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New mRNA vaccine shows promise against common virus that can harm newborns

NCT ID NCT04232280

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an experimental mRNA vaccine called mRNA-1647 to see if it is safe and triggers an immune response against cytomegalovirus (CMV). The trial involved 315 healthy adults aged 18 to 40, some of whom had never been exposed to CMV. Researchers measured side effects and antibody levels after vaccination. The goal is to develop a vaccine that could prevent CMV infection, which can cause serious problems in newborns and people with weak immune systems.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
mRNA-1647 vaccine
What this could lead to
If successful, this vaccine could help prevent cytomegalovirus infection, which is a leading cause of birth defects and complications in people with weakened immune systems.
What could go wrong
This is an early phase 2 trial with only 315 participants, so the vaccine may not work as well in larger, more diverse populations. Side effects like injection site pain, headache, and fatigue were common.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

315 people

The number who actually took part.

Started

Jan 2020

Finished

Jan 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 40 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female 18-40 years of age (Part 1); Female 18-40 years of age (Part 2) * Understands and agrees to comply with the trial procedures and provides written informed consent * According to the assessment of the Investigator, is in good general health and is capable of complying with trial procedures * Body mass index (BMI) 18-35 kilograms/meter (kg/m\^2) * Female participants must either be of non-childbearing potential or use acceptable methods of contraception from at least 28 days prior to the first vaccination and through 3 months following last vaccination and is not breastfeeding. * Male participants must agree to practice adequate contraception from the time of the first vaccination and through 3 months after the last vaccination. Exclusion Criteria: * Acutely ill or febrile on the day of the first vaccination * Prior receipt of any CMV vaccine * Abnormal screening safety laboratory test results * Diagnosis or condition that, in the judgment of Investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to trial procedures * Has received or plans to receive a vaccine ≤28 days prior to the first vaccination or plans to receive a non-study vaccine within 28 days prior to or after any study vaccination, except for any licensed influenza vaccine which can be administered \>14 days before or after any study vaccination. COVID-19 vaccines (regardless of manufacturer) may be administered \>7 days but preferably \>14 days before or after any study vaccination, with the intention of prioritizing COVID-19 vaccination over all other considerations. * Prior receipt of chronic systemic immunosuppressants or immune-modifying drugs * Receipt of intravenous immunoglobulins or plasma products within 3 months prior to the day of the first study vaccination * Previous receipt of medications in lipid nanoparticle (LNP) formulation (Part 1 participants only) * Has donated ≥450 milliliters (mL) of blood products within 28 days of the Screening visit * Participated in an interventional clinical trial within 28 days prior to the day of enrollment * Is an immediate family member or household member of trial personnel

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Alliance for Multispecialty Research

    Lexington, Kentucky, 40509, United States

  • Aventiv Research Inc

    Columbus, Ohio, 43213-6523, United States

  • Benchmark Research

    Sacramento, California, 95864, United States

  • Crossroads Clinical Research

    Victoria, Texas, 77901, United States

  • Foothill Family Clinic

    Salt Lake City, Utah, 84109, United States

  • Foothill Family Clinic-South Clinic

    Salt Lake City, Utah, 84121, United States

  • Johnson County Clin-Trials

    Lenexa, Kansas, 66219, United States

  • Optimal Research

    Peoria, Illinois, 61614, United States

  • Tekton Research Inc

    Austin, Texas, 78745, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.