Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 4 for:    vla15 | Lyme Disease

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04801420
Recruitment Status : Active, not recruiting
First Posted : March 17, 2021
Last Update Posted : July 27, 2021
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Valneva Austria GmbH

Brief Summary:
VLA15-221 is a Phase 2 study, which will be conducted in two parts: Main Study Phase (Part A) and Booster Phase (Part B). The study will compare the safety and immunogenicity of two different primary immunization schedules applying three (Month 0-2-6) or two (Month 0-6) vaccinations. Within the study, 600 healthy subjects aged 5-65 years will be included. Subjects with a history of Lyme borreliosis (previous infection with Borrelia) as well as Borrelia naïve subjects will be enrolled. Study duration per subject will be a maximum of 19 months in Part A and additional 37 months for subjects enrolled in the Part B.

Condition or disease Intervention/treatment Phase
Lyme Borreliosis Biological: VLA15 Biological: Placebo Phase 2

Detailed Description:
VLA15-221 is a randomized, observer-blind, placebo controlled, multicenter Phase 2 study, which is set up in two parts: Main Study Phase (Part A) and Booster Phase (Part B). In Part A 600 subjects aged 5-65 years will be enrolled 1:1:1 into three groups: Group 1 will be vaccinated with VLA15 at Month 0-2-6, Group 2 will be vaccinated with VLA15 at Month 0-6 and with placebo at Month 2 and Group 3 will be vaccinated with placebo at Month 0-2-6. In Part B a subset of subjects will receive a booster injection with VLA15 or placebo at Month 18.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 625 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety And Immunogenicity Study Of VLA15, A Multivalent Recombinant OspA Based Vaccine Candidate Against Lyme Borreliosis: A Randomized, Controlled, Observer-Blind Phase 2 Study In A Healthy Pediatric And Adult Study Population
Actual Study Start Date : March 15, 2021
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : January 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lyme Disease

Arm Intervention/treatment
Experimental: Part A+B - Group 1
Part A: VLA15 at Month 0, 2 and 6 - Part B: VLA15 or placebo depending on schedule selection
Biological: VLA15
a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate

Biological: Placebo
PBS (Phosphate Buffered Saline)

Experimental: Part A+B - Group 2
Part A: VLA15 at Month 0 and 6, placebo at Month 2 - Part B: VLA15 or placebo depending on schedule selection
Biological: VLA15
a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate

Biological: Placebo
PBS (Phosphate Buffered Saline)

Placebo Comparator: Part A+B - Group 3
Placebo
Biological: Placebo
PBS (Phosphate Buffered Saline)




Primary Outcome Measures :
  1. Frequency of solicited local and solicited systemic AEs (Adverse Events) [ Time Frame: 7 Days ]
    Frequency of solicited local and solicited systemic AEs (Adverse Events) within 7 days after each and any vaccination of the primary vaccination series (Part A)

  2. GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype [ Time Frame: Day 208/Month 7 ]
    GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype ST1 to ST6, determined by an IgG (Immunoglobulin G) binding assay at Day 208/Month 7 (Part A).


Secondary Outcome Measures :
  1. Frequency of solicited local and solicited systemic AEs (Adverse Events) [ Time Frame: 7 Days ]
    Frequency of solicited local and solicited systemic AEs (Adverse Events) within 7 days after booster dose administration (Part B)

  2. Frequency of SAEs (Serious Adverse Events) [ Time Frame: until Month 54 ]
    Frequency of SAEs (Serious Adverse Events) during the entire study

  3. Frequency of AESIs (Adverse Events of Special Interest) [ Time Frame: until Month 54 ]
    Frequency of AESIs (Adverse Events of Special Interest) during the entire study.

  4. Frequency of unsolicited AEs (Adverse Events) after each vaccination [ Time Frame: 28 Days ]
    Frequency of unsolicited AEs (Adverse Events) within 28 days after each vaccination

  5. Frequency of SAEs (Serious Adverse Events), AESIs(Adverse Events of Special Interest), unsolicited and solicited AEs stratified by age cohort [ Time Frame: until Month 54 ]
    Frequency of SAEs (Serious Adverse Events), AESIs (Adverse Events of Special Interest), unsolicited and solicited AEs (Adverse Events) stratified by age cohort

  6. GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (Part A) [ Time Frame: until Month 18 ]
    GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (ST1 to ST6), determined by an IgG (Immunoglobulin G) binding assay, at baseline (screening visit) and at Day 85, 180, 194, 365 and Month 18 (Part A)

  7. SCRs (Seroconversion Rates) for each OspA (Outer Surface Protein A) serotype specific IgG (Immunoglobulin G) (Part A) [ Time Frame: until Month 18 ]
    SCRs (Seroconversion Rates) for each OspA (Outer Surface Protein A) serotype specific IgG (Immunoglobulin G) (ST1 to ST6), determined by an IgG (Immunoglobulin G) binding assay, at Day 85, 180, 194, 208, 365 and Month 18 (Part A)

  8. GMFRs (Geometric Mean of the Fold Rises) for IgG against each OspA (Outer Surface Protein A) serotype (Part A) [ Time Frame: until Day 208 ]
    GMFRs (Geometric Mean of the Fold Rises) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (ST1 to ST6), determined by an IgG (Immunoglobulin G) binding assay, at Day 85 and 208 (Part A)

  9. GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype stratified by age cohort (Part A) [ Time Frame: until Month 19 ]
    GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (ST1 to ST6), determined by an IgG (Immunoglobulin G) binging assay, at specified time-points, stratified by age cohort. (Part A)

  10. SCRs (Seroconversion Rates) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype stratified by age cohort (Part A) [ Time Frame: until Month 19 ]
    SCRs (Seroconversion Rates) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (ST1 to ST6), determined by an IgG (Immunoglobulin G) binging assay, at specified time-points, stratified by age cohort. (Part A)

  11. GMFRs (Geometric Mean Fold Rises) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype stratified by age cohort (Part A) [ Time Frame: until Month 19 ]
    GMFRs (Geometric Mean Fold Rises) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (ST1 to ST6), determined by an IgG (Immunoglobulin G) binging assay, at specified time-points, stratified by age cohort. (Part A)

  12. GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (Part B) [ Time Frame: until Month 54 ]
    GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (ST1 to ST6), determined by an IgG (Immunoglobulin G) binding assay, at Month 18, 19, 23, 26, 30, 36, 42, 48 and 54 (Part B)

  13. SCRs (Seroconversion Rates) for each OspA (Outer Surface Protein A) serotype specific IgG (Immunoglobulin G) (Part B) [ Time Frame: until Month 54 ]
    SCRs (Seroconversion Rates) for each OspA (Outer Surface Protein A) serotype specific IgG (ST1 to ST6), determined by an IgG (Immunoglobulin G) binding assay, at Month 18, 19, 23, 26, 30, 36, 42, 48 and 54 (Part B)

  14. GMFRs (Geometric Mean of the Fold Rises) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (Part B) [ Time Frame: Month 19 ]
    GMFRs (Geometric Mean of the Fold Rises) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (ST1 to ST6), determined by an IgG (Immunoglobulin G) binding assay, at Month 19 (Part B)

  15. GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype stratified by age cohort (Part B) [ Time Frame: until Month 54 ]
    GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (ST1 to ST6), determined by an IgG (Immunoglobulin G) binding assay, at specified time-points, stratified by age cohort. (Part B)

  16. SCRs (Seroconversion Rates) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype stratified by age cohort (Part B) [ Time Frame: until Month 54 ]
    SCRs (Seroconversion Rates) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (ST1 to ST6), determined by an IgG (Immunoglobulin G) binding assay, at specified time-points, stratified by age cohort. (Part B)

  17. GMFRs (Geometric Mean Fold Rises) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype stratified by age cohort (Part B) [ Time Frame: until Month 54 ]
    GMFRs (Geometric Mean Fold Rises) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (ST1 to ST6), determined by an IgG (Immunoglobulin G) binding assay, at specified time-points, stratified by age cohort. (Part B)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   5 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject is aged 5 to 65 years at the day of screening (Visit 0)
  • Subject is of good general health
  • Parent(s)/legal representative(s) and subject understand the study and its procedures, agree to its provisions

    • for subjects aged 18-65 years: written informed consent prior to any study related procedures
    • for subjects aged 5-17 years: written informed consent by the subject's legal representative(s), according to local requirements, and written informed assent of the subject, if applicable, prior to any study related procedures.
  • If subject is of childbearing potential: Subject has a negative serum pregnancy test at screening (Visit 0) and agrees to employ adequate birth control measures according to following timelines:

    • Main Study Phase: duration of entire study
    • Booster Phase: until Month 23 (i.e. 5 months after booster dose)
  • 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 by telephone during study participation

Exclusion Criteria:

  • Subject has a chronic illness related to Lyme borreliosis (LB), an active symptomatic LB, or received treatment for LB within the last 3 months prior to Day 1;
  • Subject received previous vaccination against LB;
  • Subject had a tick bite within 4 weeks prior to Day 1;
  • Subject has a medical history of or currently has a clinically relevant disease;
  • Subject has a medical history of or currently has a neuro-inflammatory or autoimmune disease;
  • Subject has a known thrombocytopenia, bleeding disorder, or received anticoagulants in the 3 weeks prior to Day 1;
  • Subject has received an active or passive immunization within 4 weeks prior to Day 1;
  • Subject has received any other registered or non-registered medicinal product in another clinical trial within 4 weeks prior to vaccination at Day 1;
  • Subject has a known or suspected defect of the immune system or received immuno-suppressive therapy within 4 weeks prior to Day 1;
  • Subject has a history of anaphylaxis of unknown cause or severe allergic reactions of unknown cause or has a known hypersensitivity or allergic reactions to one of the components of the vaccine;
  • Subject had any malignancy in the past 5 years;
  • Subject is pregnant, has plans to become pregnant during the course of the study or is lactating at the time of enrollment;
  • Subject has donated or plans to donate blood or blood-derived products 4 weeks prior to Day 1;
  • Subject has any condition that may compromise its well-being, might interfere with evaluation of study endpoints, or would limit the subject's ability to complete the study;
  • Subject is in a dependent relationship;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04801420


Locations
Layout table for location information
United States, Connecticut
Stamford Therapeutics Consortium
Stamford, Connecticut, United States, 06905
Chase Medical Research, LLC
Waterbury, Connecticut, United States, 06708
United States, Minnesota
Clinical Research Institute, Inc.
Minneapolis, Minnesota, United States, 55402
United States, New Jersey
Med Clinical Research Partners, LLC/ Foundation Pediatrics
Irvington, New Jersey, United States, 07111
United States, New York
Meridian Clinical Research, LLC
Binghamton, New York, United States, 13901
Advantage Clinical Trials
Bronx, New York, United States, 10468
Rochester Clinical Research, Inc.
Rochester, New York, United States, 14609
Richmond Behavioral Associates
Staten Island, New York, United States, 10312
United States, Ohio
Velocity Clinical Research - Cleveland
Cleveland, Ohio, United States, 44122
United States, Pennsylvania
Square-1 Clinical Research, Inc. - AHN Health and Wellness Pavilion
Erie, Pennsylvania, United States, 16506
Sqare-1 Clinical Research - Liberty Family Practice
Erie, Pennsylvania, United States, 16508
Lockman & Lubell Pediatric Associates
Fort Washington, Pennsylvania, United States, 19034
United States, Rhode Island
The Miriam Hospital - Lifespan Clinical Research Center
Providence, Rhode Island, United States, 02906
Velocity Clinical Research - Providence
Warwick, Rhode Island, United States, 02886
Sponsors and Collaborators
Valneva Austria GmbH
Pfizer
Investigators
Layout table for investigator information
Study Chair: Valneva Clinical Development Valneva Austria GmbH
Layout table for additonal information
Responsible Party: Valneva Austria GmbH
ClinicalTrials.gov Identifier: NCT04801420    
Other Study ID Numbers: VLA15-221
First Posted: March 17, 2021    Key Record Dates
Last Update Posted: July 27, 2021
Last Verified: July 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Valneva Austria GmbH:
VLA15
Lyme Borreliosis
Vaccine
Additional relevant MeSH terms:
Layout table for MeSH terms
Borrelia Infections
Lyme Disease
Spirochaetales Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Tick-Borne Diseases
Vector Borne Diseases