NCT05655182ClinicalTrials.gov

A Study of BLB-201 RSV Vaccine in Infants and Children

A Phase 1/2a Trial of the Safety, Tolerability and Immunogenicity of PIV5-vectored RSV Vaccine (BLB-201) in RSV Seronegative and Seropositive Infants and Children

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En resumen

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…

Fase 1 / Fase 2137 participantes buscados16 centros1 país

Categorías

Enfermedades infecciosas63%Respiratorio37%

Registrado en 1 registro

ClinicalTrials.govNCT05655182Abrir este registro en ClinicalTrials.govSincronizado hace 2 meses

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2022-12-19; recorded start 2023-03-09
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Present: Uses blinding (masking)A masking level is recorded in the record
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Not stated: No other studies from this sponsor are in this databaseCounted from the lead sponsor named in the record (Blue Lake Biotechnology Inc.)
Not stated: No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database

The record lists 1 condition.
Lead sponsor type recorded as: industry.
Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourDEFINITIVE

A definitive-grade design for a phase 2 study, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation20/20
Participants are randomly allocated between arms
Blinding20/20
Quadruple-blind
Control arm15/15
Active-comparator control arm
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
Multi-centre8/8
Multi-centre: 15 sites
Data monitoring committee7/7
A data monitoring committee is in place
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleSMALL

A small study: 137 participants (target), run at 16 sites.

How this score is built

Enrolment20/40
137 participants (target)
Site count14/25
15 sites
Country count0/15
Single country
Planned duration10/10
Planned over about 71 months
Sponsor scale0/10
Blue Lake Biotechnology Inc. has led 1 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Resumen

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.

Afecciones

Respiratory Syncytial Virus Infections

Elegibilidad

Elegibilidad
Sexo	Todos
Edades	6 Months – 5 Years
Voluntarios sanos	Sí

Elegibilidad tal como figura en el registro

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.

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Diseño del estudio
Tipo de estudio	De intervención
Fase	Fase 1 / Fase 2
Asignación	Aleatorizado
Modelo de intervención	SEQUENTIAL
Propósito principal	PREVENTION
Enmascaramiento	QUADRUPLE (4)
Inscripción	137 participantes buscados

Patrocinador y colaboradores

Blue Lake Biotechnology Inc. Patrocinador

Grupos e intervenciones

Group 1, infants (age 18-59 months), RSV+, BLB201 10^6 PFUEXPERIMENTAL
6 RSV seropositive participants will be administered 10\^6 PFU BLB-201 by intranasal route on Day 1
Group 1, infants (age 18-59 months), RSV+, PlaceboPLACEBO_COMPARATOR
4 RSV seropositive participants will be administered placebo by intranasal route on Day 1
Group 2, infants (age 18-59 months), RSV+, BLB201 10^7 PFUEXPERIMENTAL
6 RSV seropositive participants will be administered 10\^7 PFU BLB-201 by intranasal route on Day 1
Group 2, infants (age 18-59 months), RSV+, PlaceboPLACEBO_COMPARATOR
4 RSV seropositive participants will be administered placebo by intranasal route on Day 1
Group 3, children (age 8-24 months), RSV+ or RSV-, BLB201 10^6 PFUEXPERIMENTAL
16 participants will be administered BLB201 10\^6 PFU by intranasal route on Day 1
Group 3, children (age 8-24 months), RSV+ or RSV-, PlaceboPLACEBO_COMPARATOR
8 participants will be administered placebo by intranasal route on Day 1
Group 4, children (age 6-24 months), RSV+ or RSV-, BLB201 10^7 PFUEXPERIMENTAL
32 participants will be administered BLB201 10\^7 PFU by intranasal route on Day 1
Group 4, children (age 8-24 months), RSV+ or RSV-, PlaceboACTIVE_COMPARATOR
16 participants will be administered placebo by intranasal route on Day 1
Group 6, children (age 8-24 months), RSV+ or RSV-, BLB201 10^7 PFUEXPERIMENTAL
30 participants will be administered BLB201 10\^7 PFU by intranasal route on Day 1 and Day 57
Group 6, children (age 8-24 months), RSV+ or RSV-, PlaceboPLACEBO_COMPARATOR
15 participants will be administered Placebo by intranasal route on Day 1 and Day 57

Intervenciones

Biológico PIV5-vectored RSV Vaccine (BLB-201) High Dose
BLB201 10\^7 PFU
Biológico PIV5-vectored RSV Vaccine (BLB-201) Low Dose
BLB201 10\^6 PFU
Fármaco 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).

Variables de resultado

Variable de resultado principal
Solicited Adverse Events
Frequencies and grades of solicited local and systemic AEs during a 14-day period after dosing.
Plazo Day 1-15
Variable de resultado principal
Unsolicited Adverse Events
Frequencies and grades of unsolicited AEs during a 28-day period after dosing.
Plazo Day 1-29

Fechas

Fechas
Fecha de inicio	9 de marzo de 2023 (real)
Finalización principal	30 de diciembre de 2028 (estimada)
Finalización	30 de diciembre de 2028 (estimada)
Primera publicación	19 de diciembre de 2022 (real)
Última actualización	29 de julio de 2026
Resultados publicados	No indicado en el registro
Estado verificado por última vez	julio de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

16 centros están en reclutamiento

United States

United States
Centro	Ciudad	Estado o región	Estado
Michigan Institute of Research	Allen Park	Michigan	En reclutamiento
Paradigm Clinical Research Centers, LLC - Colorado, 1550 South Potomac Street, Suite 340	Aurora	Colorado	En reclutamiento
Velocity Clinical Research, Cleveland	Beachwood	Ohio	En reclutamiento
Velocity Clinical Research, Austin	Cedar Park	Texas	En reclutamiento
Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	En reclutamiento
Velocity Clinical Research, Grand Island	Grand Island	Nebraska	En reclutamiento
Tribe Clinical Research, LLC Parkside Pediatrics	Greenville	South Carolina	En reclutamiento
Baylor College of Medicine	Houston	Texas	En reclutamiento
Paradigm Clinical Research	La Mesa	California	En reclutamiento
Velocity Clinical Research - Lafayette	Lafayette	Louisiana	En reclutamiento
Be Well Clinical Studies	Lincoln	Nebraska	En reclutamiento
Velocity Clinical Research, Boise	Meridian	Idaho	En reclutamiento
Paradigm Clinical Research - Modesto	Modesto	California	En reclutamiento
AMR Newton	Newton	Kansas	En reclutamiento
Clinical Research Prime	Rexburg	Idaho	En reclutamiento
University of California, San Diego	San Diego	California	En reclutamiento

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

28 de julio de 2026
Centro añadido
1 site added (16 total)
1516

Registro: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT05655182