Respiratory Syncytial Virus Infections study: PIV5-vectored RSV Vaccine
Official title A Study of BLB-201 RSV Vaccine in Infants and Children
ClinicalTrials.gov ID: NCT05655182
What this study is testing
What is PIV5-vectored RSV Vaccine (BLB-201) Low Dose?
This is an investigational nasal spray being studied to help prevent respiratory syncytial virus (RSV) infections in young children. It is designed to use a harmless parainfluenza virus to carry instructions into cells so the body can learn to recognize and fight RSV.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study checks if the vaccine is safe, well tolerated, and can trigger an immune response in infants and children.
- Who it's for
- Infants 8‑24 months old and children 18‑59 months old, whether or not they have had RSV before.
- What's involved
- Participants receive one of two vaccine doses or a placebo through the nose, then have follow‑up visits and blood tests to monitor safety and immune response.
- Time commitment
- The study lasts about 6 months, with several clinic visits for vaccination, monitoring, and blood sampling.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 5. Healthy volunteers may be eligible.
You may be able to join if
- Healthy children at least 18 months but less than 60 months of age whose legally-acceptable representative (LAR) understands and signs the trial...
- Determined by medical history, targeted physical exam, and clinical judgement of the investigator to be in a good state of health.
- 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...
You likely can't join if
- \ 60 months of age at the time of planned vaccine inoculation.
- Born at less than 34 weeks gestation for people ≥ 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...
See the full eligibility criteria
Who can join
- 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...
- Determined by medical history, targeted physical exam, and clinical judgement of the investigator to be in a good state of health.
- 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...
- 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.
- 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.
- 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...
- 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
What rules you out
- \ 60 months of age at the time of planned vaccine inoculation.
- Born at less than 34 weeks gestation for people ≥ 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.
- 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.
- 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.
- Pregnant woman.
- Persons with hospitalization for asthma or other chronic respiratory disease in the past 5 years.
- 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 people with any condition that would in the opinion of the...
- people testing positive for infection with RSV, Influenza, or SARS-CoV-2 in the 3 months prior to enrollment.
- 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.
- 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.
- 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...
- 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
- The following are temporary or self-limiting conditions, and once resolved, the subject may be enrolled, if otherwise eligible.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- La Mesa, California, United States
- Modesto, California, United States
- San Diego, California, United States
- Aurora, Colorado, United States
- Atlanta, Georgia, United States
- Rexburg, Idaho, United States
- Newton, Kansas, United States
- Allen Park, Michigan, United States
- Grand Island, Nebraska, United States
- Lincoln, Nebraska, United States
- Beachwood, Ohio, United States
- Cincinnati, Ohio, United States
- Greenville, South Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 months to 5 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at La Mesa, California, United States; Modesto, California, United States; San Diego, California, United States; Aurora, Colorado, United States; Atlanta, Georgia, United States; Rexburg, Idaho, United States and 7 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.