COVID-19Phase 1/2NCT05104489
Dose-finding Study for AdimrSC-2f Vaccine
A Phase 1/2 study testing AdimrSC-2f in people with COVID-19, run by Adimmune Corporation at 1 site in Indonesia.
Trial summary
AdimrSC-2f is a subunit protein-based vaccine produced using the baculovirus insect cells manufacturing process to prevent Coronavirus disease 2019 (COVID-19). The primary goal of this Phase I/II study is to evaluate the vaccine safety and immunogenicity of AdimrSC-2f in healthy adult individuals, as compared to… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- AdimrSC-2f
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 241 participants
- Where
- 1 siteIndonesia
- Study dates
- 3 Jan 2022to 26 Jul 2023
- Phase
- Phase 1/2
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects aged 18 to 60 years old (inclusive) at the time of informed consent who are in good general health in the opinion of the investigator.
- At Screening Visit, subjects with a body mass index (BMI) > 18.5 kg/m2 or ≤ 30.0 kg/m2.
- Subjects without known history of SARS-CoV-2 infection or known close contact with anyone with laboratory-confirmed SARS-CoV-2 infection or COVID-19 within 2 weeks prior to the first dosing.
- Subjects are willing and able to give informed consent prior to any screening procedure conducting and to comply with study procedures.
- Female subjects of childbearing potential (defined as any female who has experienced menarche and who is NOT surgically sterile [ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months or documented plasma follicle-stimulating hormone level ≥40 milli-International unit (mIU)/mL]) must agree to be heterosexually inactive from at least 21 days prior to the Screening Visit and through 6 months (defined as 24 weeks) after the last dosing OR agree to consistently use any of the following methods of contraception from at least 21 days prior to the Screening Visit and through 6 months (defined as 24 weeks) after the last dosing:
- Condoms (male or female) with spermicide (if acceptable in country)
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- Diaphragm with spermicide
- Cervical cap with spermicide
- Intrauterine device
- Oral or patch contraceptives
- Norplant®, Depo-Provera®, or other in country regulatory-approved contraceptive method that is designed to protect against pregnancy
- Abstinence, as a form of contraception, is acceptable
Who cannot join
- Subjects who are investigational site staff member directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the Investigator, or subjects who are Sponsor employees directly involved in the conduct of the trial.
- Any ongoing severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
- Subject with positive serology test results for human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV) at the Screening Visit (V0).
- Subject with positive test result for COVID-19 antigen rapid test at the Screen Visit or V1 prior to the 1st dosing.
- Subject with influenza-like illness as defined by any of the following symptoms at the Screening Visit or before randomization: fever (tympanic temperature ≥ 38°C), dry cough, headache, fatigue, respiratory sputum production (phlegm), dysgeusia, anosmia, shortness of breath, muscle and joint pain, or sore throat.
- Participation in other studies involving investigational drug(s) and/or device(s) within 90 days prior to the Screening Visit and/or during study participation.
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- Subject who has received any investigational coronavirus vaccine or has received any medications intended to prevent COVID-19 or plan simultaneous participation in another interventional study to prevent or treat COVID-19.
- Subject with any following ongoing disease or medical history in medical chart or by verbal confirmation:
- Diagnosis of malignancy not in remission for the past 3 years except non-melanoma skin cancer prior to the Screening Visit.
- Chronic pulmonary disease, asthma or wheezing.
- Chronic liver disease or suspected active hepatitis.
- Clinically significant cardiovascular disease such as arrhythmia, coronary artery disease or heart failure.
- Personal or family history of immune disorders, including systemic lupus erythematosus (SLE), rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, and Type 1 diabetes.
- Any confirmed or suspected abnormal immune function, immunosuppressive, or immunodeficiency.
- Personal or family history of Guillain-Barré Syndrome.
- Bleeding diathesis or condition associated with prolonged bleeding.
- History of anaphylaxis, urticarial or severe adverse reaction associated with a vaccine or AdimrSC-2f or aluminum.
- Dermatologic conditions that could affect local solicited adverse event assessment per the investigator's opinion.
- Subject who has any of the following prior medication histories:
- Received any vaccine (live, inactivated, or bacterial) within 30 days prior to the Screening Visit.
- Received any blood/plasma products or immunoglobulin within 90 days prior to the Screening Visit.
- Received any systemic corticosteroids or steroids within 30 days prior to the first dosing. Topical, inhaled/nebulized, intra-articular, or nasal corticosteroid/ steroids are permitted.
- Received treatment with immunosuppressive therapy, including cytotoxic agents, immunosupressants or system corticosteroids for organ transplant, cancer, or an autoimmune disease, or planned receipt for disease treatment during study period.
- Used bronchodilator within 90 days prior to the Screening visit.
- Subject with current use or history of chronic smoking (defined as ≥ 1 cigarette per day) in the medical chart or by verbal confirmation within 1 year prior to the Screening Visit.
- Subject with the history of illegal substance use or alcohol abuse in the medical chart or by verbal confirmation within 2 years prior to the Screening Visit.
- Female subject who is pregnant or lactating at the Screening Visit or Visit 1 or plan to be pregnant during the study period.
- Subject who has donated ≥ 250 mL of blood product within 28 days prior to the Screening Visit or who plans to donate blood products during the study period.
- Subject with levels of creatine phosphokinase outside of the reference range at the Screening Visit.
- Subject who is not suitable to participate in this study as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II, Placebo-Controlled, Randomized, Double-Blind, Dose-Finding Study to Evaluate the Safety, Tolerability, and Immunogenicity of AdimrSC-2f Vaccine in Healthy Adults
AdimrSC-2f is a subunit protein-based vaccine produced using the baculovirus insect cells manufacturing process to prevent Coronavirus disease 2019 (COVID-19). The primary goal of this Phase I/II study is to evaluate the vaccine safety and immunogenicity of AdimrSC-2f in healthy adult individuals, as compared to placebo.
Read the detailed description
This will be a Phase I/II, placebo-controlled, randomized, double-blind within dose cohort, dose-finding study to evaluate the safety, tolerability, and immune response of AdimrSC-2f vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in healthy adults aged from 18 to 60. Two hundred forty (240) subjects will be sequentially enrolled from low dose to high dose cohort and then randomized into AdimrSC-2f vaccine group or matched placebo in a 3:1 ratio. Each enrolled subject will receive a total of 3 doses with 3-week apart by 0.5 mL intramuscular (IM) injection to the deltoid region of non-dominant arm preferably. All enrolled subjects will be follow their safety and immune response for six months.
- 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
IM injection
| Study group | Role | What they receive |
|---|---|---|
| Low Dose | Experimental | 50 mcg of antigen with 250 mcg of Al(OH)3 Receives: Biological: AdimrSC-2f |
| Median Dose | Experimental | 100 mcg of antigen with 250 mcg of Al(OH)3 Receives: Biological: AdimrSC-2f |
| High Dose | Experimental | 100 mcg of antigen with 500 mcg of Al(OH)3 Receives: Biological: AdimrSC-2f |
| Placebo | Placebo comparator | 250 mcg of Al(OH)3 Receives: Biological: AdimrSC-2f |
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS-CoV-2 neutralizing antibody tiers
Measured: 21 days after the 3rd dosing
Incidence of adverse events and clinically significant changes in clinical and laboratory evaluations.
Measured: Day 1 to 24 weeks after the last dosing
Secondary outcomes (2)
SARS-CoV-2 neutralizing antibody tiers
Measured: Day 1, Day 22, Day 43, 21 days after the last dosing, and 24 weeks after the last dosing
Number of subjects with SARS-CoV-2 infection
Measured: 21 days after the 3rd dosing to 24 weeks after the last dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start3 Jan 2022
- Primary completion29 Dec 2022
- Study completion26 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adimmune Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05104489
- Sponsor's protocol ID
- ADPCT21013I
- Status last verified
- Jul 2023
- First submitted
- 4 Oct 2021
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Placebo-Controlled, Randomized, Double-Blind, Dose-Finding Study to Evaluate the Safety, Tolerability, and Immunogenicity of AdimrSC-2f Vaccine in Healthy Adults
- ClinicalTrials.gov ID
- NCT05104489
- Acronym / sponsor ID
- ADPCT21013I
- Conditions
- COVID-19
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Adimmune CorporationIndustry (pharma, biotech, devices)
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 29 Dec 2022 (actual)
- Study completion
- 26 Jul 2023 (actual)
- First posted
- 3 Nov 2021 (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.
AdimrSC-2f is a subunit protein-based vaccine produced using the baculovirus insect cells manufacturing process to prevent Coronavirus disease 2019 (COVID-19). The primary goal of this Phase I/II study is to evaluate the vaccine safety and immunogenicity of AdimrSC-2f in healthy adult individuals, as compared to placebo.
Detailed description
This will be a Phase I/II, placebo-controlled, randomized, double-blind within dose cohort, dose-finding study to evaluate the safety, tolerability, and immune response of AdimrSC-2f vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in healthy adults aged from 18 to 60. Two hundred forty (240) subjects will be sequentially enrolled from low dose to high dose cohort and then randomized into AdimrSC-2f vaccine group or matched placebo in a 3:1 ratio. Each enrolled subject will receive a total of 3 doses with 3-week apart by 0.5 mL intramuscular (IM) injection to the deltoid region of non-dominant arm preferably. All enrolled subjects will be follow their safety and immune response for six months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low Dose | Experimental | Biological: AdimrSC-2f50 mcg of antigen with 250 mcg of Al(OH)3 |
| Median Dose | Experimental | Biological: AdimrSC-2f100 mcg of antigen with 250 mcg of Al(OH)3 |
| High Dose | Experimental | Biological: AdimrSC-2f100 mcg of antigen with 500 mcg of Al(OH)3 |
| Placebo | Placebo comparator | Biological: AdimrSC-2f250 mcg of Al(OH)3 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Subjects aged 18 to 60 years old (inclusive) at the time of informed consent who are in good general health in the opinion of the investigator.
- At Screening Visit, subjects with a body mass index (BMI) > 18.5 kg/m2 or ≤ 30.0 kg/m2.
- Subjects without known history of SARS-CoV-2 infection or known close contact with anyone with laboratory-confirmed SARS-CoV-2 infection or COVID-19 within 2 weeks prior to the first dosing.
- Subjects are willing and able to give informed consent prior to any screening procedure conducting and to comply with study procedures.
- Female subjects of childbearing potential (defined as any female who has experienced menarche and who is NOT surgically sterile [ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months or documented plasma follicle-stimulating hormone level ≥40 milli-International unit (mIU)/mL]) must agree to be heterosexually inactive from at least 21 days prior to the Screening Visit and through 6 months (defined as 24 weeks) after the last dosing OR agree to consistently use any of the following methods of contraception from at least 21 days prior to the Screening Visit and through 6 months (defined as 24 weeks) after the last dosing:
Key exclusion criteria (30 listed)
- Subjects who are investigational site staff member directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the Investigator, or subjects who are Sponsor employees directly involved in the conduct of the trial.
- Any ongoing severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
- Subject with positive serology test results for human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV) at the Screening Visit (V0).
- Subject with positive test result for COVID-19 antigen rapid test at the Screen Visit or V1 prior to the 1st dosing.
- Subject with influenza-like illness as defined by any of the following symptoms at the Screening Visit or before randomization: fever (tympanic temperature ≥ 38°C), dry cough, headache, fatigue, respiratory sputum production (phlegm), dysgeusia, anosmia, shortness of breath, muscle and joint pain, or sore throat.
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 |
|---|---|---|
| AdimrSC-2fIM injection | Biological | High Dose, Low Dose, Median Dose, Placebo |
Primary outcome
SARS-CoV-2 neutralizing antibody tiers
Time frame: 21 days after the 3rd dosing
Incidence of adverse events and clinically significant changes in clinical and laboratory evaluations.
Time frame: Day 1 to 24 weeks after the last dosing
2 secondary outcomes
SARS-CoV-2 neutralizing antibody tiers
Time frame: Day 1, Day 22, Day 43, 21 days after the last dosing, and 24 weeks after the last dosing
Number of subjects with SARS-CoV-2 infection
Time frame: 21 days after the 3rd dosing to 24 weeks after the last dosing
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 28 Jul 2023.
- Individual participant dataSharing planned: No
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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 1/2 study testing AdimrSC-2f in people with COVID-19, run by Adimmune Corporation at 1 site in Indonesia.
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 12 inclusion and 30 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 28 Jul 2023. 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 Indonesia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
SARS-CoV-2 neutralizing antibody tiers (time frame: 21 days after the 3rd dosing). 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?
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 28 Jul 2023.