Evidence map›Paper›PMID 30314910›Full record

ArticleVaccine2018

An inactivated poliovirus vaccine using Sabin strains produced on the serum-free PER.C6® cell culture platform is immunogenic and safe in a non-human primate model.

Viki Bockstal, Machteld M Tiemessen, Rogier Achterberg, Carlo Van Wordragen, Ad M Knaapen, Jan Serroyen, Wilfred E Marissen, Hanneke Schuitemaker, Roland Zahn

Open access · hybridAbstract read
In one paragraph

Article in Vaccine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.0field-weighted citation impact, top 21% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 14 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 2 institutions in 1 country.

Viki BockstalJanssen Vaccines and Prevention BV, Archimedesweg 4-6, 2333CN Leiden, the Netherlands.
Machteld M TiemessenJanssen Vaccines and Prevention BV, Archimedesweg 4-6, 2333CN Leiden, the Netherlands.
Rogier AchterbergJanssen Vaccines and Prevention BV, Archimedesweg 4-6, 2333CN Leiden, the Netherlands.
Carlo Van WordragenJanssen Vaccines and Prevention BV, Archimedesweg 4-6, 2333CN Leiden, the Netherlands.
Ad M KnaapenJanssen Vaccines and Prevention BV, Archimedesweg 4-6, 2333CN Leiden, the Netherlands.
Jan SerroyenJanssen Vaccines and Prevention BV, Archimedesweg 4-6, 2333CN Leiden, the Netherlands.
Wilfred E MarissenMerus N.V., Yalelaan 62, 3584 CM Utrecht, the Netherlands(2).
Hanneke SchuitemakerJanssen Vaccines and Prevention BV, Archimedesweg 4-6, 2333CN Leiden, the Netherlands.
Roland ZahnJanssen Vaccines and Prevention BV, Archimedesweg 4-6, 2333CN Leiden, the Netherlands. Electronic address: rzahn@its.jnj.com.
Janssen (Netherlands) · NLMerus (Netherlands) · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe World Health Organization recommends the development of affordable next-generation inactivated poliovirus vaccines (IPV) using attenuated poliovirus Sabin strains. Previously, we introduced a novel PER.C6® cell culture platform, which allows for high yield production of an affordable trivalent Sabin IPV vaccine.

methodsImmunogenicity and safety of this novel PER.C6®-based Sabin-IPV (sIPV) was assessed in rats and non-human primates (NHPs). NHPs received one of four different dose dilutions vaccine according to current human schedule (three prime-immunizations and one boost immunization). For comparison, NHPs received commercially available reference Salk IPV or sIPV.

resultsDose-dependent immunogenicity and good tolerability was observed for the PER.C6®-based sIPV formulations in rats and NHPs. In NHPs, the lowest tested dose that induced anti-Sabin virus-neutralizing antibody titers that were non-inferior to commercial sIPV after three immunizations was 5-7.5-25 D-antigen units for type 1, 2 and 3 respectively. DISCUSSION: PER.C6®-based sIPV induced comparable immunogenicity to commercial Salk IPV and sIPV vaccines in NHPs. Together with the absence of any preclinical safety signals, these data warrant further testing in clinical trials. sIPV produced on the PER.C6® cell platform could be one solution to the need for an affordable and immunogenic IPV to achieve and maintain global polio eradication.

Indexed as

AnimalsAntibodies, NeutralizingAntibodies, ViralCell Culture TechniquesCulture Media, Serum-FreeFemaleImmunization ScheduleMacaca fascicularisPoliovirusPoliovirus Vaccine, InactivatedAntibodies, NeutralizingAntibodies, ViralCulture Media, Serum-FreePoliovirus Vaccine, InactivatedImmunogenicityInactivated poliovirus vaccineIPVNon-human primatesSabinSalksIPVToxicityVirus neutralizing assay

Identifiers

PMID30314910
PMCPMC6219454
OpenAlexW2896276166

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.