An Efficacy, Safety, Tolerability, Immunogenicity, and Lot-Consistency Clinical Trial of a 6-Valent OspA-Based Lyme Disease Vaccine (VLA15) (VALOR)

A Phase 3, Multicenter, Placebo-Controlled, Randomized, Observer-Blinded Trial to Evaluate the Efficacy, Safety, Tolerability, Immunogenicity, and Lot Consistency of a 6-Valent OspA-Based Lyme Disease Vaccine in Healthy Participants ≥5 Years of Age

The main purpose of this clinical study is to evaluate a 6-valent OspA-based Lyme disease vaccine (VLA15) for prevention of Lyme disease within North America and Europe. Approximately 9,000 healthy participants 5 years and older will be recruited from areas with high levels of endemic Lyme disease to receive VLA15 or placebo (an inactive substance consisting of saltwater). Each participant will have about a 50% chance of receiving VLA15 and about a 50% chance of receiving placebo. A subset of participants will receive VLA15 from 3 different lots or placebo (1:1:1:3 ratio) to assess lot equivalence.

Participants will receive a 3-dose primary vaccination series at about 0, 2, and 5 to 9 months and then receive a booster dose about 12 months later. Vaccination of participants will occur at a time of year such that the primary series is completed before the peak Lyme disease season followed by a booster dose just prior to the beginning of the second Lyme disease season.

Comparison will be made between the Lyme disease cases of people receiving the study vaccine to those of the people who are not. This will help us determine if the study vaccine is safe and effective.

If enrolled, participants will need to visit the research site at least 7 times during the study. There will also be at least 5 telephone contacts. It is expected that each participant will take part in this study for up to about 2 and a half years.

Study Overview

• Status: Active, not recruiting
• Conditions: Lyme Disease
• Intervention / Treatment: Biological: VLA15; Other: Saline

• Study Type: Interventional
• Enrollment (Actual): 8318
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• Canada
  • Nova Scotia
    • Bridgewater, Nova Scotia, Canada, B4V 3N2
      • Viable Clinical Research Corporation
    • Halifax, Nova Scotia, Canada, B3K6R8
      • Canadian Center for Vaccinology
  • Ontario
    • Burlington, Ontario, Canada, L7M 4Y1
      • Centricity Research Burlington Multispecialty
    • London, Ontario, Canada, N5W 6A2
      • Milestone Research Inc.
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital - General Campus
    • Sarnia, Ontario, Canada, N7T 4X3
      • Bluewater Clinical Research Group Inc.
    • Stouffville, Ontario, Canada, L4A 1H2
      • Stouffville Medical Research Institute Inc.
    • Toronto, Ontario, Canada, M9W 4L6
      • Centricity Research Toronto Manna Multispecialty
  • Quebec
    • Sherbrooke, Quebec, Canada, J1L 0H8
      • DIEX Recherche Sherbrooke Inc.
    • Victoriaville, Quebec, Canada, G6P 6P6
      • Diex Recherche Victoriavile Inc.
• Finland
  • Helsinki, Finland, 00290
    • MeVac - Meilahti Vaccine Research Center
  • Kokkola, Finland, 67100
    • FVR, Kokkolan rokotetutkimusklinikka
  • Pori, Finland, 28100
    • FVR, Porin rokotetutkimusklinikka
  • Tampere, Finland, 33100
    • Tampere Vaccine Research Clinic
  • Turku, Finland, 20100
    • Terveystalo Pulssi
  • Pirkanmaa
    • Tampere, Pirkanmaa, Finland, 33100
      • FVR, Tampereen rokotetutkimusklinikka
  • Uusimaa
    • Helsinki, Uusimaa, Finland, 00100
      • FVR, Etelä-Helsingin rokotetutkimusklinikka
    • Helsinki, Uusimaa, Finland, 00930
      • FVR, Itä-Helsingin rokotetutkimusklinikka
    • Järvenpää, Uusimaa, Finland, 04400
      • FVR, Järvenpään rokotetutkimusklinikka
  • Varsinais-suomi
    • Turku, Varsinais-suomi, Finland, 20520
      • FVR, Turun rokotetutkimusklinikka
• Germany
  • Mainz, Germany, 55116
    • Internistische Gemeinschaftspraxis Mainz
  • Sachsen
    • Leipzig, Sachsen, Germany, 04107
      • AmBeNet GmbH
• Netherlands
  • Noord-holland
    • Amsterdam, Noord-holland, Netherlands, 1105 AZ
      • Amsterdam UMC, locatie AMC
• Poland
  • Bialystok, Poland, 15-540
    • Uniwersytecki Szpital Kliniczny w Bialymstoku
  • Bialystok, Poland, 15-274
    • Ośrodek Wsparcia Badań Klinicznych
  • Bialystok, Poland, 15-274
    • Uniwersytecki Szpital Kliniczny w Bialymstoku
  • Boleslawiec, Poland, 59-700
    • Zespol Opieki Zdrowotnej w Boleslawcu
  • Gdynia, Poland, 81-537
    • Synexus Polska Sp. z o.o. Oddzial w Gdyni
  • Katowice, Poland, 40-018
    • Indywidualna Specjalistyczna Praktyka Lekarska Roman Spyra
  • Krakow, Poland, 31-501
    • Krakowskie Centrum Medyczne
  • Krakow, Poland, 30-348
    • Centrum Badań klinicznych Jagiellońskie Centrum Innowacji
  • Lublin, Poland, 20-044
    • NZOZ Praktyka Lekarza Rodzinnego Eskulap
  • Poznan, Poland, 60-663
    • Specjalistyczny Zespol Opieki Zdrowotnej nad Matka i Dzieckiem w Poznaniu
  • Wroclaw, Poland, 51-141
    • Centrum Medyczne AD-MED Sp. z o. o. Przychodnia Dla Rodziny
  • Wroclaw, Poland, 50-220
    • Przychodnia EuroMediCare Wroclaw Lowiecka
  • Dolnośląskie
    • Trzebnica, Dolnośląskie, Poland, 55-100
      • Szpital im. Św. Jadwigi Śląskiej w Trzebnicy
    • Wroclaw, Dolnośląskie, Poland, 50-088
      • Futuremeds spolka z ograniczona odpowiedzialnoscia
    • Wroclaw, Dolnośląskie, Poland, 53-673
      • Futuremeds spolka z ograniczona odpowiedzialnoscia
    • Wrocław, Dolnośląskie, Poland, 51-141
      • Centrum Medyczne AD-MED Sp. z o. o. Przychodnia Dla Rodziny
  • Kujawsko-pomorskie
    • Torun, Kujawsko-pomorskie, Poland, 87-100
      • MICS Centrum Medyczne Torun
  • Mazowieckie
    • Lomianki, Mazowieckie, Poland, 05-092
      • SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym
  • Małopolskie
    • Krakow, Małopolskie, Poland, 30-644
      • Przylądek Zdrowia
    • Krakow, Małopolskie, Poland, 31-202
      • Krakowski Szpital Specjalistyczny im. Jana Pawa II
    • Tarnow, Małopolskie, Poland, 33-100
      • Alergo-Med Specjalistyczna Przychodnia Lekarska
  • Opolskie
    • Strzelce Opolskie, Opolskie, Poland, 47-100
      • Centrum Medyczne Lucyna Andrzej Dymek
  • Wielkopolskie
    • Lubon, Wielkopolskie, Poland, 62-030
      • Rodzinne Centrum Medyczne LUBMED
• Sweden
  • Lund, Sweden, 222 22
    • ProbarE
  • Blekinge LÄN [se-10]
    • Karlskrona, Blekinge LÄN [se-10], Sweden, 371 79
      • Blekinge Tekniska Hogskola (BTH) (Blekinge Institute of Technology) - Karlskrona
  • Stockholms LÄN [se-01]
    • Solna, Stockholms LÄN [se-01], Sweden, 171 64
      • CTC Karolinska
    • Stockholm, Stockholms LÄN [se-01], Sweden, 113 61
      • Studieenheten Akademiskt Specialistcentrum
  • Uppsala LÄN [se-03]
    • Uppsala, Uppsala LÄN [se-03], Sweden, 752 37
      • CTC MTC
  • Örebro LÄN [se-18]
    • Örebro, Örebro LÄN [se-18], Sweden, 701 85
      • Universitetssjukhuset Örebro
• United States
  • Connecticut
    • Essex, Connecticut, United States, 06426
      • Care Access - Essex
    • New London, Connecticut, United States, 06320
      • Care Access Mobile Site
    • Stamford, Connecticut, United States, 06904
      • Stamford Hospital
    • Stamford, Connecticut, United States, 06902
      • Stamford Health Medical Group
  • Maine
    • Bangor, Maine, United States, 04401
      • Northern Light Eastern Maine Medical Center
    • Farmington, Maine, United States, 04938
      • Care Access - Farmington
    • Rockport, Maine, United States, 04856
      • Pen Bay Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins Bayview Medical Center
    • Lutherville, Maryland, United States, 21093
      • Johns Hopkins Rockland Physician Practice and Research Group
    • Westminster, Maryland, United States, 21157
      • Sumit Bhutani MD LLC
    • Westminster, Maryland, United States, 21157
      • Woodholme Gastroenterology Associates
  • Massachusetts
    • Fall River, Massachusetts, United States, 02721
      • Pediatric Associates of Fall River
    • Methuen, Massachusetts, United States, 01844
      • ActivMed Practices and Research
    • Nantucket, Massachusetts, United States, 02554
      • Care Access - Briarpatch and Mobile Site
    • Nantucket, Massachusetts, United States, 02554
      • Care Access - Nantucket
    • Nantucket, Massachusetts, United States, 02554
      • Care Access Mobile Site
    • Norwell, Massachusetts, United States, 02061
      • South Shore Medical Center
    • Rockland, Massachusetts, United States, 02370
      • Care Access - Hingham
    • Springfield, Massachusetts, United States, 01103
      • Sisu BHR
    • Wareham, Massachusetts, United States, 02571
      • Care Access - Wareham
    • Weymouth, Massachusetts, United States, 02190
      • South Shore Hospital
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Chan Medical School
  • Minnesota
    • Minneapolis, Minnesota, United States, 55402
      • Clinical Research Institute
  • New Hampshire
    • Londonderry, New Hampshire, United States, 03053
      • Care Access - Londonderry
    • Portsmouth, New Hampshire, United States, 03801
      • ActivMed Practices & Research, LLC.
  • New Jersey
    • Bridgeton, New Jersey, United States, 08302
      • Internal Medicine Associates
    • Eatontown, New Jersey, United States, 07724
      • Clinilabs
    • Flemington, New Jersey, United States, 08822
      • Hunterdon Infectious Disease Specialists
    • Hoboken, New Jersey, United States, 07030
      • Care Access - Hoboken
    • Warren, New Jersey, United States, 07059
      • IMA Clinical Research Warren
  • New York
    • Cooperstown, New York, United States, 13326
      • Bassett Medical Center
    • Cortland, New York, United States, 13045
      • Smith Allergy and Asthma Specialists
    • Halfmoon, New York, United States, 12065
      • Care Access - Albany
    • Horseheads, New York, United States, 14845
      • Smith Allergy & Asthma Specialists
    • Johnson City, New York, United States, 13790
      • United Health Services at Wilson Memorial Hospital
    • New Windsor, New York, United States, 12553
      • Mid Hudson Medical Research
    • Vestal, New York, United States, 13850
      • Velocity Clinical Research, Vestal
  • Pennsylvania
    • DuBois, Pennsylvania, United States, 15801
      • TruCare Internal Medicine & Infectious Disease
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center for Clinical Research
    • Erie, Pennsylvania, United States, 16506
      • Allegheny Health and Wellness Pavilion
    • Erie, Pennsylvania, United States, 16508
      • Central Erie Primary Care
    • Hermitage, Pennsylvania, United States, 16148
      • CCP - Kid's Way
    • Johnstown, Pennsylvania, United States, 16641
      • Richard M Kastelic M.D. and Associates, PC / Berkley Hills Clinicals
    • Pittsburgh, Pennsylvania, United States, 15243
      • Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair
    • Pittsburgh, Pennsylvania, United States, 15236
      • Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)
    • Pottsville, Pennsylvania, United States, 17901
      • Care Access - Pottsville
    • Punxsutawney, Pennsylvania, United States, 15767
      • Care Access Mobile Site
    • Sayre, Pennsylvania, United States, 18840
      • Robert Packer Hospital
    • Sayre, Pennsylvania, United States, 18840
      • Guthrie Medical Group, P. C.
    • Scottdale, Pennsylvania, United States, 15683
      • Frontier Clinical Research, LLC
    • Scranton, Pennsylvania, United States, 18510
      • Northeast Clinical Trials Group
    • Scranton, Pennsylvania, United States, 18508
      • Care Access - Scranton
    • Smithfield, Pennsylvania, United States, 15478
      • Frontier Clinical Research, LLC
    • Uniontown, Pennsylvania, United States, 15401
      • Preferred Primary Care Physicians
    • Wilkes-Barre, Pennsylvania, United States, 18702
      • Care Access - Wilkes-Barre
  • Rhode Island
    • East Greenwich, Rhode Island, United States, 02818
      • Velocity Clinical Research, Providence
    • New Shoreham, Rhode Island, United States, 02807
      • Care Access Mobile Site
    • Pawtucket, Rhode Island, United States, 02860
      • Care New England Medical Group
    • Warwick, Rhode Island, United States, 02886
      • Kent Hospital
    • Warwick, Rhode Island, United States, 02886
      • Care Access - Warwick
  • Vermont
    • Brattleboro, Vermont, United States, 05301
      • Care Access - Brattleboro - Putney Road
    • Brattleboro, Vermont, United States, 05301
      • Care Access - Brattleboro
    • Burlington, Vermont, United States, 05401
      • The University of Vermont Medical Center Inc.
    • Middlebury, Vermont, United States, 05753
      • Care Access - Middlebury
  • Virginia
    • Winchester, Virginia, United States, 22601
      • Amherst Family Practice, P.C.
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University Hospital and UW Health Clinics
    • Marshfield, Wisconsin, United States, 54449
      • Marshfield Medical Center - Marshfield
    • Weston, Wisconsin, United States, 54476
      • Marshfield Medical Center - Weston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Key Inclusion Criteria:

• Participants who reside in areas with endemic Lyme disease and who lead lifestyles that put them at increased risk for Lyme disease. For example, this could include, but not be limited to:
• Individuals who work in B burgdorferi-infected/tick-infested areas, especially those with occupations that may be associated with higher risk of exposure, such as landscaping, forestry, and wildlife and parks management.
• Individuals who pursue recreational activities such as hiking, camping, fishing, hunting, jogging, or gardening in such areas.
• Individuals who live on land plots with tree lines and come into contact with these trees regularly.
• Individuals who have dogs that regularly are outdoors and frequently return with attached ticks.
• Individuals who participate in activities in areas with tall grass, smaller wooded areas beside forests, open fields, lakesides, and riversides.

Key Exclusion Criteria:

• Any female participants that are pregnant (or have a positive urine pregnancy test) or are breastfeeding.
• Any diagnosis of Lyme disease within the past 3 months.
• Any history of Lyme carditis, neuroborreliosis, or arthritis, or other disseminated Lyme disease regardless of when diagnosed.
• Known tick bite within the past 4 weeks.
• Newly developed or unstable underlying conditions that may interfere with the assessment of Lyme disease, including but not limited to chronic arthralgia/arthritis, second/third-degree AV heart block, chronic pain syndromes, and chronic skin conditions that reduce the ability to detect cutaneous manifestations of Lyme disease.
• Any unstable autoimmune condition with a manifestation (eg, arthritic and neurologic) that may interfere with the assessment of Lyme disease.
• Chronic systemic doxycycline or minocycline or other tetracycline class drug use for acne or any other chronic suppressive antibiotics used to treat other conditions.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VLA15 Lot 1 (3-dose primary vaccination series and booster dose); Shot in the deltoid muscle (preferable in the nondominant arm)	Biological: VLA15; Shot in the deltoid muscle (preferable in the nondominant arm)
Experimental: VLA15 Lot 2 (3-dose primary vaccination series and booster dose); Shot in the deltoid muscle (preferable in the nondominant arm)	Biological: VLA15; Shot in the deltoid muscle (preferable in the nondominant arm)
Experimental: VLA15 Lot 3 (3-dose primary vaccination series and booster dose); Shot in the deltoid muscle (preferable in the nondominant arm)	Biological: VLA15; Shot in the deltoid muscle (preferable in the nondominant arm)
Placebo Comparator: Placebo (3-dose primary vaccination series and booster dose); Shot in the deltoid muscle (preferable in the nondominant arm)	Other: Saline; Shot in the deltoid muscle (preferable in the nondominant arm)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants reporting adverse events (AEs)		Through 1 month following each study intervention administration
Percentage of participants reporting newly diagnosed chronic medical conditions (NDCMCs)		Through study completion, up to approximately 30 months.
Percentage of participants reporting serious adverse events (SAEs)		Through study completion, up to approximately 30 months.
Relative risk reduction of confirmed Lyme disease cases in the VLA15 group compared to the placebo group	A confirmed case of Lyme disease, caused by B burgdorferi sensu lato, is defined as a clinically suspected case of Lyme disease that is confirmed by PCR, culture, microbial cell-free B burgdorferi-specific DNA sequencing, or serological antiborrelial antibody assay, and finally assessed and confirmed to be a case by the Endpoint Adjudication Committee	Beginning 1 month after receiving the booster dose (28 days after receiving the booster dose through the end of the Lyme disease season following the booster dose (end of October)).
Percentage of participants reporting local reactions		Within 7 days following each study intervention administration
Percentage of participants reporting systemic events		Within 7 days following each study intervention administration
Geometric mean ratio (GMR) of anti-OspA titers for each serotype (ST1-ST6) for Lot 1 to Lot 2		At 1 month after completion of the primary series and the booster dose
Geometric mean ratio (GMR) of anti-OspA titers for each serotype (ST1-ST6) for Lot 1 to Lot 3		At 1 month after completion of the primary series and the booster dose
Geometric mean ratio (GMR) of anti-OspA titers for each serotype (ST1-ST6) for Lot 2 to Lot 3		At 1 month after completion of the primary series and the booster dose
Geometric mean ratio (GMR) of anti-OspA titers for each serotype (ST1-ST6)	Immunobridging objective to determine non-inferiority between 5-17 year old and 18-44 year old participant strata.	At 1 month after completion of the booster dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaccine efficacy among participants enrolled from North American sites	A confirmed case of Lyme disease, caused by B burgdorferi sensu lato, is defined as a clinically suspected case of Lyme disease that is confirmed by PCR, culture, microbial cell-free B burgdorferi-specific DNA sequencing, or serological antiborrelial antibody assay, and finally assessed and confirmed to be a case by the Endpoint Adjudication Committee	Through the end of the Lyme disease season beginning 1 month after receiving the booster dose (28 days after completion of the booster dose until end of October)
Vaccine efficacy among participants after primary series	A confirmed case of Lyme disease, caused by B burgdorferi sensu lato, is defined as a clinically suspected case of Lyme disease that is confirmed by PCR, culture, microbial cell-free B burgdorferi-specific DNA sequencing, or serological antiborrelial antibody assay, and finally assessed and confirmed to be a case by the Endpoint Adjudication Committee	Through the end of the Lyme disease season beginning 1 month after completing the primary series (28 days after completion of the primary series until end of October)

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: Valneva Austria GmbH
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2022
• Primary Completion (Estimated): December 26, 2025
• Study Completion (Estimated): December 26, 2025

Study Registration Dates

• First Submitted: July 5, 2022
• First Submitted That Met QC Criteria: July 25, 2022
• First Posted (Actual): July 28, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Vaccine; Lyme Borreliosis; VLA15; Tick
• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Tick-Borne Diseases; Borrelia Infections; Spirochaetales Infections; Lyme Disease
• Other Study ID Numbers: C4601003; 2021-005427-20 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No