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

NCT05124561 | Withdrawn Phase 3 DMC

• 1 other identifier: CS-CTP-AD5NCOV-IH-Ⅲ
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

COVID-19

Keywords

COVID-19; Vaccine; Inhalation; Ad5; Efficacy; Safety; Immunogenicity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• Incidence of COVID-19 cases

  Day 28 to 12 months post vaccination

• Incidence of severe COVID-19 cases

  Day 14 and Day 28 to 12 months post vaccination

• Incidence of COVID-19 cases in different age groups

  Day 14 and Day 28 to 12 months post vaccination

• Incidence of Adverse Reactions (ARs)

  Within 30 minutes post vaccination

• Incidence of Adverse Reactions (ARs)

  Within 14 days post vaccination

Study Arms (2)

Experimental group

EXPERIMENTAL

6500 participants, Ad5-nCoV-IH, single dose, nebulized inhalation

Biological: Recombinant COVID-19 vaccine (adenovirus type 5 vector) for Inhalation (Ad5-nCoV-IH)

Placebo group

PLACEBO COMPARATOR

6500 participants, placebo, single dose, nebulized inhalation

Biological: Placebo

Interventions

Recombinant COVID-19 vaccine (adenovirus type 5 vector) for Inhalation (Ad5-nCoV-IH) BIOLOGICAL

Nebulized inhalation through the mouth

Experimental group

Placebo BIOLOGICAL

Nebulized inhalation through the mouth

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CanSino Biologics Inc.: lead
• Beijing Institute of Biotechnology: collaborator

MeSH Terms

Conditions

COVID-19; Respiratory Aspiration; Alzheimer Disease 5

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Fengcai Zhu

  Jiangsu Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: November 18, 2021
• Study Start: December 15, 2021
• Primary Completion: April 15, 2022
• Study Completion: August 20, 2022
• Last Updated: June 18, 2023

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share