Evidence map›Paper›PMID 30402384›Full record

ArticleOsong public health and research perspectives2018

Evaluation of Potency on Diphtheria and Tetanus Toxoid for Adult Vaccines by In Vivo Toxin Neutralization Assay Using National Reference Standards.

Chan Woong Choi, Jae Hoon Moon, Jae Ok Kim, Si Hyung Yoo, Hyeon Guk Kim, Jung-Hwan Kim, Tae Jun Park, Sung Soon Kim

Erratum issuedOpen access · diamondAbstract read
In one paragraph

Article in Osong public health and research perspectives, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.4field-weighted citation impact, top 37% 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

2 citing papers in PubMed, 5 citations in OpenAlex.

  1. Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 1 country.

Chan Woong ChoiBiologics Research Division, National Institute of Food and Drug Safety Evaluation, Cheongju, Korea.
Jae Hoon MoonGreen Cross Research Center, Yongin, Korea.
Jae Ok KimBiologics Research Division, National Institute of Food and Drug Safety Evaluation, Cheongju, Korea.
Si Hyung YooBiologics Research Division, National Institute of Food and Drug Safety Evaluation, Cheongju, Korea.
Hyeon Guk KimBiologics Division, National Institute of Food and Drug Safety Evaluation, Cheongju, Korea.
Jung-Hwan KimVaccines Division, National Institute of Food and Drug Safety Evaluation, Cheongju, Korea.
Tae Jun ParkBiologics Research Division, National Institute of Food and Drug Safety Evaluation, Cheongju, Korea.
Sung Soon KimBiologics Research Division, National Institute of Food and Drug Safety Evaluation, Cheongju, Korea.
National Institute of Food and Drug Safety Evaluation · KRGreen Cross (South Korea) · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesVaccinations against diphtheria and tetanus are essential in providing immunity against these bacterial infections. The potency of diphtheria and tetanus toxoid vaccines can be measured using the in vivo toxin neutralization assay. The limit of potency of this assay was determined only for children. Therefore, we assessed the potency of adult vaccines using this assay to identify the feasibility of limit for adult vaccines.

methodsFifteen lots of tetanus-reduced diphtheria and tetanus-diphtheria-acellular pertussis vaccines were used. In vivo toxin neutralization and lethal challenge assays were conducted on each vaccine to calculate the potencies of the toxoids. National reference standards for toxins and antitoxins were used for in vivo toxin neutralization assay.

resultsAll 15 lots satisfied the limits of potency for lethal challenge assay. The potency of diphtheria and tetanus toxoids exceeded 1 and 8 units/mL, respectively, for in vivo toxin neutralization assay.

conclusionAlthough additional studies are required for new assays and limits, the current level of potency for adult vaccines as determined by in vivo toxin neutralization assay, was demonstrated in this study. Such efforts to improve assays are expected to promote the development of diphtheria and tetanus vaccines for adults and to contribute to vaccine self-sufficiency.

Indexed as

diphtheria toxoidpotencytetanus toxoidvaccine

Identifiers

PMID30402384
PMCPMC6202014
OpenAlexW2898235454

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.