Respiratory Syncytial Virus (RSV)Phase 4RSV SBNCT07185399
Systems Biological Analysis of Immune Responses to RSV Vaccine
A Phase 4 study testing Moderna RSV vaccine in people with Respiratory Syncytial Virus (RSV), run by Emory University at 1 site in United States.
Trial summary
The purpose of this study is to characterize the immune response to the FDA-approved mRNA-based RSV vaccine in adults ≥60 years of age, using a systems biology approach. The study aims to generate high-resolution immunologic and systems biology data following vaccination to identify early biomarkers of response and… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus (RSV)
- What is being tested?
- Moderna RSV vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2025to Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults ≥60 years of age at the time of enrollment.
- Able and willing to provide written informed consent.
- Eligible for receipt of an FDA-approved RSV vaccine (MRESVIA) per Advisory Committee on Immunization Practices (ACIP)/Centers for Disease Control and Prevention (CDC) guidelines.
- Available for all study visits and procedures, including follow-up through Day 365.
- Willing to allow access to prior RSV vaccination history (if applicable) for eligibility verification
Who cannot join
- History of severe allergic reaction (e.g., anaphylaxis) to any prior vaccines or any component of the MRESVIA vaccine, including polyethylene glycol (PEG), the amino lipid SM-102 (SM-102), or other listed excipients.
- Acute illness or fever (temperature ≥100.4°F) at the time of vaccination (participant may be rescheduled).
- Immunocompromising conditions, including:
- Current cancer chemotherapy or immunosuppressive therapy.
- History of hematologic malignancies or other immune-mediated diseases that would interfere with vaccine response.
- Known or suspected HIV infection with cluster of differentiation 4 (CD4) count <200 or uncontrolled viremia.
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- Clinically significant cardiac, pulmonary, renal, hepatic, or neurological disease that, in the opinion of the investigator, would preclude participation or confound interpretation of immune data.
- Uncontrolled autoimmune disorder.
- Current use of systemic corticosteroids equivalent to ≥20 mg prednisone daily for more than 14 consecutive days in the past month.
- History of Guillain-Barré Syndrome or other demyelinating neurological disorders.
- History of myocarditis, pericarditis, or myopericarditis within the last 2 months.
- Any bleeding disorder that poses a risk for venipuncture or vaccination complications.
- Participation in another clinical trial involving an investigational agent within 30 days of enrollment.
- Receipt or plan receipt of vaccines in the past an upcoming 28 days.
- Prior receipt of any RSV vaccine.
- Receipt of blood products or immune globulin within the prior 3 months.
- History of excessive alcohol consumption or drug use, or psychiatric/social/occupational conditions that may interfere with study compliance.
- Any other condition that, in the opinion of the investigator, may interfere with study conduct or participant safety.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Hope Clinic of the Emory Vaccine Center
Decatur, Georgia, 30030
About this study
The purpose of this study is to characterize the immune response to the FDA-approved mRNA-based RSV vaccine in adults ≥60 years of age, using a systems biology approach. The study aims to generate high-resolution immunologic and systems biology data following vaccination to identify early biomarkers of response and gain mechanistic insight into host immunity.
Read the detailed description
Respiratory syncytial virus (RSV) is a leading cause of lower respiratory tract disease (LRTD) in older adults and individuals with chronic comorbidities. In response to this burden, several RSV vaccines have recently been licensed for use in adults ≥60 years of age, including products developed by Pfizer, GlaxoSmithKline (GSK), and Moderna. These vaccines represent distinct technological platforms - recombinant protein with adjuvant, bivalent prefusion F (preF) subunit, and messenger RNA (mRNA), respectively - each with demonstrated efficacy in large-scale clinical trials.
Understanding the immunological mechanisms and durability of protection across these platforms remains a major research priority, particularly given the increased use of next-generation vaccine technologies such as mRNA. Systems biology approaches, including transcriptomics, proteomics, metabolomics and advanced immune profiling, provide a powerful means to identify early biomarkers of immunogenicity and long-term antibody persistence. Such approaches have successfully revealed predictive immune signatures in response to a variety of vaccines.
In parallel studies, the researchers have collected samples from individuals who received the Pfizer and GSK RSV vaccines at retail pharmacies under routine clinical use. However, the mRNA-based RSV vaccine (MRESVIA, developed by Moderna) has been less widely deployed to date in community settings, limiting opportunities to collect samples prospectively under real-world conditions. As a result, the researchers are establishing this dedicated protocol to characterize the immune response to MRESVIA using a systems biology approach. Through comprehensive sampling at early and late timepoints post-vaccination, the researchers aim to define molecular and cellular features unique to the mRNA platform and identify early predictors of immune response magnitude and durability. These data will also support future cross-platform comparisons.
- Conditions
- Respiratory Syncytial Virus (RSV)
- Being tested
- Moderna RSV vaccine
- Keywords
- RSV vaccine, Lower respiratory track disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderna RSV vaccineBiological
Participants will receive the MRESVIA vaccine (Moderna RSV vaccine) as part of the study. The vaccine will be administered by trained clinical personnel at the Hope Clinic. MRESVIA is FDA-approved and will be used in accordance with its licensed indication for adults aged 60 years and older. MRESVIA is an mRNA-based RSV vaccine containing 50 micrograms (mcg) of nucleoside-modified mRNA encoding the RSV prefusion F glycoprotein. It is supplied as a frozen injectable suspension in single-dose, pre-filled syringes. The vaccine is administered as a single 0.5 milliliter (mL) intramuscular injection.
| Study group | Role | What they receive |
|---|---|---|
| Moderna RSV vaccine (MRESVIA) | Experimental | Adults who are ≥60 years of age and are eligible to receive FDA-approved RSV vaccines under standard clinical recommendations receive a single dose of the Moderna RSV vaccine (MRESVIA). Receives: Biological: Moderna RSV vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody Titers
The magnitude of RSV-specific antibody responses following vaccination with an mRNA RSV vaccine (MRESVIA) is assessed as antibody titers at Days 28 and 365 post-vaccination.
Measured: Days 28 and 365 post-vaccination
Secondary outcomes (4)
Frequency of Grade 2 or Higher Adverse Events
The frequency of unsolicited adverse events (AEs) of Grade 2 or higher occurring within 28 days following vaccination will be examined.
Measured: Day 28 post-vaccination
Severity of Grade 2 or Higher Adverse Events
The severity of unsolicited adverse events (AEs) of Grade 2 or higher occurring within 28 days following vaccination will be examined.
Measured: Day 28 post-vaccination
Occurrence of Serious Adverse Events
The occurrence of any serious adverse event (SAE) at any point during the 1-year follow-up period will be examined.
Measured: Up to Day 365 post-vaccination
Occurrence of Adverse Events Meeting VAERS Reporting Criteria
The occurrence of any adverse event that meets VAERS reporting criteria during the 1-year follow-up will be examined. VAERS reporting criteria include: Anaphylaxis (within 7 days); Syncope (within 7 days); Shoulder Injury Related to Vaccine Administration (SIRVA); Acute complications or sequelae of anaphylaxis, syncope, or SIRVA; Events listed as contraindications in the vaccine's package insert; Any SAE, especially if unexpected or deemed related to the vaccine.
Measured: Up to Day 365 post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start13 Oct 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus (RSV)Studies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Coefficient Giving
- Responsible party
- Principal investigator, Nadine Rouphael, Emory University
- Investigators
- Nadine Rouphael, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07185399
- Sponsor's protocol ID
- STUDY00010088
- Acronym
- RSV SB
- Status last verified
- Aug 2026
- First submitted
- 15 Sep 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be shared upon reasonable request, following completion of primary analyses. Data that will be available for sharing include de-identified demographic, safety, and immunogenicity data, as well as omics datasets (e.g., transcriptomics, proteomics, metabolomics) collected pre- and post-vaccination. Data dictionaries will also be provided.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systems Biological Analysis of Immune Responses to RSV Vaccine
- ClinicalTrials.gov ID
- NCT07185399
- Acronym / sponsor ID
- RSV SB / STUDY00010088
- Conditions
- Respiratory Syncytial Virus (RSV)
- Keywords
- RSV vaccine, Lower respiratory track disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Coefficient Giving
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 22 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to characterize the immune response to the FDA-approved mRNA-based RSV vaccine in adults ≥60 years of age, using a systems biology approach. The study aims to generate high-resolution immunologic and systems biology data following vaccination to identify early biomarkers of response and gain mechanistic insight into host immunity.
Detailed description
Respiratory syncytial virus (RSV) is a leading cause of lower respiratory tract disease (LRTD) in older adults and individuals with chronic comorbidities. In response to this burden, several RSV vaccines have recently been licensed for use in adults ≥60 years of age, including products developed by Pfizer, GlaxoSmithKline (GSK), and Moderna. These vaccines represent distinct technological platforms - recombinant protein with adjuvant, bivalent prefusion F (preF) subunit, and messenger RNA (mRNA), respectively - each with demonstrated efficacy in large-scale clinical trials.
Understanding the immunological mechanisms and durability of protection across these platforms remains a major research priority, particularly given the increased use of next-generation vaccine technologies such as mRNA. Systems biology approaches, including transcriptomics, proteomics, metabolomics and advanced immune profiling, provide a powerful means to identify early biomarkers of immunogenicity and long-term antibody persistence. Such approaches have successfully revealed predictive immune signatures in response to a variety of vaccines.
In parallel studies, the researchers have collected samples from individuals who received the Pfizer and GSK RSV vaccines at retail pharmacies under routine clinical use. However, the mRNA-based RSV vaccine (MRESVIA, developed by Moderna) has been less widely deployed to date in community settings, limiting opportunities to collect samples prospectively under real-world conditions. As a result, the researchers are establishing this dedicated protocol to characterize the immune response to MRESVIA using a systems biology approach. Through comprehensive sampling at early and late timepoints post-vaccination, the researchers aim to define molecular and cellular features unique to the mRNA platform and identify early predictors of immune response magnitude and durability. These data will also support future cross-platform comparisons.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Moderna RSV vaccine (MRESVIA) | Experimental | Biological: Moderna RSV vaccineAdults who are ≥60 years of age and are eligible to receive FDA-approved RSV vaccines under standard clinical recommendations receive a single dose of the Moderna RSV vaccine (MRESVIA). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults ≥60 years of age at the time of enrollment.
- Able and willing to provide written informed consent.
- Eligible for receipt of an FDA-approved RSV vaccine (MRESVIA) per Advisory Committee on Immunization Practices (ACIP)/Centers for Disease Control and Prevention (CDC) guidelines.
- Available for all study visits and procedures, including follow-up through Day 365.
- Willing to allow access to prior RSV vaccination history (if applicable) for eligibility verification
Key exclusion criteria (18 listed)
- History of severe allergic reaction (e.g., anaphylaxis) to any prior vaccines or any component of the MRESVIA vaccine, including polyethylene glycol (PEG), the amino lipid SM-102 (SM-102), or other listed excipients.
- Acute illness or fever (temperature ≥100.4°F) at the time of vaccination (participant may be rescheduled).
- Immunocompromising conditions, including:
- Clinically significant cardiac, pulmonary, renal, hepatic, or neurological disease that, in the opinion of the investigator, would preclude participation or confound interpretation of immune data.
- Uncontrolled autoimmune disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderna RSV vaccineParticipants will receive the MRESVIA vaccine (Moderna RSV vaccine) as part of the study. The vaccine will be administered by trained clinical personnel at the Hope Clinic. MRESVIA is FDA-approved and will be used in accordance with its licensed indication for adults aged 60 years and older. MRESVIA is an mRNA-based RSV vaccine containing 50 micrograms (mcg) of nucleoside-modified mRNA encoding the RSV prefusion F glycoprotein. It is supplied as a frozen injectable suspension in single-dose, pre-filled syringes. The vaccine is administered as a single 0.5 milliliter (mL) intramuscular injection. | Biological | Moderna RSV vaccine (MRESVIA) |
Primary outcome
Antibody Titers
Time frame: Days 28 and 365 post-vaccination
The magnitude of RSV-specific antibody responses following vaccination with an mRNA RSV vaccine (MRESVIA) is assessed as antibody titers at Days 28 and 365 post-vaccination.
4 secondary outcomes
Frequency of Grade 2 or Higher Adverse Events
Time frame: Day 28 post-vaccination
Severity of Grade 2 or Higher Adverse Events
Time frame: Day 28 post-vaccination
Occurrence of Serious Adverse Events
Time frame: Up to Day 365 post-vaccination
Occurrence of Adverse Events Meeting VAERS Reporting Criteria
Time frame: Up to Day 365 post-vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) will be shared upon reasonable request, following completion of primary analyses. Data that will be available for sharing include de-identified demographic, safety, and immunogenicity data, as well as omics datasets (e.g., transcriptomics, proteomics, metabolomics) collected pre- and post-vaccination. Data dictionaries will also be provided.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadine Rouphael, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Moderna RSV vaccine in people with Respiratory Syncytial Virus (RSV), run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibody Titers (time frame: Days 28 and 365 post-vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.