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COVID-19Phase 1NCT04522089

A Study to Evaluate the Safety and Immunogenicity of COVID-19 (AdimrSC-2f) Vaccine

A Phase 1 study testing AdimrSC-2f in people with COVID-19, run by Adimmune Corporation at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to evaluate the safety and immunogenicity of the preventative vaccine, AdimrSC-2f, in healthy volunteers aged from 20 to 60 years old. Read more about this study

Who is it for?
Ages 20 to 60 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
AdimrSC-2f
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteTaiwan
Study dates
24 Aug 2020to 6 May 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 20 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Subjects who meet ALL inclusion criteria will be included.
  • Male or non-pregnant female, aged 20 to 60 years old (inclusive).
  • Subject who is physically and mentally capable of participating the study and are willing to adhere to study procedures.
  • Subject with no clinically significant abnormal findings in medical history, physical examination, vital signs, or clinical laboratory results at the Screening visit based on the investigator's judgment.
  • Subject with negative test result in SARS-CoV-2 antibody (IgG and IgM) rapid test at the Screening visit.
  • Subject with negative serology test results for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen, and hepatitis C antibody at the Screening visit.
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  • Subjects' clinical laboratory test results are in the normal range or with abnormal values without clinical significance as judged by the investigator.
  • Female subject with childbearing potential must have negative result in urine pregnancy test at the Screening visit.
  • Female subject with childbearing potential must be willing to implement adequate, highly effective contraceptive measure during the study period. Effective birth control includes:
  • Intrauterine device plus one barrier method
  • Oral, implantable, or injectable contraceptives plus one barrier method; or
  • Two barrier methods Effective barrier methods are male or female condoms, diaphragms, or spermicides (creams or gels that contain a chemical to kill sperm). Women of childbearing potential are those who have not been surgically sterilized or have not been free from menses for ≥ 1 year.
  • Male subject who agrees to use an adequate method of contraception during the study period [e.g., barrier contraceptives (male condom)].
  • Subject who provides informed consent after receiving a detailed explanation of study procedures.

Who cannot join

  • Subjects who meet ANY exclusion criteria will be excluded.
  • Subject with a body mass index (BMI) < 18.5 kg/m2 (underweight) or ≥ 35 kg/m2 (greater than Class I obesity) at the Screening Visit.
  • Subject with history of cancer (except localized skin cancer without metastases) within 5 years prior to the Screening visit.
  • Subject has ongoing or medical history of hypertension or diabetes mellitus.
  • Subject has ongoing use of tobacco or nicotine-containing products (nicotine patch included) or e-cigarette devices or with history of using nicotine-containing product as documented in medical chart or by verbal confirmation at screening.
  • Subject with documented history of substance or alcohol abuse in the medical chart or by verbal confirmation within 6 months (approximately 180 days) prior to the Screening visit.
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  • Subject who received any vaccine (live, inactivated, or bacterial) within 1 month (approximately 30 days) prior to the Screening visit.
  • Subject with hypersensitivity to the ingredients of AdimrSC-2f (including aluminum).
  • Subject with personal or family history of Guillain-Barré Syndrome.
  • Subject who has travelled abroad within 3 months (approximately 90 days) prior to the Screening visit.
  • Subject with influenza-like illness as defined by any of the following symptoms at Screening visit: fever (tympanic temperature ≥ 38℃), dry cough, headache, fatigue, respiratory sputum production (phlegm), dysgeusia, anosmia, shortness of breath, muscle and joint pain, or sore throat.
  • Female subject who is pregnant or lactating at screening or plans to be pregnant during the study period.
  • Subject who treated with an investigational drug or device or have participated in a clinical study within 3 months (approximately 90 days) prior to the Screening visit.
  • Subject with clinically significant abnormal ECG at the Screening visit or with history of clinically significant cardiovascular disease such as arrhythmia, coronary artery disease or heart failure, as judged by the investigator.
  • Subject with any confirmed or suspected abnormal immune function, immunosuppressive, or immunodeficiency or received any immunosuppressants or immunomodulators within 6 months (approximately 180 days) prior to the Screening visit.
  • Subject with history of wheezing, asthma, chronic obstructive pulmonary disease, or have used bronchodilator within 3 months (approximately 90 days) prior to the Screening visit.
  • Subject who had blood donation within 2 weeks prior to the Screening visit.
  • Subject who received any blood products, including immunoglobulin within 3 months (approximately 90 days) prior to the Screening visit.
  • Subject who is not suitable to participate in this study as judged by the investigator.
  • Subject with chronic illness.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • National Taiwan University Hospital

    Taipei, 100

Other trials in Taiwan

About this study

Official title: A Randomized, Single Center, Open-label, Dose-finding, Phase I Study to Evaluate the Safety and Immunogenicity of Pandemic Virus Vaccine, AdimrSC-2f (SARS-CoV-2), in Healthy Volunteers

This study aims to evaluate the safety and immunogenicity of the preventative vaccine, AdimrSC-2f, in healthy volunteers aged from 20 to 60 years old.

Read the detailed description

The objectives of this phase I study are:

  1. to evaluate the safety profile of the AdimrSC-2f vaccine, and
  2. to assess the immunogenicity of the AdimrSC-2f vaccine.
Conditions
COVID-19
Being tested
AdimrSC-2f
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AdimrSC-2fBiological

    AdimrSC-2f is a candidate vaccine against COVID-19 developed by Adimmune Corporation (Adimmune). Using the baculovirus-insect cells expression system, the recombinant receptor binding domain (RBD) of SARS-CoV-2 spike (S) protein is amplified and purified. AdimrSC-2f is formulated in the different dosages of Spike (S) protein without/with aluminum content as adjuvant.

Study groups in NCT04522089
Study groupRoleWhat they receive
AdimrSC-2f Group 1Experimentallow dose mcg
Receives: Biological: AdimrSC-2f
AdimrSC-2f Group 2Experimentallow dose mcg+AL
Receives: Biological: AdimrSC-2f
AdimrSC-2f Group 3Experimentalmedium dose mcg
Receives: Biological: AdimrSC-2f
AdimrSC-2f Group 4Experimentalhigh dose mcg
Receives: Biological: AdimrSC-2f

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The solicited adverse events (SoAEs)

    Determining the solicited adverse events (SoAEs) (the percentage, severity, and relationship to the AdimrSC-2f vaccine) during 7 days following each vaccination.

    Measured: The 7 days following each vaccination

  2. Incidence of abnormal laboratory tests results

    Determining the clinically significant changes in hematology, biochemistry, and coagulation results from baseline at Visit 2 and Visit 4.

    Measured: Day 7 after vaccination

Secondary outcomes (4)

  1. Safety of AdimrSC-2f vaccine: AE

    1. Determining the SoAEs and unsolicited AES (the percentage, severity, and relationship to AdimrSC-2f vaccine) during the study period.
    2. Overall AEs and serious adverse events (SAEs) during the study period.

    Measured: Day 0 to Day 182

  2. Immunogenicity

    Determining the changes of antibody titers between baseline and the subsequent scheduled visits

    Measured: Day 7,21,28,and 42

  3. Immunogenicity

    Determining the geometric mean increase (GMI)

    Measured: Day 21 and 42

  4. Immunogenicity

    Determining the seroconversion rate (SCR)

    Measured: Day 21 and 42

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2020
  2. Study start24 Aug 2020
  3. Primary completion20 Nov 2020
  4. Study completion6 May 2021

Resources

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
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04522089
Sponsor's protocol ID
ADPCT20011X
Status last verified
Aug 2021
First submitted
12 Aug 2020
Last updated
24 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AdimrSC-2f in people with COVID-19, run by Adimmune Corporation at 1 site in Taiwan.

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 14 inclusion and 20 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 24 May 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 Taiwan. 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?

The solicited adverse events (SoAEs) (time frame: The 7 days following each vaccination). The study lists 2 primary outcomes in all. 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 NCT04522089.

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 24 May 2022.

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