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

NCT ID: NCT04552366

Last Updated: 2023-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 149 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-29
• Study Completion Date: 2021-04-30

Brief Summary

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.

Detailed 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.

Conditions

COVID-19

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group A: Intramuscular administration

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

Group Type: EXPERIMENTAL

Ad5-nCoV

Intervention Type: BIOLOGICAL

Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

Group B: Mixed administration

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

Group Type: EXPERIMENTAL

Ad5-nCoV

Intervention Type: BIOLOGICAL

Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

Group C: Mucosal administration, high dose

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

Group Type: EXPERIMENTAL

Ad5-nCoV

Intervention Type: BIOLOGICAL

Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

Group D: Mucosal administration, low dose

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

Group Type: EXPERIMENTAL

Ad5-nCoV

Intervention Type: BIOLOGICAL

Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

Group E: Intramuscular administration, one dose

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

Group Type: ACTIVE_COMPARATOR

Ad5-nCoV

Intervention Type: BIOLOGICAL

Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

Group F: Intramuscular administration, two doses

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

Group Type: EXPERIMENTAL

Ad5-nCoV

Intervention Type: BIOLOGICAL

Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

Interventions

Ad5-nCoV

Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

Intervention Type: BIOLOGICAL

Eligibility 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

• 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.).

• Severe allergic reaction after the first dose of vaccination;
• Severe adverse reactions causally related to the first vaccination;
• Other reasons for exclusion as deemed by the investigator.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zhongnan Hospital

OTHER

Sponsor Role: collaborator

Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhongnan Hospital

Wuhan, Hubei, China

Countries

China

References

Wu S, Huang J, Zhang Z, Wu J, Zhang J, Hu H, Zhu T, Zhang J, Luo L, Fan P, Wang B, Chen C, Chen Y, Song X, Wang Y, Si W, Sun T, Wang X, Hou L, Chen W. Safety, tolerability, and immunogenicity of an aerosolised adenovirus type-5 vector-based COVID-19 vaccine (Ad5-nCoV) in adults: preliminary report of an open-label and randomised phase 1 clinical trial. Lancet Infect Dis. 2021 Dec;21(12):1654-1664. doi: 10.1016/S1473-3099(21)00396-0. Epub 2021 Jul 26.

Reference Type: DERIVED

PMID: 34324836 (View on PubMed)

Other Identifiers

AMMS85-2004

Identifier Type: -

Identifier Source: org_study_id