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Immunogenicity and Safety Study of a Vaccine Against Lyme Borreliosis, in Healthy Adults Aged 18 to 65 Years. Randomized, Controlled, Observer-blind Phase 2 Study.

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: NCT03769194
Recruitment Status : Active, not recruiting
First Posted : December 7, 2018
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Valneva Austria GmbH

Tracking Information
First Submitted Date  ICMJE December 6, 2018
First Posted Date  ICMJE December 7, 2018
Last Update Posted Date October 1, 2019
Actual Study Start Date  ICMJE December 17, 2018
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2018)
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype ST1 to ST6 [ Time Frame: up to Day85 / Month 3 (Visit 4) ]
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype ST1 to ST6, determined by ELISA
Original Primary Outcome Measures  ICMJE
 (submitted: December 6, 2018)
GMTs (Geometric Mean Titers) for IgG against each OspA serotype ST1 to ST6 [ Time Frame: up to Day85 / Month 3 (Visit 4) ]
+ GMTs (Geometric Mean Titers) for IgG against each OspA serotype ST1 to ST6, determined by ELISA
Change History Complete list of historical versions of study NCT03769194 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2018)
  • GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (ST1 to ST6) [ Time Frame: up to Day 365 / Month 12 ]
    GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) (Outer Surface Protein A) serotype (ST1 to ST6), determined by ELISA,
  • SCRs (Seroconversion Rate, defined as four-fold increase in IgG (Immunoglobulin G) titer compared to baseline) for each OspA (Outer Surface Protein A) serotype specific IgG (Immunoglobulin G) (ST1 to ST6), [ Time Frame: up to Day 365 / Month 12 ]
    SCRs (Seroconversion Rate, defined as four-fold increase in IgG (Immunoglobulin G) titer compared to baseline) for each OspA serotype specific IgG (Immunoglobulin G) (ST1 to ST6), determined by ELISA,
  • GMFR (Geometric Mean of the fold rise as compared to baseline) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (ST1 to ST6) [ Time Frame: up to Day 365 / Month 12 ]
    GMFR (Geometric Mean of the fold rise as compared to baseline) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (ST1 to ST6), determined by ELISA,
  • GMTs (Geometric Mean Titers), SCRs (Seroconversion Rate) and GMFRs (Geometric Mean of the fold rise as compared to baseline) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (ST1 to ST6), [ Time Frame: up to Day 365 / Month 12 ]
    GMTs (Geometric Mean Titers), SCRs (Seroconversion Rate) and GMFRs (Geometric Mean of the fold rise as compared to baseline) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (ST1 to ST6), determined by ELISA, stratified by age group.
  • SAEs (Serious Adverse Events) [ Time Frame: up to Day 365 / Month 12 ]
    Frequency of SAEs (Serious Adverse Events) during the entire study;
  • related SAEs (Serious Adverse Events) [ Time Frame: up to Day 365 / Month 12 ]
    Frequency of related SAEs (Serious Adverse Events) during the entire study;
  • AESIs (Adverse Events of Special Interest) [ Time Frame: up to Day 365 / Month 12 ]
    Frequency of AESIs (Adverse Events of Special Interest) during the entire study;
  • related AESIs (Adverse Events of Special Interest) [ Time Frame: up to Day 365 / Month 12 ]
    Frequency of related AESIs (Adverse Events of Special Interest) during the entire study;
  • unsolicited AEs (Adverse Events) [ Time Frame: up to Day 365 / Month 12 ]
    Frequency of unsolicited AEs (Adverse Events) during the entire study (incl. clinically relevant laboratory parameters);
  • related unsolicited AEs (Adverse Events) [ Time Frame: up to Day 365 / Month 12 ]
    Frequency of related unsolicited AEs (Adverse Events) during the entire study (incl. clinically relevant laboratory parameters);
  • solicited local and solicited systemic AEs (Adverse Events) [ Time Frame: up to Day 365 / Month 12 ]
    Frequency of solicited local and solicited systemic AEs (Adverse Events) within 7 days after each and after any vaccination.
  • SAEs (Serious Adverse Events), AESIs (Adverse Events of Special Interest), solicited and unsolicited AEs (Adverse Events) [ Time Frame: up to Day 365 / Month 12 ]
    Frequency of SAEs (Serious Adverse Events), AESIs (Adverse Events of Special Interest), solicited and unsolicited AEs (Adverse Events) during the entire study stratified by age group.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2018)
  • GMTs for IgG against each OspA serotype (ST1 to ST6) [ Time Frame: up to Day 365 / Month 12 ]
    GMTs for IgG against each OspA serotype (ST1 to ST6), determined by ELISA,
  • SCRs (Seroconversion Rate, defined as four-fold increase in IgG titer compared to baseline) for each OspA serotype specific IgG (ST1 to ST6), [ Time Frame: up to Day 365 / Month 12 ]
    SCRs (Seroconversion Rate, defined as four-fold increase in IgG titer compared to baseline) for each OspA serotype specific IgG (ST1 to ST6), determined by ELISA,
  • GMFR (Geometric Mean of the fold rise as compared to baseline) for IgG against each OspA serotype (ST1 to ST6) [ Time Frame: up to Day 365 / Month 12 ]
    GMFR (Geometric Mean of the fold rise as compared to baseline) for IgG against each OspA serotype (ST1 to ST6), determined by ELISA,
  • GMTs, SCRs and GMFRs for IgG against each OspA serotype (ST1 to ST6), [ Time Frame: up to Day 365 / Month 12 ]
    GMTs, SCRs and GMFRs for IgG against each OspA serotype (ST1 to ST6), determined by ELISA, stratified by age group.
  • SAEs [ Time Frame: up to Day 365 / Month 12 ]
    Frequency of SAEs during the entire study;
  • related SAEs [ Time Frame: up to Day 365 / Month 12 ]
    Frequency of related SAEs during the entire study;
  • AESIs (Adverse Events of Special Interest) [ Time Frame: up to Day 365 / Month 12 ]
    Frequency of AESIs during the entire study;
  • related AESIs (Adverse Events of Special Interest) [ Time Frame: up to Day 365 / Month 12 ]
    Frequency of related AESIs during the entire study;
  • unsolicited AEs [ Time Frame: up to Day 365 / Month 12 ]
    Frequency of unsolicited AEs during the entire study (incl. clinically relevant laboratory parameters);
  • related unsolicited AEs [ Time Frame: up to Day 365 / Month 12 ]
    Frequency of related unsolicited AEs during the entire study (incl. clinically relevant laboratory parameters);
  • solicited local and solicited systemic AEs [ Time Frame: up to Day 365 / Month 12 ]
    Frequency of solicited local and solicited systemic AEs within 7 days after each and after any vaccination.
  • SEAs, AESIs, solicited and unsolicited AEs [ Time Frame: up to Day 365 / Month 12 ]
    Frequency of SAEs, AESIs, solicited and unsolicited AEs during the entire study stratified by age group.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immunogenicity and Safety Study of a Vaccine Against Lyme Borreliosis, in Healthy Adults Aged 18 to 65 Years. Randomized, Controlled, Observer-blind Phase 2 Study.
Official Title  ICMJE Immunogenicity and Safety Study of VLA15, A Multivalent Recombinant OspA (Outer Surface Protein A) Based Vaccine Candidate Against Lyme Borreliosis, in Healthy Adults Aged 18 to 65 Years. A Randomized, Controlled, Observer-blind Phase 2 Study.
Brief Summary This is a randomized, observer-blind, placebo controlled, multicenter Phase 2 study conducted in two study phases: a run-in phase and a main study phase. The study will investigate 3 doses of a multivalent OspA (Outer Surface Protein A)based Lyme vaccine (VLA15) in healthy adults aged 18 to 65 years of age. Study participants will receive 3 immunizations of the vaccine at a monthly interval. The study will assess the immune response as well as the safety profile of the vaccine.
Detailed Description

This is a randomized, observer-blind, placebo controlled, multicenter Phase 2 study.

In the Run-in phase, a total of 120 subjects aged 18 to 40 years will be randomized 1:1:1:1 to receive one of three VLA15 doses (VLA15 low dose, VLA15 medium dose, VLA15 high dose) or Placebo (30 subjects per treatment group) as intramuscular vaccinations on Days 1, 29 and 57. Dosing will be adjusted by injection volume.

In the Main Study phase, a total of 450 subjects aged 18 to 65 years will be randomized 2:2:1 to receive one of two VLA15 doses that are selected from the Run-in Phase for further investigation (180 subjects each) or placebo (90 subjects), as intramuscular vaccinations on Days 1, 29 and 57. Subjects will be enrolled in two age groups (18-49 years and 50-65 years) in a ratio of approx. 2:1.

In both study phases, target is to enroll approx. 10 % or more of subjects that are baseline seropositive for Borrelia burgdorferi sensu latu (Bb s.l.).

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 Outer surface protein A (OspA) based vaccine candidate
  • Biological: Placebo
    Placebo: PBS (Phosphate Buffered Saline)
Study Arms  ICMJE
  • Active Comparator: VLA15 low dose
    VLA15 low dose with Alum.
    Intervention: Biological: VLA15
  • Active Comparator: VLA15 medium dose
    VLA15 medium dose with Alum.
    Intervention: Biological: VLA15
  • Active Comparator: VLA15 high dose
    VLA15 high dose with Alum.
    Intervention: Biological: VLA15
  • Placebo Comparator: 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: September 30, 2019)
573
Original Estimated Enrollment  ICMJE
 (submitted: December 6, 2018)
570
Estimated Study Completion Date  ICMJE October 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Run-in phase:

1. Subject is aged 18 to 40 years at the day of screening (Visit 0);

Main Study phase:

  1. Subject is aged18 to 65 years at the day of screening (Visit 0);

    Run-in phase and Main Study phase:

  2. Subject is of good general health, including subjects with pharmacologically controlled chronic conditions;
  3. Subject has an understanding of the study and its procedures, agrees to its provisions, and gives written informed consent prior to any study-related procedures;
  4. If subject is of childbearing potential:

    1. Subject has a negative serum pregnancy test at screening (Visit 0);
    2. Subject agrees to employ adequate birth control measures for the duration of the study.

Exclusion Criteria:

  1. Subject has a chronic illness related to Lyme borreliosis (LB), an active symptomatic LB (Lyme borreliosis) as suspected or diagnosed by a physician, or received treatment for LB (Lyme borreliosis) within the last 3 months prior to Visit 0;
  2. Subject received previous vaccination against Lyme borreliosis (LB).;
  3. Subject had a tick bite within 4 weeks prior to Visit 1;
  4. Subject has a medical history of or currently has a clinically relevant disease (cardiovascular, respiratory, neurologic, psychiatric conditions) which poses a risk for participation in the study, based on investigators judgement, such as individuals with poorly controlled or unstable disease, ongoing suspected or active inflammation, or poor compliance with pharmacologic treatment. Subjects with pharmacologically controlled conditions like osteoarthritis, depression, or asthma are eligible;
  5. Subject has a medical history of or currently has a neuroinflammatory or autoimmune disease, including Guillain Barré Syndrome;
  6. Subject has a known thrombocytopenia, bleeding disorder, or received anticoagulants in the 3 weeks prior to first vaccination or until Day 57 (Visit 3), contraindicating intramuscular vaccination as judged by the investigator;
  7. Subject has received an active or passive immunization within 28 days before first vaccination at Visit 1 and until Day 85; except for influenza (seasonal or pandemic) and pneumococcal vaccines which may be administered outside a 7-days interval before or after any trial vaccination;
  8. Subject has received any other non-registered medicinal product in another clinical trial within 28 days prior to VLA15 vaccination at Visit 1 (Day 1) and throughout the entire study period or has received a registered medicinal product in another clinical trial within 28 days prior to VLA15 vaccination at Visit 1 (Day 1) and up to Day 85;
  9. Subject has a known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired immunodeficiency, including infection with human immunodeficiency virus (HIV), status post organ transplantation or immuno-suppressive therapy within 30 days prior to Visit 1. Immuno-suppressive therapy is defined as administration of chronic (longer than 14 days) prednisone or equivalent 0.05 mg per kg/ per day. Topical and inhaled steroids are allowed;
  10. Subject has a history of anaphylaxis or severe allergic reactions or a known hypersensitivity or allergic reactions to one of the components of the vaccine;
  11. Subject had any malignancy in the past 5 years. If treatment for cancer was successfully completed more than 5 years ago and the malignancy is considered to be cured, the subject may be enrolled;
  12. Subject had acute febrile infections within 10 days prior to first vaccination;
  13. Subject is pregnant (positive serum pregnancy test at screening), has plans to become pregnant during the course of the study or is lactating at the time of enrollment. Women of childbearing potential that are unwilling or unable to employ an adequate birth control measure for the duration of the study.
  14. Subject has donated blood or blood-derived products (plasma) within 30 days or received blood or blood-derived products (plasma) within 90 days prior to first vaccination in this study or plans to donate or use blood or blood products during the course of the study;
  15. Subject has any condition that, in the opinion of the investigator, may compromise the subject's well-being, might interfere with evaluation of study endpoints, or would limit the subject's ability to complete the study;
  16. Subject is committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities);
  17. Subject is in a dependent relationship with the sponsor, an investigator or other study team member, or the study center. Dependent relationships include close relatives and household members (i.e. children, partner/spouse, siblings, parents) as well as employees of the investigator or study center personnel.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (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 Belgium,   Germany,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03769194
Other Study ID Numbers  ICMJE VLA15-201
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
Responsible Party Valneva Austria GmbH
Study Sponsor  ICMJE Valneva Austria GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Valneva Austria GmbH
Verification Date September 2019

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