Evidence map›Paper›PMID 27960629›Full record

ArticleHuman vaccines & immunotherapeutics2017

Preclinical study and clinical trial of a novel therapeutic vaccine against multi-drug resistant tuberculosis.

Masaji Okada, Yoko Kita, Satomi Hashimoto, Hitoshi Nakatani, Shiho Nishimastu, Yumiko Kioka, Yasuko Takami

Open access · bronzeAbstract read
In one paragraph

Article in Human vaccines & immunotherapeutics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.2field-weighted citation impact, top 36% 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

3 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
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

7 authors at 1 institution in 1 country.

Masaji Okadaa Clinical Research Center, National Hospital Organization Kinki-chuo Chest Medical Center , Kita-ku, Sakai City , Osaka , Japan.
Yoko Kitaa Clinical Research Center, National Hospital Organization Kinki-chuo Chest Medical Center , Kita-ku, Sakai City , Osaka , Japan.
Satomi Hashimotoa Clinical Research Center, National Hospital Organization Kinki-chuo Chest Medical Center , Kita-ku, Sakai City , Osaka , Japan.
Hitoshi Nakatania Clinical Research Center, National Hospital Organization Kinki-chuo Chest Medical Center , Kita-ku, Sakai City , Osaka , Japan.
Shiho Nishimastua Clinical Research Center, National Hospital Organization Kinki-chuo Chest Medical Center , Kita-ku, Sakai City , Osaka , Japan.
Yumiko Kiokaa Clinical Research Center, National Hospital Organization Kinki-chuo Chest Medical Center , Kita-ku, Sakai City , Osaka , Japan.
Yasuko Takamia Clinical Research Center, National Hospital Organization Kinki-chuo Chest Medical Center , Kita-ku, Sakai City , Osaka , Japan.
National Kinki Chuo Hospital for Chest Disease · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

[Purpose] Multi-drug resistant (MDR), Mycobacterium tuberculosis (TB) is a big problem in the world. We have developed novel TB therapeutic vaccine (HVJ-E/HSP65 DNA +IL-12 DNA). [Methods and Results] DNA vaccine expressing TB heat shock protein 65 and IL-12 was delivered by the hemagglutinating virus of Japan (HVJ)-envelope. This vaccine provided remarkable protective efficacy and strong therapeutic efficacy against MDR-TB and XDR-TB in murine models. Furthermore, this vaccine provided therapeutic efficacy of prolongation of survival time of TB infected monkeys and augmented the immune responses. Therefore, the preclinical tests were studied for clinical trial. The injection of 100 μg of the vaccine /mouse i.m. three times in two weeks induced significantly strong production of IFN-γ and IL-2. 100 μg and 200 μg DNA vaccine/mouse i.m. augmented the production of these cytokines compared with 25 μg DNA vaccine/mouse i.m.. The ratio of 100 μg pDNA to 1AU HVJ-E enhanced the production of IFN-γ and IL-2. The decrease in the number of M. tuberculosis in liver of mice was observed by the vaccination of 100μg pDNA. By using these conditions, safety pharmacology study and toxicology test is being studied in monkeys administered by GMP level DNA vaccines. By the toxicology test using monkeys, high dose GMP level vaccine/ monkey is administrated. Safety pharmacological study of repeated administration is also being investigated in GLP level. Furthermore, we have planned to do clinical phase I trial. Targets are human patients with MDR-TB. The safety and tolerability of the vaccine will be evaluated. [Conclusion and recommendations] These data indicate that our novel vaccine might be useful against tuberculosis including XDR-TB and MDR-TB for human therapeutic clinical applications.

Indexed as

AnimalsBacterial LoadClinical Trials, Phase I as TopicDisease Models, AnimalDrug Evaluation, PreclinicalFemaleHaplorhiniImmunotherapyJapanLiverMice, Inbred BALB CMice, Inbred C57BLMycobacterium tuberculosisTreatment OutcomeTuberculosis, Multidrug-ResistantTuberculosis VaccinesTuberculosis VaccinesVaccines, DNAclinical trialcytokines (IFN-γIL-2IL-6)immune responses against TBmouse and monkeymulti-drug resistant tuberculosismycobacterium tuberculosis (M. TB)pharmacological efficacypreclinical studytherapeutic vaccineXDR-TB

Identifiers

PMID27960629
PMCPMC5328238
OpenAlexW2566112953

What OpenQuestion holds

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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.