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

Study Purpose

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 18,000 healthy participants 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 later. 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. 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. There will also be at least 1 telephone contact. It is expected that each participant will take part in this study for up to about 2 and a half years.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 5 Years and Over
Gender All
More Inclusion & Exclusion 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 diagnosis of Lyme disease within the past 3 months.
  • - Any history of Lyme carditis, neuroborreliosis, or arthritis, 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 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05477524
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Pfizer
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Pfizer CT.gov Call Center
Principal Investigator Affiliation Pfizer
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Germany, Poland, Sweden, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Lyme Disease
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: VLA15 Lot 1 (3-dose primary vaccination series and booster dose)

Shot in the deltoid muscle (preferable in the nondominant arm)

Experimental: VLA15 Lot 2 (3-dose primary vaccination series and booster dose)

Shot in the deltoid muscle (preferable in the nondominant arm)

Experimental: VLA15 Lot 3 (3-dose primary vaccination series and booster dose)

Shot in the deltoid muscle (preferable in the nondominant arm)

Placebo Comparator: Placebo (3-dose primary vaccination series and booster dose)

Shot in the deltoid muscle (preferable in the nondominant arm)

Interventions

Biological: - VLA15

Shot in the deltoid muscle (preferable in the nondominant arm)

Other: - Saline

Shot in the deltoid muscle (preferable in the nondominant arm)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Care Access Mobile Site, New London, Connecticut

Status

Recruiting

Address

Care Access Mobile Site

New London, Connecticut, 06320

Care Access Mobile Site, Norwich, Connecticut

Status

Recruiting

Address

Care Access Mobile Site

Norwich, Connecticut, 06360

Care Access Mobile Site, Old Saybrook, Connecticut

Status

Recruiting

Address

Care Access Mobile Site

Old Saybrook, Connecticut, 06475

Stamford Health Medical Group, Stamford, Connecticut

Status

Not yet recruiting

Address

Stamford Health Medical Group

Stamford, Connecticut, 06902

Stamford Hospital, Stamford, Connecticut

Status

Not yet recruiting

Address

Stamford Hospital

Stamford, Connecticut, 06902

Stamford Hospital, Stamford, Connecticut

Status

Not yet recruiting

Address

Stamford Hospital

Stamford, Connecticut, 06904

Care Access Mobile Site, Wilton, Connecticut

Status

Recruiting

Address

Care Access Mobile Site

Wilton, Connecticut, 06897

Care Access Mobile Site, Vassalboro, Maine

Status

Not yet recruiting

Address

Care Access Mobile Site

Vassalboro, Maine, 04989

Pediatric Associates of Fall River, Fall River, Massachusetts

Status

Recruiting

Address

Pediatric Associates of Fall River

Fall River, Massachusetts, 02721

Care Access Mobile Site, Oak Bluffs, Massachusetts

Status

Not yet recruiting

Address

Care Access Mobile Site

Oak Bluffs, Massachusetts, 02557

Care Access - Hoboken, Hoboken, New Jersey

Status

Not yet recruiting

Address

Care Access - Hoboken

Hoboken, New Jersey, 07030

Care Access Mobile Site, Mountain Lakes, New Jersey

Status

Not yet recruiting

Address

Care Access Mobile Site

Mountain Lakes, New Jersey, 07046

Bassett Medical Center, Cooperstown, New York

Status

Not yet recruiting

Address

Bassett Medical Center

Cooperstown, New York, 13326

Care Access - Albany, Halfmoon, New York

Status

Recruiting

Address

Care Access - Albany

Halfmoon, New York, 12065

Care Access - Albany, Halfmoon, New York

Status

Not yet recruiting

Address

Care Access - Albany

Halfmoon, New York, 12065

Care Access Mobile Site, Aliquippa, Pennsylvania

Status

Recruiting

Address

Care Access Mobile Site

Aliquippa, Pennsylvania, 15001

Care Access Mobile Site, Clarion, Pennsylvania

Status

Recruiting

Address

Care Access Mobile Site

Clarion, Pennsylvania, 16214

Altoona Center For Clinical Research, Duncansville, Pennsylvania

Status

Recruiting

Address

Altoona Center For Clinical Research

Duncansville, Pennsylvania, 16635

Care Access Mobile Site, Grove City, Pennsylvania

Status

Recruiting

Address

Care Access Mobile Site

Grove City, Pennsylvania, 16127

Johnstown, Pennsylvania

Status

Not yet recruiting

Address

Richard M Kastelic M.D. and Associates, PC / Berkley Hills Clinicals

Johnstown, Pennsylvania, 16641

Care Access - Pottsville, Pottsville, Pennsylvania

Status

Recruiting

Address

Care Access - Pottsville

Pottsville, Pennsylvania, 17901

Guthrie Medical Group, P. C., Sayre, Pennsylvania

Status

Not yet recruiting

Address

Guthrie Medical Group, P. C.

Sayre, Pennsylvania, 18840

Robert Packer Hospital, Sayre, Pennsylvania

Status

Not yet recruiting

Address

Robert Packer Hospital

Sayre, Pennsylvania, 18840

Frontier Clinical Research, LLC, Scottdale, Pennsylvania

Status

Recruiting

Address

Frontier Clinical Research, LLC

Scottdale, Pennsylvania, 15683

Care Access - Scranton, Scranton, Pennsylvania

Status

Recruiting

Address

Care Access - Scranton

Scranton, Pennsylvania, 18508

Care Access Mobile Site, Sharon, Pennsylvania

Status

Recruiting

Address

Care Access Mobile Site

Sharon, Pennsylvania, 16146

Preferred Primary Care Physicians, Uniontown, Pennsylvania

Status

Not yet recruiting

Address

Preferred Primary Care Physicians

Uniontown, Pennsylvania, 15401

Care Access - Wilkes-Barre, Wilkes-Barre, Pennsylvania

Status

Recruiting

Address

Care Access - Wilkes-Barre

Wilkes-Barre, Pennsylvania, 18702

Velocity Clinical Research, Providence, East Greenwich, Rhode Island

Status

Not yet recruiting

Address

Velocity Clinical Research, Providence

East Greenwich, Rhode Island, 02818

Care Access Mobile Site, New Shoreham, Rhode Island

Status

Recruiting

Address

Care Access Mobile Site

New Shoreham, Rhode Island, 02807

Care Access Mobile Site, Providence, Rhode Island

Status

Recruiting

Address

Care Access Mobile Site

Providence, Rhode Island, 02906

Care Access - Warwick, Warwick, Rhode Island

Status

Recruiting

Address

Care Access - Warwick

Warwick, Rhode Island, 02886

International Sites

AmBeNet GmbH, Leipzig, Sachsen, Germany

Status

Not yet recruiting

Address

AmBeNet GmbH

Leipzig, Sachsen, 04107

Internistische Gemeinschaftspraxis Mainz, Mainz, Germany

Status

Not yet recruiting

Address

Internistische Gemeinschaftspraxis Mainz

Mainz, , 55116

Trzebnica, Dolnośląskie, Poland

Status

Not yet recruiting

Address

Szpital im. Św. Jadwigi Śląskiej w Trzebnicy

Trzebnica, Dolnośląskie, 55-100

Wroclaw, Dolnośląskie, Poland

Status

Recruiting

Address

Futuremeds spolka z ograniczona odpowiedzialnoscia

Wroclaw, Dolnośląskie, 50-088

MICS Centrum Medyczne Torun, Torun, Kujawsko-pomorskie, Poland

Status

Not yet recruiting

Address

MICS Centrum Medyczne Torun

Torun, Kujawsko-pomorskie, 87-100

Lomianki, Mazowieckie, Poland

Status

Not yet recruiting

Address

SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym

Lomianki, Mazowieckie, 05-092

Przylądek Zdrowia, Krakow, Małopolskie, Poland

Status

Not yet recruiting

Address

Przylądek Zdrowia

Krakow, Małopolskie, 30-644

Krakow, Małopolskie, Poland

Status

Not yet recruiting

Address

Krakowski Szpital Specjalistyczny im. Jana Pawa II

Krakow, Małopolskie, 31-202

Tarnow, Małopolskie, Poland

Status

Not yet recruiting

Address

ALERGO-MED Specjalistyczna Przychodnia Lekarska

Tarnow, Małopolskie, 33-100

Centrum Medyczne Lucyna Andrzej Dymek, Strzelce Opolskie, Opolskie, Poland

Status

Not yet recruiting

Address

Centrum Medyczne Lucyna Andrzej Dymek

Strzelce Opolskie, Opolskie, 47-100

Katowice, Poland

Status

Not yet recruiting

Address

Indywidualna Specjalistyczna Praktyka Lekarska Roman SPYRA

Katowice, , 40-018

Krakowskie Centrum Medyczne, Krakow, Poland

Status

Recruiting

Address

Krakowskie Centrum Medyczne

Krakow, , 31-501

NZOZ Praktyka Lekarza Rodzinnego Eskulap, Lublin, Poland

Status

Not yet recruiting

Address

NZOZ Praktyka Lekarza Rodzinnego Eskulap

Lublin, , 20-044

EMC Instytut Medyczny, Wroclaw, Poland

Status

Not yet recruiting

Address

EMC Instytut Medyczny

Wroclaw, , 50-220

Karlskrona, Blekinge LÄN [se-10], Sweden

Status

Not yet recruiting

Address

Blekinge Tekniska Hogskola (BTH) (Blekinge Institute of Technology) - Karlskrona

Karlskrona, Blekinge LÄN [se-10], 371 79

ProbarE, Lund, Sweden

Status

Not yet recruiting

Address

ProbarE

Lund, , 222 22