VLA15 for Lyme Polyradiculitis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Lyme Polyradiculitis+2 More
VLA15 - Biological
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

1 of 3

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

2 of 3
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
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

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: Biological
Treatment
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 preview

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?
Maryland50.0%
Massachusetts25.0%
Pennsylvania25.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Rochester Clinical Research, Inc.50.0%
Velocity Clinical Research - Cleveland50.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria50.0%
Met criteria50.0%