VLA15 for Lyme Neuroborreliosis

New England Research Associates, Bridgeport, CT

VLA15 +1 morePhase 2Waitlist AvailableResearch Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject is of good general health

Must not have

Timeline

Screening 3 weeks

Treatment Varies

Follow Upup to month 54

Awards & highlights

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 Neuroborreliosis

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Select...

You are in overall good health.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to month 54

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to month 54

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to month 54 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) Against Each Outer Surface Protein A (OspA) Serotype (ST1 to ST6) at Day 208 During the Main Study Phase

Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase

Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2

+2 more

Secondary outcome measures

GMFR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Cohort During the Booster Phase

GMFR for IgG Against Each OspA Serotype (ST1 to ST6) at Month 19 During the Booster Phase

GMTs for IgG Against Each OspA Serotype (ST1 to ST6) During the Booster Phase

+14 more

Side effects data

From 2020 Phase 2 trial • 572 Patients • NCT03769194

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

Pyrexia

Arthralgia

Upper respiratory tract infection

100%

80%

60%

40%

20%

Study treatment Arm

VLA15 Low Dose

Placebo

VLA15 Medium Dose

VLA15 High Dose

Trial Design

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

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

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

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

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

VLA15

2018

Completed Phase 2

~820

Placebo

1995

Completed Phase 3

~2670

0 / 1Eligibility criteria met

Find a site

Who is running the clinical trial?

PfizerLead Sponsor

4,460 Previous Clinical Trials

26,143,276 Total Patients Enrolled

3 Trials studying Lyme Neuroborreliosis

997 Patients Enrolled for Lyme Neuroborreliosis

Valneva Austria GmbHIndustry Sponsor

42 Previous Clinical Trials

63,451 Total Patients Enrolled

3 Trials studying Lyme Neuroborreliosis

997 Patients Enrolled for Lyme Neuroborreliosis

Pfizer CT.gov Call CenterStudy Director

Pfizer

3,395 Previous Clinical Trials

23,419,787 Total Patients Enrolled

3 Trials studying Lyme Neuroborreliosis

997 Patients Enrolled for Lyme Neuroborreliosis

Valneva Clinical DevelopmentStudy Chair

Valneva Austria GmbH

6 Previous Clinical Trials

9,265 Total Patients Enrolled

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT04801420 — Phase 2

Lyme Neuroborreliosis Research Study Groups: Part A+B - Group 3, Part A+B - Group 1, Part A+B - Group 2

Lyme Neuroborreliosis Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT04801420 — Phase 2

Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT04801420 — Phase 2

Lyme Neuroborreliosis Patient Testimony for trial: Trial Name: NCT04801420 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many research centers are conducting this trial?

"The primary clinical trial site is Stamford Therapeutics Consortium in Stamford, Connecticut. Other locations where this study is running include Square-1 Clinical Research, Inc. - AHN Health and Wellness Pavilion in Erie, Rhode Island; Velocity Clinical Research - Providence in Warwick, New Jersey; as well as 14 other centres."

Answered by AI

What is the known safety profile of VLA15?

"The safety of VLA15 has been tentatively established in Phase 2 clinical trials. However, more data is needed to confirm its efficacy."

Answered by AI

If I meet the qualifications, may I join this experiment?

"This clinical trial is enrolling 625 participants with lyme polyradiculitis aged 5 and 65. Most notable, candidates must meet the following criteria: Parent(s)/legal representative(s) and subject understand the study and its procedures, agree to its provisions, Booster Phase: until Month 23 (i.e. 5 months after booster dose), Subject is aged 5 to 65 years at the day of screening (Visit 0), Subject is of good general health, Subject is willing and able to comply with scheduled visits, treatment plan, and other study procedures, Subject is available for the duration of the study and can be contacted"

Answered by AI

Can patients sign up for this trial right now?

"According to the latest update on clinicaltrials.gov, this particular trial is not looking for new patients at this time. The study was originally posted on March 15th 2021 but has not been updated since July 26th of the same year. Although this may be the case, there are 8 other trials that are currently recruiting patients."

Answered by AI

Can elderly patients participate in this scientific experiment?

"According to the rules that determine who can participate in this research, the youngest age an individual can be is 5 and the oldest is 65."

Answered by AI

Who else is applying?

What state do they live in?

Pennsylvania

New York

Maryland

Other

How old are they?

18 - 65

What site did they apply to?

Rochester Clinical Research, Inc.

Richmond Behavioral Associates

Velocity Clinical Research - Cleveland

What portion of applicants met pre-screening criteria?

Met criteria

Did not meet criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

I live in a high-risk area for ticks carrying Lyme Disease and am interested in a vaccine for this purpose.

Patient

I'm actively outdoors most of the year and have been diagnosed with Lyme disease three years ago. Although I take many precautions, I was bitten by ticks twice in the past year.

Patient

Interested I visit family that have been diagnosed with Lyme disease also interested in Spinal degenerative disease trials Hiw much are they paying it doesn’t say on either trial ty Deb Keenan 917470 4530 tel new address 3800 Amboy rd Si ny 10308 # 2.

Patient

Recent research and studies

clinicaltrials.govStudy

Phase 2 Study Of VLA15, A Vaccine Candidate Against Lyme Borreliosis, In A Healthy Pediatric And Adult Study Population

2021. "Phase 2 Study Of VLA15, A Vaccine Candidate Against Lyme Borreliosis, In A Healthy Pediatric And Adult Study Population". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04801420.

~179 spots leftby Sep 2024

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