A Clinical Trial of A COVID-19 Vaccine Named Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

COVID-19 Clinical Trial

Official title:

A Randomized, Double-blind, Placebo -Controlled Phase IIb Clinical Trial to Evaluate the Safety and Immunogenicity of Ad5-nCoV in Person 6 Years of Age and Older and Those Who Have Previously Been Vaccinated With Ad5-EBOV

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04566770
• Other study ID #: JSVCT093
• Status: Completed
• Phase: Phase 2
• Start date: September 24, 2020
• Est. completion date: January 19, 2022

Study information

• Verified date: October 2022
• Source: CanSino Biologics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a randomized, double-blind, placebo -controlled IIb clinical trial, in order to evaluate the safety and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in people 6 years old and above and .

Description:

This is a phase IIb clinical trial to evaluate safety and immuogenicity of Ad5-nCoV developed by Cansino and Beijing Institute of Biotechnology in health people aged 6 years old and above.

The study will be double-blind, placebo-controlled trial with participants randomly allocated 2:1 to placebo and experimental vaccine .

The immunization schedule is two doses intramuscular injections (deltoid).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: January 19, 2022
• Est. primary completion date: September 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years and older

Eligibility

Inclusion Criteria:

• Aged 18 to 55 years old in MID group; aged 6-17 years old in MIN group; aged 56 years and above in OLD group; aged in EBO group is not limited.

• 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.

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

Locations

Country	Name	City	State
China	Taixing City center for Disease Control and Prevention	Taizhou	Jiangsu

Sponsors (3)

Lead Sponsor	Collaborator
CanSino Biologics Inc.	Beijing Institute of Biotechnology, Jiangsu Province Centers for Disease Control and Prevention

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety indexes of adverse reactions	Occurrence of adverse reactions post vaccination	within 14 days post each vaccination
Primary	Immunogencity indexes of GMT	Evaluate the Geometric mean titer (GMT) of IgG antibody	Day 28 post the second vaccination
Primary	Immunogencity indexes of neutralizing antibody	Evaluate the Geometric mean titer (GMT) of neutralizing antibody	Day 28 post the second vaccination
Secondary	Safety indexes of adverse events	Occurrence of adverse reactions post-vaccination	Day 0-7,0-14,0-28 post each vaccination
Secondary	Safety indexes of Hematological examination measures(Hemoglobin, WBC)	Occurrence of abnormal changes of Hematological examination indexes(only fit for MID and sentinel group)	pre-vaccination, day 4 post each vaccination
Secondary	Safety indexes of Blood routine measures(ALT, AST)	Occurrence of abnormal changes of lBlood routine indexes (only fit for MID and sentinel group)	pre-vaccination, day 4 post each vaccination
Secondary	Safety indexes of SAE	Occurrence of serious adverse events post-vaccination	Within 6 months post the second vaccination
Secondary	Immunogencity indexes of GMT	Evaluate the Geometric mean titer of IgG antibody	Day 28 post the first vaccination, pre the second vaccination ,Month 6 post the second vaccination
Secondary	Immunogencity indexes of neutralizing antibody	Evaluate the Geometric mean titer (GMT) of neutralizing antibody	Day 28 post the first vaccination, pre the second vaccination ,Month 6 post the second vaccination
Secondary	Immunogencity indexes of cellular immune	Number of cell-mediated immune response against SARS-CoV-2(IL-2)	Day 28 post the first vaccination, pre and day 28 post the second vaccination