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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 117
研究概览
简要总结
Whooping cough is a severe respiratory tract infection that kills almost 200,000 children annually worldwide and is caused by the bacteria ‘Bordetella pertussis’. The incidence of whooping cough is increasing in adolescents and adults due to waning immunity to current acellular whooping cough vaccines versus whole cell vaccines. This Phase 1 study evaluated the safety, tolerability, and immune response of an investigational tetanus/diphtheria/pertussis (Tdap) booster vaccine [Tdap-1018] compared to a licensed Tdap vaccine [Boostrix] in healthy volunteers. Adult participants, aged between 18 and 22 years of age, and Adolescent participants, aged between 10 and 17 years of age, were randomly assigned to receive either (i) Tdap-1018 1500 mcg or (ii) Tdap-1018 3000 mcg or (iii) Boostrix. Overall, both dose levels of Tdap-1018 were well tolerated without any safety concerns. Typical post-injection site reactions were reported by participants (injection site pain, redness), with moderate injection site pain reported more in subjects administered Tdap-1018 compared to Boostrix. Most adverse events were mild, with few severe or related to Tdap-1018. All participants developed antibodies against tetanus and diphtheria at levels considered to provide protection. The results of anti-tetanus antibodies in all participants are associated with long term protection. For pertussis, there is no measurable value of immunity/protection (immunologic correlate of protection
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 10 Years 至 22 Years（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
- •- 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.