Clinical trial NCT05477524: An Efficacy, Safety, Tolerability, Immunogenicity, and Lot-Consistency Clinical Trial of a 6-Valent OspA-Based Lyme Disease Vaccine (VLA15)
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Lyme Disease
Keywords: VLA15
Lyme Borreliosis
Vaccine
Tick
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Valneva Austria GmbH
First posted: 2022-07-28
Enrollment: 12557
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Relative incidence rate reduction of confirmed Lyme disease cases in the VLA15 group compared to the placebo group
timeFrame: 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)).
measure: Percentage of participants reporting local reactions
timeFrame: Within 7 days following each study intervention administration
measure: Percentage of participants reporting systemic events
timeFrame: Within 7 days following each study intervention administration
measure: Percentage of participants reporting adverse events (AEs)
timeFrame: Through 1 month following each study intervention administration
measure: Percentage of participants reporting newly diagnosed chronic medical conditions (NDCMCs)
timeFrame: Through study completion, up to approximately 42 months.
measure: Percentage of participants reporting serious adverse events (SAEs)
timeFrame: Through study completion, up to approximately 42 months.
measure: Geometric mean ratio (GMR) of anti-OspA titers for each serotype (ST1-ST6) for Lot 1 to Lot 2
timeFrame: At 1 month after completion of the primary series and the booster dose
measure: Geometric mean ratio (GMR) of anti-OspA titers for each serotype (ST1-ST6) for Lot 1 to Lot 3
timeFrame: At 1 month after completion of the primary series and the booster dose
measure: Geometric mean ratio (GMR) of anti-OspA titers for each serotype (ST1-ST6) for Lot 2 to Lot 3
timeFrame: At 1 month after completion of the primary series and the booster dose
measure: Geometric mean ratio (GMR) of anti-OspA titers for each serotype (ST1-ST6)
timeFrame: At 1 month after completion of the booster dose
Secondary outcomes:
measure: Vaccine efficacy among participants enrolled from North American sites
timeFrame: 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)
measure: Vaccine efficacy among participants after primary series
timeFrame: 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)
Other outcomes:
Locations:
city: Essex
country: United States
facility: Care Access - Essex
state: Connecticut
city: New London
country: United States
facility: Care Access Mobile Site
state: Connecticut
city: Stamford
country: United States
facility: Stamford Health Medical Group
state: Connecticut
city: Stamford
country: United States
facility: Stamford Hospital
state: Connecticut
city: Bangor
country: United States
facility: Northern Light Eastern Maine Medical Center
state: Maine
city: Farmington
country: United States
facility: Care Access - Farmington
state: Maine
city: Rockport
country: United States
facility: Pen Bay Medical Center
state: Maine
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Lutherville
country: United States
facility: Johns Hopkins Rockland Physician Practice and Research Group
state: Maryland
city: Westminster
country: United States
facility: Sumit Bhutani MD LLC
state: Maryland
city: Westminster
country: United States
facility: Woodholme Gastroenterology Associates
state: Maryland
city: Fall River
country: United States
facility: Pediatric Associates of Fall River
state: Massachusetts
city: Methuen
country: United States
facility: ActivMed Practices and Research
state: Massachusetts
city: Nantucket
country: United States
facility: Care Access - Briarpatch and Mobile Site
state: Massachusetts
city: Nantucket
country: United States
facility: Care Access - Nantucket
state: Massachusetts
city: Nantucket
country: United States
facility: Care Access Mobile Site
state: Massachusetts
city: Norwell
country: United States
facility: South Shore Medical Center
state: Massachusetts
city: Rockland
country: United States
facility: Care Access - Hingham
state: Massachusetts
city: Springfield
country: United States
facility: Sisu BHR
state: Massachusetts
city: Wareham
country: United States
facility: Care Access - Wareham
state: Massachusetts
city: Weymouth
country: United States
facility: South Shore Hospital
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Chan Medical School
state: Massachusetts
city: Minneapolis
country: United States
facility: Clinical Research Institute
state: Minnesota
city: Londonderry
country: United States
facility: Care Access - Londonderry
state: New Hampshire
city: Portsmouth
country: United States
facility: ActivMed Practices & Research, LLC.
state: New Hampshire
city: Bridgeton
country: United States
facility: Internal Medicine Associates
state: New Jersey
city: Eatontown
country: United States
facility: Clinilabs
state: New Jersey
city: Flemington
country: United States
facility: Hunterdon Infectious Disease Specialists
state: New Jersey
city: Flemington
country: United States
facility: Hunterdon Medical Center
state: New Jersey
city: Hoboken
country: United States
facility: Care Access - Hoboken
state: New Jersey
city: Warren
country: United States
facility: IMA Clinical Research Warren
state: New Jersey
city: Cooperstown
country: United States
facility: Bassett Medical Center
state: New York
city: Cortland
country: United States
facility: Smith Allergy and Asthma Specialists
state: New York
city: Halfmoon
country: United States
facility: Care Access - Albany
state: New York
city: Horseheads
country: United States
facility: Smith Allergy & Asthma Specialists
state: New York
city: Johnson City
country: United States
facility: United Health Services at Wilson Memorial Hospital
state: New York
city: New Windsor
country: United States
facility: Mid Hudson Medical Research
state: New York
city: Vestal
country: United States
facility: Velocity Clinical Research, Vestal
state: New York
city: DuBois
country: United States
facility: TruCare Internal Medicine & Infectious Disease
state: Pennsylvania
city: Duncansville
country: United States
facility: Altoona Center For Clinical Research
state: Pennsylvania
city: Erie
country: United States
facility: Allegheny Health and Wellness Pavilion
state: Pennsylvania
city: Erie
country: United States
facility: Central Erie Primary Care
state: Pennsylvania
city: Hermitage
country: United States
facility: CCP - Kid's Way
state: Pennsylvania
city: Johnstown
country: United States
facility: Richard M Kastelic M.D. and Associates, PC / Berkley Hills Clinicals
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair
state: Pennsylvania
city: Pottsville
country: United States
facility: Care Access - Pottsville
state: Pennsylvania
city: Punxsutawney
country: United States
facility: Care Access Mobile Site
state: Pennsylvania
city: Sayre
country: United States
facility: Guthrie Medical Group, P. C.
state: Pennsylvania
city: Sayre
country: United States
facility: Robert Packer Hospital
state: Pennsylvania
city: Scottdale
country: United States
facility: Frontier Clinical Research, LLC
state: Pennsylvania
city: Scranton
country: United States
facility: Care Access - Scranton
state: Pennsylvania
city: Scranton
country: United States
facility: Northeast Clinical Trials Group
state: Pennsylvania
city: Smithfield
country: United States
facility: Frontier Clinical Research, LLC
state: Pennsylvania
city: Uniontown
country: United States
facility: Preferred Primary Care Physicians
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Care Access - Wilkes-Barre
state: Pennsylvania
city: East Greenwich
country: United States
facility: Velocity Clinical Research, Providence
state: Rhode Island
city: New Shoreham
country: United States
facility: Care Access Mobile Site
state: Rhode Island
city: Pawtucket
country: United States
facility: Care New England Medical Group
state: Rhode Island
city: Warwick
country: United States
facility: Care Access - Warwick
state: Rhode Island
city: Warwick
country: United States
facility: Kent Hospital
state: Rhode Island
city: Brattleboro
country: United States
facility: Care Access - Brattleboro - Putney Road
state: Vermont
city: Brattleboro
country: United States
facility: Care Access - Brattleboro
state: Vermont
city: Burlington
country: United States
facility: The University of Vermont Medical Center Inc.
state: Vermont
city: Middlebury
country: United States
facility: Care Access - Middlebury
state: Vermont
city: Winchester
country: United States
facility: Amherst Family Practice, P.C.
state: Virginia
city: Madison
country: United States
facility: University Hospital and UW Health Clinics
state: Wisconsin
city: Marshfield
country: United States
facility: Marshfield Medical Center - Marshfield
state: Wisconsin
city: Weston
country: United States
facility: Marshfield Medical Center - Weston
state: Wisconsin
city: Bridgewater
country: Canada
facility: Viable Clinical Research Corporation
state: Nova Scotia
city: Halifax
country: Canada
facility: Canadian Center for Vaccinology
state: Nova Scotia
city: Burlington
country: Canada
facility: Centricity Research Burlington Multispecialty
state: Ontario
city: London
country: Canada
facility: Milestone Research Inc.
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital - General Campus
state: Ontario
city: Sarnia
country: Canada
facility: Bluewater Clinical Research Group Inc.
state: Ontario
city: Stouffville
country: Canada
facility: Stouffville Medical Research Institute Inc.
state: Ontario
city: Toronto
country: Canada
facility: Centricity Research Toronto Manna Multispecialty
state: Ontario
city: Sherbrooke
country: Canada
facility: Diex Recherche Sherbrooke Inc.
state: Quebec
city: Victoriaville
country: Canada
facility: Diex Recherche Victoriavile Inc.
state: Quebec
city: Victoriaville
country: Canada
facility: Diex Recherche Victoriavile Inc.
state: Quebec
city: Tampere
country: Finland
facility: FVR, Tampereen rokotetutkimusklinikka
state: Pirkanmaa
city: Helsinki
country: Finland
facility: FVR, Etelä-Helsingin rokotetutkimusklinikka
state: Uusimaa
city: Helsinki
country: Finland
facility: FVR, Itä-Helsingin rokotetutkimusklinikka
state: Uusimaa
city: Järvenpää
country: Finland
facility: FVR, Järvenpään rokotetutkimusklinikka
state: Uusimaa
city: Turku
country: Finland
facility: FVR, Turun rokotetutkimusklinikka
state: Varsinais-suomi
city: Helsinki
country: Finland
facility: MeVac - Meilahti Vaccine Research Center
city: Kokkola
country: Finland
facility: FVR, Kokkolan rokotetutkimusklinikka
city: Pori
country: Finland
facility: FVR, Porin rokotetutkimusklinikka
city: Tampere
country: Finland
facility: Tampere Vaccine Research Clinic
city: Turku
country: Finland
facility: Terveystalo Pulssi
city: Leipzig
country: Germany
facility: AmBeNet GmbH
state: Sachsen
city: Mainz
country: Germany
facility: Internistische Gemeinschaftspraxis Mainz
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, locatie AMC
state: Noord-holland
city: Trzebnica
country: Poland
facility: Szpital im. Św. Jadwigi Śląskiej w Trzebnicy
state: Dolnośląskie
city: Wroclaw
country: Poland
facility: Futuremeds spolka z ograniczona odpowiedzialnoscia
state: Dolnośląskie
city: Wroclaw
country: Poland
facility: Futuremeds spolka z ograniczona odpowiedzialnoscia
state: Dolnośląskie
city: Wrocław
country: Poland
facility: Centrum Medyczne AD-MED Sp. z o. o. Przychodnia Dla Rodziny
state: Dolnośląskie
city: Torun
country: Poland
facility: MICS Centrum Medyczne Torun
state: Kujawsko-pomorskie
city: Lomianki
country: Poland
facility: SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym
state: Mazowieckie
city: Krakow
country: Poland
facility: Przylądek Zdrowia
state: Małopolskie
city: Krakow
country: Poland
facility: Krakowski Szpital Specjalistyczny im. Jana Pawa II
state: Małopolskie
city: Tarnow
country: Poland
facility: ALERGO-MED Specjalistyczna Przychodnia Lekarska
state: Małopolskie
city: Strzelce Opolskie
country: Poland
facility: Centrum Medyczne Lucyna Andrzej Dymek
state: Opolskie
city: Lubon
country: Poland
facility: Rodzinne Centrum Medyczne LUBMED
state: Wielkopolskie
city: Bialystok
country: Poland
facility: Ośrodek Wsparcia Badań Klinicznych
city: Bialystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Bialymstoku
city: Bialystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Bialymstoku
city: Boleslawiec
country: Poland
facility: Zespol Opieki Zdrowotnej w Boleslawcu
city: Gdynia
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Gdyni
city: Katowice
country: Poland
facility: Indywidualna Specjalistyczna Praktyka Lekarska Roman Spyra
city: Krakow
country: Poland
facility: Centrum Badan Klinicznych Jagiellonskie Centrum Innowacji
city: Krakow
country: Poland
facility: Krakowskie Centrum Medyczne
city: Lublin
country: Poland
facility: NZOZ Praktyka Lekarza Rodzinnego Eskulap
city: Poznan
country: Poland
facility: Specjalistyczny Zespol Opieki Zdrowotnej nad Matka i Dzieckiem w Poznaniu
city: Wroclaw
country: Poland
facility: Przychodnia EuroMediCare Wroclaw Lowiecka
city: Wroclaw
country: Poland
facility: Centrum Medyczne AD-MED Sp. z o. o. Przychodnia Dla Rodziny
city: Karlskrona
country: Sweden
facility: Blekinge Tekniska Hogskola (BTH) (Blekinge Institute of Technology) - Karlskrona
state: Blekinge LÄN [se-10]
city: Solna
country: Sweden
facility: CTC Karolinska
state: Stockholms LÄN [se-01]
city: Stockholm
country: Sweden
facility: Studieenheten Akademiskt Specialistcentrum
state: Stockholms LÄN [se-01]
city: Uppsala
country: Sweden
facility: CTC MTC
state: Uppsala LÄN [se-03]
city: Lund
country: Sweden
facility: ProbarE
city: Örebro
country: Sweden
facility: Universitetssjukhuset Örebro
state: Örebro LÄN [se-18]
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: