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Virus Therapy
mRNA Vaccine for Respiratory Syncytial Virus
Phase 1
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
Japanese older adults ≥ 60 years of age
Women of child-bearing potential ≥18 to ≤40 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 141 (cohorts 5 and 6), up to day 169 (cohorts 1, 2, 4, 12, 13, 14, and 15), up to day 281 (cohort 3), and up to day 1095 (cohorts 7, 8, 9, 10, and 11)
Awards & highlights
Study Summary
This trial will test the tolerability and reactogenicity of a new mRNA-based vaccine in different age groups, including children.
Who is the study for?
This trial is for healthy adults aged 18-49, women of child-bearing potential aged 18-40, older adults aged 65-80, Japanese older adults over 60, and children aged 12 to under 60 months. Participants must have a BMI within the specified range and be able to follow the study's procedures. Women who can bear children must use contraception and not be pregnant or breastfeeding.Check my eligibility
What is being tested?
The trial tests mRNA-1345 vaccine's safety and immune response at various doses in different age groups against RSV. It involves single injections for some participants and multiple injections spaced out by days or months for others. A placebo group is also included for comparison.See study design
What are the potential side effects?
While specific side effects are not listed here, typical reactions may include soreness at injection site, fever, fatigue, headache or muscle pain which are common with vaccinations. The term 'reactogenicity' suggests these types of temporary responses will be monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a Japanese individual aged 60 or older.
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I am a woman aged 18 to 40 and can become pregnant.
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I am between 18 and 49 years old.
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My child is between 1 and 5 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to day 141 (cohorts 5 and 6), up to day 169 (cohorts 1, 2, 4, 12, 13, 14, and 15), up to day 281 (cohort 3), and up to day 1095 (cohorts 7, 8, 9, 10, and 11)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 141 (cohorts 5 and 6), up to day 169 (cohorts 1, 2, 4, 12, 13, 14, and 15), up to day 281 (cohort 3), and up to day 1095 (cohorts 7, 8, 9, 10, and 11)
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 Serious AEs or Medically Attended AEs (MAAEs)
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Number of Participants with Unsolicited Adverse Events (AEs)
Secondary outcome measures
Geometric Mean Fold-Rise of Postbaseline/Baseline Ab Titers
Geometric Mean Titer (GMT) of Serum RSV Neutralizing and Binding Antibodies (Abs)
Proportion of Participants with ≥2-fold and ≥4-fold Increases in Ab Titers from Baseline
Trial Design
15Treatment groups
Experimental Treatment
Group I: Cohort 9: Dose C in Older AdultsExperimental Treatment2 Interventions
Two total injections, 1 injection of either Dose C of mRNA-1345 or matching-placebo per day on Day 1 and approximately 12 months later. Participants will receive second booster injection of Dose A of mRNA-1345 at Month 24.
Group II: Cohort 8: Dose B in Older AdultsExperimental Treatment2 Interventions
Two total injections, 1 injection of either Dose B of mRNA-1345 or matching-placebo per day on Day 1 and approximately 12 months later. Participants will receive second booster injection of Dose A of mRNA-1345 at Month 24.
Group III: Cohort 7: Dose A in Older AdultsExperimental Treatment2 Interventions
Two total injections, 1 injection of either Dose A of mRNA-1345 or matching-placebo per day on Day 1 and approximately 12 months later. Participants will receive second booster injection of Dose A of mRNA-1345 at Month 24.
Group IV: Cohort 6: Dose G in ChildrenExperimental Treatment2 Interventions
Three total injections, 1 injection of either Dose G of mRNA-1345 or matching-placebo per day on Day 1, Day 57, and Day 113.
Group V: Cohort 5: Dose D in ChildrenExperimental Treatment2 Interventions
Three total injections, 1 injection of either Dose D of mRNA-1345 or matching-placebo per day on Day 1, Day 57, and Day 113.
Group VI: Cohort 4: Dose C in Younger AdultsExperimental Treatment2 Interventions
Single injection of Dose C of mRNA-1345 or matching-placebo on Day 1.
Group VII: Cohort 3: Dose B in Younger AdultsExperimental Treatment2 Interventions
Three total injections, 1 injection of either Dose B of mRNA-1345 or matching-placebo per day on Day 1, Day 57, and Day 113.
Group VIII: Cohort 2: Dose B in Younger AdultsExperimental Treatment2 Interventions
Single injection of Dose B of mRNA-1345 or matching-placebo on Day 1.
Group IX: Cohort 1: Dose A in Younger AdultsExperimental Treatment2 Interventions
Single injection of Dose A of mRNA-1345 or matching-placebo on Day 1.
Group X: Cohort 15: Dose B in Japanese Older AdultsExperimental Treatment2 Interventions
Single injection of Dose B of mRNA-1345 or matching-placebo on Day 1.
Group XI: Cohort 14: Dose A in Women of Child-Bearing PotentialExperimental Treatment2 Interventions
Single injection of Dose A of mRNA-1345 or matching-placebo on Day 1.
Group XII: Cohort 13: Dose F in Women of Child-Bearing PotentialExperimental Treatment2 Interventions
Single injection of Dose F of mRNA-1345 or matching-placebo on Day 1.
Group XIII: Cohort 12: Dose E in Women of Child-Bearing PotentialExperimental Treatment2 Interventions
Single injection of Dose E of mRNA-1345 or matching-placebo on Day 1.
Group XIV: Cohort 11: Dose F in Older AdultsExperimental Treatment2 Interventions
Two total injections, 1 injection of either Dose F of mRNA-1345 or matching-placebo per day on Day 1 and approximately 12 months later. Participants will receive second booster injection of Dose A of mRNA-1345 at Month 24.
Group XV: Cohort 10: Dose E in Older AdultsExperimental Treatment2 Interventions
Two total injections, 1 injection of either Dose E of mRNA-1345 or matching-placebo per day on Day 1 and approximately 12 months later. Participants will receive second booster injection of Dose A of mRNA-1345 at Month 24.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
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
107 Previous Clinical Trials
61,377,474 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken drugs that strongly affect my immune system for more than 2 weeks in the last 6 months.I am a Japanese individual aged 60 or older.I am between 65 and 79 years old.I am willing and able to follow all study requirements.I am a woman who cannot become pregnant.My child has never received a monoclonal antibody treatment.I am within the age range specified for my group.I was diagnosed with cancer, other than non-melanoma skin or cervical in-situ, in the last 10 years.I am willing and able to follow all study requirements.My doctor has diagnosed me with a serious heart condition.I have a bleeding disorder that makes injections or blood draws unsafe.I have a history of immune system problems, including HIV.I am not pregnant, not breastfeeding, and have used birth control or abstained from sex for 28 days before vaccination.I do not have high blood pressure above 160 mmHg or poorly controlled hypertension.I might need treatment to suppress my immune system during the study.I have a history of epilepsy.I have a serious long-term lung condition like COPD or asthma.I have not taken drugs that suppress or modify the immune system.My diabetes is not well-managed.My lab results show mild abnormalities.I have chronic hepatitis or suspect I have active hepatitis.I have not had any vaccines, except flu shots, close to my study injections.I am a woman aged 18 to 40 and can become pregnant.You have had a severe allergic reaction after getting a vaccine that needed medical help.I have an autoimmune disease, but it's only Hashimoto's.I have had myocarditis, pericarditis, or myopericarditis in the past.I have had meningitis before.I have had a fever-related seizure before.I am between 18 and 49 years old.I have not received blood products (like red cells or platelets) in the last 3 months.My child is between 1 and 5 years old.I have skin conditions that could affect vaccine side effect assessments.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 6: Dose G in Children
- Group 2: Cohort 13: Dose F in Women of Child-Bearing Potential
- Group 3: Cohort 2: Dose B in Younger Adults
- Group 4: Cohort 11: Dose F in Older Adults
- Group 5: Cohort 14: Dose A in Women of Child-Bearing Potential
- Group 6: Cohort 1: Dose A in Younger Adults
- Group 7: Cohort 12: Dose E in Women of Child-Bearing Potential
- Group 8: Cohort 8: Dose B in Older Adults
- Group 9: Cohort 10: Dose E in Older Adults
- Group 10: Cohort 3: Dose B in Younger Adults
- Group 11: Cohort 4: Dose C in Younger Adults
- Group 12: Cohort 5: Dose D in Children
- Group 13: Cohort 7: Dose A in Older Adults
- Group 14: Cohort 9: Dose C in Older Adults
- Group 15: Cohort 15: Dose B in Japanese Older Adults
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.
What is the geographical scope of this research experiment?
"This trial is operating out of MedPharmics - Covington - PPDS in Slidell, Louisiana, Clinical Research Partners LLC in Richmond, Virginia, and Meridian Clinical Research, LLC (Grand Island Nebraska) in Grand Island. Additionally it has been extended to 43 further venues."
Answered by AI
Is there any potential for harm from administering mRNA-1345 to patients?
"Our assessment of the safety and efficacy of mRNA-1345 is a 1, given that it is currently undergoing Phase 1 trials which have not yet provided much evidence."
Answered by AI
Would I qualify to join this trial?
"To be eligible for this research, subjects must have an viral disorder and meet the age requirement of 12 months to 79 years old. A total of 651 individuals are being accepted into this study."
Answered by AI
Is there any availability for individuals to join this clinical investigation?
"The details presented on clinicaltrials.gov suggest that this study is not searching for new participants at the moment, having first been posted in September 2020 and most recently updated in November 2022. Nevertheless, there are 126 other trials actively recruiting subjects right now."
Answered by AI
Does this medical experiment include senior citizens in its cohort?
"The requirements to join this trial necessitate that prospective participants are between the ages of one year and seventy-nine. Additionally, there are 51 clinical trials open for children under 18 years old, as well as 88 studies available for individuals over 65."
Answered by AI
Who else is applying?
What state do they live in?
Iowa
Illinois
Louisiana
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+
What site did they apply to?
Synexus - Optimal Research - Peoria
Medpharmics
Mills Clinical Research
Why did patients apply to this trial?
What questions have other patients asked about this trial?
Can volunteers qualify if one has had a breakout?
PatientReceived 2+ prior treatments
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