← Back to Search

Virus Vaccine

mRNA-1653 for Human Metapneumovirus and Human Parainfluenza Infection

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
Female participants must be either of non-childbearing potential or if of childbearing potential may be enrolled if the participant: 1) has a negative pregnancy test at Screening and on the day of vaccination, and 2) has practiced adequate contraception or has abstained from all activities that could lead to pregnancy for 28 days prior to vaccination, and 3) has agreed to continue adequate contraception through 3 months following the last vaccination, and 4) is not currently breastfeeding
Current height and weight above the third percentile for age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year after the last dose administration
Awards & highlights

Study Summary

This trial will study whether a new vaccine is safe and effective in adults and children.

Eligible Conditions
  • Human Metapneumovirus and Human Parainfluenza Infection

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Female participants must be either of non-childbearing potential or if of childbearing potential may be enrolled if they meet all of the following criteria: 1) they have a negative pregnancy test at Screening and on the day of vaccination, 2) they have practiced adequate contraception or have abstained from all activities that could lead to pregnancy for 28 days prior to vaccination, 3) they have agreed to continue adequate contraception through 3 months following the last vaccination, and 4) they are not currently breastfeeding.
Select...
is considered overweight A person's height and weight above the 85th percentile for their age is considered overweight.
Select...
You have a body mass index (BMI) of at least 18 and less than 35.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year after the last dose administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year after the last dose administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of Participants with Serious Adverse Events (SAEs) and Medically-Attended AEs
Proportion of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Proportion of Participants with Unsolicited Adverse Events (AEs)
Secondary outcome measures
Geometric Mean Ratio (GMR) of Post-Baseline/Baseline Titers of Serum Anti-hMPV and Anti-PIV3 Neutralizing Antibodies
Geometric mean titer (GMT) of Serum Anti-hMPV and Anti-PIV3 Neutralizing Antibodies
Proportion of Participants with ≥2-Fold and ≥4-Fold Increases in Serum Anti-hMPV or Anti-PIV3 Neutralizing Antibody Titer from Baseline

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: mRNA-1653, Adult participantsExperimental Treatment1 Intervention
Participants will receive 1 of 2 doses of mRNA-1653, administered via intramuscular injection, on Day 1 and Day 57.
Group II: mRNA-1653 Pediatric participantsExperimental Treatment1 Intervention
Participants will receive 1 of 2 possible doses of mRNA-1653, administered via intramuscular injection, on Day 1 and Day 57.
Group III: Placebo, Pediatric participantsPlacebo Group1 Intervention
Participants will receive mRNA-1653-matching placebo, administered via intramuscular injection, on Day 1 and Day 57.
Group IV: Placebo, Adult participantsPlacebo Group1 Intervention
Participants will receive mRNA-1653-matching placebo, administered via intramuscular injection, on Day 1 and Day 57.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mRNA-1653
2017
Completed Phase 1
~180

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
105 Previous Clinical Trials
61,373,193 Total Patients Enrolled
1 Trials studying Human Metapneumovirus and Human Parainfluenza Infection
124 Patients Enrolled for Human Metapneumovirus and Human Parainfluenza Infection

Frequently Asked Questions

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

How many venues are conducting this research endeavor?

"Currently, this medical study is running at 20 different sites across the nation. These locations span from Birmingham to Metairie and Norfolk to other cities. To reduce travel burden, it may be beneficial for participants to select a trial location near their residence."

Answered by AI

Are there still vacancies for participants in this research endeavor?

"Contrary to expectations, the research posted on clinicaltrials.gov is no longer recruiting participants. Originally published in November 2019 and last updated in September 2022, this trial has reached its enrollment goals; however, there are 771 other active studies that may still be of interest."

Answered by AI

Does this clinical trial provide an opportunity for individuals aged 45 and above to contribute?

"Patients aged between 12 months and 49 years old are eligible for this trial. Notably, there 200 studies open to those under 18, while 607 trials are recruiting patients above the age of 65."

Answered by AI

To what extent can potential candidates access this medical trial?

"This trial is seeking 51 participants, aged between 12 months and 49 years old, with parainfluenza. In addition to meeting the age criterion, female enrollees must have a negative pregnancy test at Screening and on the day of vaccination; they are also required to practice adequate contraception or abstain from all activities that could lead to conception for 28 days before being vaccinated as well as 3 months following their last immunization. Furthermore, these patients must have an acceptable current body measurements (height/weight above third percentile) in accordance with Body Mass Indexes ranging from 18 kg/m^2 up to 35 kg/m^2,"

Answered by AI

Has the Food and Drug Administration issued a stamp of approval for mRNA-1653?

"As this is an early-stage Phase 1 trial, with limited existing research to verify safety and efficacy, the evaluation team at Power gave mRNA-1653 a score of 1."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
Alabama
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Central Research Associates Inc
How many prior treatments have patients received?
0
~10 spots leftby Mar 2025