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Recruiting NCT07734649

Phase 1/2 Study of Respiratory Syncytial Virus and Human Metapneumovirus (RSV+HMPV) Vaccine Candidate in Adults 60 Years of Age and Older

Phase I / Phase II Interventional Respiratory Syncytial Virus Immunization Human Metapneumovirus Immunization Healthy Volunteers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RSV+HMPV vaccine, Control Vaccine 3, Control Vaccine 4, Control Vaccine 2.
Who it may be relevant to
Registry conditions: Respiratory Syncytial Virus Immunization, Human Metapneumovirus Immunization, Healthy Volunteers. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 1/2, Randomized, Controlled, Observer-Blind Study in Adults 60 Years of Age and Older to Evaluate the Immunogenicity and Safety of Different Dose Levels of a Bivalent Vaccine Candidate Against Respiratory Syncytial Virus (RSV) and Human Metapneumovirus (HMPV)

Overview

This study is a Phase 1/2, randomized, observer-blind, active and placebo-controlled, multi-center study to be conducted in approximately 2400 adults 60 years of age and older. The aim of the study is to evaluate the immunogenicity and safety of an RSV+HMPV vaccine candidate for the prevention of RSV and HMPV disease among adults 60 years of age and older. While there are 3 FDA approved/licensed RSV vaccines currently available to the public, no vaccine is available for the prevention of HMPV in older adults. This study is intended to provide data in support of further clinical development of the RSV+HMPV vaccine candidate. The study will consist of 4 cohorts and 11 vaccine groups (RSV+HMPV \[6 dose levels\], placebo and 4 control groups). The duration of the study will be approximately 12 months for each participant.

Interventions

  • Biological RSV+HMPV vaccine
    RSV + HMPV Candidate Vaccine
  • Biological Control Vaccine 3
    Control Vaccine 3
  • Biological Control Vaccine 4
    Control Vaccine 4
  • Biological Control Vaccine 2
    Control Vaccine 2
  • Other Placebo
    Placebo
  • Biological Control Vaccine 1
    Control Vaccine 1

Primary outcome measures

  • RSV A serum nAb (neutralizing antibodies) titers [Time frame: At Day 1 and Day 29]
  • RSV B serum nAb titers [Time frame: At Day 1 and Day 29]
  • HMPV A serum nAb titers [Time frame: At Day 1 and Day 29]
  • HMPV B serum nAb titers [Time frame: At Day 1 and Day 29]
  • Unsolicited systemic Adverse Events (AEs) that occur within 30 minutes after vaccination [Time frame: Within 30 minutes after vaccination]
  • Presence of solicited injection site and systemic reactions [Time frame: For 8 days, including the day of vaccination]
  • Presence of Unsolicited AEs [Time frame: For 28 days, including day of vaccination]
  • Presence of medically attended AEs (MAAEs) [Time frame: Within 6 months after vaccination]
  • Presence of Serious Adverse Events (SAEs), fatal SAEs and Adverse Events of Special Interest (AESIs) [Time frame: Throughout the study (approximately 12 months)]
  • Presence of out-of-range biological test results [Time frame: At Day 09]
Secondary outcome measures (8)
  • RSV A serum nAb titers at 3, 6, 9, and 12 months post-vaccination [Time frame: 3, 6, 9, and 12-months post-vaccination]
  • RSV B serum nAb titers at 3, 6, 9, and 12 months post-vaccination [Time frame: 3, 6, 9, and 12 months post-vaccination]
  • HMPV A serum nAb titers at 3, 6, 9, and 12 months post-vaccination [Time frame: 3, 6, 9, and 12 months post-vaccination]
  • HMPV B serum nAb titers at 3, 6, 9, and 12 months post-vaccination [Time frame: 3, 6, 9, and 12 months post-vaccination]
  • Serum RSV preF immunoglobulin G (IgG) Ab concentrations at pre-vaccination (Day 01), and at 28 days (Day 29), 3, 6, 9, and 12 months post-vaccination [Time frame: pre-vaccination (Day 01), and at 28 days (Day 29), 3, 6, 9, and 12 months post-vaccination]
  • Serum HMPV preF immunoglobulin G (IgG) Ab concentrations at pre-vaccination (Day 01), and at 28 days (Day 29), 3, 6, 9, and 12 months post-vaccination [Time frame: pre-vaccination (Day 01), and at 28 days (Day 29), 3, 6, 9, and 12 months post-vaccination]
  • Ratio of RSV A and RSV B serum nAb titer fold-rise over anti-preF IgG Ab concentration fold-rise at Day 29, 3, 6, 9, and 12 months post-vaccination, from pre vaccination (Day 01) [Time frame: Day 29, 3, 6, 9, and 12 months post-vaccination, from pre-vaccination (Day 01)]
  • Ratio of HMPV A and HMPV B serum nAb titer fold-rise over anti-preF IgG Ab concentration fold-rise at Day 29, 3, 6, 9, and 12 months post-vaccination, from pre vaccination (Day 01) [Time frame: Day 29, 3, 6, 9, and 12 months post-vaccination, from pre-vaccination (Day 01)]

Eligibility criteria

Inclusion criteria

  • Aged 60 years or older on the day of inclusion
  • Non-childbearing potential (ie, post-menopausal for at least 1 year or surgically sterile)

Exclusion criteria

  • History of laboratory-confirmed RSV and/or laboratory-confirmed HMPV infection affecting the participant and/or the participant's household in the previous 12 months
  • Previous history of myocarditis, pericarditis, and/or myopericarditis
  • Screening electrocardiogram (ECG) that is consistent with possible myocarditis, pericarditis, and/or myopericarditis or, in the opinion of the investigator, demonstrates clinically relevant abnormalities that may affect participant safety or study results
  • Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
  • Previous history of Guillain-Barré Syndrome
  • Any vaccine given 4 weeks before or 4 weeks after study intervention
  • Previous vaccination against RSV and/or HMPV with an investigational or marketed vaccine
  • Receipt of any mRNA vaccine/product in the 2 months preceding study intervention administration
  • Has received a blood transfusion or blood-derived products, including immunoglobulins, in the past 3 months
  • Any screening laboratory parameter with laboratory abnormality > Grade 1 or deemed clinically significant by the investigator; if deemed appropriate, investigator may repeat these assessments

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

United States · 17 centers
  • Hawthorne Health - Gadsden City Pharmacy- Site Number : 8400025 — Gadsden
  • Scottsdale Clinical Trials- Site Number : 8400011 — Scottsdale
  • Long Beach Research Institute- Site Number : 8400005 — Long Beach
  • Alliance Clinical - San Diego- Site Number : 8400033 — San Diego
  • Accel Research Sites Network - DeLand Clinical Research Unit- Site Number : 8400064 — DeLand
  • Accel Research Sites - NeuroStudies- Site Number : 8400063 — Decatur
  • DM Clinical Research - Chicago- Site Number : 8400050 — Melrose Park
  • DM Clinical Research - Detroit- Site Number : 8400049 — Southfield
  • … and 9 more centers

Identifiers

NCT: NCT07734649 · VCA23395 · U1111-1337-4718

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗