Study to Evaluate the inHaled Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) On the Protective-Efficacy in Adults (SeiHOPE)

A Multicenter, Randomized, Double-blind, Parallel-controlled Phase III Clinical Trial on the Efficacy, Safety, and Immunogenicity of Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) for Inhalation (Ad5-nCoV-IH) in Adults Aged 18 Years and Above Who Have Received One Dose of Intramuscular Ad5-nCoV

This phase III clinical trial is an endpoint-driven randomized, double-blind, parallel-controlled, multicenter clinical trial, and around 13,000 subjects aged 18 years and above who have previously received 1 dose of intramuscular Ad5-nCoV will be recruited. Volunteers should have been vaccinated with intramuscular Ad5-nCoV > 56 days prior to enrollment. All subjects will receive 1 dose of investigational vaccine or placebo through nebulized inhalation. The ratio of subjects in the vaccine group and placebo group is 1:1 and the efficacy and safety of the investigational vaccine will be followed up for 52 weeks after vaccination.

Study Overview

• Status: Withdrawn
• Conditions: COVID-19
• Intervention / Treatment: Biological: Recombinant COVID-19 vaccine (adenovirus type 5 vector) for Inhalation (Ad5-nCoV-IH); Biological: Placebo

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adult volunteers aged 18 years and above who have received 1 dose of intramuscular Ad5-nCoV > 56 days at the enrollment.
• Volunteers who have provided informed consent and signed the informed consent form.
• Volunteers who are able and willing to comply with the requirements of the clinical study protocol, and can complete the entire follow-up period of this study.

Exclusion Criteria:

• Allergic to the active ingredient, any non-active ingredient, or substances used in the manufacturing process, or developed an allergy to similar vaccines in the past.
• History of severe anaphylactic reaction to vaccines (e.g., acute anaphylactic reactions, angioedema, dyspnea).
• History or family history of seizures, epilepsy, encephalopathy, or psychosis.
• Severe nasal or oral diseases, such as acute rhinitis (sinusitis), allergic rhinitis, oral ulcers, throat redness, and swelling.
• History of a definite diagnosis of COVID-19.
• Positive SARS-CoV-2 N antibody rapid screening kit (IgG and IgM) results.
• Received COVID-19 vaccine other than Ad5-nCoV.
• Axillary temperature > 37.0°C.
• Severe cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, or severe hypertension and cannot be controlled by drugs.
• Lung function abnormalities such as asthma, chronic obstructive pulmonary disease, and pulmonary fibrosis.
• Acute febrile illness, symptoms of upper respiratory tract infection, or infectious diseases.
• Severe chronic diseases, or diseases of the progressive stage that cannot be steadily controlled, such as diabetes or thyroid disorders.
• Asplenia or functional asplenia.
• Thrombocytopenia or other coagulation disorder.
• Received immunosuppressant or immunomodulatory therapy (continuous oral or intravenous infusion for more than 14 days), anti-allergic therapy, cytotoxic therapy within the past 6 months. Inhalational and local steroids are allowed.
• Received blood products within 4 months before receiving the investigational vaccine.
• Received other vaccines within the past 14 days or plan to receive other vaccines 14 days after scheduled immunization with the investigational vaccine.
• Volunteers under antituberculous treatment or with active tuberculosis.
• Received blood/plasma products or immunoglobulin 60 days before immunization with the investigational vaccine or planned to receive blood/plasma products or immunoglobulin during the entire study period.
• Females who are positive for the urine pregnancy test, pregnant, or breastfeeding, or females who plan to conceive within 3 months (urine pregnancy test will only be performed in female volunteers of childbearing age).
• Volunteers who are judged by the investigator with any contradiction to the study protocol or affected the signing of informed consent due to various medical, psychological,social, or other conditions.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; 6500 participants, Ad5-nCoV-IH, single dose, nebulized inhalation	Biological: Recombinant COVID-19 vaccine (adenovirus type 5 vector) for Inhalation (Ad5-nCoV-IH); Nebulized inhalation through the mouth
Placebo Comparator: Placebo group; 6500 participants, placebo, single dose, nebulized inhalation	Biological: Placebo; Nebulized inhalation through the mouth

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of COVID-19 cases.	The efficacy of Ad5-nCoV-IH in preventing virologically confirmed (PCR positive) COVID-19 disease.	Day 14 to 12 months post vaccination
Incidence of SAE	Evaluate the incidence of severe adverse events (SAE)	Within 12 months post vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of COVID-19 cases	The efficacy of Ad5-nCoV-IH in preventing virologically confirmed (PCR positive) COVID-19 disease.	Day 28 to 12 months post vaccination
Incidence of severe COVID-19 cases	Evaluate the efficacy of Ad5-nCoV in preventing severe COVID-19 disease caused by SARS-CoV-2 infection.	Day 14 and Day 28 to 12 months post vaccination
Incidence of COVID-19 cases in different age groups	The efficacy of Ad5-nCoV-IH in preventing virologically confirmed (PCR positive) COVID-19 disease in participants between 18-59 years, and participants aged 60 years and above.	Day 14 and Day 28 to 12 months post vaccination
Incidence of Adverse Reactions (ARs)	Incidence of ARs within 30 minutes post vaccination in the safety cohort.	Within 30 minutes post vaccination
Incidence of Adverse Reactions (ARs)	Incidence of ARs within 14 days post vaccination in the safety cohort.	Within 14 days post vaccination
Incidence of Adverse Events (AEs)	Incidence of AEs within 28 days post vaccination in the safety cohort.	Within 28 days post vaccination
Immunogenicity of S-RBD IgG antibody (ELISA method)	Seroconversion rate of S-RBD IgG antibody post vaccination.	Day 14, Day 28, Week 24, and Week 52 post-vaccination
Immunogenicity of S-RBD IgG antibody (ELISA method)	GMT of S-RBD IgG antibody post vaccination.	Day 14, Day 28, Week 24, and Week 52 post-vaccination
Immunogenicity of S-RBD IgG antibody (ELISA method)	GMI of S-RBD IgG antibody post vaccination.	Day 14, Day 28, Week 24, and Week 52 post-vaccination
Immunogenicity of neutralizing antibodies	Seroconversion rate of neutralizing antibodies post vaccination.	Day 14, Day 28, Week 24, and Week 52 post-vaccination
Immunogenicity of neutralizing antibodies	GMT of neutralizing antibodies post vaccination.	Day 14, Day 28, Week 24, and Week 52 post-vaccination
Immunogenicity of neutralizing antibodies	GMI of neutralizing antibodies post vaccination.	Day 14, Day 28, Week 24, and Week 52 post-vaccination

Collaborators and Investigators

• Sponsor: CanSino Biologics Inc.
• Collaborators: Beijing Institute of Biotechnology
• Investigators: Principal Investigator: Fengcai Zhu, Jiangsu Provincial Center for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Estimated): December 15, 2021
• Primary Completion (Estimated): April 15, 2022
• Study Completion (Estimated): August 20, 2022

Study Registration Dates

• First Submitted: November 17, 2021
• First Submitted That Met QC Criteria: November 17, 2021
• First Posted (Actual): November 18, 2021

Study Record Updates

• Last Update Posted (Estimated): June 16, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2023
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Safety; Efficacy; Vaccine; COVID-19; Immunogenicity; Ad5; Inhalation
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: CS-CTP-AD5NCOV-IH-Ⅲ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No