What side effects are associated with this type of intervention?

Common treatments for Respiratory Syncytial Virus (RSV) include supportive care, antiviral medications, and immunoprophylaxis. Supportive care generally has minimal side effects but can include discomfort from nasal cannulas or IV lines. Antiviral medications like ribavirin can cause hemolytic anemia, rash, and conjunctival irritation. Immunoprophylaxis with palivizumab is generally well-tolerated but can cause injection site reactions, fever, and rash. Vaccines under study may have side effects similar to other vaccines, such as injection site pain, fever, and mild systemic symptoms like fatigue or muscle aches.

What prior FDA approvals exist?

The FDA has approved several treatments for Respiratory Syncytial Virus (RSV), primarily focusing on prophylaxis and supportive care. Palivizumab, a monoclonal antibody, is one of the key FDA-approved drugs for preventing severe RSV infection in high-risk infants and young children. It works by providing passive immunity against RSV. While there are ongoing studies for vaccines that stimulate an immune response against RSV, such as the RSV and hMPV vaccine candidate, no vaccines have been approved by the FDA as of now. Current research continues to explore effective immunization strategies to prevent RSV infections.

What other types of research exist?

Promising alternatives to the RSV and hMPV vaccine candidate for RSV patients in 2024 include monoclonal antibodies like nirsevimab, which has shown efficacy in preventing RSV in infants and high-risk populations. Another alternative is the development of live-attenuated and vector-based vaccines, which are currently in various stages of clinical trials and have shown potential in stimulating robust immune responses against RSV.

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Cancer Vaccine

RSV/hMPV Vaccine for Respiratory Infections

Phase 1 & 2

Waitlist Available

Research Sponsored by Sanofi Pasteur, a Sanofi Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

A female participant is eligible to participate if she is not pregnant or breastfeeding and is of non-childbearing potential

Aged 60 years or older on the day of inclusion

Must not have

History of acute infection symptoms or a positive severe acute respiratory syndrome coronavirus reverse transcription polymerase chain reaction (SARS-CoV-2 RT-PCR) or antigen test in the 10 days prior to the visit. A prospective participant should not be included in the study until the condition has resolved

Previous vaccination against RSV and/or hMPV (with a licensed or investigational vaccine either as a monovalent vaccine or any combination of the antigens)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up throughout study (approximately 24 months)

Summary

This trial is testing a new vaccine for lung infections caused by RSV and hMPV in adults aged 60 and older. The vaccine aims to help the immune system recognize and fight these viruses.

Who is the study for?

Adults aged 60 or older can join this vaccine study if they're not pregnant, breastfeeding, and don't have a history of severe allergies to the vaccine's ingredients. They should be generally healthy or have stable chronic diseases. People with recent serious infections, heart inflammation history, bleeding disorders, or on certain medications may not qualify.

What is being tested?

The trial is testing different doses of an RSV/hMPV vaccine candidate in seniors to see how safe it is and how well it works (immunogenicity). Participants will get one shot and some will receive a booster after 12 months. A placebo group is included for comparison.

What are the potential side effects?

Possible side effects are not detailed here but typically include reactions at the injection site like pain and swelling, general symptoms like fever or fatigue, allergic reactions, and other immune responses that could affect various organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not pregnant, breastfeeding, and cannot become pregnant.

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I am 60 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had COVID-19 or its symptoms in the last 10 days.

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I have been vaccinated against RSV and/or hMPV.

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I have had myocarditis, pericarditis, or myopericarditis in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ throughout study (approximately 24 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~throughout study (approximately 24 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout study (approximately 24 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Presence of adverse events of special interest (AESIs)

Presence of fatal SAEs

Presence of medically attended adverse events (MAAEs)

+9 more

Secondary study objectives

RSV A serum anti-F IgG Ab titers at pre-booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post- booster vaccination

RSV A serum anti-F immunoglobulin G (IgG) antibody (Ab) titers at pre-vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination

RSV A serum nAb titers at pre booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post-booster vaccination

+10 more

Trial Design

9Treatment groups

Experimental Treatment

Placebo Group

Group I: Sentinel Cohort: RSV/hMPV Group 2 (Dose B)Experimental Treatment1 Intervention