Pfizer gives lyme vaccine a fifth dose — will it boost protection?
NCT ID NCT07500506
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a fifth dose of Pfizer's Lyme disease vaccine (VLA15) is safe and boosts immunity in people who already received four doses. About 1,700 healthy volunteers aged 7 and older will get either the vaccine or a saltwater shot. Researchers will compare side effects and antibody levels over 12 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- VLA15 (Lyme disease vaccine)
- What this could lead to
- If successful, this could show that a booster dose of the Lyme disease vaccine provides continued protection against Lyme disease.
- What could go wrong
- This is a Phase 3 trial, but it only tests immune response and safety, not whether the vaccine actually prevents Lyme disease. The vaccine may not work as well in real-world conditions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 1,712 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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7 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participants who are healthy as determined by medical history and clinical judgment. * Participants willing and able to comply with all scheduled visits, IP receipt, and other procedures throughout the study. * Able to provide Informed Consent. * Participants must have received 4 doses of VLA15 in the C4601003 study, and have a V7 blood sample available. Exclusion Criteria: * Pregnant or breastfeeding participants. * Allergies or contraindications to vaccines or their components. * Health issues including: blood clotting deficiencies, immunodeficiencies, bone marrow disorder, or uncontrolled psychiatric conditions. * Receipt of therapies to treat malignancies, blood/plasma products and immunoglobulins, systemic corticosteroids and immunosuppressants, or anticoagulant therapy in recent medical history. * Recent or concurrent participation in a separate interventional study. * Staff or direct family of the study site staff and Sponsor.
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Get notified about this study
Sign up to get updates when this study changes or when new studies for Lyme disease are added.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
22 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Allegheny Health and Wellness Pavilion
RECRUITINGErie, Pennsylvania, 16506, United States
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Altoona Center For Clinical Research
RECRUITINGDuncansville, Pennsylvania, 16635, United States
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Amherst Family Practice, P.C.
NOT_YET_RECRUITINGWinchester, Virginia, 22601, United States
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Central Erie Primary Care
RECRUITINGErie, Pennsylvania, 16508, United States
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Diex Recherche Inc. Division Sherbrooke
RECRUITINGSherbrooke, Quebec, J1L 0H8, Canada
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Frontier Clinical Research, LLC
RECRUITINGScottdale, Pennsylvania, 15683, United States
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Frontier Clinical Research, LLC
RECRUITINGSmithfield, Pennsylvania, 15478, United States
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Hunterdon Medical Center
NOT_YET_RECRUITINGFlemington, New Jersey, 08822, United States
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Milestone Research Inc.
NOT_YET_RECRUITINGLondon, Ontario, N5W 6A2, Canada
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Northeast Clinical Trials Group
RECRUITINGScranton, Pennsylvania, 18510, United States
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Northern Light Eastern Maine Medical Center
NOT_YET_RECRUITINGBangor, Maine, 04401, United States
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Northern Light Family Medicine and Residency Center
NOT_YET_RECRUITINGBangor, Maine, 04401, United States
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Preferred Primary Care Physicians
NOT_YET_RECRUITINGUniontown, Pennsylvania, 15401, United States
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Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)
RECRUITINGPittsburgh, Pennsylvania, 15236, United States
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Preferred Primary Care Physicians, Preferred Clinical Research - St.Clair
NOT_YET_RECRUITINGPittsburgh, Pennsylvania, 15243, United States
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Robert Packer Hospital
RECRUITINGSayre, Pennsylvania, 18840, United States
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Smith Allergy & Asthma Specialists
RECRUITINGHorseheads, New York, 14845, United States
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Smith Allergy and Asthma Specialists
RECRUITINGCortland, New York, 13045, United States
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Stouffville Medical Research Institute Inc.
NOT_YET_RECRUITINGStouffville, Ontario, L4A 1H2, Canada
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The University of Vermont Medical Center Inc.
NOT_YET_RECRUITINGBurlington, Vermont, 05401, United States
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University of Massachusetts Chan Medical School
RECRUITINGWorcester, Massachusetts, 01655, United States
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Velocity Clinical Research, Providence
NOT_YET_RECRUITINGEast Greenwich, Rhode Island, 02818, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Immune cell tracking could sharpen lyme disease diagnosis
- Lyme disease and parenthood: a hidden struggle revealed
- Lyme disease in pregnancy: new study tracks baby brain development
- New blood test aims to spot lyme disease in kids faster and more accurately
- New mRNA vaccine could stop lyme disease in its tracks
- Could a single pill stop lyme disease before it starts?