Trial of an Inactivated Chikungunya Virus Vaccine (NCT06669208) | Clinical Trial Compass
CompletedPhase 1
Trial of an Inactivated Chikungunya Virus Vaccine
United States48 participantsStarted 2024-11-04
Plain-language summary
This trial will be a randomized, placebo controlled, double-blind (within dosing group), dose escalation Phase 1 trial, evaluating dosages of 2.5 mcg and 8 mcg of HydroVax-005 CHIKV vaccine given intramuscularly on Day 1 and Day 29 in up to 48 healthy adults healthy adults ≥ 18 and \< 50 years of age. The primary objective is to assess the safety and reactogenicity of the HydroVax-005 CHIKV vaccine administered intramuscularly in a two-dose series on Days 1 and 29 at a dose of 2.5 mcg or a dose of 8 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
. 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℉.
. Pulse is 40 to 100 beats per minute, inclusive.
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 all serious adverse events (SAEs) at any time during the study
Timeframe: Day 1 post first vaccination to Day 180 post second vaccination
2
Incidence of Adverse Events of Special Interest (AESI) at any time during the study
Timeframe: Day 1 post first vaccination to Day 180 post second vaccination
3
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
4
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
5
Occurrence of solicited local AE and reactogenicity signs and symptoms in the 7 days after each vaccination
Timeframe: Through 7 days after each vaccination
6
Occurrence of solicited systemic AE and reactogenicity signs and symptoms in the 7 days after each vaccination
. Systolic blood pressure is 90 to 140 mmHg, inclusive.
. Diastolic blood pressure is 60 to 90 mmHg, inclusive.
0. Screening laboratories (White Blood Cell Count (WBC), Hemoglobin (Hgb), Platelet Count (PLTs), Sodium, Potassium, Bicarbonate, Calcium, Creatinine (Cr), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Total Bilirubin (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 negative and urine protein no greater than trace at screening for subjects to qualify for randomization and vaccination.
1. Negative test result at screening blood draw for hepatitis B virus (HBV) surface antigen (HBsAg), hepatitis C virus (HCV) antibody or human immunodeficiency virus (HIV) types 1 or 2 antibodies.
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").
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.
7
Occurrence of any AE through day 29 after the second vaccination
Timeframe: Through day 29 after the second vaccination