Study of a Respiratory Syncytial Virus Candidate Encapsulated in a Lipid Nanoparticle Based Formulation in Adults Aged 18 to 50 Years and 60 Years and Older
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05639894 |
|
Recruitment Status :
Active, not recruiting
First Posted : December 7, 2022
Last Update Posted : May 3, 2024
|
Sponsor:
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
Brief Summary of Stage 1:
The purpose Stage 1 (Phase I/IIa) is to assess the safety and immunogenicity of a single intramuscular (IM) injection of 3 dose-levels of an Respiratory Syncytial Virus (RSV) vaccine candidate formulated with 2 different lipid nanoparticles (LNPs) in healthy adult participants aged between 18 to 50 years, and 60 years and older. The primary objectives of this stage are to assess the safety and immunogenicity profiles across the dose-level groups (low, medium, and high doses) with 2 LNPs. This stage will evaluate the safety and immunogenicity of a booster vaccination administered 12 months after the primary vaccination in a subset of the study population.
Brief Summary of Stage 2:
The study also also incorporates a Stage 2 (Phase IIa, dose-ranging design) that includes adults aged 60 years and older to assess the safety and immunogenicity of different doses of RSV vaccine encapsulated in one of the LNPs. In the Phase IIa dose-ranging stage, eligible participants will be randomly assigned in a 1:1:1 ratio to receive a single IM administration of RSV vaccine candidate doses, or placebo. Multiple safety analyses will be performed, minimally at D07 and D28. Additional analyses may be performed as data are available.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Respiratory Syncytial Virus Immunization | Biological: RSV vaccine candiate formulation 1 Biological: RSV vaccine candidate formulation 2 Other: Placebo | Phase 1 Phase 2 |
Stage 1:
The duration of each participant's participation is 12 months for the Sentinel and Main Cohorts, 24 months overall for the subset of participants enrolled in the Booster Cohort.
Treatment Duration:
- Sentinel Cohort: 1 intra-muscular (IM) injection. Participants will be followed for 12 months post-vaccination.
- Main Cohort: 1 IM injection. Participants will be followed for 12 months post-vaccination.
- Booster Cohort: 1 IM injection 12 months after the primary vaccination. Participants will be followed for 12 months after administration of the booster dose.
Stage 2:
The duration of each participant's participation is approximately 6 months.
Treatment Duration:
1 IM injection. Participants will be followed for approximately 6 months post vaccination
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 865 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Sequential (Phase I)/ parallel (Phase IIa) |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Masking Description: | Sentinel Cohort: single-blind
|
| Primary Purpose: | Prevention |
| Official Title: | A Phase I/IIa, Randomized, Placebo-controlled Multi-arm Dose-finding Study to Evaluate the Safety and Immunogenicity of a RSV Vaccine Candidate in Adult Participants 18 to 50 Years of Age in Phase I, and 60 Years and Older in Phase IIa |
| Actual Study Start Date : | November 17, 2022 |
| Estimated Primary Completion Date : | April 29, 2025 |
| Estimated Study Completion Date : | April 29, 2025 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Group 1: Sentinel and Main Cohorts (Stage 1)
1 injection of RSV vaccine candidate (Dose A) via intramuscular injection
|
Biological: RSV vaccine candiate formulation 1
Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular injection |
|
Experimental: Group 2: Sentinel and Main Cohorts (Stage 1)
1 injection of RSV vaccine candidate (Dose A) via intramuscular injection
|
Biological: RSV vaccine candidate formulation 2
Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular injection |
|
Experimental: Group 3: Sentinel and Main Cohorts (Stage 1)
1 injection of RSV vaccine candidate (Dose B) via intramuscular injection
|
Biological: RSV vaccine candiate formulation 1
Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular injection |
|
Experimental: Group 4: Sentinel and Main Cohorts (Stage 1)
1 injection of RSV vaccine candidate (Dose B) via intramuscular injection
|
Biological: RSV vaccine candidate formulation 2
Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular injection |
|
Experimental: Group 5: Sentinel and Main Cohorts (Stage 1)
1 injection of RSV vaccine candidate (Dose C) via intramuscular injection
|
Biological: RSV vaccine candiate formulation 1
Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular injection |
|
Experimental: Group 6: Sentinel and Main Cohorts (Stage 1)
1 injection of RSV vaccine candidate (Dose C) via intramuscular injection
|
Biological: RSV vaccine candidate formulation 2
Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular injection |
|
Placebo Comparator: Group 7: Main, Sentinel and Booster Cohorts (Stage 1)
1 injection of placebo via intramuscular injection
|
Other: Placebo
Pharmaceutical Form: Liquid Route of Administration: Intramuscular injection |
|
Experimental: Group 0: Phase IIa/Dose-ranging (Stage 2)
1 injection of RSV vaccine candidate (Dose A) via intramuscular injection
|
Biological: RSV vaccine candiate formulation 1
Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular injection |
|
Experimental: Group 1: Phase IIa/Dose-ranging (Stage 2)
1 injection of RSV vaccine candidate (Dose B) via intramuscular injection
|
Biological: RSV vaccine candidate formulation 2
Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular injection |
|
Placebo Comparator: Group 2: Phase 11a/Dose-ranging (Stage 2)
1 injection of placebo via intramuscular injection
|
Other: Placebo
Pharmaceutical Form: Liquid Route of Administration: Intramuscular injection |
Primary Outcome Measures :
- Presence of unsolicited systemic adverse events (AEs) [ Time Frame: Within 30 minutes after vaccination ]Number of participants experienciing unsolicited systemic adverse events
- Presence of solicited injection site or systemic reactions [ Time Frame: Within 7 days after vaccination ]
Number of participants reporting:
- injection site reactions: pain, erythema and swelling
- systemic reactions: fever, headache, malaise, myalgia, arthralgia and chills
- Presence of unsolicited AEs [ Time Frame: Within 28 days after vaccination ]Number of participants experiencing unsolicited AEs
- Presence of medically attended adverse events (MAAEs) [ Time Frame: Within 28 days after vaccination ]Number of participants experiencing MAAEs
- Presence of serious adverse events (SAEs) [ Time Frame: Month 12 ]Number of participants experiencing SAEs
- Presence of adverse events of special interest (AESIs) [ Time Frame: Month 12 ]Number of participants experiencing AESIs
- Presence of out-of-range biological test results [ Time Frame: Within 7 days after vaccination ]Number of participants with biological safety assessment values out of normal range (as per the laboratory performing the test)
- Geometric Mean Titers (GMTs) of neutralizing antibody (nAb) titers pre-vaccination at Day 1 [ Time Frame: Day 1 ]Nab titers pre-vaccination
- Geometric Mean Titers (GMTs) of neutralizing antibody (nAb) titers post-primary vaccination at Day 29 [ Time Frame: Day 29 ]Nab titers post-vaccination
Secondary Outcome Measures :
- Presence of immediate unsolicited systemic AEs (Stage 1) [ Time Frame: Within 30 minutes after vaccination ]Number of participants experiencing immediate unsolicitied systemic AEs
- Presence of solicited injection site or systemic reactions post-booster vaccination (Stage 1) [ Time Frame: Within 7 days after vaccination ]
Number of participants reporting:
- injection site reactions: pain, erythema and swelling
- systemic reactions: fever, headache, malaise, myalgia, arthralgia and chills
- Presence of unsolicited AEs post-booster vaccination (Stage 1) [ Time Frame: Within 28 days after vaccination ]Number of participants experiencing unsolicited AEs
- Presence of MAAEs (Stage 1) [ Time Frame: Within 28 days after vaccination ]Number of participants experiencing MAAEs
- Presence of serious adverse events (SAEs) post-booster vaccination (Stage 1) [ Time Frame: Throughout the booster study, approximately 12 months ]Number of participants experiencing SAEs
- Presence of adverse events of special interest post-booster vaccination (Stage 1) [ Time Frame: Throughout the booster study, approximately 12 months ]Number of participants experiencing AESIs
- Presence of out-of-range biological test results post-booster vaccination (Stage 1) [ Time Frame: Within 7 days after vaccination ]Number of participants with biological safety assessment values out of normal range (as per the laboratory performing the test)
- RSV-A serum nAb titers at pre-vaccination (D01) and 28 days post- primary vaccination (D29) (Stage 1) [ Time Frame: Day 1, Day 29, Month 3, Month 6 and Month 12 ]RSV-A serum nAb titers at pre-vaccination (D01), 28 days (D29), and 3, 6, and 12 months post-primary vaccination
- GMTs of serum anti-F immunoglobulin G (IgG) antibody (Ab) titers post-primary vaccination (Stage 1) [ Time Frame: Day 1, Day 29, Month 3, Month 6 and Month 12 ]Serum anti-F IgG Ab titers at pre-vaccination (D01), 28 days (D29), and 3, 6, and 12 months post-primary vaccination
- GMTs of RSV-A serum nAb post-booster vaccination (Stage 1) [ Time Frame: Day 1, Day 29, Month 3, Month 6 and Month 12 post-booster ]RSV-A serum nAb titers at pre-booster vaccination, 28 days, and 3, 6, and 12 months post-booster vaccination
- GMTs of serum anti-F IgG Ab titers post-booster vaccination (Stage 1) [ Time Frame: Day 1, Day 29, Month 3, Month 6 and Month 12 post-booster ]Serum anti-F IgG Ab titers at pre-booster vaccination, 28 days, and 3, 6, and 12 months post- booster vaccination
- GMTs of serum anti-F IgG Ab titers pre-vaccination (Stage 2) [ Time Frame: Day 1 ]Nab titers pre-primary vaccination
- GMTs of serum anti-F IgG Ab titers post-vaccination (Stage 2) [ Time Frame: Day 29 ]Nab titers post-vaccination
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Sentinel Cohort Stage 1: Aged 18 to 50 years on the day of inclusion
- Main Cohort Stage 1 and Stage 2: Aged 60 years or older on the day of inclusion
Stage 1 and Stage 2:
-
Sentinel Cohort: A female participant is eligible to participate if she is not pregnant or breastfeeding and:
- Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year or surgically sterile OR
- Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 12 weeks after study intervention administration.
-
Main and Booster Cohorts: A female participant is eligible to participate if she is not pregnant or breastfeeding and:
- Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year or surgically sterile.
- Able to attend all scheduled visits and to comply with all study procedures
- Informed consent form has been signed and dated
Exclusion Criteria:
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- Known systemic hypersensitivity to any of the study intervention components (eg, polyethylene glycol, polysorbate); history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances; any allergic reaction (eg, anaphylaxis) after administration of mRNA COVID-19 vaccine
- History of RSV-associated illness, diagnosed clinically, serologically, or microbiologically in the last 12 months
- Previous history of myocarditis, pericarditis, and/or myopericarditis
- Thrombocytopenia or bleeding disorder, contraindicating IM injection based on investigator's judgment
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular injection
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
- Alcohol, prescription drug, or substance abuse that, in the opinion of the investigator, might interfere with the study conduct or completion
- Receipt of any vaccine other than mRNA vaccine in the 4 weeks preceding any study intervention administration or planned receipt of any vaccine other than mRNA vaccine in the 4 weeks following any study intervention administration
- Receipt of any mRNA vaccine in the 60 days preceding any study intervention administration or planned receipt of any mRNA vaccine in the 60 days following any study intervention administration
- Previous vaccination against RSV with an investigational vaccine
- Receipt of immune globulins, blood, or blood-derived products in the past 3 months
- Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
- Participation at the time of study enrollment (or in the 4 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- Self-reported or documented human immunodeficiency virus (HIV) detected by any FDA-approved/validated test, hepatitis B virus surface antigen (HBsAg), hepatits B core antibodies (HBcAb), or hepatitis C virus antibodies (HCV Abs), or positive SARS-CoV-2 RT-PCR or antigen test
- Identified as an investigator or employee of the investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the investigator or employee with direct involvement in the proposed study
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05639894
Locations
Show 37 study locations
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
| Study Director: | Clinical Sciences & Operations | Sanofi |
| Responsible Party: | Sanofi Pasteur, a Sanofi Company |
| ClinicalTrials.gov Identifier: | NCT05639894 |
| Other Study ID Numbers: |
VAE00010 U1111-1271-1514 ( Registry Identifier: ICTRP ) 2023-505343-40 ( Registry Identifier: CTIS ) |
| First Posted: | December 7, 2022 Key Record Dates |
| Last Update Posted: | May 3, 2024 |
| Last Verified: | May 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | Yes |
Additional relevant MeSH terms:
|
Vaccines Immunologic Factors Physiological Effects of Drugs |