Trial reportThe Journal of infectious diseases2026
Evaluation of the Safety, Genetic Stability, and Immunogenicity of an Attenuated Shigella Live Vector Expressing Enterotoxigenic Escherichia coli Antigens, Vaccine Strain CVD 1208S-122.
Trial report in The Journal of infectious diseases, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04634513 (Phase 1 Study of the Safety, Tolerability, and Immunogenicity of Oral Doses of CVD 1208S-122, a Prototype Attenuated Shigella Flexneri 2a Live Vector Expressing Enterotoxigenic Escherichia Coli Antigens), which is not on this map. Not yet cited in PubMed.
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1 · What the graph read from it
What it found
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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.
Phase 1 Study of the Safety, Tolerability, and Immunogenicity of Oral Doses of CVD 1208S-122, a Prototype Attenuated Shigella Flexneri 2a Live Vector Expressing Enterotoxigenic Escherichia Coli Antigens
TypeinterventionalSponsorUniversity of Maryland, BaltimoreRan2022 to 2024Enrolled53ConditionsShigella Infection, Enterotoxigenic Escherichia Coli InfectionArmsstrain CVD 1208S-122, Placebo
Wilbur H ChenCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, Maryland, USA.ORCID 0000-0001-7741-5536
Eileen M BarryCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, Maryland, USA.ORCID 0000-0002-5326-0047
Franklin R ToapantaCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, Maryland, USA.ORCID 0000-0001-9439-0828
Marcela F PasettiCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, Maryland, USA.ORCID 0000-0003-0894-4009
Marcelo B SzteinCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, Maryland, USA.ORCID 0000-0001-8282-860X
Jasnehta Permala-BoothCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, Maryland, USA.ORCID 0009-0007-0278-1292
Sharon M TennantCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, Maryland, USA.ORCID 0000-0002-0651-5748
Justin R OrtizCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, Maryland, USA.ORCID 0000-0002-3138-5965
Constance ThomasCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, Maryland, USA.
Megan McGilvrayCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, Maryland, USA.ORCID 0009-0000-5455-957X
Lynnee RoaneCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, Maryland, USA.ORCID 0009-0007-4881-0845
Reva DatarCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, Maryland, USA.ORCID 0000-0002-1968-2086
Yuanyuan LiangDivision of Biostatistics and Bioinformatics, Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland, USA.
Myron M LevineCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, Maryland, USA.ORCID 0000-0002-5721-5040
Funding
UNIVERSITY OF MARYLAND GREENEBAUM CANCER CENTERSUPPORT GRANTP30CA134274 · NCI · UNIVERSITY OF MARYLAND BALTIMORE · PI FEYRUZ VIRGILIA RASSOOL · 2008 to 2026
$51.0M
Johns Hopkins Institute for Clinical and Translational ResearchUM1TR004926 · NCATS · JOHNS HOPKINS UNIVERSITY · PI STEPHEN N. DAVIS, Daniel Ernest Ford · 2024 to 2026
$28.5M
Shigella Live Vector-Based Multivalent VaccineU19AI109776 · NIAID · UNIVERSITY OF MARYLAND BALTIMORE · PI TZIPORI, SAUL R · 2014 to 2018
$25.4M
Project 3 - Human colonoids as a model for the pathobiology of EHECP01AI125181 · NIAID · UNIVERSITY OF MARYLAND BALTIMORE · PI KAPER, JAMES B · 2016 to 2025
$18.6M
Probiotic yeast secreting single-domain antibodies to prevent Clostridium difficile and Campylobacter jejuni diseaseU19AI142725 · NIAID · UNIVERSITY OF MARYLAND BALTIMORE · PI SZTEIN, MARCELO B. · 2019 to 2023
$12.5M
Systems Biology and Biostatistics CoreU19AI181108 · NIAID · UNIVERSITY OF MARYLAND BALTIMORE · PI Marcelo B. Sztein · 2024 to 2026
$8.0M
Initial clinical evaluation of attenuated Shigella flexneri 2a live vector expressing enterotoxigenic Escherichia coli antigens, strain CVD 1208S-122.U01AI143493 · NIAID · UNIVERSITY OF MARYLAND BALTIMORE · PI BARRY, EILEEN M., CHEN, WILBUR H. · 2020 to 2023
$3.6M
Good Manufacturing Practices Master Cell and Working Cell Banks and GMP Pilot Lot of Prototype Shigella flexneri 2a live vector expressing enterotoxigenic E. coli antigens, CVD 1208S 122R01AI132257 · NIAID · UNIVERSITY OF MARYLAND BALTIMORE · PI BARRY, EILEEN M., CHEN, WILBUR H. · 2017 to 2019
$2.5M
General Clinical Research Center, University of MarylandInstitute for Clinical and Translational ResearchNational Institute of Allergy and Infectious Diseases P01AI125181National Institute of Allergy and Infectious Diseases R01AI132257National Institute of Allergy and Infectious Diseases U01AI143493National Institute of Allergy and Infectious Diseases U19AI109776National Institute of Allergy and Infectious Diseases U19AI142725National Institute of Allergy and Infectious Diseases U19AI181108NCATS NIH HHSNCATS NIH HHS UM1 TR004926NCI NIH HHS P30 CA134274NCI NIH HHS P30CA134274NIAID NIH HHS P01 AI125181NIAID NIH HHS R01 AI132257NIAID NIH HHS U01 AI143493NIAID NIH HHS U19 AI109776NIAID NIH HHS U19 AI142725NIAID NIH HHS U19 AI181108NIHUniversity of Maryland, Baltimore
6 · The paper itself
Abstract
backgroundThere are no licensed vaccines to protect against Shigella or enterotoxigenic Escherichia coli (ETEC), yet they are among the most common causes of bacterial diarrhea. We engineered an attenuated Shigella flexneri 2a expressing colonization factor antigen 1 (CFA/I) and heat-labile enterotoxin B subunit (LTB) from ETEC and conducted a first-in-human randomized-controlled trial of ascending doses of the vaccine (CVD 1208S-122).
methodsDose-escalating cohorts received a single oral dose of 108-1010 colony-forming units (CFU) of CVD 1208S-122 or placebo. A fourth cohort received 1 or 2 oral doses of 108 CFU CVD 1208S-122 or placebo. We measured the safety and clinical acceptability of the vaccine, genetic stability of fecally shed vaccine organisms, and immune responses elicited.
resultsThe 108 CFU doses were well tolerated (100%, 6/6). One recipient of 109 CFU (20%, 1/5) manifested diarrhea and 4 individuals who ingested 1010 CFU had either fever or diarrheal reactogenicity (67%, 4/6). Fecal shed vaccine organisms were genetically stable. Responses were observed to the lipopolysaccharide (LPS) and invasion plasmid antigen B (IpaB) of Shigella and CFA/I fimbriae and LTB of ETEC in serum, among antibody secreting cells, antibody in lymphocyte supernatant, and fecal samples. Serum antibodies exhibited Shigella bactericidal activity and inhibition of ETEC adherence in vitro.
conclusionsThis study demonstrates safety with low-dose but unacceptable reactogenicity following highest-dose ingestion, genetic stability of all recovered fecal isolates, and immunogenicity of a prototype combined monovalent Shigella-ETEC vaccine. These results encourage expansion to a multivalent formulation to elicit broader protection against the most prevalent Shigella serotypes and ETEC CFA types that cause diarrheal disease. CLINICAL TRIALS REGISTRATION: NCT04634513.
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.
Evaluation of the Safety, Genetic Stability, and Immunogenicity of an Attenuated Shigella Live Vector Expressing Enterotoxigenic Escherichia coli Antigens, Vaccine Strain CVD 1208S-122. · full record | OpenQuestion