New mRNA vaccine shows promise against common virus that can harm newborns
NCT ID NCT04232280
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
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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
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Jan 2020
- Finished
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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
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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
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Alliance for Multispecialty Research
Lexington, Kentucky, 40509, United States
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Aventiv Research Inc
Columbus, Ohio, 43213-6523, United States
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Benchmark Research
Sacramento, California, 95864, United States
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Crossroads Clinical Research
Victoria, Texas, 77901, United States
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Foothill Family Clinic
Salt Lake City, Utah, 84109, United States
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Foothill Family Clinic-South Clinic
Salt Lake City, Utah, 84121, United States
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Johnson County Clin-Trials
Lenexa, Kansas, 66219, United States
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Optimal Research
Peoria, Illinois, 61614, United States
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Tekton Research Inc
Austin, Texas, 78745, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- A new drug combo may shield kidney transplant patients from a common viral threat
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