Cancer Vaccine

mRNA-1982: Dose 1 for Lyme Disease

DM Clinical Research, Tomball, TX

mRNA-1982 +2 morePhase 1 & 2RecruitingResearch Sponsored by ModernaTX, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Updays 1, 29, 85, and 197

Awards & highlights

Study Summary

This trial looks at how safe and effective two vaccines are for Lyme disease in healthy adults.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 1, 29, 85, and 197

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 1, 29, 85, and 197

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1, 29, 85, and 197 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants With Medically Attended AEs

Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)

Number of Participants With Unsolicited Adverse Events (AEs)

+1 more

Secondary outcome measures

Geometric Mean Fold Rise of anti-OspA Binding IgG Antibody Titer at Days 29, 85, and 197 Compared to Day 1 (Baseline)

Geometric Mean Titer of Anti-outer Surface Protein A (anti-OspA) Binding Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay or a Similar Method

Trial Design

8Treatment groups

Experimental Treatment

Placebo Group

Group I: mRNA-1982: Dose 3Experimental Treatment1 Intervention

Participants will receive 3 IM injections of the mRNA-1982 vaccine at Dose level 3 on Days 1, 57, and 169.

Group II: mRNA-1982: Dose 2Experimental Treatment1 Intervention

Participants will receive 3 IM injections of the mRNA-1982 vaccine at Dose Level 2 on Days 1, 57, and 169.

Group III: mRNA-1982: Dose 1Experimental Treatment1 Intervention

Participants will receive 3 IM injections of the mRNA-1982 vaccine at Dose Level 1 on Days 1, 57, and 169.

Group IV: mRNA-1975: Dose 4Experimental Treatment1 Intervention

Participants will receive 3 IM injections of the mRNA-1975 vaccine at Dose level 4 on Days 1, 57, and 169.

Group V: mRNA-1975: Dose 3Experimental Treatment1 Intervention

Participants will receive 3 IM injections of the mRNA-1975 vaccine at Dose Level 3 on Days 1, 57, and 169.

Group VI: mRNA-1975: Dose 2Experimental Treatment1 Intervention

Participants will receive 3 IM injections of the mRNA-1975 vaccine at Dose level 2 on Days 1, 57, and 169.

Group VII: mRNA-1975: Dose 1Experimental Treatment1 Intervention

Participants will receive 3 intramuscular (IM) injections of the mRNA-1975 vaccine at Dose Level 1 on Days 1, 57, and 169.

Group VIII: PlaceboPlacebo Group1 Intervention

Participants will receive 3 IM injections of vaccine-matching placebo on Days 1, 57, and 169.

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor

90 Previous Clinical Trials

51,346,477 Total Patients Enrolled

Media Library

mRNA-1975 (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05975099 — Phase 1 & 2

Lyme Disease Research Study Groups: mRNA-1982: Dose 1, Placebo, mRNA-1975: Dose 3, mRNA-1982: Dose 3, mRNA-1975: Dose 1, mRNA-1975: Dose 4, mRNA-1982: Dose 2, mRNA-1975: Dose 2

Lyme Disease Clinical Trial 2023: mRNA-1975 Highlights & Side Effects. Trial Name: NCT05975099 — Phase 1 & 2

mRNA-1975 (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05975099 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How might I become involved in this experiment?

"The eligibility criteria for this study necessitate that prospective participants have lyme disease and be in the 18-70 age range. 800 people are being recruited to participate."

Answered by AI

Does this experiment currently accept individuals who are more than half a century old?

"This clinical trial is seeking patients aged between 18 and 70 to partake in the study. Separately, there are 4 distinct studies for minors below 18 years of age, as well as 8 specialised trials for seniors over 65."

Answered by AI

At which locations is this experiment presently being conducted?

"As of now, 20 sites in Connecticut, Florida and other places are running this clinical trial. To reduce the amount of travelling you'll have to do if you decide to take part, make sure to pick a location close by."

Answered by AI

Is this experiment enrolling subjects at this moment?

"Affirmative. According to clinicaltrials.gov, this clinical trial is currently inviting candidates for participation. It was first announced on July 26th 2023 and recently updated the same day; 800 patients are needed from a total of twenty medical centres."

Answered by AI

How many individuals are presently enrolled in this clinical research?

"To properly conduct the trial, 800 eligible patients must be recruited. ModernaTX Inc., will preside over this experiment and its operations in Stamford Therapeutics Consortium (Stamford, Florida) as well as Chase Medical Research LLC (Waterbury, Georgia)."

Answered by AI