Trial of an Inactivated Yellow Fever Virus Vaccine (NCT05172544) | Clinical Trial Compass
CompletedPhase 1
Trial of an Inactivated Yellow Fever Virus Vaccine
United States26 participantsStarted 2022-01-13
Plain-language summary
This trial will be a randomized, placebo controlled, double-blind (within dosing group), dose escalation Phase 1 trial, evaluating dosages of 1 mcg and 5 mcg of HydroVax-002 YFV vaccine given intramuscularly on Day 1 and Day 29 in up to 25 healthy adults healthy adults ≥ 18 and \< 50 years of age. The primary objective is to assess the safety, reactogenicity, and tolerability of the HydroVax-002 YFV vaccine administered intramuscularly in a two-dose series on Days 1 and 29 at a dose of 1 mcg or a dose of 5 mcg.
Who can participate
Age range18 Years – 49 Years
SexALL
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Inclusion criteria
✓. Provide written informed consent prior to initiation of any study procedures.
✓. Are able to understand and comply with planned study procedures and be available for all study visits.
✓. Must agree to the collection of venous blood per protocol.
✓. Are males or non-pregnant females, ≥18 and \<50 years of age, inclusive at time of enrollment.
Exclusion criteria
✕. Oral temperature is less than 100.0°F.
✕. Pulse is 47 to 100 beats per minute, inclusive.
✕. Systolic blood pressure is 85 to 140 mmHg, inclusive.
✕. Diastolic blood pressure is 55 to 90 mmHg, inclusive.
✕0. Screening laboratories (WBC, Hgb, PLTs, Sodium, Potassium, Bicarbonate, Calcium, Cr, non-fasting glucose, ALT, AST, TBIL and urine protein and glucose) are within acceptable parameters\*. \*Hematology, blood chemistry and liver enzymes must be Grade 1 or less at screening; urine glucose and protein negative at screening for subjects to qualify for randomization and vaccination.
✕1. Negative test for HIV, hepatitis B virus (HBV), and hepatitis C virus (HCV) at screening blood draw.
✕2. Women of childbearing potential\* must use an acceptable contraception method†from at least 30 days before the first study vaccination until 30 days after the second study vaccination. \*Not sterilized via, bilateral oophorectomy, salpingectomy, hysterectomy, or successful Essure® placement (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or \<1 year has passed since the last menses if menopausal. †Includes non-male sexual relationships, full abstinence from sexual intercourse with a male partner, monogamous relationship with vasectomized partner who has been vasectomized for 180 days or more and shown to be azoospermic prior to the subject receiving the study vaccination, effective intrauterine devices, NuvaRing®, tubal ligation, and licensed hormonal methods such as implants, injectables or oral contraceptives (i.e. "the pill").
What they're measuring
1
Occurrence of All Serious Adverse Events (SAEs) at Any Time During the Study
Timeframe: Day 1 post first vaccination to Day 180 post second vaccination
2
Occurrence of All Grade 3 Unsolicited Adverse Events (AEs) From First Vaccination Through Day 29 After the Second Vaccination
Timeframe: Through day 29 after the second vaccination
3
Occurrence of All Grade 3 Laboratory Toxicities From First Vaccination Through Day 15 After the Second Vaccination
Timeframe: Through day 15 after the second vaccination
4
Occurrence of Solicited Local AE and Reactogenicity Signs and Symptoms in the 7 Days After Each Vaccination
Timeframe: Through 7 days after each vaccination
5
Occurrence of Solicited Systemic AE and Reactogenicity Signs and Symptoms in the 7 Days After Each Vaccination
Timeframe: Through 7 days after each vaccination
6
Occurrence of Any AE Through Day 29 After the Second Vaccination
Timeframe: Through day 29 after the second vaccination
✕3. Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test within 24 hours prior to each study vaccination.