Key result
PER.C6-based Sabin-IPV was well tolerated and highly immunogenic in adults, yielding post-vaccination geometric mean titers ≥12,000 that were similar to conventional Salk-IPV.
Why the study?
To evaluate the safety and immunogenicity of a new inactivated poliovirus vaccine candidate based on Sabin strains grown on the PER.C6 cell line.
Does a single dose of PER.C6-based Sabin-IPV provide comparable immunogenicity and safety to conventional Salk-IPV in healthy adults?
RCT (n=32)
1:1
No
Does a single dose of PER.C6-based Sabin-IPV provide comparable immunogenicity and safety to conventional Salk-IPV in healthy adults?
The new PER.C6-based Sabin-IPV candidate is well tolerated and highly immunogenic in adults, demonstrating comparable neutralizing antibody responses to conventional Salk-IPV.
Answers are grounded in this paper and cite their sources.
Supports progression to pediatric trials; extends RCT evidence for scalable Sabin-IPV platforms.
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® 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®-based sIPV was well tolerated and highly immunogenic in adults with preexisting antibodies to poliovirus.
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Leroux‐Roels et al. (2020) conducted an RCT in Healthy adults (n=32). PER.C6-based Sabin-IPV (sIPV) vs. conventional Salk-IPV (cIPV, 40:8:32 DU/dose) was evaluated on Reactogenicity up to 7 days, immunogenicity at 28 days, and safety up to 6 months. PER.C6-based Sabin-IPV was well tolerated and highly immunogenic in adults, yielding post-vaccination geometric mean titers ≥12,000 that were similar to conventional Salk-IPV.
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