NCT05655182招募中1 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 137
- 试验地点
- 26
- 主要终点
- Solicited Adverse Events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •<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):
- 另有 17 项未显示
研究组 & 干预措施
Group 1, infants (age 18-59 months), RSV+, Placebo
Placebo Comparator
4 RSV seropositive participants will be administered placebo by intranasal route on Day 1
干预措施: Placebo (Drug)
Group 6, children (age 8-24 months), RSV+ or RSV-, Placebo
Placebo Comparator
15 participants will be administered Placebo by intranasal route on Day 1 and Day 57
干预措施: Placebo (Drug)
Group 2, infants (age 18-59 months), RSV+, Placebo
Placebo Comparator
4 RSV seropositive participants will be administered placebo by intranasal route on Day 1
干预措施: Placebo (Drug)
Group 3, children (age 8-24 months), RSV+ or RSV-, BLB201 10^6 PFU
Experimental
16 participants will be administered BLB201 10^6 PFU by intranasal route on Day 1
干预措施: PIV5-vectored RSV Vaccine (BLB-201) Low Dose (Biological)
Group 2, infants (age 18-59 months), RSV+, BLB201 10^7 PFU
Experimental
6 RSV seropositive participants will be administered 10^7 PFU BLB-201 by intranasal route on Day 1
干预措施: PIV5-vectored RSV Vaccine (BLB-201) High Dose (Biological)
Group 3, children (age 8-24 months), RSV+ or RSV-, Placebo
Placebo Comparator
8 participants will be administered placebo by intranasal route on Day 1
干预措施: Placebo (Drug)
Group 4, children (age 6-24 months), RSV+ or RSV-, BLB201 10^7 PFU
Experimental
32 participants will be administered BLB201 10^7 PFU by intranasal route on Day 1
干预措施: PIV5-vectored RSV Vaccine (BLB-201) High Dose (Biological)
Group 4, children (age 8-24 months), RSV+ or RSV-, Placebo
Active Comparator
16 participants will be administered placebo by intranasal route on Day 1
干预措施: Placebo (Drug)
Group 6, children (age 8-24 months), RSV+ or RSV-, BLB201 10^7 PFU
Experimental
30 participants will be administered BLB201 10^7 PFU by intranasal route on Day 1 and Day 57
干预措施: PIV5-vectored RSV Vaccine (BLB-201) High Dose (Biological)
Group 1, infants (age 18-59 months), RSV+, BLB201 10^6 PFU
Experimental
6 RSV seropositive participants will be administered 10^6 PFU BLB-201 by intranasal route on Day 1
干预措施: PIV5-vectored RSV Vaccine (BLB-201) Low Dose (Biological)
结局指标
主要结局
Solicited Adverse Events
时间窗: Day 1-15
Frequencies and grades of solicited local and systemic AEs during a 14-day period after dosing.
Unsolicited Adverse Events
时间窗: Day 1-29
Frequencies and grades of unsolicited AEs during a 28-day period after dosing.
次要结局
未报告次要终点
研究者
研究点 (26)
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