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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

Tracking Information
First Submitted Date  ICMJE March 8, 2021
First Posted Date  ICMJE March 17, 2021
Last Update Posted Date July 27, 2021
Actual Study Start Date  ICMJE March 15, 2021
Estimated Primary Completion Date February 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2021)
  • 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)
  • 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2021)
  • 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)
  • Frequency of SAEs (Serious Adverse Events) [ Time Frame: until Month 54 ]
    Frequency of SAEs (Serious Adverse Events) during the entire study
  • 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.
  • 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
  • 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
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 2 Study Of VLA15, A Vaccine Candidate Against Lyme Borreliosis, In A Healthy Peadiatric And Adult Study Population
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Lyme Borreliosis
Intervention  ICMJE
  • Biological: VLA15
    a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate
  • Biological: Placebo
    PBS (Phosphate Buffered Saline)
Study Arms  ICMJE
  • Experimental: Part A+B - Group 1
    Part A: VLA15 at Month 0, 2 and 6 - Part B: VLA15 or placebo depending on schedule selection
    Interventions:
    • Biological: VLA15
    • Biological: Placebo
  • 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
    Interventions:
    • Biological: VLA15
    • Biological: Placebo
  • Placebo Comparator: Part A+B - Group 3
    Placebo
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 26, 2021)
625
Original Estimated Enrollment  ICMJE
 (submitted: March 15, 2021)
600
Estimated Study Completion Date  ICMJE January 2026
Estimated Primary Completion Date February 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04801420
Other Study ID Numbers  ICMJE VLA15-221
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Valneva Austria GmbH
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Valneva Austria GmbH
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Chair: Valneva Clinical Development Valneva Austria GmbH
PRS Account Valneva Austria GmbH
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP