Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HDT 321 · 1 trial · 2 indications
Frequency and grade of solicited local and systemic AEs during the 7-day follow-up period after each study injection (i.e. the day of administration and 6 subsequent days).
Frequency and grade of unsolicited study product related AEs reported during the 28-day follow-up period after each study injection.
Occurrence of laboratory abnormalities at 7 days post injection visit (increased or decreased outside normal ranges, as determined by the FDA Guidance for Industry Toxicity Grading Scale for Healthy Adults Enrolled in Preventive Vaccine Clinical Trials, 2007)
Frequency and grade of Serious AEs (SAEs), AEs of Special Interest (AESIs), Medically-Attended AEs (MAAEs), and New-Onset of Chronic Diseases (NOCDs) during the duration of participation in the study.
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | Group 1 will include 12 participants who will receive a 10 ug two dose schedule of HDT-321 at day 1 and day 29. |
| Group 2 | EXPERIMENTAL | Group 2 will include 12 participants who will receive a 25 ug, two dose schedule of HDT-321 at day 1 and day 29. |
| Group 3 | EXPERIMENTAL | Group 3 will include 12 participants who will receive a 50 ug one dose schedule of HDT-321 at day 1. |
| Group 4 | EXPERIMENTAL | Group 4 will include 12 participants who will receive a 50 ug two dose schedule of HDT-321 at day 1 and day 29. |
| Name | Type | Description |
|---|---|---|
| 10 ug HDT 321 | BIOLOGICAL | HDT-321 Investigational Vaccine (a Nanoparticle Carrier-Formulated self-amplifying RNA encoding the NP of CCHFV) |
| 25ug HDT-321 | BIOLOGICAL | HDT-321 Investigational Vaccine (a Nanoparticle Carrier-Formulated self-amplifying RNA encoding the NP of CCHFV) |
| 50ug HDT-321 | BIOLOGICAL | HDT-321 Investigational Vaccine (a Nanoparticle Carrier-Formulated self-amplifying RNA encoding the NP of CCHFV) |
Inclusion Criteria: 1. Males and non-pregnant females 18 to 64 years of age at the time of signing the ICF. 2. Body mass index (BMI) 17 to 35 inclusive at screening. 3. Considered by the PI or designee to be in good general health as determined by medical history, physical examination, vital sign m...