Evidence map›Paper›PMID 27470209›Full record

ArticleVaccine2016

Incompatibility of lyophilized inactivated polio vaccine with liquid pentavalent whole-cell-pertussis-containing vaccine.

Heleen Kraan, Rimko Ten Have, Larissa van der Maas, Gideon Kersten, Jean-Pierre Amorij

Open access · hybridAbstract read
In one paragraph

Article in Vaccine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.1field-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

5 citing papers in PubMed, 12 citations in OpenAlex.

  1. Article
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  4. Review
  5. Article
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

5 authors at 2 institutions in 1 country.

Heleen KraanIntravacc (Institute for Translational Vaccinology), Antonie van Leeuwenhoeklaan 9, P.O. Box 450, 3720 AL Bilthoven, The Netherlands.
Rimko Ten HaveIntravacc (Institute for Translational Vaccinology), Antonie van Leeuwenhoeklaan 9, P.O. Box 450, 3720 AL Bilthoven, The Netherlands. Electronic address: rimko.ten.have@intravacc.nl.
Larissa van der MaasIntravacc (Institute for Translational Vaccinology), Antonie van Leeuwenhoeklaan 9, P.O. Box 450, 3720 AL Bilthoven, The Netherlands.
Gideon KerstenIntravacc (Institute for Translational Vaccinology), Antonie van Leeuwenhoeklaan 9, P.O. Box 450, 3720 AL Bilthoven, The Netherlands; Division of Drug Delivery Technology, Leiden Academic Center for Drug Research, Leiden University, Leiden, The Netherlands.
Jean-Pierre AmorijIntravacc (Institute for Translational Vaccinology), Antonie van Leeuwenhoeklaan 9, P.O. Box 450, 3720 AL Bilthoven, The Netherlands. Electronic address: jp.amorij@virtuvax.nl.
Intravacc (Netherlands) · NLLeiden University · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A hexavalent vaccine containing diphtheria toxoid, tetanus toxoid, whole cell pertussis, Haemophilius influenza type B, hepatitis B and inactivated polio vaccine (IPV) may: (i) increase the efficiency of vaccination campaigns, (ii) reduce the number of injections thereby reducing needlestick injuries, and (iii) ensure better protection against pertussis as compared to vaccines containing acellular pertussis antigens. An approach to obtain a hexavalent vaccine might be reconstituting lyophilized polio vaccine (IPV-LYO) with liquid pentavalent vaccine just before intramuscular delivery. The potential limitations of this approach were investigated including thermostability of IPV as measured by D-antigen ELISA and rat potency, the compatibility of fluid and lyophilized IPV in combination with thimerosal and thimerosal containing hexavalent vaccine. The rat potency of polio type 3 in IPV-LYO was 2 to 3-fold lower than standardized on the D-antigen content, suggesting an alteration of the polio type 3 D-antigen particle by lyophilization. Type 1 and 2 had unaffected antigenicity/immunogenicity ratios. Alteration of type 3 D-antigen could be detected by showing reduced thermostability at 45°C compared to type 3 in non-lyophilized liquid controls. Reconstituting IPV-LYO in the presence of thimerosal (TM) resulted in a fast temperature dependent loss of polio type 1-3 D-antigen. The presence of 0.005% TM reduced the D-antigen content by ∼20% (polio type 2/3) and ∼60% (polio type 1) in 6h at 25°C, which are WHO open vial policy conditions. At 37°C, D-antigen was diminished even faster, suggesting that very fast, i.e., immediately after preparation, intramuscular delivery of the conceived hexavalent vaccine would not be a feasible option. Use of the TM-scavenger, l-cysteine, to bind TM (or mercury containing TM degradation products), resulted in a hexavalent vaccine mixture in which polio D-antigen was more stable.

Indexed as

Immunogenicity, VaccineVaccine PotencyAnimalsDiphtheria-Tetanus-Pertussis VaccineFreeze DryingHaemophilus VaccinesHepatitis B VaccinesPoliovirus Vaccine, InactivatedRatsTemperatureThimerosaldiphtheria-tetanus-acellular pertussis-Hib-hepatitis B vaccineDiphtheria-Tetanus-Pertussis VaccineHaemophilus VaccinesHepatitis B VaccinesPoliovirus Vaccine, InactivatedThimerosalHexavalent vaccineInactivated polio vaccineLyophilizationRat potencyThimerosal

Identifiers

PMID27470209
PMCPMC5009896
OpenAlexW2476461671

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.