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

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Hol
Aliquippa, Baltimore, Bangor, Binghamton, Brattleboro, Bridgeton, Burlington, Clarion, Cooperstown, Cortland, DuBois, Duncansville, East Greenwich, Eatontown, Erie, Essex, Fall River, Farmington, Flemington, Greensburg, Halfmoon, Hazle Township, Hermitage, Hoboken, Horseheads, Kingston, Lakeville, Ledyard Center, Londonderry, Lutherville, Madison, Marshfield, Melrose, Methuen, Middlebury (village), Minneapolis, Monaca, Nantucket, New London, New Shoreham, New Windsor, North Conway, Norwell, Oak Bluffs, Pittsburgh, Portsmouth, Pottsville, Punxsutawney, Rockland, Rockport, Sandwich, Sayre, Scottdale, Scranton, Sharon, Smithfield, Springfield, Stamford, Uniontown, Vineyard Haven, Wareham, Warren Township, Warwick, Westminster, Weston, Weymouth, Wilkes-Barre, Winchester, Worcester és Yeagertown (Egyesült Államok)Mind a 82 helyszín megnézése
Fázis
3. fázis

Helyszínek itt: Egyesült Államok

  • Aliquippa, PennsylvaniaHospital not named in the registryNo longer taking part
  • Johns HopkinsBaltimore, Egyesült ÁllamokNo longer taking part
  • Johns Hopkins HospitalBaltimore, Egyesült ÁllamokNo longer taking part
  • Northern Light Eastern Maine Medical CenterBangor, Egyesült ÁllamokNo longer taking part
  • Velocity Clinical Research - BinghamtonBinghamton, Egyesült ÁllamokNo longer taking part
  • Care Access - BrattleboroBrattleboro, Egyesült ÁllamokNo longer taking part
  • Care Access - Brattleboro - Putney RoadBrattleboro, Egyesült ÁllamokNo longer taking part
  • Internal Medicine AssociatesBridgeton, Egyesült ÁllamokNo longer taking part
  • The University of Vermont Medical Center Inc.Burlington, Egyesült ÁllamokNo longer taking part
  • Clarion, PennsylvaniaHospital not named in the registryNo longer taking part
  • Bassett Medical CenterCooperstown, Egyesült ÁllamokNo longer taking part
  • Smith Allergy and Asthma SpecialistsCortland, Egyesült ÁllamokNo longer taking part
  • TruCare Internal Medicine & Infectious DiseaseDuBois, Egyesült ÁllamokNo longer taking part
  • Altoona Center For Clinical ResearchDuncansville, Egyesült ÁllamokNo longer taking part
  • Velocity Clinical Research, ProvidenceEast Greenwich, Egyesült ÁllamokNo longer taking part
  • CLINiLABSEatontown, Egyesült ÁllamokNo longer taking part
  • Allegheny Health and Wellness PavilionErie, Egyesült ÁllamokNo longer taking part
  • Central Erie Primary CareErie, Egyesült ÁllamokNo longer taking part
  • Care Access - EssexEssex, Egyesült ÁllamokNo longer taking part
  • Pediatric Associates of Fall RiverFall River, Egyesült ÁllamokNo longer taking part
  • Care Access - FarmingtonFarmington, Egyesült ÁllamokNo longer taking part
  • Hunterdon Infectious Disease SpecialistsFlemington, Egyesült ÁllamokNo longer taking part
  • Hunterdon Medical CenterFlemington, Egyesült ÁllamokNo longer taking part
  • Greensburg, PennsylvaniaHospital not named in the registryNo longer taking part
  • Halfmoon, New YorkHospital not named in the registryNo longer taking part
  • Care Access - AlbanyHalfmoon, Egyesült ÁllamokNo longer taking part
  • Care Access - MountaintopHazle Township, Egyesült ÁllamokNo longer taking part
  • CCP - Kid's WayHermitage, Egyesült ÁllamokNo longer taking part
  • Care Access - HobokenHoboken, Egyesült ÁllamokNo longer taking part
  • Smith Allergy & Asthma SpecialistsHorseheads, Egyesült ÁllamokNo longer taking part
  • Care Access - KingstonKingston, Egyesült ÁllamokNo longer taking part
  • Care Access - LakevilleLakeville, Egyesült ÁllamokNo longer taking part
  • Ledyard Center, ConnecticutHospital not named in the registryNo longer taking part
  • Care Access - LondonderryLondonderry, Egyesült ÁllamokNo longer taking part
  • Johns Hopkins Rockland Physician Practice and Research GroupLutherville, Egyesült ÁllamokNo longer taking part
  • University Hospital and UW Health ClinicsMadison, Egyesült ÁllamokNo longer taking part
  • Marshfield Medical Center-MarshfieldMarshfield, Egyesült ÁllamokNo longer taking part
  • Care Access - MelroseMelrose, Egyesült ÁllamokNo longer taking part
  • ActivMed Practices and ResearchMethuen, Egyesült ÁllamokNo longer taking part
  • Care Access - MiddleburyMiddlebury (village), Egyesült ÁllamokNo longer taking part
  • Clinical Research InstituteMinneapolis, Egyesült ÁllamokNo longer taking part
  • Monaca, PennsylvaniaHospital not named in the registryNo longer taking part
  • Nantucket, MassachusettsHospital not named in the registryNo longer taking part
  • Care Access - Briarpatch and Mobile SiteNantucket, Egyesült ÁllamokNo longer taking part
  • Care Access - NantucketNantucket, Egyesült ÁllamokNo longer taking part
  • New London, ConnecticutHospital not named in the registryNo longer taking part
  • New Shoreham, Rhode IslandHospital not named in the registryNo longer taking part
  • Mid Hudson Medical ResearchNew Windsor, Egyesült ÁllamokNo longer taking part
  • Care Access - North ConwayNorth Conway, Egyesült ÁllamokNo longer taking part
  • South Shore Medical CenterNorwell, Egyesült ÁllamokNo longer taking part
  • Oak Bluffs, MassachusettsHospital not named in the registryNo longer taking part
  • Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)Pittsburgh, Egyesült ÁllamokNo longer taking part
  • Preferred Primary Care Physicians, Preferred Clinical Research-St. ClairPittsburgh, Egyesült ÁllamokNo longer taking part
  • ActivMed Practices & Research, LLC.Portsmouth, Egyesült ÁllamokNo longer taking part
  • Care Access - PottsvillePottsville, Egyesült ÁllamokNo longer taking part
  • Punxsutawney, PennsylvaniaHospital not named in the registryNo longer taking part
  • Care Access - HinghamRockland, Egyesült ÁllamokNo longer taking part
  • MaineHealth Pen Bay HospitalRockport, Egyesült ÁllamokNo longer taking part
  • Sandwich, MassachusettsHospital not named in the registryNo longer taking part
  • Guthrie Medical Group, P.C.Sayre, Egyesült ÁllamokNo longer taking part
  • Robert Packer HospitalSayre, Egyesült ÁllamokNo longer taking part
  • Frontier Clinical Research, LLCScottdale, Egyesült ÁllamokNo longer taking part
  • Care Access - ScrantonScranton, Egyesült ÁllamokNo longer taking part
  • Northeast Clinical Trials GroupScranton, Egyesült ÁllamokNo longer taking part
  • Sharon, PennsylvaniaHospital not named in the registryNo longer taking part
  • Frontier Clinical Research, LLCSmithfield, Egyesült ÁllamokNo longer taking part
  • Sisu BHRSpringfield, Egyesült ÁllamokNo longer taking part
  • Stamford Health Medical GroupStamford, Egyesült ÁllamokNo longer taking part
  • Stamford HospitalStamford, Egyesült ÁllamokNo longer taking part
  • Preferred Primary Care PhysiciansUniontown, Egyesült ÁllamokNo longer taking part
  • Vineyard Haven, MassachusettsHospital not named in the registryNo longer taking part
  • Care Access - WarehamWareham, Egyesült ÁllamokNo longer taking part
  • IMA Clinical Research WarrenWarren Township, Egyesült ÁllamokNo longer taking part
  • Care Access WarwickWarwick, Egyesült ÁllamokNo longer taking part
  • Sumit Bhutani MD LLCWestminster, Egyesült ÁllamokNo longer taking part
  • Woodholme Gastroenterology AssociatesWestminster, Egyesült ÁllamokNo longer taking part
  • Marshfield Medical Center - WestonWeston, Egyesült ÁllamokNo longer taking part
  • South Shore HospitalWeymouth, Egyesült ÁllamokNo longer taking part
  • Care Access - Wilkes-BarreWilkes-Barre, Egyesült ÁllamokNo longer taking part
  • Amherst Family Practice P.C.Winchester, Egyesült ÁllamokNo longer taking part
  • University of Massachusetts Chan Medical SchoolWorcester, Egyesült ÁllamokNo longer taking part
  • Yeagertown, PennsylvaniaHospital not named in the registryNo longer taking part

A vizsgálat adatai

Ki végzi
Pfizer
Azonosító
NCT05477524EU 2023-509105-72-00
A regiszteradat frissítve
2026. június 4.
Eredeti leírás
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.A teljes eredeti leírásKevesebb

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 9,400 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.

Bevonási feltételek: 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.

Kizáró feltételek: 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; 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; Any female participants that are pregnant (or have a positive urine pregnancy test) or are breastfeeding; Known tick bite within the past 4 weeks.

ClinicalTrials.gov NCT05477524 · EU CTIS 2023-509105-72-00