Evidence map›Paper›PMID 36027906›Full record

Trial reportCell reports. Medicine2022

Multiple BCG vaccinations for the prevention of COVID-19 and other infectious diseases in type 1 diabetes.

Denise L Faustman, Amanda Lee, Emma R Hostetter, Anna Aristarkhova, Nathan C Ng, Gabriella F Shpilsky, Lisa Tran, Grace Wolfe, Hiroyuki Takahashi, Hans F Dias and 4 more

Open access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Cell reports. Medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 1 pooled it
5.5field-weighted citation impact, top 3% 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

44 citing papers in PubMed, 1 synthesis or guideline pooled it, 65 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

14 authors at 2 institutions in 1 country.

Denise L FaustmanMassachusetts General Hospital and Harvard Medical School, Boston, MA 02192, USA. Electronic address: dfaustman@mgh.harvard.edu.
Amanda LeeMassachusetts General Hospital, Boston, MA 02192, USA.
Emma R HostetterMassachusetts General Hospital, Boston, MA 02192, USA.
Anna AristarkhovaMassachusetts General Hospital, Boston, MA 02192, USA.
Nathan C NgMassachusetts General Hospital, Boston, MA 02192, USA.
Gabriella F ShpilskyMassachusetts General Hospital, Boston, MA 02192, USA.
Lisa TranMassachusetts General Hospital, Boston, MA 02192, USA.
Grace WolfeMassachusetts General Hospital, Boston, MA 02192, USA.
Hiroyuki TakahashiMassachusetts General Hospital and Harvard Medical School, Boston, MA 02192, USA.
Hans F DiasMassachusetts General Hospital, Boston, MA 02192, USA.
Joan BraleyMassachusetts General Hospital and Harvard Medical School, Boston, MA 02192, USA.
Hui ZhengMassachusetts General Hospital and Harvard Medical School, Boston, MA 02192, USA.
David A SchoenfeldMassachusetts General Hospital and Harvard Medical School, Boston, MA 02192, USA.
Willem M KühtreiberMassachusetts General Hospital and Harvard Medical School, Boston, MA 02192, USA.
Massachusetts General Hospital · USHarvard University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

There is a need for safe and effective platform vaccines to protect against coronavirus disease 2019 (COVID-19) and other infectious diseases. In this randomized, double-blinded, placebo-controlled phase 2/3 trial, we evaluate the safety and efficacy of a multi-dose Bacillus Calmette-Guérin (BCG) vaccine for the prevention of COVID-19 and other infectious disease in a COVID-19-unvaccinated, at-risk-community-based cohort. The at-risk population is made of up of adults with type 1 diabetes. We enrolled 144 subjects and randomized 96 to BCG and 48 to placebo. There were no dropouts over the 15-month trial. A cumulative incidence of 12.5% of placebo-treated and 1% of BCG-treated participants meets criteria for confirmed COVID-19, yielding an efficacy of 92%. The BCG group also displayed fewer infectious disease symptoms and lesser severity and fewer infectious disease events per patient, including COVID-19. There were no BCG-related systemic adverse events. BCG's broad-based infection protection suggests that it may provide platform protection against new severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants and other pathogens.

Indexed as

Communicable DiseasesCOVID-19Diabetes Mellitus, Type 1Mycobacterium bovisAdultBCG VaccineHumansSARS-CoV-2VaccinationBCG VaccineautoimmuneBacillus Calmette-GuérinBCGClinicaltrials.gov: NCT02081326COVID-19host microbe interactionshygiene hypothesisinfectious diseasesphase 2/3 trialrandomized double blinded clinical trialtype 1 diabetesvaccine

Identifiers

PMID36027906
PMCPMC9376308
OpenAlexW4291891031

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.