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

CanSino Biologics

Status and phase: Completed; Phase 2

Conditions: COVID-19

Treatments: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector); Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo

Study type: Interventional

Funder types: Other; NETWORK; Industry

Identifiers

NCT04566770

JSVCT093

Details and patient eligibility

About

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 .

Full 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).

Enrollment: 480 patients

Sex: All

Ages: 6+ years old

Volunteers: Accepts Healthy Volunteers

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 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

480 participants in 9 patient groups, including a placebo group

MID A

Experimental group

Description:

20 participants(18-49), Ad5-nCoV , two doses, Intramuscular administration

Treatment:

Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

MID B

Placebo Comparator group

Description:

10 participants(18-49), Ad5-nCoV-placebo , two doses, Intramuscular administration

Treatment:

Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo

MIN A

Experimental group

Description:

100 participants(6-17), Ad5-nCoV , two doses, Intramuscular administration

Treatment:

Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

MIN B

Placebo Comparator group

Description:

50 participants(6-17), Ad5-nCoV-placebo , two doses, Intramuscular administration

Treatment:

Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo

OLD A

Experimental group

Description:

100 participants(56 years of age and above), Ad5-nCoV , two doses(Low dose), Intramuscular administration

Treatment:

Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

OLD B

Experimental group

Description:

100 participants(56 years of age and above), Ad5-nCoV , two doses(Middle dose), Intramuscular administration

Treatment:

Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

OLD C

Placebo Comparator group

Description:

50 participants(56 years of age and above), Ad5-nCoV-placebo , two doses, Intramuscular administration

Treatment:

Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo

EBOV A

Experimental group

Description:

34 participants, Ad5-nCoV , two doses, Intramuscular administration

Treatment:

Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

EBOV B

Placebo Comparator group

Description:

17 participants, Ad5-nCoV , two doses, Intramuscular administration

Treatment:

Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo