Evidence map›Paper›PMID 31809644›Full record

ArticleHuman vaccines & immunotherapeutics2020

Effect of freezing on recombinant hepatitis E vaccine.

Kelei Li, Fangyu Dong, Fan Gao, Lianlian Bian, Shiyang Sun, Ruixiao Du, Yalin Hu, Qunying Mao, Haifa Zheng, Xing Wu and 1 more

Open access · bronzeAbstract read
In one paragraph

Article in Human vaccines & immunotherapeutics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.3field-weighted citation impact, top 39% 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

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. 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

11 authors at 2 institutions in 1 country.

Kelei LiDivision of Hepatitis Virus Vaccines, National Institute for Food and Drug Control , Beijing, China.
Fangyu DongThe Second Department of Research, Lanzhou Institute of Biological Products Co. Ltd , Lanzhou, China.
Fan GaoDivision of Hepatitis Virus Vaccines, National Institute for Food and Drug Control , Beijing, China.
Lianlian BianDivision of Hepatitis Virus Vaccines, National Institute for Food and Drug Control , Beijing, China.
Shiyang SunDivision of Hepatitis Virus Vaccines, National Institute for Food and Drug Control , Beijing, China.
Ruixiao DuDivision of Hepatitis Virus Vaccines, National Institute for Food and Drug Control , Beijing, China.
Yalin HuQuality Assurance Department, Hualan Biological Engineering Inc , Xinxiang, China.
Qunying MaoDivision of Hepatitis Virus Vaccines, National Institute for Food and Drug Control , Beijing, China.
Haifa ZhengResearch and Development Center, Minhai Biotechnology Co. Ltd , Beijing, China.
Xing WuDivision of Hepatitis Virus Vaccines, National Institute for Food and Drug Control , Beijing, China.
Zhenglun LiangDivision of Hepatitis Virus Vaccines, National Institute for Food and Drug Control , Beijing, China.
National Institutes for Food and Drug Control · CNLanzhou Institute of Husbandry and Pharmaceutical Sciences · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Studies have revealed that vaccines are more often exposed to sub-zero temperatures during cold chain transportation than what was previously known. Such exposure might be detrimental to the potency of temperature-sensitive vaccines. The aim of this study was to evaluate the impact of exposure to freezing on the physicochemical properties and biological activities of recombinant hepatitis E (rHE) vaccine. Changes in rHE vaccine due to freezing temperatures were analyzed with regard to sedimentation rate, antigenicity, and antibody affinity and potency. The freezing temperature of rHE was measured, then rHE vaccine was exposed to freezing temperatures below -10°C.Significant increase of sedimentation rate was noted, according to shake test and massed precipitates. In addition, the binding affinity of rHE vaccine to six specific monoclonal antibodies was significantly reduced and the in vivo potency for eliciting a protective IgG response was also partially lost, especially for anti-HEV neutralizing antibodies. Altogether, our work indicates that exposure of rHE vaccine to a temperature below -10°C results in the loss of structural integrity and biological potency of rHE vaccine.

Indexed as

Hepatitis EVaccinesFreezingHepatitis AntibodiesHumansRefrigerationHepatitis AntibodiesVaccinescold chainfreezing damageHepatitis E vaccinepotencyshake test

Identifiers

PMID31809644
PMCPMC7482780
OpenAlexW2994556475

What OpenQuestion holds

Textmetadata
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.