A Study of RSV-HMPV Bivalent Vaccine VXB-241 in Older Adults

NCT06556147
clinicaltrials.gov
Phase
Phase 1
clinicaltrials.gov
Recruitment status
Active, not recruiting
clinicaltrials.gov
Participants
144
clinicaltrials.gov
Lead sponsor
Sanofi
clinicaltrials.gov
Start date
2024-08-13
clinicaltrials.gov
Number of sites
4
clinicaltrials.gov

Summary
The main purposes of this study are to assess the safety, reactogenicity and immunogenicity of 4 dose levels of the bivalent combination Respiratory Syncytial Virus (RSV) / human Metapneumovirus (hMPV) vaccine candidate VXB-241 when administered as a single-dose regimen to healthy adults 60 to 83 years of age, and to assess the impact of revaccination approximately 1 year later.
clinicaltrials.gov
Short title
A Study of RSV-HMPV Bivalent Vaccine VXB-241 in Older Adults
clinicaltrials.gov
Official title
A Phase 1 Randomized, Placebo- and Active-controlled, Observer-blind Study in Older Adults With Run-in in Young Adults to Evaluate the Safety, Reactogenicity, and Immunogenicity of Four Dose Levels of VXB-241, A Molecular Clamp Stabilized Prefusion F Glycoprotein Subunit Bivalent Vaccine Candidate for the Prevention of Lower Respiratory Tract Disease Caused by Respiratory Syncytial Virus (RSV) And Human Metapneumovirus (HMPV)
clinicaltrials.gov

Control arm
Placebo
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Active, not recruiting
clinicaltrials.gov
Phase
Phase 1
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2027-05-01
clinicaltrials.gov
First posted
2024-08-15
clinicaltrials.gov
Registry last updated
2026-05-20
clinicaltrials.gov
Primary completion date
2025-02-14
clinicaltrials.gov
Start date
2024-08-13
clinicaltrials.gov

Actual participants
144
clinicaltrials.gov
Participants
144
clinicaltrials.gov
Participant count basis
Actual
clinicaltrials.gov
Protocol amendments
7
clinicaltrials.gov
Randomisation ratio
3:1
clinicaltrials.gov
Number of sites
4
clinicaltrials.gov

Data monitoring committee
Yes
clinicaltrials.gov
Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
Sanofi
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT06556147
clinicaltrials.gov
ClinicalTrials.gov ID
NCT06556147
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Randomised
Model
Sequential
Purpose
Prevention
Masking
Double masking
Masked roles
Participants, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Proportion of Older Adult Participants With 1 or More Unsolicited AEs

    Timeframe: 1 month after first IMP injection (Days 1 to 30)

  2. Proportion of Older Adult Participants With 1 or More Solicited AEs

    Timeframe: 7 days after first IMP injection (Days 1 to 8)

  3. Geometric Mean Fold Increase (GMFI) of RSV-A, RSV-B, hMPV-A, and hMPV-B Serum Neutralizing Antibody Titers in Older Adults

    Timeframe: Pre-injection baseline to 1 month (Day 30) after first IMP injection

    GMFI is defined as geometric mean of ratios of specific antibody titer/concentration at each post-vaccination time point over pre-vaccination baseline.

  4. Ratio of Dose-response Curves for GMFIs of RSV-A, RSV-B, hMPV-A and hMPV-B Serum Neutralizing Antibody Titers in Older Adults

    Timeframe: Pre-injection baseline to 1 month (Day 30) after first IMP injection

    Ratio of VXB-241 dose versus GMFI of RSV-A, RSV-B, hMPV-A and hMPV-B will be calculated.

  1. Proportion of Older Adult Participants With 1 or More Unsolicited AEs and With 1 or More Severe Unsolicited AE

    Timeframe: 1 month after first IMP injection (Days 1 to 30) and 1 month after second IMP injection (revaccination, Days 364 to 394)

  2. Proportion of Older Adult Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), and Premature Discontinuation Associated AEs (PDAEs)

    Timeframe: 1 month after first IMP injection (Days 1 to 30) and 1 month after second IMP injection (revaccination, Days 364 to394), and throughout follow-up (Days 1 to 720)

  3. Mean Change From Baseline for Abnormal and Severe Abnormal Hematology Laboratory Values for Hemoglobin in Older Adults

    Timeframe: 7 days (Day 8) and 1 month (Day 30) after first IMP injection, and 1 month (Day 394) after second IMP injection (revaccination

  4. Mean Change From Baseline for Abnormal and Severe Abnormal Hematology Laboratory Values for Red Blood Cells, White Blood Cells, and Platelet Count in Older Adults

    Timeframe: 7 days (Day 8) and 1 month (Day 30) after first IMP injection, and 1 month (Day 394) after second IMP injection (revaccination

  5. Mean Change From Baseline for Abnormal and Severe Abnormal Blood Chemistry Laboratory Values for Alanine Transaminase (ALT), Aspartate Transaminase (AST), and Alkaline Phosphatase in Older Adults

    Timeframe: 7 days (Day 8) and 1 month (Day 30) after first IMP injection, and 1 month (Day 394) after second IMP injection (revaccination

  6. Mean Change From Baseline for Abnormal and Severe Abnormal Blood Chemistry Laboratory Values for Total Bilirubin, Creatinine, and Urea in Older Adults

    Timeframe: 7 days (Day 8) and 1 month (Day 30) after first IMP injection, and 1 month (Day 394) after second IMP injection (revaccination

  7. Proportion of Older Adult With Abnormal and Severe Abnormal Values for Hematology Laboratory Parameter

    Timeframe: 7 days (Day 8) and 1 month (Day 30) after first IMP injection, and 1 month (Day 394) after second IMP injection (revaccination)

  8. Proportion of Older Adult With Abnormal Values and Severe Abnormal Values for Blood Chemistry Laboratory Parameter

    Timeframe: 7 days (Day 8) and 1 month (Day 30) after first IMP injection, and 1 month (Day 394) after second IMP injection (revaccination)

  9. Proportion of Older Adult Participants With Solicited AEs

    Timeframe: 7 days after 2nd IMP injection (revaccination, Day 364 to 371)

  10. GMFI of RSV-A, RSV-B, hMPV-A, and hMPV-B Serum Neutralizing Antibody Titers in Older Adults

    Timeframe: Pre-injection baseline to 6 months (Day 182) and 12 months (Day 364) after first IMP injection, and 1 month (Day 394), 6 months (Day 546), and 12 months (Day 720) after second IMP injection (revaccination)

  11. Geometric Mean Titers (GMTs) of RSV-A, RSV-B, hMPV-A, and hMPV-B Serum Neutralizing Antibody Titers in Older Adults

    Timeframe: Pre-injection baseline to 1 month (Day 30), 6 months (Day 182) and 12 months (Day 364) after first IMP injection, and 1 month (Day 394), 6 months (Day 546), and 12 months (Day 720) after second IMP injection (revaccination)

  12. Proportion of Older Adult Participants with Sero-response Greater Than or Equal to (>=) 4-fold (SRR-4) and 8-fold (SRR-8) Increase from Baseline in Neutralizing Antibody Titers for RSV-A, RSV-B, hMPV-A and hMPV-B

    Timeframe: Pre-injection baseline up to 1 month (Day 30), 6 months (Day 182) and 12 months (Day 364) after first IMP injection, and 1 month (Day 394), 6 months (Day 546), and 12 months (Day 720) after second IMP injection (revaccination)

  13. GMFI of RSV Pre-fusion Protein (Pre-F) and hMPV Pre-F Serum Immunoglobulins G (IgG) Concentrations in Older Adults

    Timeframe: Pre-injection baseline up to 1 month (Day 30), 6 months (Day 182) and 12 months (Day 364) after first IMP injection, and 1 month (Day 394), 6 months (Day 546), and 12 months (Day 720) after second IMP injection (revaccination)

  14. Geometric Mean Concentrations (GMC) of Serum IgG Versus RSV Pre-F and hMPV Pre-F in Older Adults

    Timeframe: Up to 1 month (Day 30), 6 months (Day 182), and 12 months (Day 364) after first IMP injection and 1 month (Day 394), 6 months (Day 546) and 12 months (Day 720) after second IMP injection (revaccination)

  15. Geometric Mean Ratios (GMRs) of Fold Increase of RSV-A and RSV-B Neutralizing Serum Antibody Titers Versus Fold Increase of RSV Pre-F Serum IgG Concentration in Older Adults

    Timeframe: Pre-injection baseline up to 1 month (Day 30), 6 months (Day 182) and 12 months (Day 364) after first IMP injection, and 1 month (Day 394), 6 months (Day 546), and 12 months (Day 720) after second IMP injection (revaccination)

  16. GMR of Fold Increase of hMPV-A and hMPV-B Neutralizing Serum Antibody Titers Versus Fold Increase of hMPV Pre-F Serum IgG Concentration in Older Adults

    Timeframe: Pre-injection baseline up to 1 month (Day 30), 6 months (Day 182) and 12 months (Day 364) after first IMP injection, and 1 month (Day 394), 6 months (Day 546), and 12 months (Day 720) after second IMP injection (revaccination)

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
83 Years
Healthy volunteers
Yes

  1. Male or female, 18 to 40 years of age (yoa) (younger adult) or 60 to 83 yoa (older adult).
  2. Evidence of signed and dated participant informed consent form (PICF) prior to any study procedure, indicating that the participant has been informed of all pertinent aspects of the study.
  3. Willingness and ability to comply with the planned study visits and calls, procedures, and restrictions for the duration of the study.
  4. Good health, which allows for pre-existing well-controlled and low impact chronic diseases, except for the diseases listed in the exclusion criteria. A disease is defined as well-controlled and low impact if it did not require meaningful change in therapy or unplanned medical visits in the previous 3 months and allows participant's primary responsibility for self-care and daily living activities.
  5. Non-smoker or occasional smoker, defined as smoking less than 10 nicotine-containing cigarettes/ vapes/cigars/pipe fills per week.
  6. Contraception: heterosexually active participants of childbearing potential able and willing to use a double contraceptive method for at least 4 weeks before and 12 weeks after the first IMP injection at Visit 2 (all participants of childbearing potential) and second IMP injection at Visit 6 (male older adults of childbearing potential).
  7. Body Mass Index (BMI) >=17.0 kilogram per square meter (kg/m^2) and less than or equal to (<=) 35.0 kg/m^2.

  1. History of RSV and/or hMPV infection affecting the participant and/or the participant's household in the previous 12 months.

  2. History of autoimmune disease (AID) or potentially autoimmune disease (pAID) requiring therapeutic intervention, even if stable and well controlled, including but not limited to systemic lupus erythematosus, autoimmune arthritis/rheumatoid arthritis, Guillain-Barré syndrome, multiple sclerosis, Sjögren's syndrome, idiopathic thrombocytopenia purpura, glomerulonephritis, autoimmune thyroiditis, temporal arteritis, psoriasis, insulin-dependent diabetes mellitus, celiac disease.

  3. Confirmed or suspected immunodeficiency, even if stable and well controlled.

  4. Ongoing severe asthma. Other allergic diseases (example, allergic rhinitis, atopic dermatitis / eczema, mild to moderate asthma, food allergies, are allowed at the investigator's or delegate's discretion).

  5. History of severe allergic reaction (example, anaphylaxis) to any substance, including vaccine components and latex.

  6. History of severe adverse event (AEs) associated with vaccine administration.

  7. Ongoing disorders of coagulation, which contraindicate IM injections.

  8. Donation or loss of >=500 milliliter (mL) whole blood on the previous 2 months and/or donation of plasma in the previous 1 week, and/or intention to donate blood or plasma during the study.

  9. Positive serum test results for serum human immunodeficiency virus (HIV), hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection and/or documented HIV, HVB or HVC infection.

  10. Other poorly controlled and/or impactful chronic disease. A disease is defined as poorly controlled if it required meaningful change in therapy and/or unplanned medical visits in the previous 3 months. A disease is defined as impactful if it has a meaningful impact on participant's self-care and/or activities of daily living.

  11. Disease expected to prevent completion of the study (that is to rapidly deteriorate within the timeframe of the study).

  12. Prior treatments.

    1. Licensed RSV vaccine or investigational RSV and/or hMPV vaccine received at any time.
    2. Investigational drug or vaccine received in the previous 6 months.
    3. Chemotherapy, radiotherapy, and/or other immunosuppressive medication including biologics received in the previous 6 months.
    4. Immunoglobulins G (IgGs) or any blood product received in the previous 3 months.
    5. Systemic corticosteroids (oral/intravenous/intramuscular) at doses equivalent to >=20 mg prednisone received for >=14 days, even if not consecutive, during the previous 3 months. Inhaled/nebulized, intra-articular, intra-bursal, skin and eye topical corticosteroids are permitted.

  13. Clinically meaningful abnormal finding from physical examination, vital sign assessment, electrocardiogram (ECG), safety laboratory test results. If deemed appropriate, the investigator or delegate may repeat these assessments.

  14. History of alcohol abuse in the previous year and/or positive alcohol breath test.

  15. History of recreational drug abuse in the previous year and/or positive test for drugs of abuse, unless there is an explanation acceptable to the investigator (example, the participant has informed in advance that he/she consumed a prescription or over-the-counter product that contained the detected drug).

  16. Intention to participate in any investigational drug/vaccine clinical trial at any time throughout the planned duration of this study.

  17. Presence of tattoo, scarring, skin discoloration, or any other skin disturbances at the injection site which may interfere with effective assessment of the injection site.

  18. Intention to move to a location that would prevent participating in the study until study end.

  19. Limited to premenopausal female participants: breastfeeding, positive pregnancy test or intention to become pregnant during the first 3 months of the study.

  20. Any other reason which would prevent the participant from participating in the study or interfere with the participant's compliance with study procedures.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sources for eligibility
clinicaltrials.gov

  • University of the Sunshine CoastMorayfield, Australia
  • University of the Sunshine CoastSippy Downs, Australia
  • University of the Sunshine CoastSouth Brisbane, Australia
  • Veritus ResearchBayswater, Australia
Sources for sites
clinicaltrials.gov

Other registry identifiers

  • VCA23394
Sources for references
clinicaltrials.gov

Related records

Drugs (5)

Lead sponsors (1)

Targets (6)