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Studio di fase 1/2a sul vaccino BLB-201 in lattanti e bambini sieronegativi e sieropositivi per RSV

20 ottobre 2026 aggiornato da: Blue Lake Biotechnology Inc.

Uno studio di fase 1/2a sulla sicurezza, tollerabilità e immunogenicità del vaccino RSV con vettore PIV5 (BLB-201) in neonati e bambini sieronegativi e sieropositivi per RSV

This Phase 1/2a trial is a randomized, placebo-controlled trial to evaluate the safety, tolerability and immunogenicity of two ascending doses (10^6 PFU and 10^7 PFU) of intranasal BLB-201 (a recombinant parainfluenza virus type 5) administered in infants (8-24 months of age) and children (18-59 months of age) who may or may not have had prior respiratory syncytial virus (RSV) infection.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This trial is designed to evaluate the safety, tolerability and immunogenicity of BLB-201 vaccine in infants (8-24 months of age) and children (18-59 months of age) who may or may not have had prior respiratory syncytial virus (RSV) infection. One (Day 1) or two doses (Day 1 and Day 57) of low (10^6 PFU) and high dosage (10^7 PFU) of BLB-201 will be evaluated.

Tipo di studio

Interventistico

Iscrizione (Stimato)

137

Fase

  • Fase 2
  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Stati Uniti
    • California
      • La Mesa, California, Stati Uniti, 91942
        • Reclutamento
        • Paradigm Clinical Research
        • Investigatore principale:
          • Shaun Berger, MD
        • Contatto:
      • Modesto, California, Stati Uniti, 95355
        • Reclutamento
        • Paradigm Clinical Research - Modesto
        • Contatto:
        • Investigatore principale:
          • Jose Rodriguez
      • San Diego, California, Stati Uniti, 92123
        • Reclutamento
        • University of California, San Diego
        • Contatto:
        • Investigatore principale:
          • Ronald Teufel, MD
    • Colorado
      • Aurora, Colorado, Stati Uniti, 80012
        • Reclutamento
        • Paradigm Clinical Research Centers, LLC - Colorado, 1550 South Potomac Street, Suite 340
    • Georgia
      • Atlanta, Georgia, Stati Uniti, 30322
        • Reclutamento
        • Emory Children's Center- Vaccine Research Clinic
        • Contatto:
        • Investigatore principale:
          • Christina Rostad
    • Idaho
      • Meridian, Idaho, Stati Uniti, 83642
        • Completato
        • Velocity Clinical Research, Boise
      • Rexburg, Idaho, Stati Uniti, 83440
        • Reclutamento
        • Clinical Research Prime
        • Contatto:
        • Investigatore principale:
          • Jeffrey B. Baker
    • Kansas
      • Newton, Kansas, Stati Uniti, 67114
        • Reclutamento
        • AMR Newton
        • Investigatore principale:
          • Troy Holdeman, MD
        • Contatto:
    • Louisiana
      • Lafayette, Louisiana, Stati Uniti, 70508
        • Completato
        • Velocity Clinical Research - Lafayette
    • Michigan
      • Allen Park, Michigan, Stati Uniti, 48101
        • Reclutamento
        • Michigan Institute of Research
        • Contatto:
        • Investigatore principale:
          • Nouh Mazloum
    • Nebraska
      • Grand Island, Nebraska, Stati Uniti, 68803
        • Reclutamento
        • Velocity Clinical Research, Grand Island
        • Investigatore principale:
          • Adam Brosz, MD
        • Contatto:
      • Lincoln, Nebraska, Stati Uniti, 68516
    • Ohio
      • Beachwood, Ohio, Stati Uniti, 44122
        • Reclutamento
        • Velocity Clinical Research, Cleveland
        • Investigatore principale:
          • Margaret Rhee, MD
        • Contatto:
      • Cincinnati, Ohio, Stati Uniti, 45229
        • Reclutamento
        • Cincinnati Children's Hospital Medical Center
        • Contatto:
        • Investigatore principale:
          • Paul Spearman, MD
    • South Carolina
      • Greenville, South Carolina, Stati Uniti, 29680
        • Reclutamento
        • Tribe Clinical Research, LLC Parkside Pediatrics
        • Investigatore principale:
          • Carole Mercer
        • Contatto:
      • Greenville, South Carolina, Stati Uniti, 29607
        • Reclutamento
        • Tribe Clinical Research, LLC Parkside Pediatrics Verdae
        • Investigatore principale:
          • Scott Dobson
        • Contatto:
    • Texas
      • Cedar Park, Texas, Stati Uniti, 78613
        • Attivo, non reclutante
        • Velocity Clinical Research, Austin
      • Houston, Texas, Stati Uniti, 77030
        • Attivo, non reclutante
        • Baylor College of Medicine

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 6 mesi a 5 anni (Bambino)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion criteria for sero+ children 18 to 59 months of age enrolled in Groups 1 and 2:

Healthy children at least 18 months but less than 60 months of age whose legally-acceptable representative (LAR) understands and signs the trial informed consent and agrees to vaccine administration following a detailed explanation of the trial.

Determined by medical history, targeted physical exam, and clinical judgement of the investigator to be in a good state of health. Screening laboratory values slightly outside lab normal ranges may be acceptable if the site investigator determines that they are not clinically significant. Permitted concomitant medications include nutritional supplements, medications for gastroesophageal reflux, eye drops, and topical medications, including topical steroids, topical antibiotics, and topical antifungal agents.

Sero+ for RSV as defined by serum RSV antibody titer assay

Participant is expected to be available for the duration of the trial.

The LAR confirms that the subject has received routine immunizations appropriate for age based on the current Advisory Committee on Immunization Practices (ACIP) Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger.

Growing normally for age as demonstrated on a World Health Organization (WHO) growth chart, AND has a current height and weight above the 3rd percentile for age.

Inclusion criteria for sero+ or sero- infants and children 8 to 24 months of age enrolled in Groups 3 through 6:

Healthy children at least 8 months but less than 25 months of age whose LAR understands and signs the trial informed consent and agrees to vaccine administration following a detailed explanation of the trial.

Determined by medical history, targeted physical exam, and clinical judgement of the investigator to be in a good state of health. Screening laboratory values slightly outside lab normal ranges may be acceptable if the site investigator determines that they are not clinically significant. Permitted concomitant medications include nutritional supplements, medications for gastroesophageal reflux, eye drops, and topical medications, including topical steroids, topical antibiotics, and topical antifungal agents.

Sero- OR sero+ for RSV antibody, defined by serum RSV antibody titer assay not more than 30 days prior to vaccination.

Participant is expected to be available for the duration of the trial.

The LAR confirms that subject has received routine immunizations appropriate for age based on the current Advisory Committee on Immunization Practices (ACIP) Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger.

Growing normally for age as demonstrated on a World Health Organization (WHO) growth chart, AND

If <1 year of age: has a current height and weight above the 5th percentile for age.

If ≥1 year of age: has a current height and weight above the 3rd percentile for age.

Subject Exclusion Criteria

<8 months of age and >60 months of age at the time of planned vaccine inoculation.

Born at less than 34 weeks gestation for subjects ≥ 1 year of age at enrollment

Born at less than 37 weeks gestation, and at the date of inoculation less than 1 year of age.

Maternal history of a positive HIV test before or during pregnancy.

Maternal history of illicit drug abuse or alcohol abuse.

Evidence of chronic disease except for chronic diseases that are mild, stable and not immune compromising or require recent change (< 60 days) in management (e.g., mild stable eczema, mild allergic rhinitis)

Clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality as determined by medical history or physical exam. Abnormal pulse oximetry testing during screening for undetected critical congenital heart disease or concern for such by medical history or physical exam.

Acute or chronic medical condition or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgement, make the participant inappropriate for the study.

History of severe infection (e.g., requiring hospitalization).

Known or suspected impairment of immunological functions, bone marrow/solid organ transplant recipients.

Receiving immunosuppressive therapy including systemic corticosteroids.

Major congenital malformations, including congenital cleft palate or cytogenetic abnormalities.

Suspected or documented developmental disorder, delay, or other developmental problem.

Cardiac abnormality requiring treatment. Participants with clinically insignificant cardiac abnormalities (e.g., clinically insignificant patent foramen ovale) requiring no treatment may be enrolled.

Lung disease or reactive airway disease.

History of wheezing episode/s or receipt of bronchodilator therapy

Previous receipt of supplemental oxygen therapy in a home setting.

History of severe RSV infection or severe respiratory virus infection (e.g., requiring hospitalization).

Previous immunization with an investigational RSV vaccine.

Previous or planned administration of any anti-RSV antibody product within 6 months of receipt of study vaccine.

Previous receipt of immunoglobulin or any other antibody products within the past 6 months.

Previous receipt of any blood products within the past 6 months.

Previous anaphylactic reaction.

Previous serious vaccine-associated adverse reaction or one that was Grade 3 or above.

Known hypersensitivity to any study vaccine product component.

Household contact with any of the following groups of individuals for the period up to 28 days after vaccination (including after each dose for cohorts receiving two doses of vaccine):

Member of a household that contains an infant who is less than 6 months of age at the date of inoculation through the 28th day after inoculation. In groups assigned to two doses of vaccine, to include date of inoculation through the 28th day after the second inoculation.

Pregnant woman.

Persons with hospitalization for asthma or other chronic respiratory disease in the past 5 years.

Member of a household that, at the date of inoculation through the 28th day after inoculation (including second dose if scheduled), contains an immunocompromised individual including but not limited to:

A person who is HIV-infected.

A person who has cancer and has received chemotherapy within the 12 months prior to enrollment.

A person with a solid organ or bone marrow transplant.

A person currently receiving immunosuppressive agents.

Attends a daycare facility that does not separate children by age and contains an infant

<6 months of age at the date of inoculation through the 28th day after inoculation.

Neurological and neurodevelopmental conditions (e.g., cerebral palsy, epilepsy, stroke, seizures).

History of postinfectious or postvaccine neurological sequelae.

Autoimmune, inflammatory, vascular, or rheumatic disease.

Household contact of another child enrolled into the trial.

Inadequate venous access for repeated phlebotomy.

Subject's LAR/s who, in the opinion of the site investigator, are not suitable participants for the study, for any reason not previously delineated, including subjects with any condition that would in the opinion of the site investigator place the subject at unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.

Subjects testing positive for infection with RSV, Influenza, or SARS-CoV-2 in the 3 months prior to enrollment.

Planned receipt of any of the following prior to planned trial vaccine receipt (Day 1 and Day 57 for group receiving 2 doses of vaccine):

Inactivated influenza vaccine within 14 days prior, or

Any other inactivated vaccine or live-attenuated rotavirus vaccine within the 14 days prior, or

Any live vaccine, other than rotavirus vaccine, within the 28 days prior, or

Another investigational vaccine or investigational drug within 28 days prior.

Salicylate (aspirin) or salicylate-containing products within 28 days prior.

Planned receipt of any of the following after planned trial vaccine receipt (Day 1 and Day 57 for groups receiving 2 doses of vaccine):

Inactivated vaccine or live-attenuated rotavirus vaccine within the 14 days after, or

Any live vaccine other than rotavirus in the 28 days after, or

Another investigational vaccine or investigational drug in the 56 days after.

Planned receipt of any of the following medications within 7 days of trial enrollment and 7 days after trial vaccine (Day 1 and also Day 57 for groups receiving 2 doses of vaccine):

Systemic antibacterial, antiviral, antifungal, anti-parasitic, or antituberculous agents, whether for treatment or prophylaxis, or systemic or nasal steroid therapy for acute illness.

Any other intranasal medications, or

Other prescription medications except permitted concomitant medications. Permitted concomitant medications (prescription or non-prescription) include nutritional supplements, medications for gastroesophageal reflux, eye drops, and topical medications, including (but not limited to) cutaneous (topical) steroids, topical antibiotics, and topical antifungal agents.

History of bleeding disorder or significant problem with bleeding

American Indian or Alaska Native Infants/Children (high risk for severe RSV infection) AND eligible to receive nirsevimab

Temporary exclusion criteria for sero+ children, sero- children, and infants:

The following are temporary or self-limiting conditions, and once resolved, the subject may be enrolled, if otherwise eligible. If the period of temporary exclusion is greater than 30 days, sero- children will need to be rescreened for levels of RSV neutralizing antibody.

Any of the following events at the time of enrollment:

Fever (temperature of ≥100.4°F per site standard based on age; e.g., oral for older children, rectal for infants, axillary screening), or

Upper respiratory signs or symptoms (rhinorrhea, cough, or pharyngitis) or

Nasal congestion significant enough to interfere with successful vaccination.

Otitis media.

Contact with a person diagnosed with RSV, Influenza, coronavirus disease-2 (COVID- 19) or other viral respiratory illnesses within the preceding 10 days.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione sequenziale
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Group 1, infants (age 18-59 months), RSV+, BLB201 10^6 PFU

6 RSV seropositive participants will be administered 10^6 PFU BLB-201 by intranasal route on Day 1
Biologico: PIV5-vectored RSV Vaccine (BLB-201) Low Dose

BLB201 10^6 PFU
Comparatore placebo: Group 1, infants (age 18-59 months), RSV+, Placebo

4 RSV seropositive participants will be administered placebo by intranasal route on Day 1
Droga: Placebo

The placebo used for the trial will be the same as the diluent (0.9% sterile saline) used for the low dose group (10^6 PFU).
Sperimentale: Group 2, infants (age 18-59 months), RSV+, BLB201 10^7 PFU

6 RSV seropositive participants will be administered 10^7 PFU BLB-201 by intranasal route on Day 1
Biologico: PIV5-vectored RSV Vaccine (BLB-201) High Dose

BLB201 10^7 PFU
Comparatore placebo: Group 2, infants (age 18-59 months), RSV+, Placebo

4 RSV seropositive participants will be administered placebo by intranasal route on Day 1
Droga: Placebo

The placebo used for the trial will be the same as the diluent (0.9% sterile saline) used for the low dose group (10^6 PFU).
Sperimentale: Group 3, children (age 8-24 months), RSV+ or RSV-, BLB201 10^6 PFU

16 participants will be administered BLB201 10^6 PFU by intranasal route on Day 1
Biologico: PIV5-vectored RSV Vaccine (BLB-201) Low Dose

BLB201 10^6 PFU
Comparatore placebo: Group 3, children (age 8-24 months), RSV+ or RSV-, Placebo

8 participants will be administered placebo by intranasal route on Day 1
Droga: Placebo

The placebo used for the trial will be the same as the diluent (0.9% sterile saline) used for the low dose group (10^6 PFU).
Sperimentale: Group 4, children (age 6-24 months), RSV+ or RSV-, BLB201 10^7 PFU

32 participants will be administered BLB201 10^7 PFU by intranasal route on Day 1
Biologico: PIV5-vectored RSV Vaccine (BLB-201) High Dose

BLB201 10^7 PFU
Comparatore attivo: Group 4, children (age 8-24 months), RSV+ or RSV-, Placebo

16 participants will be administered placebo by intranasal route on Day 1
Droga: Placebo

The placebo used for the trial will be the same as the diluent (0.9% sterile saline) used for the low dose group (10^6 PFU).
Sperimentale: Group 6, children (age 8-24 months), RSV+ or RSV-, BLB201 10^7 PFU

30 participants will be administered BLB201 10^7 PFU by intranasal route on Day 1 and Day 57
Biologico: PIV5-vectored RSV Vaccine (BLB-201) High Dose

BLB201 10^7 PFU
Comparatore placebo: Group 6, children (age 8-24 months), RSV+ or RSV-, Placebo

15 participants will be administered Placebo by intranasal route on Day 1 and Day 57
Droga: Placebo

The placebo used for the trial will be the same as the diluent (0.9% sterile saline) used for the low dose group (10^6 PFU).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Solicited Adverse Events
Lasso di tempo: Day 1-15

Frequencies and grades of solicited local and systemic AEs during a 14-day period after dosing.
Day 1-15
Unsolicited Adverse Events
Lasso di tempo: Day 1-29

Frequencies and grades of unsolicited AEs during a 28-day period after dosing.
Day 1-29

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Blue Lake Biotechnology Inc.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

9 marzo 2023

Completamento primario (Stimato)

30 dicembre 2028

Completamento dello studio (Stimato)

30 dicembre 2028

Date di iscrizione allo studio

Primo inviato

8 dicembre 2022

Primo inviato che soddisfa i criteri di controllo qualità

8 dicembre 2022

Primo Inserito (Effettivo)

19 dicembre 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

21 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 ottobre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • BLB-201-002

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

De-identified IPD underlying the results reported in any published articles (text, tables, figures, appendices) will be shared.

Periodo di condivisione IPD

5 years, beginning as soon as possible (but no later than 12 months) after article publication.

Criteri di accesso alla condivisione IPD

Data will be made available to investigators and institutions upon request. Requests should be directed to the Blue Lake Biotechnology Inc authors of the publication(s).

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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