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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05639894




Registration number
NCT05639894
Ethics application status
Date submitted
17/11/2022
Date registered
7/12/2022
Date last updated
3/05/2024

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
U1111-1271-1514
Secondary ID [2] 0 0
VAE00010
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus Immunization 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - RSV vaccine candiate formulation 1
Other interventions - RSV vaccine candidate formulation 2
Other interventions - Placebo

Experimental: Group 1: Sentinel and Main Cohorts (Stage 1) - 1 injection of RSV vaccine candidate (Dose A) via intramuscular injection

Experimental: Group 2: Sentinel and Main Cohorts (Stage 1) - 1 injection of RSV vaccine candidate (Dose A) via intramuscular injection

Experimental: Group 3: Sentinel and Main Cohorts (Stage 1) - 1 injection of RSV vaccine candidate (Dose B) via intramuscular injection

Experimental: Group 4: Sentinel and Main Cohorts (Stage 1) - 1 injection of RSV vaccine candidate (Dose B) via intramuscular injection

Experimental: Group 5: Sentinel and Main Cohorts (Stage 1) - 1 injection of RSV vaccine candidate (Dose C) via intramuscular injection

Experimental: Group 6: Sentinel and Main Cohorts (Stage 1) - 1 injection of RSV vaccine candidate (Dose C) via intramuscular injection

Placebo Comparator: Group 7: Main, Sentinel and Booster Cohorts (Stage 1) - 1 injection of placebo via intramuscular injection

Experimental: Group 0: Phase IIa/Dose-ranging (Stage 2) - 1 injection of RSV vaccine candidate (Dose A) via intramuscular injection

Experimental: Group 1: Phase IIa/Dose-ranging (Stage 2) - 1 injection of RSV vaccine candidate (Dose B) via intramuscular injection

Placebo Comparator: Group 2: Phase 11a/Dose-ranging (Stage 2) - 1 injection of placebo via intramuscular injection


Other interventions: RSV vaccine candiate formulation 1
Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular injection

Other interventions: RSV vaccine candidate formulation 2
Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular injection

Other interventions: Placebo
Pharmaceutical Form: Liquid Route of Administration: Intramuscular injection
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Presence of unsolicited systemic adverse events (AEs)
Timepoint [1] 0 0
Within 30 minutes after vaccination
Primary outcome [2] 0 0
Presence of solicited injection site or systemic reactions
Timepoint [2] 0 0
Within 7 days after vaccination
Primary outcome [3] 0 0
Presence of unsolicited AEs
Timepoint [3] 0 0
Within 28 days after vaccination
Primary outcome [4] 0 0
Presence of medically attended adverse events (MAAEs)
Timepoint [4] 0 0
Within 28 days after vaccination
Primary outcome [5] 0 0
Presence of serious adverse events (SAEs)
Timepoint [5] 0 0
Month 12
Primary outcome [6] 0 0
Presence of adverse events of special interest (AESIs)
Timepoint [6] 0 0
Month 12
Primary outcome [7] 0 0
Presence of out-of-range biological test results
Timepoint [7] 0 0
Within 7 days after vaccination
Primary outcome [8] 0 0
Geometric Mean Titers (GMTs) of neutralizing antibody (nAb) titers pre-vaccination at Day 1
Timepoint [8] 0 0
Day 1
Primary outcome [9] 0 0
Geometric Mean Titers (GMTs) of neutralizing antibody (nAb) titers post-primary vaccination at Day 29
Timepoint [9] 0 0
Day 29
Secondary outcome [1] 0 0
Presence of immediate unsolicited systemic AEs (Stage 1)
Timepoint [1] 0 0
Within 30 minutes after vaccination
Secondary outcome [2] 0 0
Presence of solicited injection site or systemic reactions post-booster vaccination (Stage 1)
Timepoint [2] 0 0
Within 7 days after vaccination
Secondary outcome [3] 0 0
Presence of unsolicited AEs post-booster vaccination (Stage 1)
Timepoint [3] 0 0
Within 28 days after vaccination
Secondary outcome [4] 0 0
Presence of MAAEs (Stage 1)
Timepoint [4] 0 0
Within 28 days after vaccination
Secondary outcome [5] 0 0
Presence of serious adverse events (SAEs) post-booster vaccination (Stage 1)
Timepoint [5] 0 0
Throughout the booster study, approximately 12 months
Secondary outcome [6] 0 0
Presence of adverse events of special interest post-booster vaccination (Stage 1)
Timepoint [6] 0 0
Throughout the booster study, approximately 12 months
Secondary outcome [7] 0 0
Presence of out-of-range biological test results post-booster vaccination (Stage 1)
Timepoint [7] 0 0
Within 7 days after vaccination
Secondary outcome [8] 0 0
RSV-A serum nAb titers at pre-vaccination (D01) and 28 days post- primary vaccination (D29) (Stage 1)
Timepoint [8] 0 0
Day 1, Day 29, Month 3, Month 6 and Month 12
Secondary outcome [9] 0 0
GMTs of serum anti-F immunoglobulin G (IgG) antibody (Ab) titers post-primary vaccination (Stage 1)
Timepoint [9] 0 0
Day 1, Day 29, Month 3, Month 6 and Month 12
Secondary outcome [10] 0 0
GMTs of RSV-A serum nAb post-booster vaccination (Stage 1)
Timepoint [10] 0 0
Day 1, Day 29, Month 3, Month 6 and Month 12 post-booster
Secondary outcome [11] 0 0
GMTs of serum anti-F IgG Ab titers post-booster vaccination (Stage 1)
Timepoint [11] 0 0
Day 1, Day 29, Month 3, Month 6 and Month 12 post-booster
Secondary outcome [12] 0 0
GMTs of serum anti-F IgG Ab titers pre-vaccination (Stage 2)
Timepoint [12] 0 0
Day 1
Secondary outcome [13] 0 0
GMTs of serum anti-F IgG Ab titers post-vaccination (Stage 2)
Timepoint [13] 0 0
Day 29

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/04/2025
Actual
Sample size
Target
Accrual to date
Final
865
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Investigational Site Number : 0360003 - Botany
Recruitment hospital [2] 0 0
Investigational Site Number : 0360002 - Camberwell
Recruitment hospital [3] 0 0
Investigational Site Number : 0360001 - Southport
Recruitment postcode(s) [1] 0 0
2019 - Botany
Recruitment postcode(s) [2] 0 0
3124 - Camberwell
Recruitment postcode(s) [3] 0 0
4215 - Southport
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Nebraska
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Oklahoma
Country [10] 0 0
United States of America
State/province [10] 0 0
Oregon
Country [11] 0 0
United States of America
State/province [11] 0 0
Rhode Island
Country [12] 0 0
United States of America
State/province [12] 0 0
South Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Utah
Country [15] 0 0
Puerto Rico
State/province [15] 0 0
Carolina
Country [16] 0 0
Puerto Rico
State/province [16] 0 0
Guayama
Country [17] 0 0
Puerto Rico
State/province [17] 0 0
Guaynabo
Country [18] 0 0
Puerto Rico
State/province [18] 0 0
San Juan

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi Pasteur, a Sanofi Company
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05639894
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries