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NCT02531685COMPLETEDanonymous

A Phase 1 Double-Blind Placebo-Control Dose Escalating Study to Evaluate the Safety and Immunogenicity of Double Mutant Heat-Labile Toxin LTR192G/L211A (dmLT) From Enterotoxigenic Escherichia Coli (ETEC) by Intradermal (ID) Vaccination in Healthy Adults

Sponsor

Source record

National Institute of Allergy and Infectious Diseases (NIAID)

Phase

Source record

Phase 1

Modality

AI-normalized

vaccine

Target

AI-normalized

Double Mutant Heat-Labile Toxin LTR192G/L211A (dmLT) from Enterotoxigenic Escherichia coli (ETEC)

Indication / condition

AI-normalized

Gastroenteritis Escherichia Coli

Intervention

Source record

Placebo, Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine

Source & freshness

Source record

NCT ID

NCT02531685

Original source

ClinicalTrials.gov

Source last updated

Oct 26, 2020

Ingested at

Jun 13, 2026

Internal sync

Jun 13, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

Open original registry record
View original source fields

NCT ID

NCT02531685

Title

A Phase 1 Double-Blind Placebo-Control Dose Escalating Study to Evaluate the Safety and Immunogenicity of Double Mutant Heat-Labile Toxin LTR192G/L211A (dmLT) From Enterotoxigenic Escherichia Coli (ETEC) by Intradermal (ID) Vaccination in Healthy Adults

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Status

COMPLETED

Phase

Phase 1

Condition raw

Gastroenteritis Escherichia Coli

Condition normalized

Gastroenteritis Escherichia Coli

Modality raw

vaccine

Modality normalized

vaccine

Target raw

Double Mutant Heat-Labile Toxin LTR192G/L211A (dmLT) from Enterotoxigenic Escherichia coli (ETEC)

Target normalized

Double Mutant Heat-Labile Toxin LTR192G/L211A (dmLT) from Enterotoxigenic Escherichia coli (ETEC)

Interventions

Placebo, Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine

Public preview

Source record

The Phase 1 clinical trial for the dmLT vaccine, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), aims to establish the safety and immunogenicity of this candidate vaccine in healthy adults. Given the global burden of enterotoxigenic Escherichia coli (ETEC) infections, particularly in developing regions, a successful outcome could position this vaccine as a critical preventive measure in public health. The market potential is significant, especially in endemic areas, and could lead to partnerships with global health organizations and governments. Competitive analysis indicates that while there are existing vaccines for cholera, the specific targeting of ETEC through dmLT could provide a unique market niche. Diligence should focus on the regulatory pathway and potential for expedited approval given the public health implications.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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TrialSignal

Clinical trial intelligence report

A Phase 1 Double-Blind Placebo-Control Dose Escalating Study to Evaluate the Safety and Immunogenicity of Double Mutant Heat-Labile Toxin LTR192G/L211A (dmLT) From Enterotoxigenic Escherichia Coli (ETEC) by Intradermal (ID) Vaccination in Healthy Adults

Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.

Generated

Jun 16, 2026

NCT ID

NCT02531685

Status

COMPLETED

Phase

Phase 1

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Executive brief

Investment-Ready Snapshot

The Phase 1 clinical trial for the dmLT vaccine, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), aims to establish the safety and immunogenicity of this candidate vaccine in healthy adults. Given the global burden of enterotoxigenic Escherichia coli (ETEC) infections, particularly in developing regions, a successful outcome could position this vaccine as a critical preventive measure in public health. The market potential is significant, especially in endemic areas, and could lead to partnerships with global health organizations and governments. Competitive analysis indicates that while there are existing vaccines for cholera, the specific targeting of ETEC through dmLT could provide a unique market niche. Diligence should focus on the regulatory pathway and potential for expedited approval given the public health implications.

Source & freshness

Provenance

SourceClinicalTrials.gov
Source updatedOct 26, 2020
Internal syncJun 13, 2026
Model versiontrialsignal-ai-v1

https://clinicaltrials.gov/study/NCT02531685

Indication

Gastroenteritis Escherichia Coli

Modality

vaccine

Target

Double Mutant Heat-Labile Toxin LTR192G/L211A (dmLT) from Enterotoxigenic Escherichia coli (ETEC)

Intervention

Placebo, Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine

Source record

Protocol Description

Detailed source ingestion pending.

Source record

Outcome Measures

Detailed source ingestion pending.

Source record

Eligibility

Detailed source ingestion pending.

AI analysis

Known Results And Readout Context

Detailed source ingestion pending.

IP intelligence

Patent And IP Landscape

Detailed source ingestion pending.

Source record

Contacts

Detailed source ingestion pending.