A Clinical Trial of a Recombinant Adenovirus 5 Vectored COVID-19 Vaccine (Ad5-nCoV) With Two Doses in Healthy Adults

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

Status and phase: Completed; Phase 1

Conditions: COVID-19

Treatments: Biological: Ad5-nCoV

Study type: Interventional

Funder types: Other

Identifiers

NCT04552366

AMMS85-2004

Details and patient eligibility

About

This is a clinical trial to evaluate the safety and immunogenicity of a recombinant adenovirus 5 vectored COVID-19 vaccine (Ad5-nCoV) with two doses and with different adminstration routes in healthy adults aged 18 years and older.

Full description

A total of 168 healthy adult volunteers will be vaccinated in this clinical trial according to open, partly randomized design from the healthy adults aged 18 years and older. The safety and immunogenicity of intramuscular vaccination and mucosal vaccination of two doses of Ad5-nCoV in different administration schedules will be evaluated.

Enrollment: 149 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Aged 18 years and older;
• Able to provide consent to participate in and having signed an Informed Consent Form (ICF);
• Able and willing to complete all the scheduled study procedures during the whole study follow-up period (about 6-8 months, depending on group);
• Negative result of HIV screening;
• Axillary temperature ≤37.0°C.
• Negative IgG and IgM antibodies against COVID-19;
• Good general health status, as determined by history and physical examination.

Exclusion Criteria for the first vaccination:

• Hematological examination is abnormal, or clinically significant as assessed by the study investigator (including white blood cell count, lymphocyte count, neutrophil count, eosinophil count, platelet, hemoglobin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, blood glucose and creatinine);
• With oral ulcers, throat swelling and other oral diseases.
• With symptoms of upper respiratory tract infection.
• Personal history of seizure disorder, encephalopathy or psychosis;
• Allergic history to any vaccine, or allergic to any ingredient of the Ad5-nCoV;
• Any acute febrile disease or active infectious disease on the day of vaccination;
• History of SARS or COVID-19;
• History of COVID-19 candidate vaccine administration;
• History of chronic obstructive pulmonary disease (COPD).
• Serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension not controlled with medication;
• Serious chronic disease or in the advanced stage that cannot be controlled well， such as asthma, diabetes and thyroid disease, etc.;
• Congenital or acquired angioedema;
• Suffered from urticaria within 1 year before receiving the trial vaccine.
• Asplenia or functional asplenia;
• Platelet disorder or other bleeding disorder that may cause intramuscular injection contraindication;
• Faint with needles in intramuscular administration group;
• Immunosuppressive medication, anti-allergic, cytotoxic therapy, inhaled corticosteroids (excluding surface corticosteroid therapy for acute non-complicated dermatitis) in the last 6 months;
• Prior administration of blood products in last 4 months;
• Other vaccination(s) or investigational drugs within 1 month before study onset;
• Prior administration of live attenuated vaccine within 1 month before study onset;
• Prior administration of subunit or inactivated vaccine within 14 days before study onset;
• Current anti-tuberculosis therapy;
• Woman is pregnant or lactating, positive urine pregnancy test or plan to become pregnant during the next 8 months;
• Any condition that in the opinion of the investigators may interfere with the participants' compliance or evaluation of study objectives or informed consent (i.e. medical, psychological, social or other conditions, etc.).

Exclusion Criteria for the second vaccination:

• Severe allergic reaction after the first dose of vaccination;
• Severe adverse reactions causally related to the first vaccination;
• For those newly discovered or newly occured after the first vaccination that does not meet the first-dose selection criteria or meets the first-dose exclusion criteria, the investigator will determine whether to continue participating in the study;
• Other reasons for exclusion as deemed by the investigator.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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149 participants in 6 patient groups

Group A: Intramuscular administration

Experimental group

Description:

24 subjects. 5E10 VP of Ad5-nCoV on Day 0 and on Day 56.

Treatment:

Biological: Ad5-nCoV

Group B: Mixed administration

Experimental group

Description:

24 subjects. An intramuscular administration of 5E10 VP of Ad5-nCoV on day 0 and a mucosal administration of 2E10 VP on Day 28.

Treatment:

Biological: Ad5-nCoV

Group C: Mucosal administration, high dose

Experimental group

Description:

24 subjects. A mucosal administration of 2E10 VP of Ad5-nCoV on Day 0 and Day 28.

Treatment:

Biological: Ad5-nCoV

Group D: Mucosal administration, low dose

Experimental group

Description:

24 subjects. A mucosal administration of 1E10 VP of Ad5-nCoV on day 0 and Day 28.

Treatment:

Biological: Ad5-nCoV

Group E: Intramuscular administration, one dose

Active Comparator group

Description:

24 subjects. An intramuscular administration of 5E10 VP of Ad5-nCoV on day 0.

Treatment:

Biological: Ad5-nCoV

Group F: Intramuscular administration, two doses

Experimental group

Description:

24 subjects. Two intramuscular administrations of 5E10 VP of Ad5-nCoV at left and right arms on day 0.

Treatment:

Biological: Ad5-nCoV