Safety and Immunogenicity of ChimeriVax-WN02 West Nile Vaccine in Healthy Adults (NCT00442169) | Clinical Trial Compass
CompletedPhase 2
Safety and Immunogenicity of ChimeriVax-WN02 West Nile Vaccine in Healthy Adults
United States208 participantsStarted 2005-12
Plain-language summary
The purpose of this study is to determine whether a single subcutaneous injection of ChimeriVax-WN02 vaccine is well tolerated, safe and induces protective antibodies against West Nile Disease. The study is divided into two parts; in the first part, a comparison of 3 dose levels of the vaccine will be made, with an inactive control. In the second part, the optimum dose level chosen after the first part will be given to older volunteers.
Who can participate
Age range
18 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: Part 1
* Healthy adult aged 18 to 40 years.
* Women of child-bearing potential should be using hormonal contraception.
* Subject had to be available for the study duration, including all planned follow-up visits.
Exclusion Criteria: Part 1
* Previous vaccination against yellow fever or Japanese encephalitis
* History of flavivirus infection
* Any abnormalities of immune system, or using drugs that affect the immune system.
* History of anaphylaxis to foods, bee stings, vaccines or drugs.
* Receipt of blood or blood products within the preceding 6 months.
* Receipt of any vaccine in the preceding 30 days
* Seropositive to hepatitis C virus (HCV), hepatitis B surface antigen (HBsAg) or Human immunodeficiency virus (HIV)
* Lactation or intended pregnancy in female subjects
* Previous or current military service with overseas deployment
* Travel to Mexico or other flavivirus endemic areas in the tropics for periods of four weeks or more in the previous ten years.
Inclusion Criteria: Part 2
* Aged ≥ 41 years.
* Subjects had to be in general good health.
* Unimpaired cognitive performance as assessed by clock drawing test score
* Subject had to be available for all required study visits, including all planned follow-up visits.
* Women of child-bearing potential should be using hormonal contraception.
Exclusion Criteria: Part 2
* Clinically significant abnormalities on the Screening 12-lead electrocardiogram (ECG).
* An acute or chronic medical condition t…
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
Number of Participants With Fourfold or Greater Post-vaccination Titers (Seroconversion).
Timeframe: Day 28 post-vaccination
2
Number of Viremic Participants Post-vaccination
Timeframe: Day 21 post-vaccination
3
Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination.