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

June 14, 2023 updated by: CanSino Biologics Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of COVID-19 cases.
Time Frame: Day 14 to 12 months post vaccination
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
Time Frame: Within 12 months post vaccination
Evaluate the incidence of severe adverse events (SAE)
Within 12 months post vaccination

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of COVID-19 cases
Time Frame: Day 28 to 12 months post vaccination
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
Time Frame: Day 14 and Day 28 to 12 months post vaccination
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
Time Frame: Day 14 and Day 28 to 12 months post vaccination
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)
Time Frame: Within 30 minutes post vaccination
Incidence of ARs within 30 minutes post vaccination in the safety cohort.
Within 30 minutes post vaccination
Incidence of Adverse Reactions (ARs)
Time Frame: Within 14 days post vaccination
Incidence of ARs within 14 days post vaccination in the safety cohort.
Within 14 days post vaccination
Incidence of Adverse Events (AEs)
Time Frame: Within 28 days post vaccination
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)
Time Frame: Day 14, Day 28, Week 24, and Week 52 post-vaccination
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)
Time Frame: Day 14, Day 28, Week 24, and Week 52 post-vaccination
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)
Time Frame: Day 14, Day 28, Week 24, and Week 52 post-vaccination
GMI of S-RBD IgG antibody post vaccination.
Day 14, Day 28, Week 24, and Week 52 post-vaccination
Immunogenicity of neutralizing antibodies
Time Frame: Day 14, Day 28, Week 24, and Week 52 post-vaccination
Seroconversion rate of neutralizing antibodies post vaccination.
Day 14, Day 28, Week 24, and Week 52 post-vaccination
Immunogenicity of neutralizing antibodies
Time Frame: Day 14, Day 28, Week 24, and Week 52 post-vaccination
GMT of neutralizing antibodies post vaccination.
Day 14, Day 28, Week 24, and Week 52 post-vaccination
Immunogenicity of neutralizing antibodies
Time Frame: Day 14, Day 28, Week 24, and Week 52 post-vaccination
GMI of neutralizing antibodies post vaccination.
Day 14, Day 28, Week 24, and Week 52 post-vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CanSino Biologics Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Beijing Institute of Biotechnology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Fengcai Zhu, Jiangsu Provincial Center for Disease Control and Prevention

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 15, 2022

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 20, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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