None listed
Conditions
Brief summary
The purpose of the study is to determine what dose of Tdap-1018, a vaccine intended for booster immunization against tetanus, diphtheria, and pertussis in individuals 10 to 22 years of age is optimum for use. The study will enroll healthy adolescent and adult volunteers aged between 10 and 22 years. The total duration of the study will be approximately 16 weeks. Study details: The study will be conducted in 2 parts: • Part 1 will enroll approximately 90 healthy adult participants 18 to 22 years of age, inclusive. Part 1 has two groups evaluating two dose levels of Tdap-1018. • Part 2 will enroll approximately 48 healthy adolescent participants 10 to 17 years of age, inclusive. Part 2 will also have two groups for evaluating two dose levels of Dtap-1018. All participants will receive 1 dose of their assigned treatment (Tdap 1018 Dose 1, Tdap-1018 Dose 2, or Boostrix). All participants will undergo assessments of safety and immunogenicity. Participants will be followed for safety for 12 weeks after the study injection. All participants will have a pre-vaccination blood draw and receive the assigned treatment vaccine at Day 1. Blood draws for measuring post-vaccination antibody levels and exploratory evaluations will be done at Week 4. Safety assessments will be done at Weeks 4 and 12. It is perhaps intended that this study will determine the dose of Tdap-1018 vaccine intended for active booster immunization against tetanus, diphtheria, and pertussis.
Interventions
The study will be conducted in 2 parts:
• Part 1 will enroll approximately 90 healthy adult volunteers 18 to 22 years of age, inclusive in two escalating dose levels of Tdap-1018. 45 participants will be enrolled into each of the groups:
- Group A (Tdap 1018, 1500mcg n=30; Boostrix n=15)
- Group B (Tdap-1018, 3000 mcg n=30; Boostrix n=15)
• Part 2 will enroll healthy adolescent volunteers 10 to 17 years of age, inclusive. Part 2 will consist of approximately 48 participants in 2 escalating dos
The study will be conducted in 2 parts: • Part 1 will enroll approximately 90 healthy adult volunteers 18 to 22 years of age, inclusive in two escalating dose levels of Tdap-1018. 45 participants will be enrolled into each of the groups: - Group A (Tdap 1018, 1500mcg n=30; Boostrix n=15) - Group B (Tdap-1018, 3000 mcg n=30; Boostrix n=15) • Part 2 will enroll healthy adolescent volunteers 10 to 17 years of age, inclusive. Part 2 will consist of approximately 48 participants in 2 escalating dose levels of Tdap-1018 (Group C: 1500 mcg; Group D: 3000 mcg) with approximately 24 participants (Tdap 1018 n = 16; Boostrix n = 8) in each group. A Safety Monitoring Committee (SMC) will oversee the dose escalation. Enrollment of adolescent participants will be initiated after 12 vaccine recipients in Part 1, Group B have completed week 4 and a preliminary safety assessment is completed by the SMC. All adult and adolescent participants will receive 1 dose of their assigned treatment. All participants will undergo assessments of safety and immunogenicity. Participants will be followed for safety for 12 weeks after the study injection. All participants will have a pre-vaccination blood draw and receive the assigned treatment vaccine at Day 1. Blood draws for measuring post-vaccination antibody levels and exploratory evaluations will be done at Week 4. Safety assessments will be done at Weeks 4 and 12.
Sponsors
Dynavax Technologies Corporation
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
10 Years to 22 Years
Healthy volunteers
Yes
Inclusion criteria
A participant must meet all of the following criteria to be eligible for enrollment (defined as receiving any study vaccine) in the study: 1) Willing to participate: pediatric assent and written parental/legal guardian consent; or adult informed consent provided for the study 2) Male or female, 18 to 22 (Part 1) or 10 to 17 (Part 2) years of age 3) Have documentation of 2 or more prior acellular pertussis (aP) vaccinations 4) Be in good health in the opinion of the investigator, based upon medical history, physical examination (adults), and laboratory evaluation (adults) 5) Adult participant, or adolescent participant and/or adult guardian of adolescent participant, be able to comprehend and follow all required study procedures and be available for all visits scheduled in the study 6) Seronegative for human immunodeficiency virus (HIV), adults only
Exclusion criteria
A participant with any 1 of the following criteria is not eligible for enrollment (defined as receiving any study vaccine) in the study: 1) Received acellular Tdap booster within the previous 3 years 2) History of diphtheria, tetanus or pertussis disease 3) History of encephalopathy within 7 days of a previous dose of pertussis vaccine 4) History of any progressive neurologic disorder, uncontrolled epilepsy, or progressive encephalopathy 5) If female of childbearing potential, is pregnant, breastfeeding, or planning a pregnancy 6) Known history of HIV (HIV 1/2 antibodies) 7) Has a history of sensitivity to any component of study vaccines 8) Has received any blood products or immunoglobulin within 90 days prior to study injection, or is likely to require infusion of blood products during the study period 9) Has received the following prior to the injection: • 14 days: any non-live virus vaccine • 28 days: - Any live virus vaccine, including a COVID-19 vaccine - Systemic corticosteroids (more than 3 consecutive days) or other immunomodulators or immune suppressive medication, with the exception of inhaled steroids - Granulocyte or granulocyte-macrophage colony-stimulating factor - Any other investigational medicinal agent including COVID-19 vaccine • 90 days: immunoglobulins or any blood products • At any time: an injection of deoxyribonucleic acid plasmids or oligonucleotides 10) Is undergoing chemotherapy or expected to receive chemotherapy during the study period; has a diagnosis of cancer within the last 5 years other than squamous or basal cell carcinoma of the skin 11) History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator 12) Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study 13) Requires vaccination for travel or medical reasons (eg, potential exposure to one of the diseases, prophylaxis for exposure to vulnerable people, babies) 14) History of autoimmune disease.
Outcome results
None listed