PMID- 33175637
OWN - NLM
STAT- MEDLINE
DCOM- 20210705
LR  - 20231111
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 17
IP  - 5
DP  - 2021 May 4
TI  - Safety and immunogenicity of a new Sabin inactivated poliovirus vaccine candidate 
      produced on the PER.C6(R) cell-line: a phase 1 randomized controlled trial in 
      adults.
PG  - 1366-1373
LID - 10.1080/21645515.2020.1812315 [doi]
AB  - This first-in-human study (NCT03032588), conducted in Belgium, evaluated a new 
      inactivated poliovirus vaccines (IPV) candidate based on Sabin poliovirus strains 
      grown on the high-yield PER.C6(R) cell line. Healthy adults (N = 32) were 
      randomized (1:1) to receive a single dose of PER.C6-based Sabin-IPV (sIPV, 
      15:35:112.5 DU/dose) or conventional Salk-IPV (cIPV, 40:8:32 DU/dose). 
      Reactogenicity was assessed up to 7 days after vaccination, immunogenicity 
      28 days after vaccination, and safety up to 6 months after vaccination.Solicited 
      adverse events (AEs) were mild to moderate, no changes of concern in vital signs 
      or safety laboratory values were observed, and no severe AEs (SAEs) or 
      vaccine-related unsolicited AEs were reported after vaccination. A trend to more 
      frequent solicited AEs after sIPV than after cIPV administration was observed. 
      Most participants had preexisting neutralizing antibodies against poliovirus 
      types (titer >/=8), which were strongly boosted by sIPV. Post-vaccination geometric 
      mean titers were high (>/=12,000) and similar across the two vaccination groups. 
      Only participants with very high preexisting antibody levels did not show a 
      vaccine-induced response, defined in seropositive participants as a 4-fold titer 
      increase. The 10 initially seronegative (titer <8) participants (n = 5 in each 
      study group) seroconverted and all participants had seroprotective antibody 
      levels post-vaccination. The antibodies elicited by sIPV neutralized both Sabin 
      and Salk poliovirus strains.In conclusion, the PER.C6(R)-based sIPV was well 
      tolerated and highly immunogenic in adults with preexisting antibodies to 
      poliovirus.
FAU - Leroux-Roels, Isabel
AU  - Leroux-Roels I
AD  - Center for Vaccinology, Ghent University and Ghent University Hospital, Ghent, 
      Belgium.
FAU - Leroux-Roels, Geert
AU  - Leroux-Roels G
AUID- ORCID: 0000-0001-5968-2542
AD  - Center for Vaccinology, Ghent University and Ghent University Hospital, Ghent, 
      Belgium.
FAU - Shukarev, Georgi
AU  - Shukarev G
AD  - Janssen Vaccines AG, Bern, Switzerland.
FAU - Schuitemaker, Hanneke
AU  - Schuitemaker H
AUID- ORCID: 0000-0001-8563-2266
AD  - Janssen Vaccines & Prevention B.V., Leiden, The Netherlands.
FAU - Cahill, Conor
AU  - Cahill C
AUID- ORCID: 0000-0001-7108-1168
AD  - Takeda Pharmaceuticals, Zurich, Switzerland.
FAU - de Rooij, Richard
AU  - de Rooij R
AUID- ORCID: 0000-0003-2255-2810
AD  - Takeda Pharmaceuticals, Zurich, Switzerland.
FAU - Struijs, Martin
AU  - Struijs M
AD  - Janssen Vaccines & Prevention B.V., Leiden, The Netherlands.
FAU - van Zeeburg, Hester
AU  - van Zeeburg H
AD  - DCPrime BV, 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
SI  - ClinicalTrials.gov/NCT03032588
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20201111
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (Antibodies, Viral)
RN  - 0 (Poliovirus Vaccine, Inactivated)
RN  - 0 (Poliovirus Vaccine, Oral)
SB  - IM
MH  - Adult
MH  - Antibodies, Viral
MH  - Belgium
MH  - Cell Line
MH  - Humans
MH  - Immunogenicity, Vaccine
MH  - *Poliomyelitis
MH  - *Poliovirus
MH  - Poliovirus Vaccine, Inactivated
MH  - Poliovirus Vaccine, Oral
PMC - PMC8078678
OTO - NOTNLM
OT  - IPV
OT  - Inactivated
OT  - PER.C6
OT  - Sabin
OT  - poliovirus
OT  - vaccine
EDAT- 2020/11/12 06:00
MHDA- 2021/07/06 06:00
PMCR- 2020/11/11
CRDT- 2020/11/11 17:12
PHST- 2020/11/12 06:00 [pubmed]
PHST- 2021/07/06 06:00 [medline]
PHST- 2020/11/11 17:12 [entrez]
PHST- 2020/11/11 00:00 [pmc-release]
AID - 1812315 [pii]
AID - 10.1080/21645515.2020.1812315 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2021 May 4;17(5):1366-1373. doi: 
      10.1080/21645515.2020.1812315. Epub 2020 Nov 11.