Phase I Clinical Trial of a COVID-19 Vaccine in 18-60 Healthy Adults
CTCOVID-19
A Single-center,Open-label，Dose-escalating Phase I Clinical Trial to Evaluate Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in Healthy Adults Aged 18-60 Years Old
1 other identifier
interventional
108
1 country
1
Brief Summary
The 2019 novel-coronavirus (2019-nCov) is the cause of a cluster of unexplained pneumonia that started in Hubei province in China. It has manifest into a global health crisis with escalating confirmed cases and spread across many countries. In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of diseases caused by COVID-19 can be tough for current treatment. This study is a phase I clinical trial. The investigators intent to evaluate the safety, reactogenicity and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 covid19
Started Mar 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2020
CompletedStudy Start
First participant enrolled
March 16, 2020
CompletedFirst Posted
Study publicly available on registry
March 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 20, 2021
CompletedAugust 4, 2021
May 1, 2020
10 months
March 15, 2020
August 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety indexes of adverse reactions
Occurrence of adverse reactions post-vaccination
0-7 days post-vaccination
Secondary Outcomes (12)
Safety indexes of adverse events
0-28 days post-vaccination
Safety indexes of SAE
0-28 days, within 6 mouths post-vaccination
Safety indexes of lab measures
pre-vaccination, day 7 post-vaccination
Immunogencity indexes of GMT(ELISA)
day14,28，month 3,6 post-vaccination
Immunogencity indexes of GMT(pseudoviral neutralization test method)
day14,28，month 6 post-vaccination
- +7 more secondary outcomes
Other Outcomes (7)
Consistency analysis(ELISA and pseudoviral neutralization test method)
day,14,28, month 6 post-vaccination
Dose-response relationship（Humoral immunity）
day14,28，month 3,6 post-vaccination
Persistence analysis of anti-S protein antibodies
day14,28，month 3,6 post-vaccination
- +4 more other outcomes
Study Arms (3)
Low-dose Group
EXPERIMENTALSubjects received one dose of 5E10 vp Ad5-nCoV at 18 to 60 years old
Middle-dose Group
EXPERIMENTALSubjects received one dose of 1E11 vp Ad5-nCoV at 18 to 60 years old
High-dose Group
EXPERIMENTALSubjects received one dose of 1.5E11vp Ad5-nCoV at 18 to 60 years old
Interventions
Intramuscular other name:Ad5-nCoV
Eligibility Criteria
You may qualify if:
- Aged between 18 and 60 years.
- Able to understand the content of informed consent and willing to sign the informed consent
- Able and willing to complete all the secluded study process during the whole 6 months study follow-up period.
- Negative in HIV diagnostic test.
- Negative in serum antibodies (IgG and IgM) screening of COVID-19.
- Normal in lung CT images (no imaging features of COVID-19
- Axillary temperature ≤37.0°C.
- The BMI index is 18.5-30.0.
- Negative in Nasopharyngeal swabs / sputum and anal swabs through RT-PCR
- Laboratory tests such as hematological examination and clinical biochemistry examination are in the normal range or without meaning judged by clinical doctor.
- General good health as established by medical history and physical examination.
You may not qualify if:
- Family history of seizure, epilepsy, brain or mental disease
- Subject allergic to any component of the investigational vaccine, or a more severe allergic reaction and history of allergies in the past.
- Woman who is pregnant, breast-feeding or positive in β-HCG (human chorionic gonadotropin) pregnancy test (urine) on day of enrollment, or become pregnant during the next 6 months
- Any acute fever disease or infections.
- History of SARS
- Major congenital defects or not well-controlled chronic illness, such as asthma, diabetes, or thyroid disease.
- Serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension without controllable drugs, etc.
- Hereditary angioneurotic edema or acquired angioneurotic edema
- Urticaria in last one year
- No spleen or functional spleen.
- Platelet disorder or other bleeding disorder may cause injection contraindication
- Faint at the sight of needles.
- Prior administration of immunodepressant or corticosteroids, antianaphylaxis treatment, cytotoxic treatment in last 6 months.
- Prior administration of blood products in last 4 months
- Prior administration of other research medicines in last 1 month
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hubei Provincial Center for Disease Control and Prevention
Wuhan, Hubei, China
Related Publications (1)
Zhu FC, Li YH, Guan XH, Hou LH, Wang WJ, Li JX, Wu SP, Wang BS, Wang Z, Wang L, Jia SY, Jiang HD, Wang L, Jiang T, Hu Y, Gou JB, Xu SB, Xu JJ, Wang XW, Wang W, Chen W. Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in-human trial. Lancet. 2020 Jun 13;395(10240):1845-1854. doi: 10.1016/S0140-6736(20)31208-3. Epub 2020 May 22.
PMID: 32450106DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhu Fengcai
Jiangsu Province Centers for Disease Control and Prevention
- PRINCIPAL INVESTIGATOR
Guan Xuhua
Hubei Provincial Center for Disease Control and Prevention
- PRINCIPAL INVESTIGATOR
Wang Wei
Tongji Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2020
First Posted
March 18, 2020
Study Start
March 16, 2020
Primary Completion
January 20, 2021
Study Completion
February 20, 2021
Last Updated
August 4, 2021
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will be available beginning 3 months and ending one year following article publication
- Access Criteria
- Data access requests will be reviewed by the sponsor，investigator and collaborators on the basis of scientific merit. To gain access, data requestors will need to sign a data access agreement.
We support data sharing of the individual participant data. The individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendixes) will be shared. Individual participant data will be available beginning 3 months and ending one year following article publication. Supporting clinical documents including study protocol, statistical analysis plan (SAP), and the informed consent form (ICF) will be available immediately following publication for at least one year. Supporting clinical documents access information will be available at http://www.jshealth.com/. Researchers who provide a scientifically sound proposal will be allowed to access to the individual participant data. Proposals should be directed to jszfc@vip.sina.com or cw0226@foxmail.com.