RSV Preventive Monoclonal Antibody for Immunization

Recruiting at 5 trial locations

Overseen By Emily A Randolph, MBA

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Duke University

Must be taking: RSV monoclonal antibody

Must not be taking: Antipyretics, Steroids, Chemotherapy, others

Disqualifiers: Acute illness, Immunosuppression, Bleeding disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

524 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best method for administering a new preventative treatment for RSV, a common respiratory virus, in infants. It compares administering the RSV preventive monoclonal antibody alongside routine vaccines in one visit versus spreading them over two visits. Infants eligible for this trial are between 6 and 30 weeks old and must receive at least one regular childhood vaccine. The goal is to ensure the safety and effectiveness of both methods. As a Phase 4 trial, this research helps to understand how the already FDA-approved treatment benefits more patients, offering a chance to contribute to improving infant healthcare.

Will I have to stop taking my current medications?

The trial does not specify if participants must stop taking their current medications. However, if your child has received any experimental medication or certain vaccines recently, they may not be eligible to participate.

What is the safety track record for the RSV preventive monoclonal antibody?

Research has shown that the RSV preventive monoclonal antibody is generally well-tolerated. Common side effects are mild, such as pain, redness, or swelling at the injection site, and these usually resolve quickly. Occasionally, a rash or fever may occur, but these are uncommon.

Reports of more serious reactions exist, but they are rare. In the past, serious events accounted for about 54% of reported side effects. The FDA has approved this treatment for certain conditions, suggesting it is generally safe.

Overall, existing data indicates that the RSV preventive monoclonal antibody is safe for most people. Prospective trial participants should discuss any concerns with their doctor. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard of care for RSV, which typically involves supportive care like hydration and oxygen therapy, the RSV Preventive Monoclonal Antibody offers a proactive approach by providing immunization against the virus. This treatment is unique because it uses a monoclonal antibody specifically designed to prevent RSV infections, targeting the virus directly rather than just alleviating symptoms. Researchers are excited because this approach could significantly reduce the incidence of RSV in children, offering protection right from the start, and potentially providing longer-lasting immunity compared to traditional methods.

What evidence suggests that this trial's treatments could be effective for RSV prevention?

Research has shown that monoclonal antibodies, such as the RSV preventive monoclonal antibody studied in this trial, can help prevent RSV infections in children. Studies have found that this treatment can reduce the risk of RSV by about 68.4%. It is even more effective at preventing hospital visits due to RSV, with over 80% effectiveness. In very serious cases, it can be up to 84.6% effective. Another study found that monoclonal antibodies provide better protection for both preterm and full-term babies compared to maternal vaccination. These findings suggest that monoclonal antibodies could be a powerful way to protect children from RSV. Participants in this trial will receive the RSV preventive monoclonal antibody either simultaneously with routine childhood vaccinations or sequentially, following the initial vaccinations. ^{6 7 8 9 10}

Who Is on the Research Team?

Michael J Smith, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for healthy children who are due to receive routine childhood vaccines. They must not have any known allergies to vaccine components or a history of adverse reactions to immunizations. Children with immune system problems or on certain medications may be excluded.

Inclusion Criteria

Parent/legal guardian willing and capable of providing permission for infant to participate through written informed consent process

Parent/legal guardian able to read and comprehend English or Spanish

Parent/legal guardian available for follow-up study contact by telephone from enrollment to completion of study period

Exclusion Criteria

Condition that would place participant at unacceptable risk of injury or render participant unable to meet protocol requirements

First-degree relative of any research study personnel

Infant born to mother who received maternal RSV immunization more than 14 days prior to delivery and is not eligible for RSV preventative monoclonal antibody

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Simultaneous or sequential administration of RSV preventive monoclonal antibody and routine childhood vaccines

1 day

Visit 1 and Visit 2

Follow-up

Participants are monitored for fever and other adverse events for 7 days following each visit

7 days

What Are the Treatments Tested in This Trial?

Interventions

• RSV Preventive Monoclonal Antibody

Trial Overview The study tests the safety of giving an RSV preventive monoclonal antibody at the same time as other routine vaccines, compared to giving them separately at different visits. The goal is to see if simultaneous administration increases risks.

How Is the Trial Designed?

Group I: Simultaneous Immunization Experimental Treatment 1 Intervention

The simultaneous immunization group will receive routine childhood vaccinations and respiratory syncytial virus (RSV) preventive monoclonal antibody at Visit 1.

Group II: Sequential Immunization Experimental Treatment 1 Intervention

The sequential immunization group will receive routine childhood vaccinations at Visit 1, followed by respiratory syncytial virus (RSV) preventive monoclonal antibody at Visit 2.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Centers for Disease Control and Prevention

Collaborator

Trials

902

Recruited

25,020,000+

Children's Hospital Medical Center, Cincinnati

Collaborator

Trials

844

Recruited

6,566,000+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

Kaiser Permanente

Collaborator

Trials

563

Recruited

27,400,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12390192/

Efficacy and Safety of Anti-Respiratory Syncytial Virus ... Indeed, our results indicate that nirsevimab could be an effective tool for preventing RSV infection in newborns by reducing hospital ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2831181

Estimated Effectiveness of Nirsevimab Against Respiratory ... Nirsevimab's estimated effectiveness was 68.4% against RSV infections, 80.5% against RSV-associated hospitalization, and 84.6% against severe RSV disease.

3. cdc.gov cdc.gov/mmwr/volumes/74/wr/mm7432a3.htm

Use of Clesrovimab for Prevention of Severe Respiratory ... Efficacy against RSV-associated LRTI hospitalization§§ was 90.9% (95% CI = 76.2%–96.5%), with the outcome occurring in five participants (0.2%) ...

4. nature.com nature.com/articles/s43856-025-00807-9

Efficacy of monoclonal antibodies and maternal ... Our results predict that immunization of both preterm and full-term infants could protect against RSV disease better than maternal vaccination.

5. publications.aap.org publications.aap.org/pediatrics/article/156/2/e2024069510/202651/Effectiveness-of-Nirsevimab-Against-RSV-and-RSV

Effectiveness of Nirsevimab Against RSV and RSV-Related ... In real-world studies, immunization with the long-acting monoclonal antibody nirsevimab has demonstrated effectiveness against hospitalized RSV ...

6. cdc.gov cdc.gov/rsv/hcp/vaccine-clinical-guidance/infants-young-children.html

RSV Immunization Guidance for Infants and Young Children Side effects are usually mild, such as pain, redness, or swelling where the injection was given, and resolve quickly. Hypersensitivity reactions ...

7. fda.gov fda.gov/media/173044/download

FDA explains safety reporting for new RSV monoclonal ... The efficacy of nirsevimab against medically attended RSV lower respiratory tract disease ranged from 70% to 75%, evaluated through 150 days ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12197746/

Post-Marketing Surveillance of Nirsevimab: Safety Profile and ... Common events included rash (8.51%), drug ineffectiveness (7.09%), and pyrexia (7.09%). Serious events constituted 53.70% of reports, including ...

9. aap.org aap.org/en/patient-care/respiratory-syncytial-virus-rsv-prevention/rsv-frequently-asked-questions/?srsltid=AfmBOoo2YVY1sTnZGBpe0PjOKD-nqC2HoohiFLhjveCIjF6qRfln3wwC

RSV Immunization Frequently Asked Questions It states that “After getting an RSV preventive antibody, your child might have temporary pain, redness, swelling where the injection was given, ...

10. merck.com merck.com/news/u-s-fda-approves-mercks-enflonsia-clesrovimab-cfor-for-prevention-of-respiratory-syncytial-virus-rsv-lower-respiratory-tract-disease-in-infants-born-during-or-entering-their-fir/

U.S. FDA Approves Merck's ENFLONSIA™ (clesrovimab- ... The most common adverse reactions were injection-site erythema occurring within 5 days post-dose (ENFLONSIA: 3.8%; placebo: 3.3%), injection- ...