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Alternative Schedule Study For VLA15, a Vaccine Candidate Against Lyme Borreliosis

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: NCT03970733
Recruitment Status : Active, not recruiting
First Posted : May 31, 2019
Results First Posted : July 8, 2021
Last Update Posted : July 8, 2021
Sponsor:
Information provided by (Responsible Party):
Valneva Austria GmbH

Brief Summary:

In the Main Study Phase a total of 246 subjects were randomized 2:2:1 into three treatment groups to receive either VLA15 with Alum (lower or higher dose) or Placebo. Main Study Phase vaccinations were administered as intramuscular injections on Day 1, Day 57 and Day 180.

In the Booster Phase subjects from the higher dose group who completed their primary immunization schedule according to protocol will be randomized 2:1 to receive an additional higher dose VLA15 vaccination or Placebo at Month 18.

Study duration in the Main Study Phase per subject is a maximum of 20 months. Overall study Duration is estimated to be 22 months.

Study duration per subject in the Booster Phase is a maximum of approximately 13 months.

Study duration per subject in the Main Study Phase and Booster Phase together is estimated to be a maximum of approximately 33 months.

Overall study duration (i.e., First-Subject-In to Last-Subject Out/ end of Booster Phase) is estimated to be approximately 37 months.


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

Detailed Description:

This is a randomized, observer-blind (subject, Sponsor and investigator/site staff involved in Clinical Evaluation of subjects are blinded), Placebo controlled, multicenter Phase 2 study.

In Main Study Phase a total of 246 healthy subjects,aged 18 to 65 years, were randomized 2:2:1 to receive either VLA15 with Alum (lower or higher doser Placebo. Main Study Phase vaccinations were administered as intramuscular injections on Day 1 (Month 0), Day 57 (Month 2) and Day 180 (Month 6).

Subjects from the higher dose group who completed their primary immunization schedule according to protocol, will be randomized 2:1 to receive an additional injection of the higher dose VLA15 with Alum or Placebo in a Booster Phase. The additional vaccination is administered as intramuscular injection approximately 18 months after the first immunization.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 246 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Alternative Schedule Study For 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
Actual Study Start Date : June 26, 2019
Actual Primary Completion Date : April 7, 2020
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lyme Disease

Arm Intervention/treatment
Experimental: VLA15 with Alum lower dose
Main Study Phase: VLA15 with Alum lower dose - Booster Phase: arm discontinued
Biological: VLA15
a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate

Experimental: VLA15 with Alum higher dose
Main Study Phase: VLA15 with Alum higher dose - Booster Phase: VLA15 higher dose or placebo
Biological: VLA15
a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate

Placebo Comparator: Placebo
Main Study Phase: placebo - Booster Phase: arm discontinued
Biological: Placebo
PBS (Phosphate Buffered Saline)




Primary Outcome Measures :
  1. GMTs for IgG Against Each OspA 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 ELISA (Enzyme-Linked Immunosorbent Assay) at Day 208 (Month 7)


Secondary Outcome Measures :
  1. GMTs for IgG Against Each OspA Serotype During the Main Study Phase [ Time Frame: up to Day 545 (Month 18) ]
    GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype ST1 to ST6, determined by ELISA (Enzyme-Linked Immunosorbent Assay), at Day 1 (Month 0), 57 (Month 2), 85 (Month 3), 180 (Month 6), 365 (Month 12) and 545 (Month 18)

  2. SCRs for Each OspA Serotype Specific IgG During the Main Study Phase [ Time Frame: up to Day 545 (Month 18) ]
    SCR (Seroconversion Rate) for each OspA (Outer Surface Protein A) serotype specific IgG (Immunoglobulin G) ST1 to ST6, determined by ELISA (Enzyme-Linked Immunosorbent Assay), at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12) and 545 (Month 18)

  3. GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase [ Time Frame: up to Day 545 (Month 18) ]
    GMTs (Geometric Mean Fold Rise) as compared to baseline for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype ST1 to ST6, determined by ELISA (Enzyme-Linked Immunosorbent Assay), at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12) and 545 (Month 18)

  4. GMTs, SCRs and GMFRs for IgG Against Each OspA Serotpye Stratified by Age Group During the Main Study Phase [ Time Frame: up to Day 545 (Mónth 18) ]
    GMTs (Geometric Mean Titers), SCR (Seroconversion Rate) and GMTs (Geometric Mean Fold Rise) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype ST1 to ST6, determined by ELISA (Enzyme-Linked Immunosorbent Assay), at Day 1 (Month 0), 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12) and 545 (Month 18) stratified by age group

  5. Frequency of SAEs During the Main Study Phase [ Time Frame: up to Day 545 (Month 18) ]
    Frequency of SAEs (Serious Adverse Events) during the entire study

  6. Frequency of Related SAEs During the Main Study Phase [ Time Frame: up to Day 545 (Month 18) ]
    Frequency of related SAEs (Serious Adverse Events) during the entire study

  7. Frequency of AESIs During the Main Study Phase [ Time Frame: up to Day 545 (Month 18) ]
    Frequency of AESIs (Adverse Event of Special Interest) during the entire study

  8. Frequency of Related AESIs During the Main Study Phase [ Time Frame: up to Day 545 (Month 18) ]
    Frequency of related AESIs (Adverse Event of Special Interest) during the entire study

  9. Frequency of Unsolicited AEs During the Main Study Phase [ Time Frame: up to Day 545 (Month 18) ]
    Frequency of unsolicited AEs (Adverse Events) during the entire study

  10. Frequency of Related Unsolicited AEs During the Main Study Phase [ Time Frame: up to Day 545 (Month 18) ]
    Frequency of related unsolicited AEs (Adverse Events) during the entire study

  11. Frequency of Solicited Local and Solicited Systemic AEs [ Time Frame: up to day 7 after each vaccination ]
    Frequency of solicited local and solicited systemic AEs (Adverse Events) within 7 days after each and after any vaccination

  12. Frequency of SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group [ Time Frame: up to Day 545 (Month 18) ]
    Frequency of SAEs (Serious Adverse Events), AESIs (Adverse Event of Special Interest), solicited and unsolicited AEs during the Main Study Phase stratified by age group

  13. GMTs for IgG Against Each OspA Serotype (ST1 to ST6) During the Booster Phase [ Time Frame: until Month 30 ]
    GMTs (Geometric Mean Titer) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (ST1 to ST6), determined by ELISA (Enzyme-Linked Immunosorbent Assay)

  14. SCRs for Each OspA Serotype Specific IgG (ST1 to ST6) During the Booster Phase [ Time Frame: until Month 30 ]
    SCRs (Seroconversion Rate) for each OspA (Outer Surface Protein A) serotype specific IgG (ST1 to ST6), determined by ELISA (Enzyme-Linked Immunosorbent Assay)

  15. GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6) During the Booster Phase [ Time Frame: until Month 30 ]
    GMFR (Geometric Mean Fold Rise) as compared to baseline for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (ST1 to ST6), determined by ELISA (Enzyme-Linked Immunosorbent Assay)

  16. GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6) During the Booster Phase [ Time Frame: at Month 19, Month 24 and Month 30 ]
    GMFR (Geometric Mean Fold Rise) as compared to Day 208 for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (ST1 to ST6), determined by ELISA (Enzyme-Linked Immunosorbent Assay)

  17. GMFR as Compared to Month 18 (Pre-boost) for IgG Against Each OspA Serotype (ST1 to ST6) During the Booster Phase [ Time Frame: at Month 19, Month 24 and Month 30 ]
    GMFR (Geometric Mean Fold Rise) as compared to Month 18 (pre-boost) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (ST1 to ST6), determined by ELISA (Enzyme-Linked Immunosorbent Assay)

  18. GMTs, SCRs for IgG Against Each OspA Serotype (ST1 to ST6) During the Booster Phase [ Time Frame: until Month 30 ]
    GMTs (Geometric Mean Titer), SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) against each OspA serotype (ST1 to ST6), determined by ELISA (Enzyme-Linked Immunosorbent Assay) stratified by age group

  19. Frequency of Related SAEs During the Entire Booster Phase [ Time Frame: up to Month 30 ]
    Frequency of related SAEs (Serious Adverse Events) during the entire Booster Phase

  20. Frequency of AESIs During the Entire Booster Phase [ Time Frame: up to Month 30 ]
    Frequency of AESIs (Adverse Event of Special Interest) during the entire Booster Phase

  21. Frequency of Related AESIs During the Entire Booster Phase [ Time Frame: up to Month 30 ]
    Frequency of related AESIs (Adverse Event of Special Interest) during the entire Booster Phase

  22. Frequency of Unsolicited AEs [ Time Frame: up to Month 19 ]
    Frequency of unsolicited AEs (Adverse Events) (incl. clinically relevant laboratory parameters)

  23. Frequency of Related Unsolicited AEs [ Time Frame: up to Month 19 ]
    Frequency of related unsolicited AEs (Adverse Events) (incl. clinically relevant laboratory parameters)

  24. Frequency of Solicited Local and Solicited Systemic AEs [ Time Frame: up to Day 7 ]
    Frequency of solicited local and solicited systemic AEs (Adverse Events) within 7 days after booster vaccination

  25. Frequency of SAEs, AESIs, Solicited and Unsolicited AEs [ Time Frame: up to Month 30 ]
    Frequency of SAEs (Serious Adverse Events), AESIs (Adverse Event of Special Interest), solicited and unsolicited AEs (Adverse Events), stratified by age group



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.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria - Main Study Phase:

  • Subject is aged 18 to 65 years at the day of screening
  • Subject is of good general health, including subjects with pharmacologically controlled chronic conditions;
  • 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;
  • If subject is of childbearing potential:
  • Subject has a negative serum pregnancy test at screening;
  • Subject agrees to employ adequate birth control measures for the duration of the study.

Inclusion Criteria - Booster Phase:

  1. Randomization into higher dose group in the Main Study Phase
  2. No relevant protocol deviation in the Main Study Phase, i.e., included in the Per-Protocol population for the Day 208 interim analysis of the Main Study;
  3. Subject is of good general health, including subjects with pharmacologically controlled chronic conditions;
  4. 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;
  5. If subject is of childbearing potential:

    1. Subject has a negative Urine pregnancy test before booster vaccination;
    2. Subject agrees to employ adequate birth control measures for the duration of the study

Exclusion Criteria - Main Study Phase:

  • Subject has a chronic illness related to Lyme borreliosis (LB), an active symptomatic LB as suspected or diagnosed by a physician, or received treatment for LB within the last 3 months prior to screening;
  • Subject received previous vaccination against LB.;
  • Subject had a tick bite within 4 weeks prior to vaccination visit;
  • Subject has a medical history of or currently has a clinically relevant disease (e.g. 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;
  • Subject has a medical history of or currently has a neuroinflammatory or autoimmune disease, including Guillain Barré Syndrome;
  • Subject has a known thrombocytopenia, bleeding disorder, or received anticoagulants in the three weeks prior to each study vaccination, contraindicating I.M. vaccination as judged by the investigator;
  • Subject has received an active or passive immunization within 28 days before or after any vaccination; except for influenza (seasonal or pandemic) vaccines which may be administered outside a 7-days interval before or after any trial vaccination;
  • Subject has received any other non-registered medicinal product in another clinical Trial within 28 days prior to VLA15 vaccination and throughout the entire study period or has received a registered medicinal product in another clinical Trial within 28 days prior to VLA15 vaccination and up to Day 208;
  • 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 first vaccination. Immuno-suppressive therapy is defined as administration of chronic (longer than 14 days) prednisone or equivalent >=0.05 mg/kg/day. Topical and inhaled steroids are allowed;
  • 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; 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;
  • Subject had acute febrile infections within 10 days prior to first vaccination;
  • 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.
  • Subject has donated blood or blood-derived products (e.g. plasma) within 30 days or received blood or blood-derived products (e.g. 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;
  • 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;
  • Subject is committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities);
  • 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.

Exclusion Criteria - Booster Phase:

  1. Subject met an individual stopping criterion during the Main Study Phase;
  2. Subject has developed a chronic illness related to Lyme borreliosis (LB), an active symptomatic LB as suspected or diagnosed by a physician, or received treatment for LB within the last 3 months prior to vaccination visit;
  3. Subject has developed a clinically relevant disease (e.g. cardiovascular, respiratory, neurologic, psychiatric conditions) which poses a risk for further 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;
  4. Subject has developed a neuroinflammatory or autoimmune disease, including Guillain Barré Syndrome;
  5. Subject has developed an immunodeficiency, including known infection with human immunodeficiency virus (HIV), status post organ transplantation, or immuno-suppressive therapy within 30 days prior to vaccination visit. Immuno-suppressive therapy is defined as administration of chronic (longer than 14 days) prednisone or equivalent >= 0.05 mg/kg/day. Topical and inhaled steroids are allowed;
  6. Subject has developed anaphylaxis or severe allergic reactions;
  7. Subject has developed allergic reactions to one of the components of the vaccine;
  8. Subject has developed a malignancy;
  9. Subject has developed thrombocytopenia or received anticoagulants in the 3 weeks prior to the booster vaccination contraindicating I.M. vaccination as judged by the investigator;
  10. Subject has received any other non-registered medicinal product in another clinical trial within 28 days prior to VLA15 booster vaccination at Month 18 or plans to participate in another clinical trial with a non-registered medicinal product until Month 24;
  11. Subject is pregnant, or plans to become pregnant prior to Month 24, or is lactating. Women of childbearing potential that are unwilling or unable to employ an adequate birth control measure for the duration of the study;
  12. Subject has developed 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;
  13. Subject has been committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities);
  14. 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, sibling).

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): NCT03970733


Locations
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United States, Connecticut
Clinical Research Consulting, LLC
Milford, Connecticut, United States, 06460
Stamford Therapeutics Consortium
Stamford, Connecticut, United States, 06905
United States, New York
United Medical Associates
Binghamton, New York, United States, 13901
Regional Clinical Research, Inc.
Endwell, New York, United States, 13760
Rochester Clinical Research, Inc.
Rochester, New York, United States, 14609
Sponsors and Collaborators
Valneva Austria GmbH
  Study Documents (Full-Text)

Documents provided by Valneva Austria GmbH:
Study Protocol  [PDF] December 22, 2020
Statistical Analysis Plan  [PDF] July 14, 2020

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Responsible Party: Valneva Austria GmbH
ClinicalTrials.gov Identifier: NCT03970733    
Other Study ID Numbers: VLA15-202
First Posted: May 31, 2019    Key Record Dates
Results First Posted: July 8, 2021
Last Update Posted: July 8, 2021
Last Verified: July 2021

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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:
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Borrelia Infections
Lyme Disease
Spirochaetales Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Tick-Borne Diseases
Vector Borne Diseases