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CompletedNCT04568811Updated Mar 31, 2022

The Phase I Clinical Trial of Booster Vaccination of Adenovirus Type-5 Vectored COVID-19 Vaccine

A Phase 1 interventional study of Adenovirus Type-5 Vectored COVID-19 Vaccine in Adenovirus Type-5 Vectored COVID-19 Vaccine, sponsored by Jiangsu Province Centers for Disease Control and Prevention. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2022-03-31.

Sponsored by Jiangsu Province Centers for Disease Control and Prevention · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
89
Allocation
Not applicable
Sex
All
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Study 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.

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.

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Conditions studied

  • Adenovirus Type-5 Vectored COVID-19 Vaccine
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In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 89 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Jiangsu Province Centers for Disease Control and Prevention is the lead sponsor of 75 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
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Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
89 participants (actual)

Study arms

  • Experimental
    Adenovirus Type-5 Vectored COVID-19 Vaccine

    Biological: Adenovirus Type-5 Vectored COVID-19 Vaccine

Interventions

  • BiologicalAdenovirus Type-5 Vectored COVID-19 Vaccine

    Low dose adenovirus type-5 vectored COVID-19 vaccine (5E10 vp)

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 0-14 days post-vaccination

Secondary outcomes

  1. 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

    Time frame: 0-14 days post-vaccination

  2. 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

    Time frame: 0-28 days post-vaccination

  3. 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

    Time frame: 0-28 days post-vaccination

  4. 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

    Time frame: 6 months post-vaccination

  5. 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

    Time frame: 12 months post-vaccination

  6. 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

    Time frame: 1 day post-vaccination

  7. 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

    Time frame: 14 days, 28 days, 6 months and 12 months post-vaccination

  8. Cellular immunity at day 14 after booster vaccination

    Cellular immunity at day 14 after booster vaccination of adenovirus type-5 vectored COVID-19 vaccine

    Time frame: 14 days post-vaccination

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Study locations

1 site
  • A rehabilitation centre in Wuhan
    Wuhan, Hubei, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04568811
Lead sponsor
Jiangsu Province Centers for Disease Control and Prevention
Responsible party
Sponsor
First posted
Sep 29, 2020
Start date
Sep 26, 2020
Primary completion
Oct 25, 2020
Completion
Sep 11, 2021
Last update
Mar 31, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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