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

Academy of Military Medical Sciences of the People's Liberation Army

Status and phase: Completed; Phase 2

Conditions: COVID-19

Treatments: Other: Placebo; Biological: Recombinant novel coronavirus vaccine (Adenovirus type 5 vector)

Study type: Interventional

Funder types: Other; NETWORK; Industry

Identifiers

NCT04341389

JSVCT089

Details and patient eligibility

About

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.

Full 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

Enrollment: 508 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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 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: Crossover Assignment

Masking: Double Blind

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508 participants in 3 patient groups, including a placebo group

Arm 1

Active Comparator group

Description:

1×10\^11vp of Ad5-nCoV administered through 1.0 mL intramuscular injection in the deltoid muscle on Day 0

Treatment:

Biological: Recombinant novel coronavirus vaccine (Adenovirus type 5 vector)

Arm 2

Active Comparator group

Description:

5×10\^10vp of Ad5-nCoV administered through 1.0 mL intramuscular injection in the deltoid muscle on Day 0

Treatment:

Biological: Recombinant novel coronavirus vaccine (Adenovirus type 5 vector)

Arm 3

Placebo Comparator group

Description:

Placebo administered through 1.0 mL intramuscular injection in the deltoid muscle on Day 0

Treatment:

Other: Placebo