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.

NCT03769194 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: VLA15-201
• Study Type: interventional
• Target: 572
• Locations: 3 countries
• Sites: 9

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 was investigated 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 received 3 immunizations of the vaccine at a monthly interval. The study assessed the immune response as well as the safety profile of the vaccine.

Conditions

Lyme Borreliosis

Keywords

VLA15, Lyme Borreliosis, Vaccine

Outcome Measures

Primary Outcomes (1)

• GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype ST1 to ST6

  GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype ST1 to ST6, determined by ELISA at Day 85. GMTs are calculated based on the number of subjects with non-missing results.

  at Day 85 / Month 3

Secondary Outcomes (19)

• GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)

  up to Day 365 / Month 12

• SCRs (Seroconversion Rate) for Each OspA (Outer Surface Protein A) Serotype Specific IgG (Immunoglobulin G) (ST1 to ST6),

  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)

  up to Day 365 / Month 12

• GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years

  up to Day 365 / Month 12

• GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years

  up to Day 365 / Month 12

Study Arms (4)

VLA15 low dose

ACTIVE COMPARATOR

VLA15 low dose with Alum.

Biological: VLA15

VLA15 medium dose

ACTIVE COMPARATOR

VLA15 medium dose with Alum.

Biological: VLA15

VLA15 high dose

ACTIVE COMPARATOR

VLA15 high dose with Alum.

Biological: VLA15

Placebo

PLACEBO COMPARATOR

Biological: Placebo

Interventions

VLA15 BIOLOGICAL

a multivalent recombinant Outer surface protein A (OspA) based vaccine candidate

VLA15 high dose; VLA15 low dose; VLA15 medium dose

Placebo BIOLOGICAL

Placebo: 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:

• Run-in phase:
• \. Subject is aged 18 to 40 years at the day of screening (Visit 0);
• Main Study phase:
• Subject is aged18 to 65 years at the day of screening (Visit 0);
• Run-in phase and Main Study phase:
• 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 (Visit 0);
• 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 (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;
• Subject received previous vaccination against Lyme borreliosis (LB).;
• Subject had a tick bite within 4 weeks prior to Visit 1;
• 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;
• 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 3 weeks prior to first vaccination or until Day 57 (Visit 3), contraindicating intramuscular vaccination as judged by the investigator;
• 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;
• 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;
• 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;
• 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 (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;
• 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;

Sponsors & Collaborators

• Pfizer: lead

Study Sites (9)

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, 13706, United States

Location

Rochester Clinical Research Inc.

Rochester, New York, 14609, United States

Location

Omega Medical Research

Warwick, Rhode Island, 02886, United States

Location

Cevac Center for vaccinology

Ghent, 9000, Belgium

Location

Berliner Centrum für Reise- und Tropenmedizin (BCRT)

Berlin, 10117, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20359, Germany

Location

Related Publications (1)

• 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

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: December 6, 2018
• First Posted: December 7, 2018
• Study Start: December 17, 2018
• Primary Completion: December 18, 2019
• Study Completion: October 2, 2020
• Last Updated: January 10, 2023
• Results First Posted: June 30, 2021

Record last verified: 2022-12

Locations

BE (1); US (6); DE (2)