What is the mechanism of action of this treatment?

The most common treatments for Respiratory Syncytial Virus (RSV) immunization involve the use of vaccines that stimulate the immune system to recognize and combat the virus. Vaccines encapsulated in lipid nanoparticles (LNPs) are particularly promising as they enhance the delivery and immunogenicity of the vaccine. LNPs protect the vaccine's active ingredients, ensuring they reach the target cells more effectively and elicit a stronger immune response. This is crucial for RSV immunization patients as it can lead to better protection against the virus, reducing the severity and incidence of RSV infections.

What side effects are associated with this type of intervention?

The most common side effects of RSV immunization treatments, particularly those involving lipid nanoparticle (LNP) formulations, include local reactions at the injection site such as pain, redness, and swelling. Systemic side effects may include fever, fatigue, headache, and muscle aches. In some cases, more severe reactions like allergic responses or increased oxygen requirements have been observed. It is important to monitor for these side effects and consult with a healthcare provider for appropriate management.

What prior FDA approvals exist?

The FDA has approved several treatments and prophylactic measures for Respiratory Syncytial Virus (RSV) immunization, including monoclonal antibodies like palivizumab, which is used to prevent severe RSV infection in high-risk infants. While specific details about prior FDA approvals for lipid nanoparticle-based RSV vaccines are not provided, the ongoing study of an RSV vaccine candidate encapsulated in lipid nanoparticles aims to enhance delivery and immunogenicity, reflecting a novel approach in the field of RSV immunization.

What other types of research exist?

Promising novel alternatives to the RSV vaccine candidate using lipid nanoparticles for enhanced delivery and immunogenicity include mRNA-based vaccines, vector-based vaccines (such as those using adenovirus vectors), and protein subunit vaccines. These platforms have shown potential in recent clinical trials and preclinical studies for their ability to induce strong immune responses and provide protection against RSV.

← Back to Search

Virus Therapy

RSV mRNA Vaccine for Respiratory Syncytial Virus Immunization

Phase 1 & 2

Waitlist Available

Research Sponsored by Sanofi

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 12

Summary

This trial tests a new RSV vaccine that uses tiny fat particles to help deliver it into the body. It aims to see if the vaccine is safe and effective in healthy adults aged 18-50 and those aged 60 and older. The vaccine works by teaching the immune system to recognize and fight RSV.

Who is the study for?

Adults aged 18-50 and those 60 or older can join this trial if they're not pregnant, breastfeeding, or planning to become pregnant soon. They must be able to follow the study schedule and agree to use effective contraception. People with weakened immune systems, recent RSV illness, chronic diseases affecting study participation, substance abuse issues, other vaccine receipts close to the trial period, certain medication intakes recently, or involvement in another clinical study cannot participate.

What is being tested?

The trial is testing a new RSV mRNA vaccine candidate given as an injection at low, medium, and high doses using two different lipid nanoparticles (CL-0059 or CL-0137). Participants will be monitored for safety and how well their bodies respond to the vaccine over a year; some will get a booster shot after 12 months.

What are the potential side effects?

Possible side effects include typical reactions at the injection site like pain and swelling; flu-like symptoms such as fever and fatigue; allergic reactions; muscle pains; headaches. The severity of these side effects varies from person to person.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 12 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Geometric Mean Titers (GMTs) of neutralizing antibody (nAb) titers post-primary vaccination at Day 29

Geometric Mean Titers (GMTs) of neutralizing antibody (nAb) titers pre-vaccination at Day 1

Presence of adverse events of special interest (AESIs)

+6 more

Secondary study objectives

GMTs of RSV-A serum nAb post-booster vaccination (Stage 1)

GMTs of serum anti-F IgG Ab titers post-booster vaccination (Stage 1)

GMTs of serum anti-F IgG Ab titers post-vaccination (Stage 2)

+10 more

Trial Design

10Treatment groups

Experimental Treatment

Placebo Group

Group I: Group 6: Sentinel and Main Cohorts (Stage 1)Experimental Treatment1 Intervention

1 injection of RSV vaccine candidate (Dose C) via intramuscular injection

Group II: Group 5: Sentinel and Main Cohorts (Stage 1)Experimental Treatment1 Intervention

1 injection of RSV vaccine candidate (Dose C) via intramuscular injection

Group III: Group 4: Sentinel and Main Cohorts (Stage 1)Experimental Treatment1 Intervention

1 injection of RSV vaccine candidate (Dose B) via intramuscular injection

Group IV: Group 3: Sentinel and Main Cohorts (Stage 1)Experimental Treatment1 Intervention

1 injection of RSV vaccine candidate (Dose B) via intramuscular injection

Group V: Group 2: Sentinel and Main Cohorts (Stage 1)Experimental Treatment1 Intervention

1 injection of RSV vaccine candidate (Dose A) via intramuscular injection

Group VI: Group 1: Sentinel and Main Cohorts (Stage 1)Experimental Treatment1 Intervention

1 injection of RSV vaccine candidate (Dose A) via intramuscular injection

Group VII: Group 1: Phase IIa/Dose-ranging (Stage 2)Experimental Treatment1 Intervention

1 injection of RSV vaccine candidate (Dose B) via intramuscular injection

Group VIII: Group 0: Phase IIa/Dose-ranging (Stage 2)Experimental Treatment1 Intervention

1 injection of RSV vaccine candidate (Dose A) via intramuscular injection

Group IX: Group 7: Main, Sentinel and Booster Cohorts (Stage 1)Placebo Group1 Intervention

1 injection of placebo via intramuscular injection

Group X: Group 2: Phase 11a/Dose-ranging (Stage 2)Placebo Group1 Intervention

1 injection of placebo via intramuscular injection

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Respiratory Syncytial Virus (RSV) immunization involve the use of vaccines that stimulate the immune system to recognize and combat the virus. Vaccines encapsulated in lipid nanoparticles (LNPs) are particularly promising as they enhance the delivery and immunogenicity of the vaccine. LNPs protect the vaccine's active ingredients, ensuring they reach the target cells more effectively and elicit a stronger immune response. This is crucial for RSV immunization patients as it can lead to better protection against the virus, reducing the severity and incidence of RSV infections.