A Phase 2b, Multi-Centre, Placebo-Controlled, Randomized Study of BPZE1 Intranasal Pertussis Vaccine in Healthy School-Age Children to Assess the Immunological Response and Safety Profile of a Single Dose BPZE1 With and Without Co-Administration of Tetanus, Diphtheria, and Acellular Pertussis (BoostrixTM) IB-201P
Open to recruitment: Open to recruitment
Aim of the study: We are asking for your child to join this study, to find out if a new nasal spray vaccine called BPZE1 can help prevent people from getting whooping cough (pertussis) or spreading it to others.
Each subject must meet all the following criteria to be enrolled in this study:
- Male or female, 6 to 16 years of age on Day 1 (day of vaccination)
- Participant (and/or legal guardian) is capable of understanding the written informed consent, provide signed and witnessed informed consent and understand and comply with protocol requirements
- Female subjects of reproductive age must be nonpregnant and nonlactating. If of childbearing potential must agree to be heterosexually inactive or agrees to use birth control
- Participant has a stable heath status
- Participant (and/or legal guardian) has access to consistent and reliable means of electronic or telephone contact
- Participant is willing to refrain from routine nasal sprays or washes at least 7 days following any study vaccination
- The participant (and/or legal guardian) lives within a reasonable distance from the clinical site, willing and able to travel from clinical site for follow-up visits and agrees medical evaluation in the event of an Adverse Event
- The participant (and/or legal guardian) agrees to stay in contact with clinical site for the duration of the study
Subjects meeting any of the following criteria will be excluded from the study:
- Participant has history of Tdap vaccination or documented pertussis infection within 3 years to Day 1
- Participant has chronic significant illness actively being treated or history of recent intervention for worsening or fluctuating symptoms
- Participant has a history of cancer
- Participant has a congenital, hereditary, or acquired disease or disorder classified as autoimmune, immunodeficient, coagulopathy, hepatic, renal, neurologic or cognitive
- Participant currently uses smoking products
- Participant has received immunoglobulin, blood-derived products, systemic corticosteroids or other immunosuppressant drugs within 90 days to Day 1
- Participant has chronic pulmonary disease requiring active medication or pulmonary therapies with the following exceptions:
- Participants with exercise-induced bronchospasm
- Participants with Step 1 (intermittent) asthma classification
- Participants has history of oro/nasopharynx surgery within 60 days prior to Day 1
- Participant has known hypersensitivity to latex or any component of any study vaccine
- Participant has participated in any other clinical trial for the testing of an unlicensed product within 6 months prior to Day 1 or planning to participate in any other clinical trial during study conduct through Day 85 following last study vaccination
- Participant has routine and/or repeated contact with, or is currently living in a household with, an immunocompromised individual
- Participant has any medical conditions that, in the opinion of the investigator, might interfere with the study evaluation or individual’s safety
- Participant is a study team member or first-degree relative of a study team member
- Participant resides in a residence during the vaccination period where an infant less than 6 months of age resides or may reside
What participating in the study involves:
If you agree to your child’s participation in this study, your child’s study doctor will first check your child’s eligibility for participation. Your child can qualify to be entered into the study and receive vaccination on the same day or you may need/want to return for the vaccination on another day.
Your child will be randomly assigned into 1 of 3 different study treatment groups to receive the BPZE1 vaccine, the Boostrix vaccine, or both. This means a computer program will randomly assign your child to be in one of these groups by chance; similar to tossing a coin.
The BPZE1 vaccine will be given using an atomization device (a small, cone-shaped device that attaches to a syringe and sprays the vaccine into the nose), which will spray a mist of the liquid vaccine into both nostrils. Your child will be asked to be partially reclined or sitting upright with your head and neck tilted back for a short time after this vaccine is given. Your child will receive the intranasal vaccination first and wait at least 10 min before receiving the next vaccination.
The Boostrix vaccine will be injected into your child’s upper arm using a standard size needle and syringe that are usually used for vaccination. Your child will stay in the clinic for at least 30 minutes after this last vaccination to be monitored for any safety concerns. If your child is one of the first 45 participants in the trial, they will wait at least 30 minutes after the intranasal vaccination before receiving the intramuscular vaccination and again need to wait 30 min after the last vaccination before exiting the clinic.
If your child is one of the first 45 participants in the trial, they will also provide 1 teaspoon (approximately 5 ml) more blood for extra immunity testing and have a clinic visit 1 week after the vaccination day to assess any reaction to the vaccine and any ongoing health concerns. At this time, a nasal swab and blood sample will be taken. Because your child is having this extra visit and providing samples at that time, your child will not be required to have an onsite visit after 3 months or provide samples. Instead, this visit can be done by phone call or telemedicine.
You can also choose for your child to take part in a smaller study called a substudy within this research study. If you decide for your child to participate in this substudy, then your child will receive a BPZE1 nasal vaccination 3 months after their first vaccination. A separate informed consent document will explain the substudy to help you decide if you would like your child to participate in that substudy. This is considered “open label” as every child participating in the substudy will know they have received BPZE1 (unlike the beginning of the study when you/your child and the study doctor do not know what study vaccine was received). There will be 3 extra visits over the course of 1 month after your child receives the BPZE1 vaccination if they are in this sub-study.