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Phase 1 Trial for Safety, Tolerability, and Immunogenicity of a Live, Attenuated, Oral Shigella/ETEC Combination Vaccine to Healthy Adults

NCT05409196 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2022-06-08

No results posted yet for this study

Summary

This is a Phase 1 dose escalating study to assess the safety, tolerability, and immunogenicity of ShigETEC, a live, attenuated Shigella/ETEC combination vaccine given orally to healthy European adults 18 to 45 years of age.

The major aim is the development of an efficacious and safe vaccine that prevents diarrhea caused by Shigella and ETEC in travelers, military personal visiting endemic countries and children of the developing world.

This Phase 1 safety and immunogenicity study used a double-blind, placebo-control design and was conducted in two stages, a single ascending and a multiple ascending stage.

Conditions

  • Diarrheal Disease, Infectious
  • Gastrointestinal Disease
  • Reactive Arthritis

Interventions

BIOLOGICAL

ShigETEC live, attenuated, oral vaccine

Vaccine or placebo will be delivered orally as a single dose in Stage 1 and between 2 and 4 doses at 3-day intervals in Stage 2 of the Study.

DRUG

Placebo

Vaccine or placebo will be delivered orally as a single dose in Stage 1 and between 2 and 4 doses at 3-day intervals in Stage 2 of the Study.

Sponsors & Collaborators

  • Eveliqure Biotechnologies GmbH

    lead INDUSTRY

Principal Investigators

  • Dénes Páll, MD, PhD · University of Debrecen

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-16
Primary Completion
2021-06-21
Completion
2021-06-21

Countries

  • Hungary

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05409196 on ClinicalTrials.gov