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

COVID-19 Clinical Trial

— CTCOVID-19  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04313127
• Other study ID #: JSVCT088
• Status: Completed
• Phase: Phase 1
• Start date: March 16, 2020
• Est. completion date: February 20, 2021

Study information

• Verified date: May 2020
• Source: CanSino Biologics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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) .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: February 20, 2021
• Est. primary completion date: January 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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 ß-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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Intramuscular other name:Ad5-nCoV

Locations

Country	Name	City	State
China	Hubei Provincial Center for Disease Control and Prevention	Wuhan	Hubei

Sponsors (5)

Lead Sponsor	Collaborator
CanSino Biologics Inc.	Hubei Provincial Center for Disease Control and Prevention, Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China, Jiangsu Province Centers for Disease Control and Prevention, Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Consistency analysis(ELISA and pseudoviral neutralization test method)	Consistency analysis of S-specific antibodies against 2019 novel coronavirus tested by ELISA against those tested by pseudoviral neutralization test method	day,14,28, month 6 post-vaccination
Other	Dose-response relationship(Humoral immunity)	Relationship between Geometric mean titer (GMT) of S protein-specific antibodies against 2019 novel coronavirus and vaccine dose among study groups	day14,28,month 3,6 post-vaccination
Other	Persistence analysis of anti-S protein antibodies	Persistence analysis of anti-S protein antibodies among study groups	day14,28,month 3,6 post-vaccination
Other	Time-dose-response relationship(Humoral immunity)	Relationship between the appearance time of S-specific antibodies against 2019 novel coronavirus and the vaccination dose.	day14,28,month 3,6 post-vaccination
Other	Dose-response relationship( cellular immunity)	Relationship between cellular immune levels against 2019 novel coronavirus and vaccine dose among study groups	day 14, 28,month 6 post-vaccination
Other	Persistence analysis of cellular immuse	Persistence analysis of specific cellular immune response	day 14, 28,month 6 post-vaccination
Other	Time-dose-response relationship(cellular immunity)	Relationship between the appearance time of cellular immunity against 2019 novel coronavirus and the vaccination dose.	day 14, 28,month 6 post-vaccination
Primary	Safety indexes of adverse reactions	Occurrence of adverse reactions post-vaccination	0-7 days post-vaccination
Secondary	Safety indexes of adverse events	Occurrence of adverse events post-vaccination	0-28 days post-vaccination
Secondary	Safety indexes of SAE	Occurrence of serious adverse events post-vaccination	0-28 days, within 6 mouths post-vaccination
Secondary	Safety indexes of lab measures	Occurrence of abnormal changes of laboratory safety examinations	pre-vaccination, day 7 post-vaccination
Secondary	Immunogencity indexes of GMT(ELISA)	Geometric mean titer(GMT)of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum	day14,28,month 3,6 post-vaccination
Secondary	Immunogencity indexes of GMT(pseudoviral neutralization test method)	Geometric mean titer(GMT)of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum	day14,28,month 6 post-vaccination
Secondary	Immunogencity indexes of seropositivity rates(ELISA)	the seropositivity rates of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum	day14,28,month 3,6 post-vaccination
Secondary	Immunogencity indexes of seropositivity rates(pseudoviral neutralization test method)	the seropositivity rates of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum	day14,28,month 6 post-vaccination
Secondary	Immunogencity indexes of GMI(ELISA)	Geometric mean fold increase(GMI)of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum	day14,28,month 3,6 post-vaccination
Secondary	Immunogencity indexes of GMI(pseudoviral neutralization test method)	Geometric mean fold increase(GMI)of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum	day14,28,month 6 post-vaccination
Secondary	Immunogencity indexes of GMC(Ad5 vector)	Geometric mean concentration(GMC)of anti-Ad5 vector neutralizing antibody responses	day?14,28,month3,6 post-vaccination
Secondary	Immunogencity indexes of GMI(Ad5 vector)	Geometric mean fold increase(GMI)of anti-Ad5 vector neutralizing antibody responses	day?14,28,month3,6 post-vaccination
Secondary	Immunogencity indexes of cellular immune	specific cellular immune responses	day 14, 28,month 6 post-vaccination