CompletedPhase 1ACTRN12620001177943

A study to evaluate the Safety, Tolerability, and Immunogenicity of an Investigational Tetanus/Diphtheria/Pertussis Booster Vaccine (Tdap-1018) Compared to Boostrix in Healthy Volunteers Between 10 and 22 Years of Age

A Phase 1 Randomized, Participant-Blinded, Active-Controlled, Dose Escalation, Multi-center Study to Evaluate the Safety, Tolerability, and Immunogenicity of an Investigational Tetanus/Diphtheria/Pertussis Booster Vaccine (Tdap-1018) Compared to Boostrix in Healthy Volunteers Between 10 and 22 Years of Age

Sponsor

Dynavax Technologies Corporation

Enrollment

138 participants

Start Date

Jan 27, 2021

Study Type

Interventional

Conditions

Diptheria Pertussis Tetanus

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.

Eligibility

Sex: Both males and femalesMin Age: 10 YearssMax Age: 22 Yearss

Inclusion Criteria7

A participant must meet all of the following criteria to be eligible for enrollment (defined as receiving any study vaccine) in the study:
Willing to participate: pediatric assent and written parental/legal guardian consent; or adult informed consent provided for the study
Male or female, 18 to 22 (Part 1) or 10 to 17 (Part 2) years of age
Have documentation of 2 or more prior acellular pertussis (aP) vaccinations
Be in good health in the opinion of the investigator, based upon medical history, physical examination (adults), and laboratory evaluation (adults)
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
Seronegative for human immunodeficiency virus (HIV), adults only

Exclusion Criteria23

A participant with any 1 of the following criteria is not eligible for enrollment (defined as receiving any study vaccine) in the study:
Received acellular Tdap booster within the previous 3 years
History of diphtheria, tetanus or pertussis disease
History of encephalopathy within 7 days of a previous dose of pertussis vaccine
History of any progressive neurologic disorder, uncontrolled epilepsy, or progressive encephalopathy
If female of childbearing potential, is pregnant, breastfeeding, or planning a pregnancy
Known history of HIV (HIV 1/2 antibodies)
Has a history of sensitivity to any component of study vaccines
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
Has received the following prior to the injection:
days: any non-live virus vaccine
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
days: immunoglobulins or any blood products
At any time: an injection of deoxyribonucleic acid plasmids or oligonucleotides
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
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
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study
Requires vaccination for travel or medical reasons (eg, potential exposure to one of the diseases, prophylaxis for exposure to vulnerable people, babies)
History of autoimmune disease.

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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 w

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.