CompletedPhase 1

VRC 313: A Trivalent Virus-like Particle (VLP) Encephalitis Vaccine (WEVEE) in Healthy Adults

United States30 participantsStarted 2019-04-02

Plain-language summary

Western Equine Encephalitis Virus (WEEV), Eastern Equine Encephalitis Virus (EEEV), and Venezuelan Equine Encephalitis Virus (VEEV) are transmitted to humans by infected mosquitoes and can cause encephalitis (swelling of the brain) and other neurological manifestations, including fever, chills, discomfort, feeling sick, muscle pain and then headache, vomiting, restlessness, irritability, seizures, coma, and death. Vaccines teach the body to prevent or fight an infection. When the body learns to fight an infection, this is called an immune response. Researchers developed a vaccine against Western, Eastern and Venezuelan equine encephalitis viruses to help the body make an immune response. There are no live or killed viruses in the vaccine, so you cannot get infected with any of these 3 viruses from getting the vaccine. The experimental trivalent encephalitis vaccine, VRC-WEVVLP073-00-VP, is composed of Western equine encephalitis (WEE), Eastern equine encephalitis (EEE), and Venezuelan equine encephalitis (VEE) virus-like particles (VLP). The purpose of this study is to test three doses (6 mcg, 30 mcg, and 60 mcg) of this experimental vaccine against Western, Eastern and Venezuelan equine encephalitis viruses.

Who can participate

Age range

18 Years – 50 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: A volunteer must have met all of the following criteria: * Age 18 to 50 years * Available for clinical follow-up through 36 weeks after randomization * Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process * Able and willing to complete the informed consent process * Willing to donate blood for sample storage to be used for future research * In good general health, without clinically significant medical history, and has satisfactorily completed screening * Physical examination and laboratory results without clinically significant findings within the 28 days prior to randomization Laboratory Criteria within 28 days prior to randomization: * Hemoglobin within institutional normal range or accompanied by Principal Investigator (PI) or designee approval * White blood cell (WBC) and differential either within institutional normal range or accompanied by PI or designee approval * Total lymphocyte count: ≥800 cells/mm3 * Platelets: 125,000-500,000/mm3 * Alanine aminotransferase (ALT): ≤ 1.25 x upper limit of normal range * Serum creatinine: ≤1.1 x upper limit of normal * Negative for HIV infection by an FDA-approved method of detection Criteria applicable to women of childbearing potential: * Negative beta-human chorionic gonadotropin (β-HCG) pregnancy test (urine or serum) on day of randomization before receiving the study product * Agrees to use an effective method of birth control, if sexually acti…

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

Number of Subjects Reporting Local Reactogenicity Signs and Symptoms For 7 Days After Each Product Administration

Timeframe: 7 days after each product administration, at approximately Week 1 and Week 9

Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms For 7 Days After Each Product Administration

Timeframe: 7 days after each product administration, at approximately Week 1 and Week 9

Number of Subjects With Abnormal Laboratory Measures of Safety

Timeframe: Day 0 through Day 252

Number of Subjects With One or More Unsolicited Non-Serious Adverse Events (AEs)

Timeframe: Day 0 through 4 weeks of each study product administration, up to Week 12

Number of Subjects With Serious Adverse Events (SAEs)

Timeframe: Day 0 through Day 252

Trial details

NCT IDNCT03879603

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2020-02-26

Results submitted2021-02-23

View on ClinicalTrials.gov More Venezuelan Equine Encephalitis trials

Plain-language summary

Who can participate

Age range

18 Years – 50 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.

What they're measuring

Number of Subjects Reporting Local Reactogenicity Signs and Symptoms For 7 Days After Each Product Administration

Timeframe: 7 days after each product administration, at approximately Week 1 and Week 9

Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms For 7 Days After Each Product Administration

Timeframe: 7 days after each product administration, at approximately Week 1 and Week 9

Number of Subjects With Abnormal Laboratory Measures of Safety

Timeframe: Day 0 through Day 252

Number of Subjects With One or More Unsolicited Non-Serious Adverse Events (AEs)

Timeframe: Day 0 through 4 weeks of each study product administration, up to Week 12

Number of Subjects With Serious Adverse Events (SAEs)

Timeframe: Day 0 through Day 252