Phase 2 Study Of VLA15, A Vaccine Candidate Against Lyme Borreliosis, In A Healthy Pediatric And Adult Study Population

NCT04801420 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: VLA15-221C4601008
• Study Type: interventional
• Target: 625
• Locations: 2 countries
• Sites: 22

Brief Summary

VLA15-221 is a Phase 2 study, which will be conducted in two parts: Main Study Phase (Part A) and Booster Phase (Part B). The study will compare the safety and immunogenicity of two different primary immunization schedules applying three (Month 0-2-6) or two (Month 0- 6) vaccinations. Within the study, 600 healthy subjects aged 5-65 years will be included. Subjects with a history of Lyme borreliosis (previous infection with Borrelia) as well as Borrelia naïve subjects will be enrolled. Study duration per subject will be a maximum of 50 months per subject.

Conditions

Lyme Borreliosis

Keywords

VLA15; Lyme Borreliosis; Vaccine; Lyme disease; Borrelia

Outcome Measures

Primary Outcomes (5)

• Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1

  Participants or their legal guardians were required to record any solicited local and systemic adverse events in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema (redness), swelling and induration (hardening). Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever. Two-sided 95% confidence intervals were calculated according to Altman method.

  From Day 1 to Day 7 after vaccination 1 at Month 0

• Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2

  Participants or their legal guardians were required to record any solicited local and systemic adverse events in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema (redness), swelling and induration (hardening). Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever. Two-sided 95% confidence intervals were calculated according to Altman method.

  From Day 1 to Day 7 after vaccination 2 at Month 2

• Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3

  Participants or their legal guardians were required to record any solicited local and systemic adverse events in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema (redness), swelling and induration (hardening). Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever. Two-sided 95% confidence intervals were calculated according to Altman method.

  From Day 1 to Day 7 after vaccination 3 at Month 6

• Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase

  Participants or their legal guardians were required to record any solicited local and systemic adverse events in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema (redness), swelling and induration (hardening). Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever. Two-sided 95% confidence intervals were calculated according to Altman method.

  From Day 1 to Day 7 after vaccination 1, 2 or 3 at Month 0, 2 and 6 respectively

• Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) Against Each Outer Surface Protein A (OspA) Serotype (ST1 to ST6) at Day 208 During the Main Study Phase

  GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay at Day 208 is presented in this outcome measure.

  Day 208 (Month 7)

Secondary Outcomes (17)

• Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Booster Dose

  Within 7 days after booster dose

• Percentage of Participants With Serious Adverse Events (SAEs)

  From Day 1 of vaccination up to Day 208 (Month 7)

• Percentage of Participants With Adverse Events of Special Interest (AESIs)

  From Day 1 of vaccination up to Day 208 (Month 7)

• Percentage of Participants With Unsolicited Adverse Events

  From Day 1 to Day 28 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively

• Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group

  SAEs, AESIs: From Day 1 of vaccination (vac) up to Day 208 (Month 7), Solicited AEs: From Day 1 to Day 7 after vac 1, 2 and 3 at Month 0, 2 and 6, respectively; Unsolicited AEs: From Day 1 to Day 28 after vac 1, 2 and 3 at Month 0, 2 and 6, respectively

Study Arms (3)

Part A+B - Group 1

EXPERIMENTAL

Part A: VLA15 at Month 0, 2 and 6 Part B: VLA15 at Month 18, 30 and 42

Biological: VLA15

Part A+B - Group 2

EXPERIMENTAL

Part A: VLA15 at Month 0 and 6, placebo at Month 2 Part B: VLA15 at Month 18, 30 and 42

Biological: VLA15; Biological: Placebo

Part A+B - Group 3

PLACEBO COMPARATOR

Part A: Placebo at Month 0, 2 and 6 Part B: Placebo at Month 18, 30 and 42

Biological: Placebo

Interventions

VLA15 BIOLOGICAL

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

Part A+B - Group 1; Part A+B - Group 2

Placebo BIOLOGICAL

PBS (Phosphate Buffered Saline)

Part A+B - Group 2; Part A+B - Group 3

Eligibility Criteria

• Age: 5 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is aged 5 to 65 years at the day of screening (Visit 0)
• Subject is of good general health
• Parent(s)/legal representative(s) and subject understand the study and its procedures, agree to its provisions
• for subjects aged 18-65 years: written informed consent prior to any study related procedures
• for subjects aged 5-17 years: written informed consent by the subject's legal representative(s), according to local requirements, and written informed assent of the subject, if applicable, prior to any study related procedures.
• If subject is of childbearing potential: Subject has a negative serum pregnancy test at screening (Visit 0) and agrees to employ adequate birth control measures according to following timelines:
• Main Study Phase: duration of entire study
• Booster Phase: until 5 months after each booster vaccination (Booster 1 until Month 23, Booster 2 until Month 35 and Booster 3 until Month 47)
• Subject is willing and able to comply with scheduled visits, treatment plan, and other study procedures
• Subject is available for the duration of the study and can be contacted by telephone during study participation

You may not qualify if:

• Subject has a chronic illness related to Lyme borreliosis (LB), an active symptomatic LB, or received treatment for LB within the last 3 months prior to Day 1;
• Subject received previous vaccination against LB;
• Subject had a tick bite within 4 weeks prior to Day 1;
• Subject has a medical history of or currently has a clinically relevant disease;
• Subject has a medical history of or currently has a neuro- inflammatory or autoimmune disease;
• Subject has a known thrombocytopenia, bleeding disorder, or received anticoagulants in the 3 weeks prior to Day 1;
• Subject has received an active or passive immunization within 4 weeks prior to Day 1;
• Subject has received any other registered or non-registered medicinal product in another clinical trial within 4 weeks prior to vaccination at Day 1;
• Subject has a known or suspected defect of the immune system or received immuno-suppressive therapy within 4 weeks prior to Day 1;
• Subject has a history of anaphylaxis of unknown cause or severe allergic reactions of unknown cause or has a known hypersensitivity or allergic reactions to one of the components of the vaccine;
• Subject had any malignancy in the past 5 years;
• Subject is pregnant, has plans to become pregnant during the course of the study or is lactating at the time of enrollment;
• Subject has donated or plans to donate blood or blood-derived products 4 weeks prior to Day 1;
• Subject has any condition that may compromise its well-being, might interfere with evaluation of study endpoints, or would limit the subject's ability to complete the study;
• Subject is in a dependent relationship with the sponsor/investigator

Sponsors & Collaborators

• Pfizer: lead
• Valneva Austria GmbH: collaborator

Study Sites (22)

New England Research Associates

Bridgeport, Connecticut, 06606, United States

Location

Stamford Therapeutics Consortium

Stamford, Connecticut, 06905, United States

Location

Chase Medical Research, LLC

Waterbury, Connecticut, 06708, United States

Location

Pediatric Associates of Conn. PC

Waterbury, Connecticut, 06708, United States

Location

Quest Diagnostics

Marlborough, Massachusetts, 01752, United States

Location

Clinical Research Institute, Inc.

Minneapolis, Minnesota, 55402, United States

Location

Foundation Pediatrics

East Orange, New Jersey, 07018, United States

Location

Med Clinical Research Partners, LLC

Irvington, New Jersey, 07111, United States

Location

Meridian Clinical Research LLC

Binghamton, New York, 13905, United States

Location

Pfizer Vaccine Research and Development

Pearl River, New York, 10965, United States

Location

Rochester Clinical Research, Inc.

Rochester, New York, 14609, United States

Location

Richmond Behavioral Associates

Staten Island, New York, 10314, United States

Location

Advantage Clinical Trials

The Bronx, New York, 10467, United States

Location

Velocity Clinical Research, Inc.

Cleveland, Ohio, 44122, United States

Location

Allegheny Health and Wellness Pavilion

Erie, Pennsylvania, 16506, United States

Location

Liberty Family Practice

Erie, Pennsylvania, 16508, United States

Location

Lockman & Lubell Pediatric Associates

Fort Washington, Pennsylvania, 19034, United States

Location

Hasbro Children's Hospital

Providence, Rhode Island, 02903, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Velocity Clinical Research Providence

Warwick, Rhode Island, 02886, United States

Location

Synevo Studien Service Labor GmbH c/o Institut für Medizinische Diagnostik

Berlin, 12247, Germany

Location

Related Publications (2)

• Wagner L, Obersriebnig M, Hochreiter R, Kadlecek V, Larcher-Senn J, Hegele L, Maguire JD, Murphy T, Derhaschnig U, Bezay N, Jaramillo JC, Eder-Lingelbach S, Messier M. Immunogenicity and safety of an 18-month booster dose of the VLA15 Lyme borreliosis vaccine candidate after primary immunisation in children, adolescents, and adults in the USA: a randomised, observer-blind, placebo-controlled, phase 2 trial. Lancet Infect Dis. 2025 Nov 7:S1473-3099(25)00541-9. doi: 10.1016/S1473-3099(25)00541-9. Online ahead of print.

  PMID: 41213278 DERIVED

• Wagner L, Obersriebnig M, Kadlecek V, Hochreiter R, Ghadge SK, Larcher-Senn J, Hegele L, Maguire JD, Derhaschnig U, Jaramillo JC, Eder-Lingelbach S, Bezay N. Immunogenicity and safety of different immunisation schedules of the VLA15 Lyme borreliosis vaccine candidate in adults, adolescents, and children: a randomised, observer-blind, placebo-controlled, phase 2 trial. Lancet Infect Dis. 2025 Sep;25(9):986-999. doi: 10.1016/S1473-3099(25)00092-1. Epub 2025 Apr 25.

  PMID: 40294611 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: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• 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: March 8, 2021
• First Posted: March 17, 2021
• Study Start: March 8, 2021
• Primary Completion: March 25, 2022
• Study Completion: July 2, 2025
• Last Updated: November 12, 2025
• Results First Posted: June 7, 2023

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

DE (1); US (21)