Phase 1b Open-Label Study of the Safety, Reactogenicity, and Immunogenicity of a Prophylactic COVID-19 Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenoviral Platform in Healthy South African Adults (ProVIVA-SA-1)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Number of Participants With Medically Attended Adverse Events (MAAE)
研究概览
简要总结
This is a phase 1b, open-label study in adult healthy participants. 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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •A history of illness compatible with COVID-19 disease since March
- •Serious adverse reaction to any vaccine, any unrelated medication or any component of the investigational vaccine, including a history of anaphylaxis and symptoms of a severe allergic reaction and history of allergies in the past.
- •Pregnant or breastfeeding women.
- •Live in a nursing home or long-term care facility.
- •Chronic lung disease or moderate to severe asthma.
- •Bone marrow or organ transplantation recipients.
- •Chronic kidney disease undergoing dialysis.
- •Liver disease.
- •Any disease associated with acute fever, or any infection.
- •Self-reported history of severe acute respiratory syndrome (SARS).
- •Chronic hepatitis B or hepatitis C infection.
- •HIV positive or other acquired or hereditary immunodeficiency.
- •Serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension without controllable drugs, etc.
- •History of hereditary, idiopathic or acquired angioedema.
- •Urticaria in the last 12 months prior to screening.
- •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. (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 within 120 days before first study vaccination.
- •Prior administration of other research medicines or investigational product within 30 days before first study vaccination.
- •Prior administration of attenuated vaccine within 30 days before first study vaccination..
- •Prior administration of inactivated vaccine within 14 days before first study vaccination.
- •Current treatment with investigational agents for prophylaxis of COVID-
- •Have a household contact that has been diagnosed with COVID-19 within 14 days before fist study vaccine.
- •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 any medical, psychiatric, psychological, social, occupational or other conditions that could affect the participants ability to sign informed consent, provide safety assessment data or comply with the requirements of the study protocol.
- •Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
研究组 & 干预措施
Cohort 1 (n = 10): hAd5-S-Fusion+N-ETSD at 5 × 10e10 Viral Particles (VP) per dose
hAd5-S-Fusion+N-ETSD at 5 × 10e10 Viral Particles (VP) per dose on Days 1 and 22
干预措施: hAd5-S-Fusion+N-ETSD vaccine (Biological)
Cohort 2 (n = 10): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP per dose
hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP per dose on Days 1 and 22
干预措施: hAd5-S-Fusion+N-ETSD vaccine (Biological)
Cohort 3 (n = 10): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP per dose
hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP per dose (or 5 × 10e10 VP per dose if safety concerns identified at higher dose) on Day 1
干预措施: hAd5-S-Fusion+N-ETSD vaccine (Biological)
Cohort 6 (n=10):hAd5-S-Fusion+N-ETSD at 4 × 10e10 VP per dose
hAd5-S-Fusion+N-ETSD at 2 × 10e10 VP per nostril (or 4 × 10e10 VP per dose) on Day 1
干预措施: hAd5-S-Fusion+N-ETSD vaccine (Biological)
结局指标
主要结局
Number of Participants With Medically Attended Adverse Events (MAAE)
时间窗: From first dose of study treatment through 6 months post final vaccine administration; up to 202 days for Cohorts 1 and 2, and up to 181 days for Cohorts 3 and 6.
Number of Participants with MAAEs through 6 months post final vaccine administration
Number of Participants With Solicited Local Reactogenicity AEs
时间窗: From first dose of study treatment through 1 week post final vaccine administration; up to 29 days for Cohorts 1 and 2, and up to 8 days for Cohorts 3 and 6.
Number of Participants with solicited local reactogenicity AEs through 1 week post final vaccine administration
Number of Participants With Solicited Systemic Reactogenicity AEs
时间窗: From first dose of study treatment through 1 week post final vaccine administration; up to 29 days for Cohorts 1 and 2, and up to 8 days for Cohorts 3 and 6.
Number of Participants with solicited systemic reactogenicity AEs through 1 week post final vaccine administration
Number of Participants With Unsolicited AEs
时间窗: From first dose of study treatment through 6 months post final vaccine administration; up to 202 days for Cohorts 1 and 2, and up to 181 days for Cohorts 3 and 6.
Number of Participants with unsolicited AEs through 6 months post final vaccine administration
次要结局
未报告次要终点