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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 belowSelect...
I am not pregnant, breastfeeding, and cannot become pregnant.
Select...
I am 60 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had COVID-19 or its symptoms in the last 10 days.
Select...
I have been vaccinated against RSV and/or hMPV.
Select...
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)
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 moreSecondary 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 moreTrial Design
9Treatment groups
Experimental Treatment
Placebo Group
Group I: Sentinel Cohort: RSV/hMPV Group 2 (Dose B)Experimental Treatment1 Intervention
Participants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate
Group II: Sentinel Cohort: RSV/hMPV Group 1 (Dose A)Experimental Treatment1 Intervention
Participants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate
Group III: Sentinel Cohort: RSV/hMPV Group 0 (Dose L)Experimental Treatment1 Intervention
Participants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate
Group IV: Main Cohort: RSV/hMPV Group 2 (Dose B)Experimental Treatment1 Intervention
Participants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate
Group V: Main Cohort: RSV/hMPV Group 1 (Dose A)Experimental Treatment1 Intervention
Participants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate
Group VI: Booster Cohort-RSV/hMPVExperimental Treatment2 Interventions
Participants will be randomized to receive a determined dose of single IM injection of RSV/hMPV vaccine candidate from a subset of Main cohort
Group VII: Main Cohort: Placebo-Group 3Placebo Group1 Intervention
Participants will be randomized to receive a single IM injection of placebo
Group VIII: Booster Cohort-PlaceboPlacebo Group1 Intervention
Participants will be randomized to receive of single IM injection of placebo from a subset of Main cohort
Group IX: Sentinel Cohort: Placebo-Group 3Placebo Group1 Intervention
Participants will be randomized to receive a single IM injection of placebo
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) include supportive care, antiviral medications, and vaccines. Supportive care involves measures such as oxygen therapy and hydration to manage symptoms.
Antiviral medications like ribavirin work by inhibiting viral replication, though their use is limited due to mixed efficacy and potential side effects. The development of vaccines, such as the RSV and hMPV vaccine candidate, aims to stimulate the immune system to recognize and fight the virus more effectively.
This is crucial for RSV patients as it can potentially prevent severe infections, reduce hospitalizations, and improve overall outcomes by providing long-term immunity.
New therapies for acute RSV infections: where are we?
New therapies for acute RSV infections: where are we?
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Sanofi Pasteur, a Sanofi CompanyLead Sponsor
418 Previous Clinical Trials
6,108,406 Total Patients Enrolled
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