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

NCT03970733 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: VLA15-202C4601007
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 5

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.

Conditions

Lyme Borreliosis

Keywords

VLA15; Lyme Borreliosis; Vaccine

Outcome Measures

Primary Outcomes (1)

• GMTs for IgG Against Each OspA Serotype

  Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) against each Outer Surface Protein A (OspA) serotype ST1 to ST6, determined by Enzyme-Linked Immunosorbent Assay (ELISA) at Day 208 (Month 7)

  Day 208 (Month 7)

Secondary Outcomes (34)

• GMTs for IgG Against Each OspA Serotype During the Main Study Phase

  At Day 1 (Month 0), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 365 (Month 12) and Day 545 (Month 18)

• SCRs for Each OspA Serotype Specific IgG During the Main Study Phase

  Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18)

• GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase

  Day 1 (baseline from where comparison was done), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18)

• GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years

  At Day 1 (Month 0), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18)

• GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years

  At Day 1 (Month 0), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18)

Study Arms (3)

VLA15 with Alum lower dose

EXPERIMENTAL

Main Study Phase: VLA15 with Alum lower dose - Booster Phase: arm discontinued

Biological: VLA15

VLA15 with Alum higher dose

EXPERIMENTAL

Main Study Phase: VLA15 with Alum higher dose - Booster Phase: VLA15 higher dose or placebo

Biological: VLA15

Placebo

PLACEBO COMPARATOR

Main Study Phase: placebo - Booster Phase: arm discontinued

Biological: Placebo

Interventions

VLA15 BIOLOGICAL

a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate

VLA15 with Alum higher dose; VLA15 with Alum lower dose

Placebo BIOLOGICAL

PBS (Phosphate Buffered Saline)

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Randomization into higher dose group in the Main Study Phase
• 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;
• 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 Urine pregnancy test before booster vaccination;
• Subject agrees to employ adequate birth control measures for the duration of the study

You may not qualify if:

• 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);

Sponsors & Collaborators

• Pfizer: lead
• Valneva Austria GmbH: collaborator

Study Sites (5)

Clinical Research Consulting, LLC

Milford, Connecticut, 06460, United States

Location

Stamford Therapeutics Consortium

Stamford, Connecticut, 06905, United States

Location

United Medical Associates

Binghamton, New York, 13901, United States

Location

Regional Clinical Research, Inc

Endwell, New York, 13760, United States

Location

Rochester Clinical Research, Inc.

Rochester, New York, 14609, United States

Location

Related Publications (2)

• Ghadge SK, Schneider M, Dubischar K, Wagner L, Kadlecek V, Obersriebnig M, Hochreiter R, Klingler A, Larcher-Senn J, Derhaschnig U, Bender W, Eder-Lingelbach S, Bezay N. Immunogenicity and safety of an 18-month booster dose of the VLA15 Lyme borreliosis vaccine candidate after primary immunisation in healthy adults in the USA: results of the booster phase of a randomised, controlled, phase 2 trial. Lancet Infect Dis. 2024 Nov;24(11):1275-1286. doi: 10.1016/S1473-3099(24)00372-4. Epub 2024 Jul 16.

  PMID: 39029481 DERIVED

• Bezay N, Wagner L, Kadlecek V, Obersriebnig M, Wressnigg N, Hochreiter R, Schneider M, Dubischar K, Derhaschnig U, Klingler A, Larcher-Senn J, Eder-Lingelbach S, Bender W. Optimisation of dose level and vaccination schedule for the VLA15 Lyme borreliosis vaccine candidate among healthy adults: two randomised, observer-blind, placebo-controlled, multicentre, phase 2 studies. Lancet Infect Dis. 2024 Sep;24(9):1045-1058. doi: 10.1016/S1473-3099(24)00175-0. Epub 2024 May 31.

  PMID: 38830375 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Lyme Disease

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Borrelia Infections; Spirochaetales Infections; Tick-Borne Diseases; Vector Borne Diseases

Results Point of Contact

• Title: Director Clinical Strategy
• Organization: Valneva Austria GmbH

office@valneva.com

+43120620

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: May 31, 2019
• Study Start: July 1, 2019
• Primary Completion: April 7, 2020
• Study Completion: March 28, 2022
• Last Updated: April 21, 2023
• Results First Posted: July 8, 2021

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share

Locations

US (5)