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

Sponsor
CanSino Biologics Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05124561
Collaborator
Beijing Institute of Biotechnology (Other)
13,000
Enrollment
2
Arms
8.1
Anticipated Duration (Months)

Study Details

Study Description

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 DiseaseIntervention/TreatmentPhase
  • Biological: Recombinant COVID-19 vaccine (adenovirus type 5 vector) for Inhalation (Ad5-nCoV-IH)
  • Biological: Placebo
Phase 3

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Dec 15, 2021
Anticipated Primary Completion Date :
Apr 15, 2022
Anticipated Study Completion Date :
Aug 20, 2022

Arms and Interventions

ArmIntervention/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

Outcome Measures

Primary Outcome Measures

  1. Incidence of COVID-19 cases. [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 [Within 12 months post vaccination]

    Evaluate the incidence of severe adverse events (SAE)

Secondary Outcome Measures

  1. Incidence of COVID-19 cases [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 [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 [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 Adversed Reactions (ARs) [Within 30 minutes post vaccination]

    Incidence of ARs within 30 minutes post vaccination in the safety cohort.

  5. Incidence of Adversed Reactions (ARs) [Within 14 days post vaccination]

    Incidence of ARs within 14 days post vaccination in the safety cohort.

  6. Incidence of Adversed Events (AEs) [Within 28 days post vaccination]

    Incidence of AEs within 28 days post vaccination in the safety cohort.

  7. Immunogencity of S-RBD IgG antibody (ELISA method) [Day 14, Day 28, Week 24, and Week 52 post-vaccination]

    Seroconversion rate of S-RBD IgG antibody post vaccination.

  8. Immunogencity of S-RBD IgG antibody (ELISA method) [Day 14, Day 28, Week 24, and Week 52 post-vaccination]

    GMT of S-RBD IgG antibody post vaccination.

  9. Immunogencity of S-RBD IgG antibody (ELISA method) [Day 14, Day 28, Week 24, and Week 52 post-vaccination]

    GMI of S-RBD IgG antibody post vaccination.

  10. Immunogenicity of neutralizing antibodies [Day 14, Day 28, Week 24, and Week 52 post-vaccination]

    Seroconversion rate of neutralizing antibodies post vaccination.

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

    GMT of neutralizing antibodies post vaccination.

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

    GMI of neutralizing antibodies post vaccination.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Adult volunteers aged 18 years and above who have received 1 dose of intramuscular Ad5-nCoV > 56 days at the enrollment.

  • Subjects who have provided informed consent and signed the informed consent form.

  • Subjects 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:
  • Those who are 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.

  • Those with a history of severe anaphylactic reaction to vaccines (e.g., acute anaphylactic reactions, angioedema, dyspnea).

  • Those with a 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.

  • Those with severe cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, or severe hypertension and cannot be controlled by drugs.

  • Volunteers with lung function abnormalities such as asthma, chronic obstructive pulmonary disease, and pulmonary fibrosis.

  • Those with acute febrile illness, symptoms of upper respiratory tract infection, or infectious diseases.

  • Those with severe chronic diseases, or diseases of the progressive stage that cannot be steadily controlled, such as diabetes or thyroid disorders.

  • Those with asplenia or functional asplenia.

  • Those with thrombocytopenia or other coagulation disorder.

  • Those who 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.

  • Those who 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.

  • Those who are 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).

  • Those 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • CanSino Biologics Inc.
  • Beijing Institute of Biotechnology

Investigators

  • Principal Investigator: Fengcai Zhu, Jiangsu Provincial Center for Disease Control and Prevention

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
CanSino Biologics Inc.
ClinicalTrials.gov Identifier:
NCT05124561
Other Study ID Numbers:
  • CS-CTP-AD5NCOV-IH-Ⅲ
First Posted:
Nov 18, 2021
Last Update Posted:
Nov 18, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by CanSino Biologics Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2021