Phase 1b Open-Label Study of the Safety, Reactogenicity, and Immunogenicity of Prophylactic Vaccination With 2nd Generation (E1/E2B/E3-Deleted) Adenoviral-COVID-19 in Normal Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 4
- 主要终点
- Incidence and severity of solicited systemic reactogenicity AEs
研究概览
简要总结
This is a phase 1b, open-label study in adult healthy subjects. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity of the hAd5-S-Fusion+N-ETSD vaccine and select a dose for future studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults, age 18 - 55 years, inclusive, at time of enrollment.
- •Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
- •Agrees to the collection of biospecimens (eg, nasopharyngeal [NP] swabs) and venous blood per protocol.
- •Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
- •Temperature < 38°C.
- •Negative for SARS-CoV-2 (qPCR or LAMP test) and no known previous COVID-19 exposure or disease.
- •Agreement to practice effective contraception for female subjects of childbearing
- •potential and non-sterile males. Female subjects of childbearing potential must agree to use effective contraception while on study until at least 1 month after the last dose of vaccine. Non-sterile male subjects must agree to use a condom while on study until at least 1 month after the last dose of vaccine. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm) used with spermicide, intrauterine devices (IUDs), oral contraceptives, and abstinence.
排除标准
- •Allergy to any component of the investigational vaccine, or a more severe allergic reaction and history of allergies in the past.
- •Pregnant and nursing women. A negative serum or urine pregnancy test during screening and on the day of and prior to each dose must be documented before the vaccine is administered to a female subject of childbearing potential.
- •Live in a nursing home or long-term care facility.
- •Chronic lung disease including chronic obstructive pulmonary disease (COPD) or moderate to severe asthma.
- •Pulmonary fibrosis.
- •Active smoker.
- •Bone marrow or organ transplantation.
- •Obesity (defined as body mass index [BMI] of 30 kg/m2 or higher).
- •Chronic kidney disease.
- •Liver disease.
- •Sickle cell disease.
- •Thalassemia.
- •Doctors, nurses, first responders, and other healthcare workers working in direct contact with COVID-19 patients.
- •Any disease associated with acute fever, or any infection.
- •Self-reported history of severe acute respiratory syndrome (SARS).
- •History of hepatitis B or hepatitis C.
- •HIV or other acquired or hereditary immunodeficiency.
- •Serious cardiovascular diseases, such as heart failure, coronary artery disease, cardiomyopathies, arrhythmia, conduction block, myocardial infarction, pulmonary hypertension, severe hypertension without controllable drugs, etc.
- •Cerebrovascular disease.
- •Cystic fibrosis.
- •Neurologic conditions, such as dementia.
- •Hereditary or acquired angioneurotic edema.
- •Urticaria in the last 12 months.
- •No spleen or functional asplenia.
- •Platelet disorder or other bleeding disorder that may cause injection contraindication.
- •Chronic use (more than 14 continuous days) of any medications that may be associated with impaired immune responsiveness within 3 months before administration of study vaccine. (Including, but not limited to, systemic corticosteroids exceeding 10 mg/day of prednisone equivalent, allergy injections, immunoglobulin, interferon, immunomodulators. The use of low dose topical, ophthalmic, inhaled and intranasal steroid preparations will be permitted.)
- •Prior administration of blood products in last 4 months.
- •Prior administration of other research medicines in last 1 month.
- •Received or plans to receive an attenuated vaccine within 1 month before or after each study vaccination.
- •Received or plans to receive an inactivated vaccine within 14 days before or after each study vaccination.
- •Current treatment with investigational agents for prophylaxis of COVID-
- •Have a household contact that has been diagnosed with COVID-
- •Current anti-tuberculosis prophylaxis or therapy.
- •Currently receiving treatment for cancer or history of cancer in the last five years (except basal cell carcinoma of the skin and cervical carcinoma in situ).
- •According to the judgement of investigator, various medical, psychological, social or other conditions that could affect the subjects ability to sign informed consent.
- •Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
结局指标
主要结局
Incidence and severity of solicited systemic reactogenicity AEs
时间窗: 1 week
Incidence and severity of solicited systemic reactogenicity AEs through 1 week post final vaccine administration
Incidence of abnormal changes of laboratory safety examinations
时间窗: 30 days
Incidence of abnormal changes of laboratory safety examinations
Vital Signs - Fever
时间窗: 30 days
Changes in vital signs from Grades 1-4: - Fever - measured in (°C) or (°F)
Vital Signs - Hypertension
时间窗: 30 Days
Changes in vital signs from Grades 1-4: - Hypertension (systolic/diastolic) - measured in mm Hg
GMT of S-specific, RBD-specific, and N-specific antibodies against 2019 novel coronavirus
时间窗: Day 387
GMT of S-specific, RBD-specific, and N-specific antibodies against 2019 novel coronavirus tested by ELISA in serum
GMFR in neutralizing antibody
时间窗: Day 387
GMFR in neutralizing antibody
Incidence of MAAEs and SAEs
时间窗: 30 days to 6 months
Incidence of MAAEs and SAEs through 30 days and 6 months post final vaccine administration
Vital Signs - Tachycardia
时间窗: 30 Days
Changes in vital signs from Grades 1-4: - Tachycardia - measured in beats per minute
Vital Signs - Hypotension
时间窗: 30 Days
Changes in vital signs from Grades 1-4: - Hypotension (systolic) - measured in mm Hg
Vital Signs - Respiratory Rate
时间窗: 30 Days
Changes in vital signs from Grades 1-4: - Respiratory Rate - measured in how many breaths per minute
GMFR in IgG titer
时间窗: Day 387
GMFR in IgG titer
Vital Signs - Bradycardia
时间窗: 30 Days
Changes in vital signs from Grades 1-4: - Bradycardia - measured in how many beats per minute
CD8+ T-Cell activity against SARS-CoV-2 S protein, RBD, and N protein
时间窗: Day 387
CD8+ T-Cell activity against SARS-CoV-2 S protein, RBD, and N protein measured by ELISPOT assay
CD4+ T-Cell activity against SARS-CoV-2 S protein, RBD, and N protein
时间窗: Day 387
CD4+ T-Cell activity against SARS-CoV-2 S protein, RBD, and N protein measured by standard immune assay
Incidence and severity of solicited local reactogenicity AEs
时间窗: 1 week
Incidence and severity of solicited local reactogenicity AEs through 1 week post final vaccine administration
Incidence and severity of unsolicited AEs
时间窗: 30 days
Incidence and severity of unsolicited AEs through 30 days post final vaccine administration
Percentage of subjects who seroconverted
时间窗: Day 387
Percentage of subjects who seroconverted (as defined as 4-fold change in antibody titer relative to baseline)
GMT
时间窗: Day 387
GMT of neutralizing antibody
Seroconversion rate of neutralizing antibody
时间窗: Day 387
Seroconversion rate of neutralizing antibody (as defined as 4-fold change in antibody titer relative to baseline)
次要结局
未报告次要终点