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An Efficacy, Safety, Tolerability, Immunogenicity, and Lot-Consistency Clinical Trial of a 6-Valent OspA-Based Lyme Disease Vaccine (VLA15)
Sponsor: Pfizer
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.
Official title: 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
Key Details
Gender
All
Age Range
5 Years - Any
Study Type
INTERVENTIONAL
Enrollment
12547
Start Date
2022-08-04
Completion Date
2025-12-26
Last Updated
2025-09-29
Healthy Volunteers
Yes
Conditions
Interventions
VLA15
Shot in the deltoid muscle (preferable in the nondominant arm)
Saline
Shot in the deltoid muscle (preferable in the nondominant arm)
Locations (120)
Care Access - Essex
Essex, Connecticut, United States
Care Access Mobile Site
New London, Connecticut, 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 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
Care Access - Lakeville
Lakeville, Massachusetts, United States
Care Access - Melrose
Melrose, 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
Care Access Mobile Site
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
Care Access - North Conway
North Conway, 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
Hunterdon Medical Center
Flemington, New Jersey, United States
Care Access - Hoboken
Hoboken, New Jersey, United States
IMA Clinical Research Warren
Warren Township, New Jersey, United States
Velocity Clinical Research, Binghamton
Binghamton, New York, 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
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
Care Access - Mountaintop
Hazle Township, Pennsylvania, United States
CCP - Kid's Way
Hermitage, Pennsylvania, United States
Care Access - Kingston
Kingston, 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
Care Access Mobile Site
Punxsutawney, Pennsylvania, United States
Guthrie Medical Group, P.C.
Sayre, Pennsylvania, United States
Robert Packer Hospital
Sayre, Pennsylvania, United States
Frontier Clinical Research, LLC
Scottdale, Pennsylvania, United States
Care Access - Scranton
Scranton, Pennsylvania, United States
Northeast Clinical Trials Group
Scranton, Pennsylvania, United States
Frontier Clinical Research, LLC
Smithfield, Pennsylvania, United States
Preferred Primary Care Physicians
Uniontown, Pennsylvania, United States
Care Access - Wilkes-Barre
Wilkes-Barre, Pennsylvania, United States
Care Access Mobile Site
Yeagertown, Pennsylvania, United States
Velocity Clinical Research, Providence
East Greenwich, Rhode Island, United States
Care Access Mobile Site
New Shoreham, Rhode Island, United States
Care Access - Warwick
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 (village), Vermont, United States
Amherst Family Practice, P.C.
Winchester, Virginia, United States
University of Wisconsin Carbone Cancer Center-University Hospital
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
Sherbrooke, Quebec, Canada
Diex Recherche Victoriaville
Victoriaville, Quebec, Canada
FVR, Tampereen rokotetutkimusklinikka
Tampere, Pirkanmaa, Finland
FVR, Turun rokotetutkimusklinikka
Turku, Southwest Finland, Finland
FVR, Etelä-Helsingin rokotetutkimusklinikka
Helsinki, Uusimaa, Finland
FVR, Itä-Helsingin rokotetutkimusklinikka
Helsinki, Uusimaa, Finland
FVR, Järvenpään rokotetutkimusklinikka
Jarvenpaa, Uusimaa, Finland
MeVac - Meilahti Vaccine Research Center
Helsinki, Finland
FVR, Kokkolan rokotetutkimusklinikka
Kokkola, Finland
FVR, Porin rokotetutkimusklinikka
Pori, Finland
Terveystalo Pulssi
Turku, Finland
AmBeNet GmbH
Leipzig, Saxony, Germany
Internistische Gemeinschaftspraxis Mainz
Mainz, Germany
Amsterdam UMC, locatie AMC
Amsterdam, North Holland, Netherlands
Rodzinne Centrum Medyczne LUBMED
Luboń, Greater Poland Voivodeship, Poland
MICS Centrum Medyczne Torun
Torun, Kuyavian-Pomeranian Voivodeship, Poland
Przylądek Zdrowia
Krakow, Lesser Poland Voivodeship, Poland
Krakowski Szpital Specjalistyczny im. Jana Pawa II
Krakow, Lesser Poland Voivodeship, Poland
ALERGO-MED Specjalistyczna Przychodnia Lekarska
Tarnów, Lesser Poland Voivodeship, Poland
Szpital im. Św. Jadwigi Śląskiej w Trzebnicy
Trzebnica, Lower Silesian Voivodeship, Poland
Futuremeds spolka z ograniczona odpowiedzialnoscia
Wroclaw, Lower Silesian Voivodeship, Poland
SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym
Łomianki, Masovian Voivodeship, Poland
Centrum Medyczne Lucyna Andrzej Dymek
Strzelce Opolskie, Opole Voivodeship, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, Poland
Zespol Opieki Zdrowotnej w Boleslawcu
Bolesławiec, 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
Przychodnia EuroMediCare Wroclaw Lowiecka
Wroclaw, Poland
Centrum Medyczne AD-MED Sp. z o. o. Przychodnia Dla Rodziny
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