Covid19Phase 1COVID-19NCT04866069
Study of a Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Adjuvanted Inactivated Vaccine in Healthy Adults
A Phase 1 study testing SARS-CoV-2 vaccine in people with Covid19, run by Osman ERGANIS, PhD, Prof at 1 site in Turkey (Türkiye).
Trial summary
This phase I study is designed as double-blinded, randomised, placebo controlled, three-armed study composed of two different dose arms of protective adjuvanted inactivated vaccine against SARS-CoV-2 in dose escalations (first low dose group, followed by high dose group) and placebo arm. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- SARS-CoV-2 vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Apr 2021to 5 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- To be eligible for the study, each participant must satisfy all the following criteria:
- Healthy participants between 18-45 years of age,
- Sign an informed consent document,
- Negative immunoglobulin G (IgG) and immunoglobulin M (IgM) antibody for COVID-19,
- Negative quantitative polymerase chain reaction (qPCR) SARS-CoV-2 results of nasopharyngeal/sputum samples,
- Able to comply with the study protocol during the study period,
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- Negative tests for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV),
- Body temperature <37.2 C and no signs of active infection,
- Body mass index 18-35 kg/m2,
- Normal laboratory levels of whole blood count, alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin, urea, creatinine, and fasting blood glucose, or abnormal finding detected in any laboratory parameter which is not greater than Grade 1 according to the investigator's evaluation,
- Good general health (no known disease in the history and physical examination within 14 days prior to the enrolment),
- Female and male participants who will be able to have appropriate contraception methods within 30 days prior to vaccine injection and within 6 months after vaccination,
Who cannot join
- Participants with any of the following criteria will be excluded:
- History of seizure, encephalopathy, or psychosis,
- History of allergic reactions to any known vaccine or to any component of the study vaccine,
- Pregnant, breastfeeding, or positive pregnancy test or planning to conceive within 6 months,
- History of SARS-CoV-2 infection,
- Severe cardiovascular disorders (arrhythmia, conduction disorders, history of myocardial infarction, uncontrolled hypertension),
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- Severe chronic disorders (asthma, diabetes mellitus, thyroid disorders…etc),
- Congenital or acquired angioedema,
- Diagnosis of immunodeficiency,
- Diagnosis of bleeding diathesis,
- Use of immunosuppressive treatment, anti-allergic treatment, cytotoxic treatment, inhaler corticosteroids (allergic rhinitis or topical steroid ointments are excluded),
- Those who received blood and blood product transfusions in the last 6 months,
- Those on any vaccine program or experimental medication within 1 month prior to the study,
- History of any vaccination against SARS-CoV-2 within 1 month prior to the study,
- Use of active tuberculosis treatment,
- History of addictive drug use,
- History of alcohol abuse and/or history of alcohol intake more than 2 units per day or 10 units per week and/or positive breath alcohol test (one unit of alcohol equals to 250 mL beer, 125 mL wine or 25 mL whiskey),
- According to the investigator's evaluation, those who have any condition (medical, psychological, social, etc.) that may impair the patient's compliance with the study will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara City Hospital Phase I Drug Research Center
Ankara, 06800
About this study
Official title: Phase I Study Evaluating the Safety and Efficacy of the Protective Adjuvanted Inactivated Vaccine Developed Against SARS-CoV-2 in Healthy Participants, Administered as Two Injections Subcutaneously in Two Different Dosages.
This phase I study is designed as double-blinded, randomised, placebo controlled, three-armed study composed of two different dose arms of protective adjuvanted inactivated vaccine against SARS-CoV-2 in dose escalations (first low dose group, followed by high dose group) and placebo arm.
Read the detailed description
This phase I study is designed as double-blinded, randomised, placebo controlled, three-armed study composed of two different dose arms of protective adjuvanted inactivated vaccine against SARS-CoV-2 in dose escalations (first low dose group, followed by high dose group) and placebo arm. Each dose of vaccine will be defined as a cohort in itself, with vaccine administration to 20 participants and placebo administration to 5 participants. After completion of low-dose group, decision of switch to high-dose will be taken by the Independent Data Monitoring Committee and will continue accordingly.
In the study, 50 healthy participants of 18-45 years of age will be recruited.
All injections will be done subcutaneously.
Injections will be administered at 1 and 21 days.
The participants will be followed for 6 months and the study will be completed in 12 months.
- Conditions
- Covid19
- Being tested
- SARS-CoV-2 vaccine, Placebo
- Keywords
- SARS-CoV-2, Adjuvanted inactivated vaccine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-CoV-2 vaccineBiological
Adjuvanted inactivated vaccine
PlaceboBiological
0.9% NaCl
| Study group | Role | What they receive |
|---|---|---|
| Low-Dose Group (Group A) | Experimental | 20 participants will receive 10 µg-3M inactivated virus + 1 mg Al(OH)3 + 300 µg CpGODN adjuvanted vaccine Receives: Biological: SARS-CoV-2 vaccine |
| High-Dose Group (Group B) | Experimental | 20 participants will receive 20 µg-6M inactivated virus + 1 mg Al(OH)3 + 300 µg CpGODN adjuvanted vaccine Receives: Biological: SARS-CoV-2 vaccine |
| Placebo Group | Placebo comparator | 10 participants will receive 1 ml of 0.9% sodium chloride (NaCl) Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute adverse events (AEs)
Frequency of acute adverse events in all dosage groups
Measured: 24 hours
Solicited local and systemic adverse events (AEs)
Frequency of local and systemic AEs in all dosage groups
Measured: 15 days
Unsolicited local and systemic adverse events (AEs)
Frequency of local and systemic AEs in all dosage groups
Measured: 28 days
Secondary outcomes (2)
Neutralizing antibody response
Immunogenicity response by measuring neutralizing antibody titer (anti-spike and anti-RBD) developed against SARS-CoV-2 (by ELISA)
Measured: Before first dose administration, on Day 21-28-35 and Month 3 and Month 6 after first dose administration.
Cellular immune response
Interferon-γ (IFN-γ) positive cell level (by ELISPOT)
Measured: Before first dose administration, on Day 21-28-35 and Month 3 and Month 6 after first dose administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start25 Apr 2021
- Primary completion5 Sep 2021
- Study completion5 Sep 2021
Why it stopped: Although cellular responses to virus were satisfactory, neutralizing titres against virus were lower then expected levels
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osman ERGANIS, PhD, Prof
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey, VETAL Inc., MonitorCRO
- Responsible party
- Sponsor-investigator, Osman ERGANIS, PhD, Prof, The Scientific and Technological Research Council of Turkey
- Investigators
- Oguz Akbas, MD, Study director, MonitorCRO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04866069
- Sponsor's protocol ID
- ISV2AOH3ODN
- Acronym
- COVID-19
- Status last verified
- Apr 2023
- First submitted
- 26 Apr 2021
- Last updated
- 18 Apr 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 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study Evaluating the Safety and Efficacy of the Protective Adjuvanted Inactivated Vaccine Developed Against SARS-CoV-2 in Healthy Participants, Administered as Two Injections Subcutaneously in Two Different Dosages.
- ClinicalTrials.gov ID
- NCT04866069
- Acronym / sponsor ID
- COVID-19 / ISV2AOH3ODN
- Conditions
- Covid19
- Keywords
- SARS-CoV-2, Adjuvanted inactivated vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Although cellular responses to virus were satisfactory, neutralizing titres against virus were lower then expected levels
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Osman ERGANIS, PhD, ProfUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey, VETAL Inc., MonitorCRO
- Study start
- 25 Apr 2021 (actual)
- Primary completion
- 5 Sep 2021 (actual)
- Study completion
- 5 Sep 2021 (actual)
- First posted
- 29 Apr 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.
This phase I study is designed as double-blinded, randomised, placebo controlled, three-armed study composed of two different dose arms of protective adjuvanted inactivated vaccine against SARS-CoV-2 in dose escalations (first low dose group, followed by high dose group) and placebo arm.
Detailed description
This phase I study is designed as double-blinded, randomised, placebo controlled, three-armed study composed of two different dose arms of protective adjuvanted inactivated vaccine against SARS-CoV-2 in dose escalations (first low dose group, followed by high dose group) and placebo arm. Each dose of vaccine will be defined as a cohort in itself, with vaccine administration to 20 participants and placebo administration to 5 participants. After completion of low-dose group, decision of switch to high-dose will be taken by the Independent Data Monitoring Committee and will continue accordingly.
In the study, 50 healthy participants of 18-45 years of age will be recruited.
All injections will be done subcutaneously.
Injections will be administered at 1 and 21 days.
The participants will be followed for 6 months and the study will be completed in 12 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-Dose Group (Group A) | Experimental | Biological: SARS-CoV-2 vaccine20 participants will receive 10 µg-3M inactivated virus + 1 mg Al(OH)3 + 300 µg CpGODN adjuvanted vaccine |
| High-Dose Group (Group B) | Experimental | Biological: SARS-CoV-2 vaccine20 participants will receive 20 µg-6M inactivated virus + 1 mg Al(OH)3 + 300 µg CpGODN adjuvanted vaccine |
| Placebo Group | Placebo comparator | Biological: Placebo10 participants will receive 1 ml of 0.9% sodium chloride (NaCl) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Healthy participants between 18-45 years of age,
- Sign an informed consent document,
- Negative immunoglobulin G (IgG) and immunoglobulin M (IgM) antibody for COVID-19,
- Negative quantitative polymerase chain reaction (qPCR) SARS-CoV-2 results of nasopharyngeal/sputum samples,
- Able to comply with the study protocol during the study period,
Key exclusion criteria (18 listed)
- History of seizure, encephalopathy, or psychosis,
- History of allergic reactions to any known vaccine or to any component of the study vaccine,
- Pregnant, breastfeeding, or positive pregnancy test or planning to conceive within 6 months,
- History of SARS-CoV-2 infection,
- Severe cardiovascular disorders (arrhythmia, conduction disorders, history of myocardial infarction, uncontrolled hypertension),
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 |
|---|---|---|
| SARS-CoV-2 vaccineAdjuvanted inactivated vaccine | Biological | High-Dose Group (Group B), Low-Dose Group (Group A) |
| Placebo0.9% NaCl | Biological | Placebo Group |
Primary outcome
Acute adverse events (AEs)
Time frame: 24 hours
Frequency of acute adverse events in all dosage groups
Solicited local and systemic adverse events (AEs)
Time frame: 15 days
Frequency of local and systemic AEs in all dosage groups
Unsolicited local and systemic adverse events (AEs)
Time frame: 28 days
Frequency of local and systemic AEs in all dosage groups
2 secondary outcomes
Neutralizing antibody response
Time frame: Before first dose administration, on Day 21-28-35 and Month 3 and Month 6 after first dose administration.
Cellular immune response
Time frame: Before first dose administration, on Day 21-28-35 and Month 3 and Month 6 after first dose administration.
Results and safety
The study was stopped early (reason given: Although cellular responses to virus were satisfactory, neutralizing titres against virus were lower then expected levels). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 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.
Oguz Akbas, MD study director
MonitorCRO
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 SARS-CoV-2 vaccine in people with Covid19, run by Osman ERGANIS, PhD, Prof at 1 site in Turkey (Türkiye).
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 18 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: stopped early, as of the sponsor's last update on 18 Apr 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 Turkey (Türkiye). 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 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 was stopped early (reason given: Although cellular responses to virus were satisfactory, neutralizing titres against virus were lower then expected levels). Results are not available in the source record.
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?
Acute adverse events (AEs) (time frame: 24 hours). The study lists 3 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 18 Apr 2023.