Phase 1 Trial of Inactivated West Nile Virus Vaccine (NCT02337868) | Clinical Trial Compass
CompletedPhase 1
Phase 1 Trial of Inactivated West Nile Virus Vaccine
United States96 participantsStarted 2015-03-31
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 4 mcg of HydroVax-001 WNV vaccine given intramuscularly on Day 1 and Day 29 in up to 50 healthy adults \> /=18 and \< 50 years of age. The primary objective is to assess the safety, reactogenicity, and tolerability of the HydroVax-001 WNV vaccine administered intramuscularly in a two-dose series on Days 1 and 29 at a dose of 1 mcg or a dose of 4 mcg.
Who can participate
Age range
18 Years – 49 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
.Age \>/=18 years and \< 50 years 2.Able to read, sign, and date the informed consent document 3. Available and willing to participate for the planned duration of the study 4.Are in good health, as judged by the investigator and determined by vital signs, medical history, and physical examination 5.Sexually active males must agree to use a medically acceptable form of contraception\* in order to be in this study and must agree to continue such use until day 30 after the last vaccination.Medically acceptable contraceptives include: (1) surgical sterilization (such as a vasectomy), or (2) a condom used with a spermicide. Contraceptive measures such as Plan B (TM), sold for emergency use after unprotected sex, are not acceptable methods for routine use. 6.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 vaccination \*Not sterilized via tubal ligation, bilateral oophorectomy, or hysterectomy and still menstruating or \< 1 year of the last menses if menopausal 7. Women of childbearing potential must have used an acceptable method of contraception\* in the 30 days prior to enrollment and must agree to continue such use until day 30 after the last vaccination. \*Includes, but is not limited to, abstinence from sex with men,barrier methods such as condoms or diaphragms with spermicide or foam, effective intrauterine devices, NuvaRing®, successful Essure® placement (permanent, non-surgical, non-hormonal sterilization) with documented confirmation test at least 3 months after the procedure, and licensed hormonal methods such as implants, injectables, or oral contraceptives
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 any AE related to the study vaccine through day 57 after the second vaccination
Timeframe: Day 1 post first vaccination to Day 57 post second vaccination
2
Occurrence of Grade 3 laboratory toxicities related to the study vaccine from first vaccination through day 15 after the second vaccination
Timeframe: Day 1 post first vaccination to Day 15 post second vaccination
3
Occurrence of Grade 3 unsolicited adverse events related to the study vaccine from first vaccination through day 57 after the second vaccination
Timeframe: Day 1 post first vaccination to Day 57 post second vaccination
4
Occurrence of SAEs related to the study vaccine at any time during the study
Timeframe: Day 1 post first vaccination to Day 365 post second vaccination
5
Occurrence of solicited local AE and reactogenicity signs and symptoms in the 14 days after each vaccination
Timeframe: Day 1 post first vaccination to Day 14 post first and second vaccination
6
Occurrence of solicited systemic AE and reactogenicity signs and symptoms in the 14 days after each vaccination
Trial details
NCT IDNCT02337868
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)