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

Lyme Disease Clinical Trial

— VALOR  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05477524
• Other study ID #: C4601003
• Secondary ID: 2021-005427-2020
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: August 4, 2022
• Est. completion date: December 26, 2025

Study information

• Verified date: June 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12550
• Est. completion date: December 26, 2025
• Est. primary completion date: December 26, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lyme Disease

Intervention

Biological:
• VLA15
Shot in the deltoid muscle (preferable in the nondominant arm)

Other:
• Saline
Shot in the deltoid muscle (preferable in the nondominant arm)

Locations

Country	Name	City	State
Canada	Viable Clinical Research Corporation	Bridgewater	Nova Scotia
Canada	Centricity Research Burlington Multispecialty	Burlington	Ontario
Canada	Canadian Center for Vaccinology	Halifax	Nova Scotia
Canada	Milestone Research Inc.	London	Ontario
Canada	The Ottawa Hospital - General Campus	Ottawa	Ontario
Canada	Bluewater Clinical Research Group Inc.	Sarnia	Ontario
Canada	Diex Recherche Sherbrooke Inc.	Sherbrooke	Quebec
Canada	Stouffville Medical Research Institute Inc.	Stouffville	Ontario
Canada	Centricity Research Toronto Manna Multispecialty	Toronto	Ontario
Canada	Diex Recherche Victoriavile Inc.	Victoriaville	Quebec
Canada	Diex Recherche Victoriavile Inc.	Victoriaville	Quebec
Finland	FVR, Etelä-Helsingin rokotetutkimusklinikka	Helsinki	Uusimaa
Finland	FVR, Itä-Helsingin rokotetutkimusklinikka	Helsinki	Uusimaa
Finland	MeVac - Meilahti Vaccine Research Center	Helsinki
Finland	FVR, Järvenpään rokotetutkimusklinikka	Järvenpää	Uusimaa
Finland	FVR, Kokkolan rokotetutkimusklinikka	Kokkola
Finland	FVR, Porin rokotetutkimusklinikka	Pori
Finland	FVR, Tampereen rokotetutkimusklinikka	Tampere	Pirkanmaa
Finland	Tampere Vaccine Research Clinic	Tampere
Finland	FVR, Turun rokotetutkimusklinikka	Turku	Varsinais-suomi
Finland	Terveystalo Pulssi	Turku
Germany	AmBeNet GmbH	Leipzig	Sachsen
Germany	Internistische Gemeinschaftspraxis Mainz	Mainz
Netherlands	Amsterdam UMC, locatie AMC	Amsterdam	Noord-holland
Poland	Osrodek Wsparcia Badan Klinicznych	Bialystok
Poland	Uniwersytecki Szpital Kliniczny w Bialymstoku	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	Krakowski Szpital Specjalistyczny im. Jana Pawa II	Krakow	Malopolskie
Poland	Krakowskie Centrum Medyczne	Krakow
Poland	Przyladek Zdrowia	Krakow	Malopolskie
Poland	SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym	Lomianki	Mazowieckie
Poland	NZOZ Praktyka Lekarza Rodzinnego Eskulap	Lublin
Poland	Rodzinne Centrum Medyczne LUBMED	Lubon	Wielkopolskie
Poland	Specjalistyczny Zespol Opieki Zdrowotnej nad Matka i Dzieckiem w Poznaniu	Poznan
Poland	Centrum Medyczne Lucyna Andrzej Dymek	Strzelce Opolskie	Opolskie
Poland	ALERGO-MED Specjalistyczna Przychodnia Lekarska	Tarnow	Malopolskie
Poland	MICS Centrum Medyczne Torun	Torun	Kujawsko-pomorskie
Poland	Szpital im. Sw. Jadwigi Slaskiej w Trzebnicy	Trzebnica	Dolnoslaskie
Poland	Centrum Medyczne AD-MED Sp. z o. o. Przychodnia Dla Rodziny	Wroclaw	Dolnoslaskie
Poland	Centrum Medyczne AD-MED Sp. z o. o. Przychodnia Dla Rodziny	Wroclaw
Poland	Futuremeds spolka z ograniczona odpowiedzialnoscia	Wroclaw	Dolnoslaskie
Poland	Futuremeds spolka z ograniczona odpowiedzialnoscia	Wroclaw	Dolnoslaskie
Poland	Przychodnia EuroMediCare Wroclaw Lowiecka	Wroclaw
Sweden	Blekinge Tekniska Hogskola (BTH) (Blekinge Institute of Technology) - Karlskrona	Karlskrona	Blekinge LÄN [se-10]
Sweden	ProbarE	Lund
Sweden	Universitetssjukhuset Örebro	Örebro	Örebro LÄN [se-18]
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]
United States	Johns Hopkins	Baltimore	Maryland
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Northern Light Eastern Maine Medical Center	Bangor	Maine
United States	Care Access - Brattleboro	Brattleboro	Vermont
United States	Care Access - Brattleboro - Putney Road	Brattleboro	Vermont
United States	Internal Medicine Associates	Bridgeton	New Jersey
United States	The University of Vermont Medical Center Inc.	Burlington	Vermont
United States	Bassett Medical Center	Cooperstown	New York
United States	Smith Allergy and Asthma Specialists	Cortland	New York
United States	TruCare Internal Medicine & Infectious Disease	DuBois	Pennsylvania
United States	Altoona Center For Clinical Research	Duncansville	Pennsylvania
United States	Velocity Clinical Research, Providence	East Greenwich	Rhode Island
United States	Clinilabs	Eatontown	New Jersey
United States	Allegheny Health and Wellness Pavilion	Erie	Pennsylvania
United States	Central Erie Primary Care	Erie	Pennsylvania
United States	Care Access - Essex	Essex	Connecticut
United States	Pediatric Associates of Fall River	Fall River	Massachusetts
United States	Care Access - Farmington	Farmington	Maine
United States	Hunterdon Infectious Disease Specialists	Flemington	New Jersey
United States	Care Access - Albany	Halfmoon	New York
United States	CCP - Kid's Way	Hermitage	Pennsylvania
United States	Care Access - Hoboken	Hoboken	New Jersey
United States	Smith Allergy & Asthma Specialists	Horseheads	New York
United States	United Health Services at Wilson Memorial Hospital	Johnson City	New York
United States	Richard M Kastelic M.D. and Associates, PC / Berkley Hills Clinicals	Johnstown	Pennsylvania
United States	Care Access - Londonderry	Londonderry	New Hampshire
United States	Johns Hopkins Rockland Physician Practice and Research Group	Lutherville	Maryland
United States	University Hospital and UW Health Clinics	Madison	Wisconsin
United States	Marshfield Medical Center - Marshfield	Marshfield	Wisconsin
United States	ActivMed Practices and Research	Methuen	Massachusetts
United States	Care Access - Middlebury	Middlebury	Vermont
United States	Clinical Research Institute	Minneapolis	Minnesota
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	Care Access Mobile Site	New London	Connecticut
United States	Care Access Mobile Site	New Shoreham	Rhode Island
United States	Mid Hudson Medical Research	New Windsor	New York
United States	South Shore Medical Center	Norwell	Massachusetts
United States	Care New England Medical Group	Pawtucket	Rhode Island
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	ActivMed Practices & Research, LLC.	Portsmouth	New Hampshire
United States	Care Access - Pottsville	Pottsville	Pennsylvania
United States	Care Access Mobile Site	Punxsutawney	Pennsylvania
United States	Care Access - Hingham	Rockland	Massachusetts
United States	Pen Bay Medical Center	Rockport	Maine
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	Sisu BHR	Springfield	Massachusetts
United States	Stamford Health Medical Group	Stamford	Connecticut
United States	Stamford Hospital	Stamford	Connecticut
United States	Preferred Primary Care Physicians	Uniontown	Pennsylvania
United States	Velocity Clinical Research, Vestal	Vestal	New York
United States	Care Access - Wareham	Wareham	Massachusetts
United States	IMA Clinical Research Warren	Warren	New Jersey
United States	Care Access - Warwick	Warwick	Rhode Island
United States	Kent Hospital	Warwick	Rhode Island
United States	Sumit Bhutani MD LLC	Westminster	Maryland
United States	Woodholme Gastroenterology Associates	Westminster	Maryland
United States	Marshfield Medical Center - Weston	Weston	Wisconsin
United States	South Shore Hospital	Weymouth	Massachusetts
United States	Care Access - Wilkes-Barre	Wilkes-Barre	Pennsylvania
United States	Amherst Family Practice, P.C.	Winchester	Virginia
United States	University of Massachusetts Chan Medical School	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	Valneva Austria GmbH

Countries where clinical trial is conducted

United States,  Canada,  Finland,  Germany,  Netherlands,  Poland,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative incidence rate 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 independent 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)).
Primary	Percentage of participants reporting local reactions		Within 7 days following each study intervention administration
Primary	Percentage of participants reporting systemic events		Within 7 days following each study intervention administration
Primary	Percentage of participants reporting adverse events (AEs)		Through 1 month following each study intervention administration
Primary	Percentage of participants reporting newly diagnosed chronic medical conditions (NDCMCs)		Through study completion, up to approximately 42 months.
Primary	Percentage of participants reporting serious adverse events (SAEs)		Through study completion, up to approximately 42 months.
Primary	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
Primary	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
Primary	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
Primary	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	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 independent 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)
Secondary	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 independent 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)

External Links

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