Study Stopped
The trial protocol was not approved by the regulatory authorities.
A Study to Evaluate the Safety and Immunogenicity of Ad5-vector Based Vaccine Against Coronavirus Variants in Adults (≥18 Years) Immunized With 2 Doses of mRNA Vaccines Plus One Dose of Booster AZD1222 Vaccine
A Multicenter, Randomized, and Observer-blind Clinical Trial to Evaluate the Safety and Immunogenicity of Ad5-based COVID-19 Vaccine Against Coronavirus Variants in Adults (≥ 18 Years) Who Have Been Immunized With 2 Doses of mRNA Vaccines Plus One Dose of Booster AZD1222 Vaccine
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
Subjects who have completed the primary mRNA vaccine immunizations and the 1st booster AZD1222 immunization for more than 6 months will be randomized to receive a 2nd booster dose of Ad5-nCoV/O, Ad5-nCoV/O-IH or mRNA-based COVID-19 vaccine in a ratio of 2:2:1.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Nov 2022
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2022
CompletedFirst Posted
Study publicly available on registry
July 5, 2022
CompletedStudy Start
First participant enrolled
November 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedJune 18, 2023
October 1, 2022
4 months
June 16, 2022
June 14, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Immunogenicity of Ad5-nCoV/O or Ad5-nCoV/O-IH versus BNT162b2 as the 2nd booster dose.
The geometric mean titers (GMT) of anti-Omicron pseudovirus neutralizing antibody on Day 28 post vaccination in all participants
Day 28 post vaccination
Secondary Outcomes (17)
Incidence of Adverse Reactions (ARs)
within 30 min post vaccination
Incidence of Adverse Reactions (ARs)
within 14 days post vaccination
The incidence of AR and AE
within 28 days post vaccination
Incidence of SAE
within 12 months post vaccination
Immunogenicity of pseudovirus neutralizing antibody
on Day 14 and Day 28 post-vaccination
- +12 more secondary outcomes
Study Arms (3)
Ad5-nCoV/O group
EXPERIMENTALAd5-nCoV/O-IH group
EXPERIMENTALmRNA-based COVID-19 vaccine group
ACTIVE COMPARATORInterventions
Subjects who have completed the primary mRNA vaccine immunizations and the 1st booster AZD1222 immunization for more than 6 months will be randomized to receive a 2nd booster dose of Ad5-nCoV/O
Subjects who have completed the primary mRNA vaccine immunizations and the 1st booster AZD1222 immunization for more than 6 months will be randomized to receive a 2nd booster dose of Ad5-nCoV/O-IH
Subjects who have completed the primary mRNA vaccine immunizations and the 1st booster AZD1222 immunization for more than 6 months will be randomized to receive a 2nd booster dose of mRNA-based COVID-19 vaccine
Eligibility Criteria
You may qualify if:
- Participants aged 18 years and above at the time of screening.
- Received the 1st booster vaccination at least 180 days earlier.
- Agree to attend all visits and sign the written informed consent form.
You may not qualify if:
- Have a history of seizures, epilepsy, encephalopathy, psychosis.
- History of severe anaphylaxis or allergy to any vaccine component.
- Positive urine pregnancy test result, pregnant, lactating women.
- Medical history of Guillain-Barré syndrome.
- Have had asthma attacks within 2 years.
- Have severe nasal or oral diseases, such as rhinitis (sinusitis), allergic rhinitis, oral ulcer, throat swelling, etc.
- Bleeding disorder (e.g. protein S or factor deficiency, coagulopathy or platelet disorder).
- Have chronic systematic infection or chronic obstructive pulmonary disease (COPD), etc.
- Administration of immunoglobulins and/or any blood products within three months prior to the planned administration of the vaccine candidate.
- Current diagnosis or receiving treatment for tuberculosis or cancer.
- History of SARS-CoV-2 infection for less than 3 months.
- Received or plan to receive any vaccines (licensed or investigational), within 14 days before and after study vaccination.
- Have an axillary temperature of \> 37.0℃.
- Any other significant diseases, disorders or findings which may significantly increase the risk to the volunteer because of participation in the study, and affect the ability of the volunteer to participate in the study or impair interpretation of the study data.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- observer-blind clinical trial
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2022
First Posted
July 5, 2022
Study Start
November 30, 2022
Primary Completion
March 30, 2023
Study Completion
June 30, 2023
Last Updated
June 18, 2023
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share