Phase 1 Trial for Safety, Tolerability, and Immunogenicity of a Live, Attenuated, Oral Shigella/E… (NCT05409196) | Clinical Trial Compass
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 range18 Years – 45 Years
SexALL
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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;
✕. Who have a known or suspected disease of cancer (excluding healed skin lesions), the immune system, or those who are receiving immunosuppressive therapy, including systemic corticosteroids or cytotoxic agents;
✕. Who have received any blood products, including immunoglobulin, in the period from six months prior to vaccination or are anticipated to receive such products through to the conclusion of the study;
What they're measuring
1
Number and percentage of participants with treatment related acute adverse events post vaccination
Timeframe: Day 1-6 following each vaccination
2
Number and percentage of participants with any adverse event.
Timeframe: until 60 days after the last vaccination (max 60 days in stage 1)
3
Number and percentage of participants with any adverse event.
Timeframe: until 60 days after the last vaccination (max 110 days in stage 2)
4
Number and percentage of participants with serious adverse event.
Timeframe: until 60 days after the last vaccination (max 60 days in stage 1)
5
Number and percentage of participants with serious adverse event.
Timeframe: until 60 days after the last vaccination (max 110 days in stage 2)
6
Number and percentage of participants with Vaccine Shedding
✕. Who are receiving antibiotics or completed antibiotic therapy in previous 7 days;
✕. Who have or are participating in or have concluded participation in a clinical research study in the last 30 days or have not cleared the experimental product or the biological effects of such experimental products prior to vaccination or received a licensed vaccine in the 30 days prior to vaccination;
✕. Who have a chronic non-gastrointestinal medical condition (e.g. hypertension, hyperlipidemia) that is not well controlled with medication;
✕. Who have a significant history of or current diagnosis of diseases of the gastrointestinal tract (i.e. liver, gallbladder, bowel, or stomach), are on medication for such disease, or have had significant bowel surgery (with the exclusion of hernia repair or appendectomy);