Lyme Disease Vaccine for Lyme Disease

Palo Alto (17 mi)

Overseen byPfizer CT.gov Call Center

Age: Any Age

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Pfizer

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial tests the VLA15 vaccine, which aims to protect against Lyme disease. It includes healthy people aged 5-65 years, both with and without a history of Lyme disease. The vaccine helps the immune system recognize and fight the bacteria that cause Lyme disease. The VLA15 vaccine builds on previous vaccines for Lyme disease.

Eligibility Criteria

Healthy individuals aged 5-65, with or without a past Lyme disease infection, can join this trial. They must understand and agree to the study's procedures, attend all visits, and be reachable by phone. Women of childbearing age need a negative pregnancy test and must use birth control during the study.

Inclusion Criteria

I am in the booster phase, 5 months post-booster dose.

My legal guardian has given written consent, and I have agreed to participate if I'm between 5-17 years old.

I am between 5 and 65 years old.

Exclusion Criteria

I have not donated blood or plan to donate within 4 weeks before starting the trial.

I have Lyme disease or was treated for it in the last 3 months.

I have or had a neuro-inflammatory or autoimmune disease.

I have been vaccinated against Lyme disease.

I have had cancer within the last 5 years.

Treatment Details

The VLA15-221 trial is testing VLA15, a vaccine candidate for Lyme disease. Participants will receive either three shots (at months 0, 2, and 6) or two shots (months 0 and 6), compared to placebo. The main phase lasts up to 19 months with an optional booster phase extending it.

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Part A+B - Group 2Experimental Treatment2 Interventions

Part A: VLA15 at Month 0 and 6, placebo at Month 2 Part B: VLA15 at Month 18, 30 and 42

Group II: Part A+B - Group 1Experimental Treatment2 Interventions

Part A: VLA15 at Month 0, 2 and 6 Part B: VLA15 at Month 18, 30 and 42

Group III: Part A+B - Group 3Placebo Group1 Intervention

Part A: Placebo at Month 0, 2 and 6 Part B: Placebo at Month 18, 30 and 42