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ClinicalTrials.gov 5 recruiting now official registry

Lyme Disease clinical trials

5 of 10 indexed Lyme Disease trials are currently recruiting.

10 US clinical trials · 5 currently recruiting

Lyme Disease is the subject of 10 registered US clinical trials on ClinicalTrials.gov, 5 of them currently open to new participants. 3 are in Phase 3-4 (later-stage) and 2 in Phase 1-2 (earlier-stage). The most active sponsor is National Institute of Allergy and Infectious Diseases (NIAID), running 4 of these trials.

The research picture

Lyme Disease has 10 registered US clinical trials, 5 of them open to new participants right now, about 50% of the total.

5
recruiting participants now
50%
of trials open to enrollment
3
in Phase 3–4 (later-stage)
4
top sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Phase 12Phase 33

Active & Recent Trials

10 total, page 1 of 1

RECRUITING 700 participants

A Comprehensive Clinical, Microbiological and Immunological Assessment of Patients With Suspected Post Treatment Lyme Disease Syndrome and Selected Control Populations

National Institute of Allergy and Infectious Diseases (NIAID)

NCT00001539

RECRUITING 500 participants

Evaluation, Treatment, and Follow-up of Patients With Lyme Disease

National Institute of Allergy and Infectious Diseases (NIAID)

NCT00028080

RECRUITING Phase 1 60 participants

Human Immune Response to Ixodes Scapularis Tick Bites

National Institute of Allergy and Infectious Diseases (NIAID)

NCT05036707

RECRUITING 40 participants

Pregnancy and Early Neurodevelopmental Outcomes Following In Utero Lyme Disease Exposure

Children's National Research Institute

NCT06026969

RECRUITING 30 participants

Navigating Pregnancy and Parenthood With Lyme Disease

Children's National Research Institute

NCT06397794

ACTIVE NOT RECRUITING Phase 3 12,547 participants

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

Pfizer

NCT05477524

COMPLETED Phase 3 20,000 participants

Lyme Disease Prevention Program

Brigham and Women's Hospital

NCT00000432

COMPLETED 893 participants

ImmuneSense Lyme Study

Adaptive Biotechnologies

NCT04422314

COMPLETED Phase 3 55 participants

Study and Treatment of Post Lyme Disease (STOP-LD)

National Institute of Allergy and Infectious Diseases (NIAID)

NCT00000937

COMPLETED Phase 1 44 participants

First Clinical Study of the Safety and Blood Levels of a Human Monoclonal Antibody (2217LS) Against Lyme Disease Bacteria in Healthy People

MassBiologics

NCT04863287

Phase Distribution

PhaseTrial count
Phase 1 2
Phase 3 3

Source: ClinicalTrials.gov, National Library of Medicine. Data is informational only.

Reading the Lyme Disease Trial Landscape

10 indexed Lyme Disease studies · 5 recruiting (50%).

Phase mix: 3 late (III/IV) vs 2 early (I/II).

Top sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (4 trials), 5 others listed. 10 shown below, recruiting first.

How to read this condition's trial landscape

That ratio is a useful proxy for activity level: a high share of recruiting studies often signals that research interest is current and that new enrollment opportunities are appearing, while a low share typically means the field is dominated by completed or follow-up work where most participant spots have already been filled. These counts reflect the public registry only and include studies at every stage of design, so they should be read as an index of research attention rather than as a measure of treatment availability.

Phase 1 and Phase 2 studies focus on early safety signals, dosing, and preliminary effect, while Phase 3 studies are typically the larger efficacy and safety trials submitted toward regulatory review, and Phase 4 studies follow approved interventions in real-world use. A condition weighted toward later phases often reflects a mature research pipeline with several interventions already close to or past approval, whereas a heavier early-phase tilt suggests the field is still exploring new mechanisms and candidate approaches.

All figures are derived from the public ClinicalTrials.gov dataset maintained by the National Library of Medicine and are reproduced here for reference. Inclusion of a trial, sponsor, or intervention on this page is neither an endorsement nor a recommendation, eligibility, protocol changes, and site-level status can shift frequently, so always verify current details on ClinicalTrials.gov and consult a qualified healthcare provider before acting on anything you see here.

Frequently Asked Questions

How many clinical trials are there for Lyme Disease?

PlainTrial tracks 10 US clinical trials for Lyme Disease, of which 5 are currently recruiting participants. Data sourced from ClinicalTrials.gov.

How do I find a recruiting trial for Lyme Disease?

Use the trial list above filtered by "Recruiting" status, or visit our trial finder at /recruiting to search by condition and state. Always discuss trial participation with your healthcare provider before enrolling.

Is this data current?

Data is sourced from ClinicalTrials.gov and reflects our most recent data pull. Trial status may have changed since then. Always verify current information at ClinicalTrials.gov before making decisions about participation.

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from ClinicalTrials.gov (National Library of Medicine). Consult a qualified professional before making decisions based on this data.

Source: ClinicalTrials.gov (NIH/NLM) ClinicalTrials.gov AACT registry · 2026 Trial counts and statuses sourced from ClinicalTrials.gov. Sponsor counts include both industry and federal/academic sponsors.

Verify with NIH →

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page aggregates every registered trial for this condition, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.