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

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ClinicalTrials.gov Identifier: NCT05124561
Recruitment Status : Not yet recruiting
First Posted : November 18, 2021
Last Update Posted : December 2, 2021
Sponsor:
Collaborator:
Beijing Institute of Biotechnology
Information provided by (Responsible Party):
CanSino Biologics Inc.

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.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: Recombinant COVID-19 vaccine (adenovirus type 5 vector) for Inhalation (Ad5-nCoV-IH) Biological: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 13000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Estimated Study Start Date : December 15, 2021
Estimated Primary Completion Date : April 15, 2022
Estimated Study Completion Date : August 20, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.

  2. Incidence of SAE [ Time Frame: Within 12 months post vaccination ]
    Evaluate the incidence of severe adverse events (SAE)


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Incidence of Adverse Reactions (ARs) [ Time Frame: Within 30 minutes post vaccination ]
    Incidence of ARs within 30 minutes post vaccination in the safety cohort.

  5. Incidence of Adverse Reactions (ARs) [ Time Frame: Within 14 days post vaccination ]
    Incidence of ARs within 14 days post vaccination in the safety cohort.

  6. Incidence of Adverse Events (AEs) [ Time Frame: Within 28 days post vaccination ]
    Incidence of AEs within 28 days post vaccination in the safety cohort.

  7. 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.

  8. 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.

  9. 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.

  10. Immunogenicity of neutralizing antibodies [ Time Frame: Day 14, Day 28, Week 24, and Week 52 post-vaccination ]
    Seroconversion rate of neutralizing antibodies post vaccination.

  11. Immunogenicity of neutralizing antibodies [ Time Frame: Day 14, Day 28, Week 24, and Week 52 post-vaccination ]
    GMT of neutralizing antibodies post vaccination.

  12. Immunogenicity of neutralizing antibodies [ Time Frame: Day 14, Day 28, Week 24, and Week 52 post-vaccination ]
    GMI of neutralizing antibodies post vaccination.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05124561


Contacts
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Contact: Ruijie Wang +86-022-58213600 ext 6051 ruijie.wang@cansinotech.com

Sponsors and Collaborators
CanSino Biologics Inc.
Beijing Institute of Biotechnology
Investigators
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Principal Investigator: Fengcai Zhu Jiangsu Provincial Center for Disease Control and Prevention
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Responsible Party: CanSino Biologics Inc.
ClinicalTrials.gov Identifier: NCT05124561    
Other Study ID Numbers: CS-CTP-AD5NCOV-IH-Ⅲ
First Posted: November 18, 2021    Key Record Dates
Last Update Posted: December 2, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CanSino Biologics Inc.:
COVID-19
Vaccine
Inhalation
Ad5
Efficacy
Safety
Immunogenicity
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases