Phase I Clinical Trial of a COVID-19 Vaccine in 18-60 Healthy Adults

NCT ID: NCT04313127

Last Updated: 2021-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-16
• Study Completion Date: 2021-02-20

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) .

Detailed Description

This is a single-center,open-label，dose-escalating phase I clinical trial in healthy 18 to 60 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) manufactured by Beijing Institute of Biotechnology and CanSino Biologics Inc.One hundred and eight subjects will be enrolled into one of three cohorts and will receive an intramuscular (IM) injection of experimental vaccine or placebo on Days 1 in the deltoid muscle.

Conditions

COVID-19

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Low-dose Group

Subjects received one dose of 5E10 vp Ad5-nCoV at 18 to 60 years old

Group Type: EXPERIMENTAL

Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

Intervention Type: BIOLOGICAL

Intramuscular other name:Ad5-nCoV

Middle-dose Group

Subjects received one dose of 1E11 vp Ad5-nCoV at 18 to 60 years old

Group Type: EXPERIMENTAL

Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

Intervention Type: BIOLOGICAL

Intramuscular other name:Ad5-nCoV

High-dose Group

Subjects received one dose of 1.5E11vp Ad5-nCoV at 18 to 60 years old

Group Type: EXPERIMENTAL

Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

Intervention Type: BIOLOGICAL

Intramuscular other name:Ad5-nCoV

Interventions

Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

Intramuscular other name:Ad5-nCoV

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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
• Prior administration of attenuated vaccine in last 1 month
• Prior administration of inactivated vaccine in last 14 days
• Current anti-tuberculosis prophylaxis or therapy
• According to the judgement of investigator,various medical, psychological, social or other conditions, those could affect the subjects to sign informed consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China

OTHER

Sponsor Role: collaborator

Jiangsu Province Centers for Disease Control and Prevention

NETWORK

Sponsor Role: collaborator

Hubei Provincial Center for Disease Control and Prevention

OTHER

Sponsor Role: collaborator

Tongji Hospital

OTHER

Sponsor Role: collaborator

CanSino Biologics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhu Fengcai

Role: PRINCIPAL_INVESTIGATOR

Jiangsu Province Centers for Disease Control and Prevention

Guan Xuhua

Role: PRINCIPAL_INVESTIGATOR

Hubei Provincial Center for Disease Control and Prevention

Wang Wei

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital

Locations

Hubei Provincial Center for Disease Control and Prevention

Wuhan, Hubei, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 32450106 (View on PubMed)

Other Identifiers

JSVCT088

Identifier Type: -

Identifier Source: org_study_id