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 range18 Years – 45 Years
SexALL
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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.
✕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.