Phase 1 Study of dmLT ID Vaccination in Healthy Adults (NCT02531685) | Clinical Trial Compass
CompletedPhase 1
Phase 1 Study of dmLT ID Vaccination in Healthy Adults
United States100 participantsStarted 2016-06-02
Plain-language summary
This study is to determine the safety and immunogenicity of an Enterotoxigenic Escherichia coli (ETEC) candidate vaccine, attenuated recombinant Double Mutant Heat-Labile Toxin (dmLT) from ETEC, administered by the Intradermal (ID) route. The sample size has been determined based on the historic sample, not on power calculations.The study will involve 99 subjects (83 vaccinees and 16 placebo controls) in 4 consecutive cohorts of 16 individuals each (13 vaccinees and 3 placebo controls) and the final cohort of 35 (31 vaccinees and 4 placebos) subjects. The primary objective is to assess the safety and tolerability of dmLT vaccine when administered in three doses intradermally over a range of dosages in healthy adult subjects.
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
. Male or female ages 18-45, inclusive.
. Provide written informed consent before initiation of any study procedures.
. Are in general good health.
. Within 46 days of vaccination, have normal screening laboratories.
. Have normal screening laboratories for urine protein. Trace protein is acceptable.
. Hemoglobin (Hgb) A1C \< 6.5 percent at screening.
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
1
Occurrence of solicited adverse events (AEs)
Timeframe: 7 Days following each vaccination
2
Occurrence of vaccine-related, non-solicited adverse events (AEs)
Timeframe: Day 1 through 30 days following last vaccination
Trial details
NCT IDNCT02531685
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. Agrees to complete all study visits and procedures and to provide a screening stool sample.
Exclusion criteria
. Women who are pregnant or lactating or have a positive serum pregnancy test at screening or positive urine pregnancy test on vaccination days.
. Abnormal vital signs, defined as:
Hypertension (systolic blood pressure \> 140 mm Hg or diastolic blood pressure \>90 mm Hg) at rest on 2 separate days.
-Palpated heart rate \< 55 or \> 100 beats/minute at rest on 2 separate days.
--If heart rate between 45 and 55, subjects may be enrolled with an EKG that demonstrates normal sinus rhythm and does not document conduction disorders.
---Oral Temperature \>= 38.0 Degrees Celsius (100.4 Degrees Fahrenheit).
. Symptoms of an acute self-limited illness, including an oral temperature \>= 38.0 Degrees Celsius (100.4 Degrees Fahrenheit), such as an upper respiratory infection or gastroenteritis within 7 days of administration of Double Mutant Heat-Labile Toxin (dmLT).
. Positive hepatitis C, or Human Immunodeficiency Virus (HIV) serology or positive hepatitis B serology not consistent with prior hepatitis B immunization.