Evidence map›Paper›PMID 32167011›Full record

Trial reportGut microbes2020

Oral delivery of Hyperimmune bovine serum antibodies against CS6-expressing enterotoxigenic

K R Talaat, C K Porter, A L Bourgeois, T K Lee, C A Duplessis, M Maciel, R L Gutierrez, B DeNearing, B Adjoodani, R Adkinson and 16 more

Open access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Gut microbes, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.2field-weighted citation impact, top 40% 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

7 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
  2. Article
  3. The Controlled Human Infection Model for Enterotoxigenic Escherichia coli.Current topics in microbiology and immunology · 2024
    Review
  4. Article
  5. Review
  6. Confronting challenges to enterotoxigenicFrontiers in tropical diseases · 2021
    Article
  7. EnterotoxigenicGut microbes
    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

26 authors at 4 institutions in 1 country.

K R TalaatBloomberg School of Public Health, Johns Hopkins University , Baltimore, MD, USA.ORCID 0000-0002-4899-6260
C K PorterEnteric Diseases Department, Naval Medical Research Center , Silver Spring, MD, USA.
A L BourgeoisBloomberg School of Public Health, Johns Hopkins University , Baltimore, MD, USA.
T K LeeEnteric Diseases Department, Naval Medical Research Center , Silver Spring, MD, USA.
C A DuplessisEnteric Diseases Department, Naval Medical Research Center , Silver Spring, MD, USA.
M MacielThe Henry M. Jackson Foundation , Bethesda, MD, USA.ORCID 0000-0003-4877-9458
R L GutierrezEnteric Diseases Department, Naval Medical Research Center , Silver Spring, MD, USA.
B DeNearingBloomberg School of Public Health, Johns Hopkins University , Baltimore, MD, USA.
B AdjoodaniBloomberg School of Public Health, Johns Hopkins University , Baltimore, MD, USA.
R AdkinsonBloomberg School of Public Health, Johns Hopkins University , Baltimore, MD, USA.
K J TestaThe Henry M. Jackson Foundation , Bethesda, MD, USA.
B FeijooBloomberg School of Public Health, Johns Hopkins University , Baltimore, MD, USA.
A N AlcalaThe Henry M. Jackson Foundation , Bethesda, MD, USA.
J BrubakerBloomberg School of Public Health, Johns Hopkins University , Baltimore, MD, USA.
A BeselmanBloomberg School of Public Health, Johns Hopkins University , Baltimore, MD, USA.
S ChakrabortyBloomberg School of Public Health, Johns Hopkins University , Baltimore, MD, USA.
D SackBloomberg School of Public Health, Johns Hopkins University , Baltimore, MD, USA.
J HalpernBloomberg School of Public Health, Johns Hopkins University , Baltimore, MD, USA.
S TropThe Henry M. Jackson Foundation , Bethesda, MD, USA.
H WuSAB Biotherapeutics Inc , Sioux Falls, SD, USA.
J JiaoSAB Biotherapeutics Inc , Sioux Falls, SD, USA.
E SullivanSAB Biotherapeutics Inc , Sioux Falls, SD, USA.ORCID 0000-0001-7468-2006
M S RiddleEnteric Diseases Department, Naval Medical Research Center , Silver Spring, MD, USA.
S S JosephThe Henry M. Jackson Foundation , Bethesda, MD, USA.
S T PooleThe Henry M. Jackson Foundation , Bethesda, MD, USA.ORCID 0000-0002-8047-2651
M G ProutyEnteric Diseases Department, Naval Medical Research Center , Silver Spring, MD, USA.
Johns Hopkins University · USHenry M. Jackson Foundation · USNaval Medical Research Command · USSab Biotherapeutics (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

background. Oral administration of bovine antibodies active against enterotoxigenic

methods. This was a randomized, double-blind, placebo-controlled trial in which healthy adults received oral hyperimmune BSIgG anti-CS6, anti-B7A whole cell killed or non-hyperimmune BSIgG (placebo) in a 1:1:1 ratio then challenged with ETEC B7A. Two days pre-challenge, volunteers began a thrice daily, seven day course of immunoprophylaxis. On day 3, subjects received 1 × 10

results. A total of 59 volunteers received product and underwent ETEC challenge. The BSIgG products were well-tolerated across all subjects. Upon challenge, 14/20 (70%) placebo recipients developed MSD, compared to 12/19 (63%;

conclusions. Bovine-derived serum antibodies appear safe and well tolerated. Antibodies derived from cattle immunized with whole cell B7A provided 50% protection against MSD following B7A challenge; however, no protection was observed in subjects receiving serum antibodies targeting CS6. The lack of observed efficacy in this group may be due to low CS6 surface expression on B7A, the high dose challenge inoculum and/or the use of serum derived antibodies versus colostrum-derived antibodies.

Indexed as

AdolescentAdultAnimalsAntibodies, BacterialAntigens, BacterialCattleDiarrheaDouble-Blind MethodEnterotoxigenic Escherichia coliEnterotoxinsEscherichia coli InfectionsEscherichia coli ProteinsEscherichia coli VaccinesFemaleHumansImmunoglobulin GAntibodies, BacterialAntigens, BacterialCS6 antigen, E coliEnterotoxinsEscherichia coli ProteinsEscherichia coli VaccinesImmunoglobulin GPlaceboscontrolled human infection modeldiarrheaEnterotoxigenic Escherichia colipassive prophylaxis

Identifiers

PMID32167011
PMCPMC7524165
OpenAlexW3012449693

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.