Assessment of Delayed-type Hypersensitivity Reactions to SARS-CoV-2 Peptide Antigens (COVID-19 DTH)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
This dose finding, multi-cohort study is designed to evaluate the safety and efficacy of intradermally-injectedTNX-2100, synthesized SARS-CoV-2 peptide antigens and assess the presence and magnitude of DTH reactions.
Full description
Three IPs (TNX-2110, TNX- 2120, TNX-2130) will be administered by intradermal injection (0.1 mL) in two concentration strengths (Stage 1: "1:10 dilution" and Stage 2: "undiluted"). Subjects will also receive one intradermal injection (0.1 mL) of a positive control (CANDIN®), and one intradermal injection (0.1 mL) of a negative control "diluent".
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Male or female subjects aged 18 - 65 years of age, inclusive, in good general health as determined by medical evaluation Subject receives a negativeSARS-CoV-2 PCR test result at their screening or baseline visit
Exclusion criteria
Subjects will be excluded if they have clinically significant underlying conditions associated with high risk for severe COVID-19 infections as identified by the Centers for Disease Control and Prevention (CDC) (Appendix 2). These conditions include, but are not limited to: chronic obstructive pulmonary disease, diabetes mellitus (Type 1 and 2), obesity, hypertension, heart disease, and cerebrovascular disease.
Trial design
Primary purpose
Allocation
Interventional model
Masking
9 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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