VLA15 Lot 1 (3-dose primary vaccination series and booster dose) for Lyme Disease

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
ProbarE, Lund, Sweden
Lyme Disease
VLA15 - Biological
Eligibility
Any Age
All Sexes
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Study Summary

The main purpose of this clinical study is to evaluate a 6-valent OspA-based Lyme disease vaccine (VLA15) for prevention of Lyme disease within North America and Europe. Approximately 18,000 healthy participants 5 years and older will be recruited from areas with high levels of endemic Lyme disease to receive VLA15 or placebo (an inactive substance consisting of saltwater). Each participant will have about a 50% chance of receiving VLA15 and about a 50% chance of receiving placebo. A subset of participants will receive VLA15 from 3 different lots or placebo (1:1:1:3 ratio) to assess lot equivalence. Participants will receive a 3-dose primary vaccination series at about 0, 2, and 5 to 9 months and then receive a booster dose about 12 months later. Vaccination of participants will occur at a time of year such that the primary series is completed before the peak Lyme disease season followed by a booster dose just prior to the beginning of the second Lyme disease season. Comparison will be made between the Lyme disease cases of people receiving the study vaccine to those of the people who are not. This will help us determine if the study vaccine is safe and effective. If enrolled, participants will need to visit the research site at least 7 times during the study. There will also be at least 1 telephone contact. It is expected that each participant will take part in this study for up to about 2 and a half years.

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

9 Primary · 3 Secondary · Reporting Duration: Through study completion, up to approximately 30 months.

Month 1
Geometric mean ratio (GMR) of anti-OspA titers for each serotype (ST1-ST6) for Lot 1 to Lot 2
Geometric mean ratio (GMR) of anti-OspA titers for each serotype (ST1-ST6) for Lot 1 to Lot 3
Geometric mean ratio (GMR) of anti-OspA titers for each serotype (ST1-ST6) for Lot 2 to Lot 3
Month 1
Relative risk reduction of Lyme disease-specific seroconversion in otherwise-undiagnosed Lyme disease cases in the VLA15 group compared to the placebo group
Relative risk reduction of confirmed Lyme disease cases in the VLA15 group compared to the placebo group
Vaccine efficacy among participants enrolled from European sites
Vaccine efficacy among participants enrolled from North American sites
Month 1
Percentage of participants reporting adverse events (AEs)
Month 30
Percentage of participants reporting newly diagnosed chronic medical conditions (NDCMCs)
Percentage of participants reporting serious adverse events (SAEs)
Day 7
Percentage of participants reporting prompted local reactions
Percentage of participants reporting prompted systemic events

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

VLA15 Low Dose
90%Injection site pain
52%Myalgia
34%Headache
28%Fatigue
28%Injection site erythema
17%Nausea
14%Injection site swelling
10%Injection site induration
10%Influenza like illness
7%Pyrexia
7%Arthralgia
3%Upper respiratory tract infection
0%Herpes oster
0%Peripheral arterial occlusive disease
0%Urinary retention
0%Diverticulitis
0%Neurosyphilis
0%Cellulitis
0%Plasmacytoma
0%Psychotic disorder
0%Appendicitis
0%Acute myocardial infarction
0%Upper limb fracture
0%Multiple injuries
0%Herpes zoster
0%Biliary colic
0%Nasopharyngitis
This histogram enumerates side effects from a completed 2020 Phase 2 trial (NCT03769194) in the VLA15 Low Dose ARM group. Side effects include: Injection site pain with 90%, Myalgia with 52%, Headache with 34%, Fatigue with 28%, Injection site erythema with 28%.

Trial Design

4 Treatment Groups

VLA15 Lot 1 (3-dose primary vaccination series and booster dose)
1 of 4
VLA15 Lot 2 (3-dose primary vaccination series and booster dose)
1 of 4
VLA15 Lot 3 (3-dose primary vaccination series and booster dose)
1 of 4
Placebo (3-dose primary vaccination series and booster dose)
1 of 4
Experimental Treatment
Non-Treatment Group

18000 Total Participants · 4 Treatment Groups

Primary Treatment: VLA15 Lot 1 (3-dose primary vaccination series and booster dose) · Has Placebo Group · Phase 3

VLA15 Lot 1 (3-dose primary vaccination series and booster dose)
Biological
Experimental Group · 1 Intervention: VLA15 · Intervention Types: Biological
VLA15 Lot 2 (3-dose primary vaccination series and booster dose)
Biological
Experimental Group · 1 Intervention: VLA15 · Intervention Types: Biological
VLA15 Lot 3 (3-dose primary vaccination series and booster dose)
Biological
Experimental Group · 1 Intervention: VLA15 · Intervention Types: Biological
Placebo (3-dose primary vaccination series and booster dose)
Other
PlaceboComparator Group · 1 Intervention: Saline · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VLA15
2018
Completed Phase 2
~580

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, up to approximately 30 months.
Closest Location: Frontier Clinical Research, LLC · Scottdale, PA
2017First Recorded Clinical Trial
1 TrialsResearching Lyme Disease
19 CompletedClinical Trials

Eligibility Criteria

Age Any Age · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Individuals who work in B burgdorferi-infected/tick-infested areas, especially those with occupations that may be associated with higher risk of exposure, such as landscaping, forestry, and wildlife and parks management.
You live on a land plot with tree lines and come into contact with these trees regularly.
You have dogs that regularly are outdoors and frequently return with attached ticks.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.