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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.

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ClinicalTrials.gov Identifier: NCT03769194
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Valneva Austria GmbH

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.

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

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.).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 570 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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.
Actual Study Start Date : December 17, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: VLA15 low dose
VLA15 low dose with Alum.
Biological: VLA15
a multivalent Outer surface protein A (OspA) based vaccine candidate

Active Comparator: VLA15 medium dose
VLA15 medium dose with Alum.
Biological: VLA15
a multivalent Outer surface protein A (OspA) based vaccine candidate

Active Comparator: VLA15 high dose
VLA15 high dose with Alum.
Biological: VLA15
a multivalent Outer surface protein A (OspA) based vaccine candidate

Placebo Comparator: Placebo Biological: Placebo
Placebo: PBS (Phosphate Buffered Saline)




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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,

  2. 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,

  3. 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,

  4. 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.

  5. SAEs (Serious Adverse Events) [ Time Frame: up to Day 365 / Month 12 ]
    Frequency of SAEs (Serious Adverse Events) during the entire study;

  6. related SAEs (Serious Adverse Events) [ Time Frame: up to Day 365 / Month 12 ]
    Frequency of related SAEs (Serious Adverse Events) during the entire study;

  7. 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;

  8. 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;

  9. 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);

  10. 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);

  11. 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.

  12. 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.



Information from the National Library of Medicine

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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:

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.

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): NCT03769194


Contacts
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Contact: Scientist Clinical Strategy 0043 1 206 20 ext 0 info@valneva.com

Locations
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United States, Connecticut
Clinical Research Consulting, LLC Recruiting
Milford, Connecticut, United States, 06460
Contact: Susann Varano, MD         
Stamford Therapeutics Consortium Recruiting
Stamford, Connecticut, United States, 06905
Contact: David Radin, MD         
United States, New York
United Medical Associates Recruiting
Binghamton, New York, United States, 13901
Contact: Frank Eder, MD         
Regional Clinical Research, Inc. Recruiting
Endwell, New York, United States, 13706
Contact: Suchet Patel, MD         
Rochester Clinical Research Inc. Recruiting
Rochester, New York, United States, 14609
Contact: Matthew Davis, MD         
United States, Rhode Island
Omega Medical Research Active, not recruiting
Warwick, Rhode Island, United States, 02886
Belgium
Cevac Center for vaccinology Not yet recruiting
Gent, Belgium, 9000
Contact: Isabel Leroux-Roels, Prof. Dr.         
Germany
Berliner Centrum für Reise- und Tropenmedizin (BCRT) Recruiting
Berlin, Germany, 10117
Contact: Tomas Jelinek, Prof. Dr.         
Universitätsklinikum Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20359
Contact: Johanna Fischer-Herr, Dr.         
Sponsors and Collaborators
Valneva Austria GmbH

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Responsible Party: Valneva Austria GmbH
ClinicalTrials.gov Identifier: NCT03769194     History of Changes
Other Study ID Numbers: VLA15-201
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019

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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
Gram-Negative Bacterial Infections
Bacterial Infections
Spirochaetales Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs