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Cancer Vaccine
mRNA Vaccines for Lyme Disease
Phase 1 & 2
Waitlist Available
Research 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 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.
Who is the study for?
Adults aged 18-70 with a BMI of 18-39 kg/m2 can join this Lyme disease vaccine trial. Women must not be pregnant, use reliable contraception, or abstain from pregnancy-causing activities. Excluded are those who've had recent immunosuppressants, immune therapies, Lyme treatment/vaccination, tick bites within 4 weeks, skin conditions affecting assessments, or severe vaccine reactions.Check my eligibility
What is being tested?
The study is testing the safety and body's response to two experimental vaccines against Lyme disease: heptavalent mRNA-1975 and monovalent mRNA-1982 compared to a placebo. Participants will receive injections and their health responses will be monitored.See study design
What are the potential side effects?
Potential side effects may include typical vaccine reactions such as soreness at the injection site, fatigue, headache or fever. More serious allergic reactions like anaphylaxis could occur but are rare.
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
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 moreSecondary 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.
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
ModernaTX, Inc.Lead Sponsor
108 Previous Clinical Trials
61,378,510 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have chronic symptoms related to Lyme disease or an active Lyme infection.I have been treated for Lyme disease in the last 3 months.I have had myocarditis, pericarditis, or myopericarditis in the past.I have not taken strong immune system suppressants for more than 2 weeks in the last 6 months.I don't have skin conditions or tattoos that could interfere with vaccine reaction assessments on my arm.I have not received immune therapies or blood products in the last 90 days.
Research Study Groups:
This trial has the following groups:- Group 1: mRNA-1975: Dose 1
- Group 2: mRNA-1975: Dose 3
- Group 3: mRNA-1975: Dose 2
- Group 4: mRNA-1982: Dose 2
- Group 5: mRNA-1982: Dose 3
- Group 6: mRNA-1975: Dose 4
- Group 7: mRNA-1982: Dose 1
- Group 8: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
Who else is applying?
What site did they apply to?
ActivMed Research LLC
Rochester Clinical Research, Inc.
Lynn Health Science Institute
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I spend a great deal of time outdoors and contracted Lyme disease in 2020. I am currently healthy, but would get a vaccine if it was available.
PatientReceived no prior treatments
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