VLA15 for Lyme Polyradiculitis
Phase-Based Progress Estimates
Effectiveness
Safety
Lyme Polyradiculitis+2 More
VLA15 - BiologicalEligibility
Any Age
All Sexes
What conditions do you have?
Select
Eligibility
Any Age
All Sexes
What conditions do you have?
Select
Study Summary
This trial is testing the safety and effectiveness of two different schedules of vaccinations for Lyme disease. The study will last a maximum of 19 months for participants, who will be given either 3 or 2 vaccinations. 600 people aged 5-65 years will be enrolled.
Eligible Conditions
- Lyme Polyradiculitis
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 17 Secondary · Reporting Duration: until Month 54
28 Days
Frequency of unsolicited AEs (Adverse Events) after each vaccination
7 Days
Frequency of solicited local and solicited systemic AEs (Adverse Events)
Day 208/Month 7
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype
Month 19
GMFRs (Geometric Mean of the Fold Rises) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (Part B)
until Day 208
Immunoglobulin G
until Month 18
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (Part A)
SCRs (Seroconversion Rates) for each OspA (Outer Surface Protein A) serotype specific IgG (Immunoglobulin G) (Part A)
until Month 19
GMFRs (Geometric Mean Fold Rises) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype stratified by age cohort (Part A)
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype stratified by age cohort (Part A)
SCRs (Seroconversion Rates) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype stratified by age cohort (Part A)
until Month 54
Frequency of AESIs (Adverse Events of Special Interest)
Frequency of SAEs (Serious Adverse Events)
Frequency of SAEs (Serious Adverse Events), AESIs(Adverse Events of Special Interest), unsolicited and solicited AEs stratified by age cohort
GMFRs (Geometric Mean Fold Rises) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype stratified by age cohort (Part B)
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (Part B)
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype stratified by age cohort (Part B)
SCRs (Seroconversion Rates) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype stratified by age cohort (Part B)
SCRs (Seroconversion Rates) for each OspA (Outer Surface Protein A) serotype specific IgG (Immunoglobulin G) (Part B)
Trial Safety
Safety Progress
This is further along than 68% 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
Trial Design
3 Treatment Groups
Part A+B - Group 1
1 of 3
Part A+B - Group 2
1 of 3
Part A+B - Group 3
1 of 3
Experimental Treatment
Non-Treatment Group
625 Total Participants · 3 Treatment Groups
Primary Treatment: VLA15 · Has Placebo Group · Phase 2
Part A+B - Group 1Experimental Group · 2 Interventions: VLA15, Placebo · Intervention Types: Biological, Biological
Part A+B - Group 2Experimental Group · 2 Interventions: VLA15, Placebo · Intervention Types: Biological, Biological
Part A+B - Group 3
Biological
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: BiologicalTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VLA15
2018
Completed Phase 2
~580
Placebo
1995
Completed Phase 3
~2670
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: until month 54
Who is running the clinical trial?
Valneva Austria GmbHLead Sponsor
42 Previous Clinical Trials
63,556 Total Patients Enrolled
PfizerIndustry Sponsor
4,260 Previous Clinical Trials
7,104,294 Total Patients Enrolled
Valneva Clinical DevelopmentStudy ChairValneva Austria GmbH
6 Previous Clinical Trials
9,370 Total Patients Enrolled
Eligibility Criteria
Age Any Age · All Participants · 9 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:For subjects aged 5-17 years, written informed consent by the subject's legal representative(s) is required according to local requirements, and written informed assent of the subject is also required, if applicable, prior to any study related procedures.
, and consent to the subject's participation
The parents/legal representatives understand the study and its procedures and agree to its provisions
, 9 years
The main study phase of the study is nine years long.
A booster dose of 18F-FDG PET/CT was administered to all patients at Month 23.
The subject is between the ages of 5 and 65 at the time of the screening.
Subject is in good physical health.
The subject is willing and able to comply with the study's scheduled visits, treatment plan, and other specified procedures.
The subject is available for the entire study and can be contacted by telephone during the study.
If you are over the age of 18, we will need your written consent before any study-related procedures can take place.
About The Reviewer
Michael Gill - B. Sc.
First Published: October 4th, 2021
Last Reviewed: November 21st, 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.
Who else is applying?
What state do they live in?
| Maryland | 50.0% |
| Massachusetts | 25.0% |
| Pennsylvania | 25.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Rochester Clinical Research, Inc. | 50.0% |
| Velocity Clinical Research - Cleveland | 50.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 50.0% |
| Met criteria | 50.0% |
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