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

Phase 3

Active, not recruiting

• Conditions: Lyme Disease
• Interventions: Biological: VLA15; Other: Saline

• Registration Number: NCT05477524
• Lead Sponsor: Pfizer

Brief Summary

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 9,400 healthy participants (this number excludes participants from 8 sites which were terminated for quality issues) 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 after end of primary vaccination series. 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. A subset of participants will be followed for a third 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, and for a subset of participants up to 9 times. 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. The subset of participants followed for a third Lyme disease season will take part in this study for up to about to 3 and a half years.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-05
• Study First Submitted QC: 2022-07-25
• Study First Posted: 2022-07-28
• Study Start: 2022-08-04
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-10-31
• Primary Completion: 2025-12-26
• Study Completion: 2025-12-26

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 12554

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VLA15 Lot 1 (3-dose primary vaccination series and booster dose)	VLA15	Shot in the deltoid muscle (preferable in the nondominant arm)
VLA15 Lot 2 (3-dose primary vaccination series and booster dose)	VLA15	Shot in the deltoid muscle (preferable in the nondominant arm)
VLA15 Lot 3 (3-dose primary vaccination series and booster dose)	VLA15	Shot in the deltoid muscle (preferable in the nondominant arm)
Placebo (3-dose primary vaccination series and booster dose)	Saline	Shot in the deltoid muscle (preferable in the nondominant arm)

Primary Outcome Measures

Name	Time	Method
Percentage of participants reporting adverse events (AEs)	Through 1 month following each study intervention administration
Percentage of participants reporting serious adverse events (SAEs)	Through study completion, up to approximately 42 months.
Relative incidence rate reduction of confirmed Lyme disease cases in the VLA15 group compared to the placebo group	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)).	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 independent Adjudication Committee
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
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
Percentage of participants reporting newly diagnosed chronic medical conditions (NDCMCs)	Through study completion, up to approximately 42 months.
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)	At 1 month after completion of the booster dose	Immunobridging objective to determine non-inferiority between 5-17 year old and 18-44 year old participant strata.
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

Secondary Outcome Measures

Name	Time	Method
Vaccine efficacy among participants enrolled from North American sites	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)	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 independent Adjudication Committee
Vaccine efficacy among participants after primary series	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)	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 independent Adjudication Committee

Trial Locations

Locations (116)

Hunterdon Medical Center; 🇺🇸 Flemington, New Jersey, United States

Care Access - Essex; 🇺🇸 Essex, Connecticut, United States

Care Access Mobile Site; 🇺🇸 New Shoreham, Rhode Island, United States

Stamford Health Medical Group; 🇺🇸 Stamford, Connecticut, United States

Stamford Hospital; 🇺🇸 Stamford, Connecticut, United States

Northern Light Eastern Maine Medical Center; 🇺🇸 Bangor, Maine, United States

Care Access - Farmington; 🇺🇸 Farmington, Maine, United States

Pen Bay Medical Center; 🇺🇸 Rockport, Maine, United States

Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States

Johns Hopkins Bayview Medical Center; 🇺🇸 Baltimore, Maryland, United States

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

Johns Hopkins Rockland Physician Practice and Research Group; 🇺🇸 Lutherville, Maryland, United States

Sumit Bhutani MD LLC; 🇺🇸 Westminster, Maryland, United States

Woodholme Gastroenterology Associates; 🇺🇸 Westminster, Maryland, United States

Pediatric Associates of Fall River; 🇺🇸 Fall River, Massachusetts, United States

ActivMed Practices and Research; 🇺🇸 Methuen, Massachusetts, United States

Care Access - Briarpatch and Mobile Site; 🇺🇸 Nantucket, Massachusetts, United States

Care Access - Nantucket; 🇺🇸 Nantucket, Massachusetts, United States

South Shore Medical Center; 🇺🇸 Norwell, Massachusetts, United States

Care Access - Hingham; 🇺🇸 Rockland, Massachusetts, United States

Sisu BHR; 🇺🇸 Springfield, Massachusetts, United States

Care Access - Wareham; 🇺🇸 Wareham, Massachusetts, United States

South Shore Hospital; 🇺🇸 Weymouth, Massachusetts, United States

University of Massachusetts Chan Medical School; 🇺🇸 Worcester, Massachusetts, United States

Clinical Research Institute; 🇺🇸 Minneapolis, Minnesota, United States

Care Access - Londonderry; 🇺🇸 Londonderry, New Hampshire, United States

ActivMed Practices & Research, LLC.; 🇺🇸 Portsmouth, New Hampshire, United States

Internal Medicine Associates; 🇺🇸 Bridgeton, New Jersey, United States

Clinilabs; 🇺🇸 Eatontown, New Jersey, United States

Hunterdon Infectious Disease Specialists; 🇺🇸 Flemington, New Jersey, United States

Care Access - Hoboken; 🇺🇸 Hoboken, New Jersey, United States

IMA Clinical Research Warren; 🇺🇸 Warren, New Jersey, United States

Bassett Medical Center; 🇺🇸 Cooperstown, New York, United States

Smith Allergy and Asthma Specialists; 🇺🇸 Cortland, New York, United States

Care Access - Albany; 🇺🇸 Halfmoon, New York, United States

Smith Allergy & Asthma Specialists; 🇺🇸 Horseheads, New York, United States

United Health Services at Wilson Memorial Hospital; 🇺🇸 Johnson City, New York, United States

Mid Hudson Medical Research; 🇺🇸 New Windsor, New York, United States

Velocity Clinical Research, Vestal; 🇺🇸 Vestal, New York, United States

TruCare Internal Medicine & Infectious Disease; 🇺🇸 DuBois, Pennsylvania, United States

Altoona Center For Clinical Research; 🇺🇸 Duncansville, Pennsylvania, United States

Allegheny Health and Wellness Pavilion; 🇺🇸 Erie, Pennsylvania, United States

Central Erie Primary Care; 🇺🇸 Erie, Pennsylvania, United States

CCP - Kid's Way; 🇺🇸 Hermitage, Pennsylvania, United States

Richard M Kastelic M.D. and Associates, PC / Berkley Hills Clinicals; 🇺🇸 Johnstown, Pennsylvania, United States

Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18); 🇺🇸 Pittsburgh, Pennsylvania, United States

Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair; 🇺🇸 Pittsburgh, Pennsylvania, United States

Care Access - Pottsville; 🇺🇸 Pottsville, Pennsylvania, United States

Guthrie Medical Group, P. C.; 🇺🇸 Sayre, Pennsylvania, United States

Robert Packer Hospital; 🇺🇸 Sayre, Pennsylvania, United States

Frontier Clinical Research, LLC; 🇺🇸 Smithfield, Pennsylvania, United States

Care Access - Scranton; 🇺🇸 Scranton, Pennsylvania, United States

Northeast Clinical Trials Group; 🇺🇸 Scranton, Pennsylvania, United States

Preferred Primary Care Physicians; 🇺🇸 Uniontown, Pennsylvania, United States

Care Access - Wilkes-Barre; 🇺🇸 Wilkes-Barre, Pennsylvania, United States

Velocity Clinical Research, Providence; 🇺🇸 East Greenwich, Rhode Island, United States

Care New England Medical Group; 🇺🇸 Pawtucket, Rhode Island, United States

Care Access - Warwick; 🇺🇸 Warwick, Rhode Island, United States

Kent Hospital; 🇺🇸 Warwick, Rhode Island, United States

Care Access - Brattleboro - Putney Road; 🇺🇸 Brattleboro, Vermont, United States

Care Access - Brattleboro; 🇺🇸 Brattleboro, Vermont, United States

The University of Vermont Medical Center Inc.; 🇺🇸 Burlington, Vermont, United States

Care Access - Middlebury; 🇺🇸 Middlebury, Vermont, United States

Amherst Family Practice, P.C.; 🇺🇸 Winchester, Virginia, United States

University Hospital and UW Health Clinics; 🇺🇸 Madison, Wisconsin, United States

Marshfield Medical Center - Marshfield; 🇺🇸 Marshfield, Wisconsin, United States

Marshfield Medical Center - Weston; 🇺🇸 Weston, Wisconsin, United States

Viable Clinical Research Corporation; 🇨🇦 Bridgewater, Nova Scotia, Canada

Canadian Center for Vaccinology; 🇨🇦 Halifax, Nova Scotia, Canada

Centricity Research Burlington Multispecialty; 🇨🇦 Burlington, Ontario, Canada

Milestone Research Inc.; 🇨🇦 London, Ontario, Canada

The Ottawa Hospital - General Campus; 🇨🇦 Ottawa, Ontario, Canada

Bluewater Clinical Research Group Inc.; 🇨🇦 Sarnia, Ontario, Canada

Stouffville Medical Research Institute Inc.; 🇨🇦 Stouffville, Ontario, Canada

Centricity Research Toronto Manna Multispecialty; 🇨🇦 Toronto, Ontario, Canada

Diex Recherche Sherbrooke Inc.; 🇨🇦 Sherbrooke, Quebec, Canada

Diex Recherche Victoriavile Inc.; 🇨🇦 Victoriaville, Quebec, Canada

FVR, Tampereen rokotetutkimusklinikka; 🇫🇮 Tampere, Pirkanmaa, Finland

FVR, Etelä-Helsingin rokotetutkimusklinikka; 🇫🇮 Helsinki, Uusimaa, Finland

FVR, Itä-Helsingin rokotetutkimusklinikka; 🇫🇮 Helsinki, Uusimaa, Finland

FVR, Järvenpään rokotetutkimusklinikka; 🇫🇮 Järvenpää, Uusimaa, Finland

FVR, Turun rokotetutkimusklinikka; 🇫🇮 Turku, Varsinais-suomi, Finland

MeVac - Meilahti Vaccine Research Center; 🇫🇮 Helsinki, Finland

FVR, Kokkolan rokotetutkimusklinikka; 🇫🇮 Kokkola, Finland

FVR, Porin rokotetutkimusklinikka; 🇫🇮 Pori, Finland

Tampere Vaccine Research Clinic; 🇫🇮 Tampere, Finland

Terveystalo Pulssi; 🇫🇮 Turku, Finland

AmBeNet GmbH; 🇩🇪 Leipzig, Sachsen, Germany

Internistische Gemeinschaftspraxis Mainz; 🇩🇪 Mainz, Germany

Amsterdam UMC, locatie AMC; 🇳🇱 Amsterdam, Noord-holland, Netherlands

Szpital im. Św. Jadwigi Śląskiej w Trzebnicy; 🇵🇱 Trzebnica, Dolnośląskie, Poland

Futuremeds spolka z ograniczona odpowiedzialnoscia; 🇵🇱 Wroclaw, Dolnośląskie, Poland

Centrum Medyczne AD-MED Sp. z o. o. Przychodnia Dla Rodziny; 🇵🇱 Wroclaw, Poland

MICS Centrum Medyczne Torun; 🇵🇱 Torun, Kujawsko-pomorskie, Poland

SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym; 🇵🇱 Lomianki, Mazowieckie, Poland

Przylądek Zdrowia; 🇵🇱 Krakow, Małopolskie, Poland

Krakowski Szpital Specjalistyczny im. Jana Pawa II; 🇵🇱 Krakow, Małopolskie, Poland

ALERGO-MED Specjalistyczna Przychodnia Lekarska; 🇵🇱 Tarnow, Małopolskie, Poland

Centrum Medyczne Lucyna Andrzej Dymek; 🇵🇱 Strzelce Opolskie, Opolskie, Poland

Rodzinne Centrum Medyczne LUBMED; 🇵🇱 Lubon, Wielkopolskie, Poland

Ośrodek Wsparcia Badań Klinicznych; 🇵🇱 Bialystok, Poland

Uniwersytecki Szpital Kliniczny w Bialymstoku; 🇵🇱 Bialystok, Poland

Zespol Opieki Zdrowotnej w Boleslawcu; 🇵🇱 Boleslawiec, Poland

Synexus Polska Sp. z o.o. Oddzial w Gdyni; 🇵🇱 Gdynia, Poland

Indywidualna Specjalistyczna Praktyka Lekarska Roman Spyra; 🇵🇱 Katowice, Poland

Centrum Badan Klinicznych Jagiellonskie Centrum Innowacji; 🇵🇱 Krakow, Poland

Krakowskie Centrum Medyczne; 🇵🇱 Krakow, Poland

NZOZ Praktyka Lekarza Rodzinnego Eskulap; 🇵🇱 Lublin, Poland

Specjalistyczny Zespol Opieki Zdrowotnej nad Matka i Dzieckiem w Poznaniu; 🇵🇱 Poznan, Poland

Przychodnia EuroMediCare Wroclaw Lowiecka; 🇵🇱 Wroclaw, Poland

Blekinge Tekniska Hogskola (BTH) (Blekinge Institute of Technology) - Karlskrona; 🇸🇪 Karlskrona, Blekinge LÄN [se-10], Sweden

CTC Karolinska; 🇸🇪 Solna, Stockholms LÄN [se-01], Sweden

Studieenheten Akademiskt Specialistcentrum; 🇸🇪 Stockholm, Stockholms LÄN [se-01], Sweden

CTC MTC; 🇸🇪 Uppsala, Uppsala LÄN [se-03], Sweden

ProbarE; 🇸🇪 Lund, Sweden

Universitetssjukhuset Örebro; 🇸🇪 Örebro, Örebro LÄN [se-18], Sweden