Study Assessing the Safety, Immunogenicity and Dose Response of VLA15, A New Vaccine Candidate Ag… (NCT03010228) | Clinical Trial Compass
CompletedPhase 1
Study Assessing the Safety, Immunogenicity and Dose Response of VLA15, A New Vaccine Candidate Against Lyme Borreliosis
United States, Belgium179 participantsStarted 2017-01-31
Plain-language summary
Observer-blind, partially randomized, multi-center dose escalation Phase I study in healthy adults below 40 years of age.
180 subjects will be enrolled in 6 treatment groups (different doses; different formulation: with/without adjuvant); vaccinations will be given I.M.(intramuscular) into the deltoid region on Days 0, 28 and 56. Study participants will be followed up until one year after first vaccination.
Booster Extension:
Subjects in the 48µg and 90µg Treatment groups who received a complete Primary immunization schedule will be included into a Booster Extension 13 months after the first immunization.
Who can participate
Age range
18 Years – 39 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.
Exclusion criteria
. Chronic illness related to Lyme borreliosis (LB), a history of or active symptomatic LB as suspected or diagnosed by a physician.
. Musculoskeletal disorders as deemed clinically relevant by the investigator, arthritis or chronic musculoskeletal pain.
. Severe hypersensitivity reactions and anaphylaxis.
. Allergic bronchial asthma and severe allergic rhinoconjunctivitis.
. Hypersensitivity or allergic reactions to one of the components of the vaccine.
. Autoimmune disease, including Type I Diabetes mellitus. Subjects with vitiligo or thyroid disease taking thyroid hormone replacement are not excluded.
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
Rate of SAEs to Day 84
Timeframe: up to Day 84 (Month 3) after first vaccination
2
Rate of related SAEs to Day 84
Timeframe: up to Day 84 (Month 3) after first vaccination
3
Rate of any solicited or unsolicited Grade 3 or Grade 4 events up to Day 84
Timeframe: up to Day 84 (Month 3) after first vaccination
4
Rate of any solicited or related unsolicited Grade 3 or Grade 4 events up to Day 84
Timeframe: up to Day 84 (Month 3) after first vaccination
5
Rate of solicited local AEs within 7 days after each and after any vaccination up to Day 84
Timeframe: up to Day 84 (Month 3) after first vaccination
6
Rate of solicited systemic AEs within 7 days after each and after any vaccination up to Day 84
Timeframe: up to Day 84 (Month 3) after first vaccination
7
Rate of unsolicited AEs to Day 84, including clinically significant laboratory parameter changes