A Double-Blind Placebo-Control Dose Escalating Study to Evaluate the Safety and Immunogenicity of… (NCT03548064) | Clinical Trial Compass
TerminatedPhase 1
A Double-Blind Placebo-Control Dose Escalating Study to Evaluate the Safety and Immunogenicity of dmLT by Oral, Sublingual and Intradermal Vaccination in Adults Residing in an Endemic Area
Stopped: COVID 19 cases at the site
United States, Bangladesh75 participantsStarted 2019-03-10
Plain-language summary
This is a trial to evaluate the safety and immunogenicity of double mutant heat-labile toxin LTR192G/L211A (dmLT) from Enterotoxigenic Escherichia coli (ETEC) by oral, sublingual, or intradermal vaccination in approximately 135 healthy adult volunteers, age 18-45 years. Study duration is approximately 2.5 years, with each participant duration for up to 9 months depending on the route of dmLT administered. There is no specific hypothesis being tested in this study. The primary objective of this study is to assess the reactogenicity, safety, and tolerability of dmLT when administered in three sequential doses, over a range of dosages by oral, sublingual, or intradermal routes.
Who can participate
Age range18 Years – 45 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male or female age 18-45 years old, inclusive.
✓. Provides written informed consent before initiation of any study procedures.
✓. Healthy as judged by the site investigators and determined by medical history, medication history, and physical examination.
✓. Capable of understanding, consenting, and complying with all the study visits and procedures.
✓. Body Mass Index of no less than 18.5.
✓. Agrees not to participate in another clinical trial during the study period.
✓. Agrees to complete all study visits and procedures.
✓. Agrees not to donate blood to a blood bank for 12 months after receiving the last vaccine.
Exclusion criteria
✕. Women who are pregnant or lactating or have a positive urine pregnancy test at screening or on the day of vaccinations.
What they're measuring
1
Number of Participants in the Oral Arms With Solicited Local Reactogenicity Events Post Each Dose
Timeframe: Day 1 through Day 8 (post dose 1), Day 15 through Day 22 (post dose 2), Day 29 through Day 36 (post dose 3)
2
Number of Participants in the Sublingual Arms With Solicited Local Reactogenicity Events Post Each Dose
Timeframe: Day 1 through Day 8 (post dose 1), Day 15 through Day 22 (post dose 2), Day 29 through Day 36 (post dose 3)
3
Number of Participants in the Intradermal Arms With Solicited Local Reactogenicity Events Post Each Dose
Timeframe: Day 1 through Day 8 (post dose 1), Day 22 through Day 29 (post dose 2)
4
Number of Participants in the Oral and Sublingual Arms With Solicited Systemic Reactogenicity Events Post Each Dose
Timeframe: Day 1 through Day 8 (post dose 1), Day 15 through Day 22 (post dose 2), Day 29 through Day 36 (post dose 3)
5
Number of Participants in the Intradermal Arms With Solicited Systemic Reactogenicity Events Post Each Dose
Timeframe: Day 1 through Day 8 (post dose 1), Day 22 through Day 29 (post dose 2)
6
Number of Participants Who Withdrew From the Study
Timeframe: Day 1 through Day 209 (Day 223 for Intradermal cohorts)
7
Trial details
NCT IDNCT03548064
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. Presence or history of a chronic medical condition\* that would, in the opinion of the investigator, render vaccination unsafe or interfere with the evaluation of the vaccine.
✕. Presence of a significant dermatologic condition\*, or tattoo(s), scarring or significant skin damage at the vaccination site that would impede evaluation of local reactogenicity.
✕. Any developmental abnormality of the palate.
✕. Participants diagnosed with autoimmune disorders, chronic inflammatory disorders or neurological disorders with a potential autoimmune correlation.
✕. Use of long-term (\> / = 2 weeks) oral steroids, intranasal or topical prednisone (or equivalent), parenteral steroids, or high-dose inhaled steroids (\> 800 microgram/day of beclomethasone dipropionate or equivalent) within the preceding 6 months.
✕. Has major psychiatric illness\* during last 12 months that in the investigator's opinion would preclude participation.
✕. Use of prescription or over-the-counter (OTC) anti-inflammatory medications\* 48 hours prior to receiving the investigational product.
Number of Participants Who Discontinued Study Vaccination
Timeframe: Day 1 through Day 29 (Day 43 for Intradermal cohorts)
8
Number of Vaccine-related Unsolicited Adverse Events From First Dose Through 28 Days After Last Dose
Timeframe: Day 1 through Day 57 (Day 71 for Intradermal cohorts)