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BLB-201 疫苗在 RSV 血清阴性和血清阳性婴儿和儿童中的 1/2a 期研究

2026年10月20日 更新者：Blue Lake Biotechnology Inc.

PIV5 载体 RSV 疫苗 (BLB-201) 在 RSV 血清阴性和血清阳性婴儿和儿童中的安全性、耐受性和免疫原性的 1/2a 期试验

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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

137

阶段

  • 阶段2
  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

6个月 至 5年 (孩子)

接受健康志愿者

是的

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：顺序分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：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
生物：PIV5-vectored RSV Vaccine (BLB-201) Low Dose

BLB201 10^6 PFU
安慰剂比较：Group 1, infants (age 18-59 months), RSV+, Placebo

4 RSV seropositive participants will be administered placebo by intranasal route on Day 1
药品：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).
实验性的：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
生物：PIV5-vectored RSV Vaccine (BLB-201) High Dose

BLB201 10^7 PFU
安慰剂比较：Group 2, infants (age 18-59 months), RSV+, Placebo

4 RSV seropositive participants will be administered placebo by intranasal route on Day 1
药品：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).
实验性的：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
生物：PIV5-vectored RSV Vaccine (BLB-201) Low Dose

BLB201 10^6 PFU
安慰剂比较：Group 3, children (age 8-24 months), RSV+ or RSV-, Placebo

8 participants will be administered placebo by intranasal route on Day 1
药品：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).
实验性的：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
生物：PIV5-vectored RSV Vaccine (BLB-201) High Dose

BLB201 10^7 PFU
有源比较器：Group 4, children (age 8-24 months), RSV+ or RSV-, Placebo

16 participants will be administered placebo by intranasal route on Day 1
药品：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).
实验性的：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
生物：PIV5-vectored RSV Vaccine (BLB-201) High Dose

BLB201 10^7 PFU
安慰剂比较：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
药品：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).

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Solicited Adverse Events
大体时间：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
大体时间：Day 1-29

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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Blue Lake Biotechnology Inc.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年3月9日

初级完成 (估计的)

2028年12月30日

研究完成 (估计的)

2028年12月30日

研究注册日期

首次提交

2022年12月8日

首先提交符合 QC 标准的

2022年12月8日

首次发布 (实际的)

2022年12月19日

研究记录更新

最后更新发布 (实际的)

2026年10月21日

上次提交的符合 QC 标准的更新

2026年10月20日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • BLB-201-002

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

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

IPD 共享时间框架

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

IPD 共享访问标准

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).

IPD 共享支持信息类型

  • 研究方案

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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