CompletedPhase 1

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

Hungary84 participantsStarted 2020-09-16

Plain-language 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.

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Generally healthy male and non-pregnant, non-nursing female adults aged 18 to 45 years
. Who are determined by medical history, physical examination and clinical judgment to be eligible for this study;
. Who provide written informed consent after the nature of the study had been explained;
. Who are available for the two to three months duration of follow-up (from enrolment to study completion);
. Who are available to be interviewed by study staff for the 2-month post-immunization follow-up;

Exclusion criteria

. Subjects who are perceived to be unavailable or difficult to contact for evaluation or study visits during the study period;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number and percentage of participants with treatment related acute adverse events post vaccination

Timeframe: Day 1-6 following each vaccination

Number and percentage of participants with any adverse event.

Timeframe: until 60 days after the last vaccination (max 60 days in stage 1)

Number and percentage of participants with any adverse event.

Timeframe: until 60 days after the last vaccination (max 110 days in stage 2)

Number and percentage of participants with serious adverse event.

Timeframe: until 60 days after the last vaccination (max 60 days in stage 1)

Number and percentage of participants with serious adverse event.

Timeframe: until 60 days after the last vaccination (max 110 days in stage 2)

Number and percentage of participants with Vaccine Shedding

Timeframe: 14 days after last immunization

Trial details

NCT IDNCT05409196

SponsorEveliqure Biotechnologies GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-06-21

View on ClinicalTrials.gov More Diarrheal Disease, Infectious trials