VLA15 Vaccine for Lyme Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a potential new vaccine for Lyme disease called VLA15. The main goal is to assess the vaccine's safety and its effects on the body when administered at different times. Participants will receive four doses of the vaccine and one dose of a saltwater placebo. It suits adults aged 18 to 44 who are generally healthy, have never received a Lyme disease vaccine, and are not on certain medications like chemotherapy or blood thinners. The trial includes 11 visits over about two years, with some visits at a clinic and others conducted over the phone. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking Lyme disease prevention method.
Will I have to stop taking my current medications?
The trial requires that you are not currently taking, or haven't recently taken, medications like chemotherapy, blood products, or blood thinners. If you are on these medications, you may need to stop them to participate.
Is there any evidence suggesting that the VLA15 vaccine is likely to be safe for humans?
Research has shown that VLA15, a vaccine for Lyme disease, is generally safe for people. In earlier studies, the vaccine triggered a strong immune response and maintained a good safety record six months after the booster shot. This indicates that the vaccine prepared the body to fight Lyme disease without causing serious side effects.
Another study examined different dosing schedules and found the vaccine safe for many people, including children. These studies suggest that VLA15 is well-tolerated. Most side effects, if any, were mild and included common reactions like soreness at the injection site.
Overall, the evidence collected so far supports the safety of VLA15, making it a promising option for preventing Lyme disease.12345Why do researchers think this study treatment might be promising?
Most treatments for Lyme disease focus on antibiotics to fight the bacterial infection. However, VLA15 is unique because it's a vaccine aimed at preventing Lyme disease altogether. Unlike antibiotics, which are used after infection, VLA15 stimulates the immune system to recognize and attack the bacteria before it can cause illness. Researchers are excited about VLA15 because it targets multiple strains of the bacteria responsible for Lyme disease, potentially offering broad protection. This preventive approach could significantly reduce the incidence of Lyme disease, making it a groundbreaking advancement in managing this condition.
What evidence suggests that this trial's treatments could be effective for Lyme disease?
Research shows that VLA15, the investigational vaccine studied in this trial, is a promising option for Lyme disease. Studies have found it safe and well-tolerated, even after several doses. Earlier results suggest that VLA15 might be as effective as, or even better than, an older Lyme disease vaccine that was 76% effective. The vaccine targets the bacteria causing Lyme disease, making it a strong option for prevention. Participants in this trial will receive VLA15 in different dosing schedules across various treatment groups.24567
Who Is on the Research Team?
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Are You a Good Fit for This Trial?
Healthy adults aged 18-44 who have never had a Lyme disease vaccine, aren't on certain medications like chemotherapy or blood thinners, and women who are not pregnant/breastfeeding or planning to become pregnant during the study.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 4 doses of VLA15 and 1 dose of placebo at different visits
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- VLA15
Trial Overview
The trial is testing the Lyme disease vaccine VLA15. Participants will receive five doses with varying schedules to assess safety and effects. The study involves 11 visits over two years for health checks and vaccinations.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Participants will receive 4 doses of VLA15 and 1 dose of placebo injection at different visits. Placebo will be given at Visit 9. Injections will be given as intramuscular shots.
Participants will receive 4 doses of VLA15 and 1 dose of placebo injection at different visits. Placebo will be given at Visit 7. Injections will be given as intramuscular shots.
Participants will receive 4 doses of VLA15 and 1 dose of placebo injection at different visits. Placebo will be given at Visit 5. Injections will be given as intramuscular shots.
Participants will receive 4 doses of VLA15 and 1 dose of placebo injection at different visits. Placebo will be given at Visit 3. Injections will be given as intramuscular shots.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University
Citations
Valneva Reports Further Positive Phase 2 Safety and ...
There are currently no approved human vaccines for Lyme disease, and VLA15 has advanced the furthest in clinical development, with two Phase 3 ...
Valneva and Pfizer Report Further Positive Phase 2 ...
The safety and tolerability profile of VLA15 after a second booster dose was comparable to the profile observed after the first booster.
Lyme borreliosis vaccine VLA15 tested safe and ...
If the efficacy of VLA15 meets or potentially exceeds the 76% observed in the phase 3 study of LYMErix,
a randomised, observer-blind, placebo-controlled, phase 2 ...
We aimed to investigate the safety and immunogenicity of two-dose and three-dose schedules of VLA15 within a broader population, including children and ...
5.
cidrap.umn.edu
cidrap.umn.edu/lyme-disease/antibodies-against-lyme-disease-resurge-after-booster-dose-valnevas-vaccine-candidateAntibodies against Lyme disease resurge after booster ...
The phase 1 trial data, published in 2023, revealed good immunogenicity and safety of the vaccine, which is based on Borrelia burgdorferi outer ...
6.
valneva.com
valneva.com/press-release/valneva-announces-positive-final-phase-2-results-for-lyme-disease-vaccine-candidate/Valneva Announces Positive Final Phase 2 Results for Lyme ...
The results showed strong anamnestic immune response and favorable safety profile six months after a third booster dose (month 48) in all age ...
Immunogenicity and safety of an 18-month booster dose ...
A booster dose of VLA15 is safe and induces substantial anamnestic immune responses against all six OspA serotypes. As with previously ...
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