A Phase II Clinical Trial to Evaluate the Recombinant Vaccine for COVID-19 (Adenovirus Vector)

COVID-19 Clinical Trial

— CTII-nCoV  

Official title:

A Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of the Recombinant Novel Coronavirus Vaccine (Adenovirus Vector) in Healthy Adults Aged Above 18 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04341389
• Other study ID #: JSVCT089
• Status: Completed
• Phase: Phase 2
• Start date: April 12, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2023
• Source: Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a phase II, randomised, double-blinded and placebo-controlled clinical trial in healthy adults above 18 years of age. This clinical trial is designed to evaluate the immunogenicity and safety of Ad5-nCoV which encodes for a full-length spike (S) protein of SARS-CoV-2.

Description:

This is a phase II, randomised, double-blinded and placebo-controlled clinical trial in healthy adults above 18 years of age,inclusive, who meet all eligibility criteria. This clinical trial is designed to evaluate the immunogenicity and safety of Ad5-nCoV which encodes for a full-length spike (S) protein of SARS-CoV-2. 500 subjects will be enrolled, 250 subjects in middle-dose vaccine group, 125 subjects in low-dose and placebo group, respectively. Immunogenicity will be tested on days 0, 14, 28 and 6 months after vaccination

Recruitment information / eligibility

• Status: Completed
• Enrollment: 508
• Est. completion date: December 31, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

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.

• Axillary temperature =37.0°C.

• The BMI index is 18.5-30.0.

• 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 injection

Other:
• Placebo
Intramuscular injection

Locations

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

Sponsors (5)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of adverse reactions		0-14 days post vaccination
Primary	Anti SARS-CoV-2 S IgG antibody response(ELISA)		28 days post vaccination
Primary	Neutralizing antibody response to SARS-CoV-2		28 days post vaccination
Secondary	Occurrence of adverse events		0-28 days post vaccination
Secondary	Occurrence of serious adverse reaction		0-6 months post vaccination
Secondary	Anti SARS-CoV-2 S IgG antibody response(ELISA)		0, 14 days and 6 months post vaccination
Secondary	Neutralizing antibody response to SARS-CoV-2		0 and 6 months post vaccination
Secondary	Neutralizing antibody response to Ad5-vector		0, 28 days and 6 months post vaccination
Secondary	IFN-? ELISpot responses to SARS-CoV-2 spike protein		0 and 28 days post vaccination