Adenovirus Type-5 Vectored COVID-19 VaccinePhase 1NCT04568811
The Phase I Clinical Trial of Booster Vaccination of Adenovirus Type-5 Vectored COVID-19 Vaccine
A Phase 1 study testing Adenovirus Type-5 Vectored COVID-19 Vaccine in people with Adenovirus Type-5 Vectored COVID-19 Vaccine, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.
Trial summary
The 2019 novel-coronavirus (2019-nCov) is the cause of a cluster of unexplained pneumonia that started in Hubei province in China. It has manifest into a global health crisis with escalating confirmed cases and spread across many countries. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Adenovirus Type-5 Vectored COVID-19 Vaccine
- What is being tested?
- Adenovirus Type-5 Vectored COVID-19 Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteChina
- Study dates
- 26 Sep 2020to 11 Sep 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Participants who has received prime vaccination of adenovirus type-5 vectored COVID-19 vaccine
- Able to understand the content of informed consent and willing to sign the informed consent
- Negative in HIV diagnostic test.
- Axillary temperature ≤37.0°C.
- General good health as established by medical history and physical examination.
- Able to complete 12 months visit
Who cannot join
- Family history of seizure, epilepsy, brain or mental disease
- Subject allergic to any component of the investigational vaccine, or a more severe allergic reaction and history of allergies in the past.
- Woman who is pregnant, breast-feeding on day of enrollment, or become pregnant during the next 12 months
- Any acute fever disease or infections.
- History of SARS
- Major congenital defects or not well-controlled chronic illness, such as asthma, diabetes, or thyroid disease.
Show all 19Show fewer
- Serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension without controllable drugs, etc.
- Hereditary angioneurotic edema or acquired angioneurotic edema
- Urticaria in last one year
- No spleen or functional spleen.
- Platelet disorder or other bleeding disorder may cause injection contraindication
- Faint at the sight of needles.
- Prior administration of immunodepressant or corticosteroids, antianaphylaxis treatment, cytotoxic treatment in last 6 months.
- Prior administration of blood products in last 4 months
- Prior administration of other research medicines in last 1 month
- Prior administration of attenuated vaccine in last 1 month
- Prior administration of inactivated vaccine in last 14 days
- Current anti-tuberculosis prophylaxis or therapy
- According to the judgement of investigator,various medical, psychological, social or other conditions, those could affect the subjects to sign informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Single-center, Open-label Phase I Clinical Trial of Booster Vaccination of Adenovirus Type-5 Vectored COVID-19 Vaccine in Healthy Adults Aged 18-60 Years
The 2019 novel-coronavirus (2019-nCov) is the cause of a cluster of unexplained pneumonia that started in Hubei province in China. It has manifest into a global health crisis with escalating confirmed cases and spread across many countries.
In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of diseases caused by COVID-19 can be tough for current treatment.
This study is a phase I clinical trial of booster vaccination of adenovirus type-5 vectored COVID-19 vaccine 6 months after prime vaccination. The investigators intent to evaluate the safety and immunogenicity of booster vaccination of adenovirus type-5 vectored COVID-19 vaccine in healthy adults aged aged 18-60 years.
Read the detailed description
The 2019 novel-coronavirus (2019-nCov) is the cause of a cluster of unexplained pneumonia that started in Hubei province in China. It has manifest into a global health crisis with escalating confirmed cases and spread across many countries.
In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of diseases caused by COVID-19 can be tough for current treatment.
This is a single-center, open-label phase I clinical trial of booster vaccination in healthy 18 to 60 years of age, inclusive, who has been prime vaccinated with adenovirus type-5 vectored COVID-19 vaccine. This clinical trial is designed to assess the safety and immunogenicity of booted vaccination of adenovirus type-5 vectored COVID-19 vaccine manufactured by Beijing Institute of Biotechnology and CanSino Biologics Inc.
- Being tested
- Adenovirus Type-5 Vectored COVID-19 Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adenovirus Type-5 Vectored COVID-19 VaccineBiological
Low dose adenovirus type-5 vectored COVID-19 vaccine (5E10 vp)
| Study group | Role | What they receive |
|---|---|---|
| Adenovirus Type-5 Vectored COVID-19 Vaccine | Experimental | Not described Receives: Biological: Adenovirus Type-5 Vectored COVID-19 Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of adverse reactions within 14 days after booster vaccination
Occurrence of adverse reactions within 14 days after booster vaccination of adenovirus type-5 vectored COVID-19 vaccine
Measured: 0-14 days post-vaccination
Secondary outcomes (8)
Occurrence of adverse events within 14 days after booster vaccination
Occurrence of adverse events within 14 days after booster vaccination of adenovirus type-5 vectored COVID-19 vaccine
Measured: 0-14 days post-vaccination
Occurrence of adverse events within 28 days after booster vaccination
Occurrence of adverse events within 28 days after booster vaccination of adenovirus type-5 vectored COVID-19 vaccine
Measured: 0-28 days post-vaccination
Occurrence of serious adverse events within 28 days after booster vaccination
Occurrence of serious adverse events within 28 days after booster vaccination of adenovirus type-5 vectored COVID-19 vaccine
Measured: 0-28 days post-vaccination
Occurrence of serious adverse events within 6 months after booster vaccination
Occurrence of serious adverse events within 6 months after booster vaccination of adenovirus type-5 vectored COVID-19 vaccine
Measured: 6 months post-vaccination
Occurrence of serious adverse events within 12 months after booster vaccination
Occurrence of serious adverse events within 12 months after booster vaccination of adenovirus type-5 vectored COVID-19 vaccine
Measured: 12 months post-vaccination
Changes in laboratory test indicators before and 1 day after vaccination
Changes in laboratory test indicators (including white blood cell count, lymphocyte count, neutrophils, platelets, hemoglobin, ALT, AST, total bilirubin, fasting blood glucose, creatinine) before and 1 day after vaccination
Measured: 1 day post-vaccination
Antibody of S-RBD at day 14, day 28, month 6 and month 12 after booster vaccination
Antibody of S-RBD at day 14, day 28, month 6 and month 12 after booster vaccination of adenovirus type-5 vectored COVID-19 vaccine
Measured: 14 days, 28 days, 6 months and 12 months post-vaccination
Cellular immunity at day 14 after booster vaccination
Cellular immunity at day 14 after booster vaccination of adenovirus type-5 vectored COVID-19 vaccine
Measured: 14 days post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start26 Sep 2020
- Primary completion25 Oct 2020
- Study completion11 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adenovirus Type-5 Vectored COVID-19 VaccineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Centers for Disease Control and Prevention
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04568811
- Sponsor's protocol ID
- JSVCT100
- Status last verified
- Mar 2022
- First submitted
- 28 Sep 2020
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jia S, Zhang J, Wang X, Zhang Z, Wang B, Zhang J, Jiang H, Guo G, Wang Y, Wan J, Wang W, Hou L, Zhu F. Safety and Immunogenicity of Homologous Recombinant Adenovirus Type 5-Vectored COVID-19 Vaccine Booster Dose in Healthy Adults Aged 18-60 Years: a Single-Center, Open-Label Trial. Infect Dis Ther. 2023 Dec;12(12):2757-2769. doi: 10.1007/s40121-023-00892-0. Epub 2023 Dec 1.
PubMed 38038866
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Single-center, Open-label Phase I Clinical Trial of Booster Vaccination of Adenovirus Type-5 Vectored COVID-19 Vaccine in Healthy Adults Aged 18-60 Years
- ClinicalTrials.gov ID
- NCT04568811
- Acronym / sponsor ID
- JSVCT100
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Jiangsu Province Centers for Disease Control and PreventionResearch network
- Study start
- 26 Sep 2020 (actual)
- Primary completion
- 25 Oct 2020 (actual)
- Study completion
- 11 Sep 2021 (actual)
- First posted
- 29 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The 2019 novel-coronavirus (2019-nCov) is the cause of a cluster of unexplained pneumonia that started in Hubei province in China. It has manifest into a global health crisis with escalating confirmed cases and spread across many countries.
In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of diseases caused by COVID-19 can be tough for current treatment.
This study is a phase I clinical trial of booster vaccination of adenovirus type-5 vectored COVID-19 vaccine 6 months after prime vaccination. The investigators intent to evaluate the safety and immunogenicity of booster vaccination of adenovirus type-5 vectored COVID-19 vaccine in healthy adults aged aged 18-60 years.
Detailed description
The 2019 novel-coronavirus (2019-nCov) is the cause of a cluster of unexplained pneumonia that started in Hubei province in China. It has manifest into a global health crisis with escalating confirmed cases and spread across many countries.
In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of diseases caused by COVID-19 can be tough for current treatment.
This is a single-center, open-label phase I clinical trial of booster vaccination in healthy 18 to 60 years of age, inclusive, who has been prime vaccinated with adenovirus type-5 vectored COVID-19 vaccine. This clinical trial is designed to assess the safety and immunogenicity of booted vaccination of adenovirus type-5 vectored COVID-19 vaccine manufactured by Beijing Institute of Biotechnology and CanSino Biologics Inc.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adenovirus Type-5 Vectored COVID-19 Vaccine | Experimental | Biological: Adenovirus Type-5 Vectored COVID-19 Vaccine |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Participants who has received prime vaccination of adenovirus type-5 vectored COVID-19 vaccine
- Able to understand the content of informed consent and willing to sign the informed consent
- Negative in HIV diagnostic test.
- Axillary temperature ≤37.0°C.
- General good health as established by medical history and physical examination.
Key exclusion criteria (19 listed)
- Family history of seizure, epilepsy, brain or mental disease
- Subject allergic to any component of the investigational vaccine, or a more severe allergic reaction and history of allergies in the past.
- Woman who is pregnant, breast-feeding on day of enrollment, or become pregnant during the next 12 months
- Any acute fever disease or infections.
- History of SARS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adenovirus Type-5 Vectored COVID-19 VaccineLow dose adenovirus type-5 vectored COVID-19 vaccine (5E10 vp) | Biological | Adenovirus Type-5 Vectored COVID-19 Vaccine |
Primary outcome
Occurrence of adverse reactions within 14 days after booster vaccination
Time frame: 0-14 days post-vaccination
Occurrence of adverse reactions within 14 days after booster vaccination of adenovirus type-5 vectored COVID-19 vaccine
8 secondary outcomes
Occurrence of adverse events within 14 days after booster vaccination
Time frame: 0-14 days post-vaccination
Occurrence of adverse events within 28 days after booster vaccination
Time frame: 0-28 days post-vaccination
Occurrence of serious adverse events within 28 days after booster vaccination
Time frame: 0-28 days post-vaccination
Occurrence of serious adverse events within 6 months after booster vaccination
Time frame: 6 months post-vaccination
Occurrence of serious adverse events within 12 months after booster vaccination
Time frame: 12 months post-vaccination
Changes in laboratory test indicators before and 1 day after vaccination
Time frame: 1 day post-vaccination
Antibody of S-RBD at day 14, day 28, month 6 and month 12 after booster vaccination
Time frame: 14 days, 28 days, 6 months and 12 months post-vaccination
Cellular immunity at day 14 after booster vaccination
Time frame: 14 days post-vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Derived from this study: PubMed 38038866Jia S, Zhang J, Wang X, Zhang Z, Wang B, Zhang J, Jiang H, Guo G, Wang Y, Wan J, Wang W, Hou L, Zhu F. Safety and Immunogenicity of Homologous Recombinant Adenovirus Type 5-Vectored COVID-19 Vaccine Booster Dose in Healthy Adults Aged 18-60 Years: a Single-Center, Open-Label Trial. Infect Dis Ther. 2023 Dec;12(12):2757-2769. doi: 10.1007/s40121-023-00892-0. Epub 2023 Dec 1.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Adenovirus Type-5 Vectored COVID-19 Vaccine in people with Adenovirus Type-5 Vectored COVID-19 Vaccine, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of adverse reactions within 14 days after booster vaccination (time frame: 0-14 days post-vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04568811, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.