubmed]
PHST- 2022/06/15 06:00 [medline]
PHST- 2022/03/28 17:09 [entrez]
PHST- 2022/03/28 00:00 [pmc-release]
AID - 2044255 [pii]
AID - 10.1080/21645515.2022.2044255 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2022 Nov 30;18(5):2044255. doi: 
      10.1080/21645515.2022.2044255. Epub 2022 Mar 28.