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Respiratory Syncytial Virus InfectionsPhase 1/2STR-V003NCT06344975

A Study to Describe the Safety and Immunogenicity of a Respiratory Syncytial Virus Vaccine STR-V003 in Healthy Adults

A Phase 1/2 study of Respiratory Syncytial Virus Infections, run by Starna Therapeutics.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a randomized, double-blind, placebo-controlled, single ascending dose escalation and two-dose study in healthy adults. This study will be conducted in healthy men and women ≥18 years old to assess the safety, tolerability and immunogenicity of STR-V003. This trial consists of two parts: Part A and Part B. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Respiratory Syncytial Virus Infections
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
No sites listed yet
Study dates
May 2024to May 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Able to understand and willing to sign the ICF.
  • Healthy male and female subjects, non-smokers defined as having abstained from tobaccoornicotine containing products (e.g., cigarettes, chewing tobacco, snuff, nicotine patches,and electronic cigarettes) in the 6 months prior to the Screening.
  • Must be ≥18 years of age.
  • With no significant medical history, and in good health as determined by detailed medical history (neurological, endocrinal, cardiovascular, pulmonary, hematological, immunologic,psychiatric, gastrointestinal, renal, hepatic, and metabolic disease), full physicalexamination, vital signs, 12-lead electrocardiogram (ECG), urinalysis and laboratory tests at screening.
  • 4.1) Abnormal laboratory or vital signs results may be repeated once if abnormal result is observed at the initial reading.
  • 4.2) Abnormalities found in the ECG may need to be confirmed by repeated measurements.
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  • Subjects must have adequate organ function according to the following laboratory values:
  • 5.1) Bone marrow function (absolute neutrophil count ≥ 1500/mm3 and platelet count ≥100,000/mm3) 5.2) Adequate liver function [alanine aminotransferase (ALT) ≤ 1.5 × upper limit normal(ULN) and alkaline phosphatase ≤ 1.5 × ULN, total bilirubin ≤ 1.5 mg/dL] 5.3) Adequate renal function creatinine clearance 60 mL/min based on Cockcroft-Gaultequation, or serum creatinine level ≤ 1.5 times the ULN
  • Be a female of non-childbearing potential [i.e., physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal and have an FSH > 40mIU/mL, or surgically sterile (defined as having a bilateral oophorectomy, hysterectomy or tubal ligation)] or agree to one of the following to prevent pregnancy.
  • If a woman of childbearing potential, she must have a negative serum pregnancy test at screening:
  • 7.1) Practicing abstinence. 7.2) If a sexually active woman of childbearing potential (sexually active with a non-sterile male partner) she must agrees to prevent pregnancy by using double methods of contraception as until at least 6 months after the last dose of the investigational product.
  • Male subjects who are not vasectomized for at least 6 months and who are sexually active with a non-sterile female partner must agree to use double methods of contraception as and must not donate sperm until 6 months after the last dose during their study participation period:
  • Body mass index (BMI) 18.0-30.0 kg/m2 documented at screening and day-1.
  • Blood pressure ≤ 139/89 mm Hg.
  • Subjects are able to follow the study protocol and complete the trial.

Who cannot join

  • Pregnancy or lactation.
  • History or presence of conditions which, in the judgment of the Investigator, are known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
  • History of any clinically significant medical illness or medical disorders the Investigator considers should exclude the subject, including (but not limited to) immune deficient state; neuromuscular, hematological, cardiac, vascular, metabolic, endocrine, rheumatologic,respiratory, hepatic, gastrointestinal, neurological, neoplastic, dermatological, renal, urinary tract, or psychiatric disease, hypertension, osteoarthritis or ophthalmological disorders.
  • Clinically significant abnormalities on ECG, including a QT corrected according to Fridericia's formula (QTcF) interval > 450 msec (males) or > 470 msec (for females).
  • History of surgery or major trauma within 6 months prior to study screening.
  • History of any significant hypersensitivity reaction to medications, including manifestations suggestive of anaphylaxis.
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  • History or presence of any active infection within 14 days, or an infection requiring prescription therapy or hospitalization within 30 days of enrollment.
  • History of alcohol abuse, illicit drug use, physical dependence on any opioid, or any history of drug abuse or addiction within 12 months of Screening.
  • Use of prescription medications within 30 days or 5 half-lives, whichever is longer, prior to administration of the study drug.
  • 9.1) Hormonal birth control will be permitted.
  • Use of OTC drugs (including herbal preparations) within 14 days or 5 half-lives (if known),whichever is longer, prior to administration of the study drug.
  • Received a vaccination within 30 days prior to administration of the study drug.
  • Any investigational drugs or participated in any clinical study within 30 days or 5 half-lives(if known), whichever is longer, prior to administration of the study drug in this study.
  • Significant blood loss (> 450 mL) or has donated 1 or more units of blood or plasma within 6 weeks prior to study participation.
  • Strenuous activity (as assessed by the Investigator) within 48 hours prior to CRU admission.
  • Consumption of alcohol, xanthine (i.e., chocolate), caffeine-containing food or beverages within 3 days prior to CRU admission. Consumption of alcohol is restricted to within 48hours of follow-up visits.
  • Positive test for HIV-1 or HIV-2 antibodies, or positive test for HBV or HCV consistent with current infection. Confirmatory tests will be allowed at the discretion of the Investigator to rule out false positives.
  • History or presence of any bleeding disorders, or symptoms suggestive of a bleeding disorder.
  • Unwilling or unlikely to comply with the requirements of the study.
  • Immunocompromised individuals and those with a history of autoimmune disease.
  • Increased risk for severe RSV infection
  • Positive serological test for SARS-CoV-2 IgM and/or IgG at the screening visit, and a SARS-CoV-2 nucleic acid amplification test-positive nasal swab within 24 h before study vaccination.
  • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction(e.g., anaphylaxis) to any component of the investigational product(s), including natural rubber latex.
  • Previous clinical or microbiological diagnosis of RSV, receipt of medications intended to prevent RSV, previous vaccinations including any investigational or licensed RSV vaccine or other related RSV product.
  • Any participant who is acutely ill or febrile (body temperature ≥ 38.0°C/100.4°F) within 48hours prior to or on the date of vaccination. The participant should not be included in the study until the condition has resolved for at least 2 consecutive days before the vaccination day.
  • Any participant who has received or plans to receive an mRNA vaccine within 60 days of study vaccination.
  • Any participant with a history of myocarditis or pericarditis.
  • Any participant with history of an immune-mediated neurological disease, including Guillain-Barré Syndrome (GBS).
  • Have a screening abnormality that is > Grade 1.

About this study

Official title: A Phase 1/2, Randomized, Placebo-Controlled, Double-Blind, Dose-Finding, First-in-Human Study of Respiratory Syncytial Virus (RSV) mRNA Vaccine STR-V003 in Healthy Adults

This is a randomized, double-blind, placebo-controlled, single ascending dose escalation and two-dose study in healthy adults. This study will be conducted in healthy men and women ≥18 years old to assess the safety, tolerability and immunogenicity of STR-V003. This trial consists of two parts: Part A and Part B.

Being tested
STR-V003/Placebo
Medical subject headings
Respiratory Syncytial Virus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • STR-V003/PlaceboBiological

    IM

Study groups in NCT06344975
Study groupRoleWhat they receive
Cohort1ExperimentalCohort 1: Dose A in Younger/older Adults Single injection of Dose A of STR-V003 or placebo on Day 0.
Receives: Biological: STR-V003/Placebo
Cohort2ExperimentalCohort 2: Dose B in Younger/older Adults Single injection of Dose B of STR-V003 or placebo on Day 0.
Receives: Biological: STR-V003/Placebo
Cohort3ExperimentalCohort 3: Dose C in Younger/older Adults Single injection of Dose C of STR-V003 or placebo on Day 0.
Receives: Biological: STR-V003/Placebo
Cohort4ExperimentalCohort 4: Dose B in Younger/older Adults Two injections of Dose B of STR-V003 or placebo on Day 0 and Day21.
Receives: Biological: STR-V003/Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Immediate unsolicited AEs for 30 minutes post-vaccination

    Percentage of Participants With Immediate unsolicited AEs Through 30 minutes After Initial Vaccination

    Measured: 30 minutes

  2. Solicited injection site (local) and systemic reactions for 7 days postvaccination.

    Percentage of Participants With Solicited injection site (local) and systemic reactions for 7 days After Initial Vaccination

    Measured: 7 days

  3. Unsolicited AEs for 28 days postvaccination

    Percentage of Participants With Unsolicited AEs for 28 days After Initial Vaccination

    Measured: 28 days

  4. Medically attended adverse events (MAAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) for the entire study duration

    Percentage of Participants With Medically attended adverse events (MAAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) for the entire study duration

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2024
  2. Study startMay 2024 (estimated)
  3. Primary completionDec 2024 (estimated)
  4. Study completionMay 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06344975
Sponsor's protocol ID
Starna Therapeutics
Acronym
STR-V003
Status last verified
Mar 2024
First submitted
25 Mar 2024
Last updated
3 Apr 2024
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study of Respiratory Syncytial Virus Infections, run by Starna Therapeutics.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Immediate unsolicited AEs for 30 minutes post-vaccination (time frame: 30 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06344975.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.

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