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Promising lyme vaccine moves to next stage in human trials

NCT ID NCT04801420

Vaccine Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 16, 2026 · Updated 3 times

Summary

This study tested a new vaccine called VLA15 to prevent Lyme disease, which is spread by tick bites. Researchers gave the vaccine or a placebo to 625 healthy people aged 5 to 65. The goal was to check safety and how well the vaccine triggers an immune response. Results showed the vaccine was generally safe and produced antibodies against Lyme bacteria.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
VLA15 vaccine (targets Lyme disease bacteria)
What this could lead to
If successful, this could lead to a vaccine that prevents Lyme disease, reducing the risk of infection after tick bites.
What could go wrong
This is a Phase 2 trial, so it is still early. The vaccine may not work in larger studies or may have side effects not yet seen.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

625 people

The number who actually took part.

Started

Mar 2021

Finished

Jul 2025

Lead sponsor

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

5 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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: * Subject is aged 5 to 65 years at the day of screening (Visit 0) * Subject is of good general health * Parent(s)/legal representative(s) and subject understand the study and its procedures, agree to its provisions * for subjects aged 18-65 years: written informed consent prior to any study related procedures * for subjects aged 5-17 years: written informed consent by the subject's legal representative(s), according to local requirements, and written informed assent of the subject, if applicable, prior to any study related procedures. * If subject is of childbearing potential: Subject has a negative serum pregnancy test at screening (Visit 0) and agrees to employ adequate birth control measures according to following timelines: * Main Study Phase: duration of entire study * Booster Phase: until 5 months after each booster vaccination (Booster 1 until Month 23, Booster 2 until Month 35 and Booster 3 until Month 47) * Subject is willing and able to comply with scheduled visits, treatment plan, and other study procedures * Subject is available for the duration of the study and can be contacted by telephone during study participation Exclusion Criteria: * Subject has a chronic illness related to Lyme borreliosis (LB), an active symptomatic LB, or received treatment for LB within the last 3 months prior to Day 1; * Subject received previous vaccination against LB; * Subject had a tick bite within 4 weeks prior to Day 1; * Subject has a medical history of or currently has a clinically relevant disease; * Subject has a medical history of or currently has a neuro- inflammatory or autoimmune disease; * Subject has a known thrombocytopenia, bleeding disorder, or received anticoagulants in the 3 weeks prior to Day 1; * Subject has received an active or passive immunization within 4 weeks prior to Day 1; * Subject has received any other registered or non-registered medicinal product in another clinical trial within 4 weeks prior to vaccination at Day 1; * Subject has a known or suspected defect of the immune system or received immuno-suppressive therapy within 4 weeks prior to Day 1; * Subject has a history of anaphylaxis of unknown cause or severe allergic reactions of unknown cause or has a known hypersensitivity or allergic reactions to one of the components of the vaccine; * Subject had any malignancy in the past 5 years; * Subject is pregnant, has plans to become pregnant during the course of the study or is lactating at the time of enrollment; * Subject has donated or plans to donate blood or blood-derived products 4 weeks prior to Day 1; * Subject has any condition that may compromise its well-being, might interfere with evaluation of study endpoints, or would limit the subject's ability to complete the study; * Subject is in a dependent relationship with the sponsor/investigator

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Conditions

The condition(s) this trial relates to.

Lyme disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lyme borreliosis

Contacts and locations

Locations

  • Advantage Clinical Trials

    The Bronx, New York, 10467, United States

  • Allegheny Health and Wellness Pavilion

    Erie, Pennsylvania, 16506, United States

  • Chase Medical Research, LLC

    Waterbury, Connecticut, 06708, United States

  • Clinical Research Institute, Inc.

    Minneapolis, Minnesota, 55402, United States

  • Foundation Pediatrics

    East Orange, New Jersey, 07018, United States

  • Hasbro Children's Hospital

    Providence, Rhode Island, 02903, United States

  • Liberty Family Practice

    Erie, Pennsylvania, 16508, United States

  • Lockman & Lubell Pediatric Associates

    Fort Washington, Pennsylvania, 19034, United States

  • Med Clinical Research Partners, LLC

    Irvington, New Jersey, 07111, United States

  • Meridian Clinical Research LLC

    Binghamton, New York, 13905, United States

  • New England Research Associates

    Bridgeport, Connecticut, 06606, United States

  • Pediatric Associates of Conn. PC

    Waterbury, Connecticut, 06708, United States

  • Rhode Island Hospital

    Providence, Rhode Island, 02903, United States

  • Richmond Behavioral Associates

    Staten Island, New York, 10314, United States

  • Rochester Clinical Research, Inc.

    Rochester, New York, 14609, United States

  • Stamford Therapeutics Consortium

    Stamford, Connecticut, 06905, United States

  • The Miriam Hospital

    Providence, Rhode Island, 02906, United States

  • Velocity Clinical Research Providence

    Warwick, Rhode Island, 02886, United States

  • Velocity Clinical Research, Inc.

    Cleveland, Ohio, 44122, United States

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