COVID-19Phase 1NCT05526183
Phase I Clinical Trial With New SARS-CoV-2 CoVacHGMix Type 5 Adenoviral Vector Vaccine
A Phase 1 study testing Adeno-viral vector vaccine in people with COVID-19, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The CoVacHGMix adenoviral vector vaccine is a new vaccine developed to protect against SARS-CoV-2 and is a Phase I study designed based on adaptive clinical trial standards. In this Phase I study, it is aimed to test the safety and efficacy of the investigational product at 2 different dose levels (low: 5x1010 and… Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Adeno-viral vector vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Jan 2022to 1 Mar 2023
- 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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- I-1 Healthy volunteers of both sexes aged 18-59 years I-2 Able to give signed informed consent, I-3 Will be able to comply with the study protocol for approximately 6 months (depending on the group), I-4 HIV, Hepatitis B and C tests are negative, I-5 Body temperature below 37.2oC I-6 COVID-19 IgG and IgM antibodies negative and no history of symptomatic disease, I-7 Those who have not previously received any COVID-19 vaccines I-8 Negative qPCR SARS-CoV-2 result in nasopharynx or sputum samples, I-9 Body mass index between 18-35 kg/m2, I-10 Abnormal finding in complete blood count, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, urea, creatinine and fasting blood sugar between the normal reference values or detected in any laboratory parameter is Grade 1 according to the opinion of the investigator volunteers not older (>Grade 1) I-11 Good general health (history and physical examination within 14 days prior to enrollment in the study), I-12 if female, healthy volunteers who are not pregnant or who can use appropriate contraception within 30 days before vaccine injection and within 6 months after vaccination will be included in the study.
- I-13 Male volunteers who can use appropriate contraception within 6 months after vaccine injection will be included in the study.
Who cannot join
- E-1. Subjects with a history of seizures, encephalopathy or psychosis, E-2. Subjects who have a known allergy to any vaccine or are allergic to any component of the vaccine to be administered, E-3. Pregnant or lactating women, women who have a positive pregnancy test or plan to become pregnant within the next 6 months.
- E-4. Subjects whose body temperature is above 37.2oC at the time of vaccination or who have signs of active infection, E-5. Subjects with a positive history of SARS (SARS-CoV-1) (based on voluntary declaration), E-6.Subjects with severe cardiovascular disease (arrhythmia, conduction block, myocardial infarction, uncontrolled hypertension), E-7. Subjects with serious chronic diseases (asthma, diabetes, thyroid diseases, etc.), E-8. Subjects with congenital or acquired angioedema, E-9. Subjects with a diagnosis of immunodeficiency, E-10. Subjects with a diagnosis of bleeding diathesis, E-11. Subjects who take immunosuppressive treatment, those who take anti-allergic treatment, those who take cytotoxic treatment, those who take inhaled corticosteroids (except for allergic rhinitis or topical steroid ointments), E-12. Subjects who received blood and blood product transfusion in the last 4 months, E-13. Subjects who participated in any vaccine study or took experimental drugs within 1 month before starting the study, E-14. Subjects who received any live vaccines in the 1 month prior to the study E-15. Subjects who received inactivated vaccine within 14 days of starting the study E-16. Subjects receiving active tuberculosis treatment, E-17. Subjects with a personal or family history of thrombosis and thromboembolism, persons prone to thrombosis E-18. According to the researcher's evaluation, those who have any condition (medical, psychological, social, etc.) that may impair the volunteer's compliance with the study will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara City Hospital, Bilkent
Ankara, Bilkent, 06800
Ekmel Olcay, MD, 905337335535, ekmelolcay@gmail.com
Bedia Dinc, MD, 905053540776, bediadinc@gmail.com
About this study
Official title: Phase I Randomized Double-Blind Clinical Trial With New SARS-CoV-2 CoVacHGMix Type 5 Adenoviral Vector Vaccine in Healthy Volunteers Aged 18-45 Years
The CoVacHGMix adenoviral vector vaccine is a new vaccine developed to protect against SARS-CoV-2 and is a Phase I study designed based on adaptive clinical trial standards. In this Phase I study, it is aimed to test the safety and efficacy of the investigational product at 2 different dose levels (low: 5x1010 and high: 1x1011) in volunteers aged 18-59 years. Vaccination will be performed as two doses: on days 0 and 28. In line with adaptive design standards, Phase I will be transferred to Phase II. In this phase, 2 different dose levels will be tested, and the dose and application forms in Phase II will be determined according to the results of Phase I. One of the aims of the study is to collect sufficient data to determine the final dose and method of administration to be applied in the phase III study and clinic.
Read the detailed description
The study is planned as a safety and immunogenicity efficacy study in healthy volunteers . Dose groups are as follows:
- Low Dose (2 injections 28 days apart): Treatment (n=18) CoVacHGMix (Adenoviral vector mix (0.5 mL) containing equal amounts of CoVacHGA1320, CoVacHGB420, CoVacHGC720 and CoVacHGD1480)
- High Dose (2 injections 28 days apart): Treatment (n=18) CoVacHGMix (adenoviral vector mix (1 mL) containing equal amounts of CoVacHGA1320, CoVacHGB420, CoVacHGC720, and CoVacHGD1480 After the first dose of vaccine (low dose group) was administered to the first two volunteers on day zero, no application will be made on the first day. On the second day, 1st dose of vaccine will be administered to 2 volunteers in the high dose group. Volunteers to be treated will remain in quarantine for 1 day before the application and will be monitored in the clinic for 24 hours after the application. Volunteers will be physically examined daily and blood samples will be taken for analysis. On the seventh day, the Independent Data Monitoring Committee (IDMC) will evaluate the clinical and laboratory data of the first 4 volunteers. Following the approval of the committee (Day 8), the first dose in all groups will continue to be freely available. On the 27th day, all volunteers who received their first dose of vaccines will be subjected to the PCR test and those who are negative according to the test results will be hospitalized for the administration of their second dose.
İe., On the 28th day, the first two volunteers from the low-dose group (two volunteers who received the low-dose vaccine on the first day) will be administered the 2nd dose of vaccine. On the thirtieth day, the first two volunteers from the high-dose group (two volunteers who received the high-dose vaccine on the first day) will be administered the 2nd vaccine dose. After the evaluation and approval of the clinical and laboratory data of the 4 volunteers whose second dose applications were completed by the safety committee, second dose administrations to the rest of volunteers will be continued from the 35th day.
- Conditions
- COVID-19
- Being tested
- Adeno-viral vector vaccine
- Keywords
- Vaccine-SARS-Cov-2-Adenoviral vector
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adeno-viral vector vaccineBiological
The vaccine will be injected intramuscularly, as two doses 28 days apart. Two different dosages will be given to volunteers (low dose: 5x1010 and high dose: 1x1011)
| Study group | Role | What they receive |
|---|---|---|
| Low dose arm | Experimental | Low dose (5x1010 VP, i.m.); CoVacHGMix (with equal amounts of CoVacHGA1320, CoVacHGB420, CoVacHGC720 and CoVacHGD1480 adenoviral vector mix, as 0.5 solution) Intramuscular injection, two injections 28 days apart Receives: Biological: Adeno-viral vector vaccine |
| High dose arm | Experimental | High dose (1x1011 VP, i.m.); CoVacHGMix (with equal amounts of CoVacHGB420, CoVacHGC720 and CoVacHGD1480 adenoviral vector mix, as 1.0 solution) Intramuscular injections, two injections 28 days apart Receives: Biological: Adeno-viral vector vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events
Adverse events
Measured: Day1 to 168 days after vaccination
Secondary outcomes (1)
Immunogenicity
Serum IgG and IgM titres (as compared to neutralizing antibody titres derived from convalescent plasma samples of patients).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start21 Jan 2022
- Primary completion30 Dec 2022 (estimated)
- Study completion1 Mar 2023 (estimated)
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.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- Model description
- Parallel arm, double blind study with no control arm. Two doses of vaccine will be administered and the randomization will be performed for dose levels.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey, MonitorCRO
- Responsible party
- Sponsor
- Investigators
- Ekmel Olcay, MD, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05526183
- Sponsor's protocol ID
- MON.760.159.3
- Status last verified
- Sep 2022
- First submitted
- 31 Aug 2022
- Last updated
- 6 Sep 2022
- 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 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Randomized Double-Blind Clinical Trial With New SARS-CoV-2 CoVacHGMix Type 5 Adenoviral Vector Vaccine in Healthy Volunteers Aged 18-45 Years
- ClinicalTrials.gov ID
- NCT05526183
- Acronym / sponsor ID
- MON.760.159.3
- Conditions
- COVID-19
- Keywords
- Vaccine-SARS-Cov-2-Adenoviral vector
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey, MonitorCRO
- Study start
- 21 Jan 2022 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 2 Sep 2022 (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 CoVacHGMix adenoviral vector vaccine is a new vaccine developed to protect against SARS-CoV-2 and is a Phase I study designed based on adaptive clinical trial standards. In this Phase I study, it is aimed to test the safety and efficacy of the investigational product at 2 different dose levels (low: 5x1010 and high: 1x1011) in volunteers aged 18-59 years. Vaccination will be performed as two doses: on days 0 and 28. In line with adaptive design standards, Phase I will be transferred to Phase II. In this phase, 2 different dose levels will be tested, and the dose and application forms in Phase II will be determined according to the results of Phase I. One of the aims of the study is to collect sufficient data to determine the final dose and method of administration to be applied in the phase III study and clinic.
Detailed description
The study is planned as a safety and immunogenicity efficacy study in healthy volunteers . Dose groups are as follows:
- Low Dose (2 injections 28 days apart): Treatment (n=18) CoVacHGMix (Adenoviral vector mix (0.5 mL) containing equal amounts of CoVacHGA1320, CoVacHGB420, CoVacHGC720 and CoVacHGD1480)
- High Dose (2 injections 28 days apart): Treatment (n=18) CoVacHGMix (adenoviral vector mix (1 mL) containing equal amounts of CoVacHGA1320, CoVacHGB420, CoVacHGC720, and CoVacHGD1480 After the first dose of vaccine (low dose group) was administered to the first two volunteers on day zero, no application will be made on the first day. On the second day, 1st dose of vaccine will be administered to 2 volunteers in the high dose group. Volunteers to be treated will remain in quarantine for 1 day before the application and will be monitored in the clinic for 24 hours after the application. Volunteers will be physically examined daily and blood samples will be taken for analysis. On the seventh day, the Independent Data Monitoring Committee (IDMC) will evaluate the clinical and laboratory data of the first 4 volunteers. Following the approval of the committee (Day 8), the first dose in all groups will continue to be freely available. On the 27th day, all volunteers who received their first dose of vaccines will be subjected to the PCR test and those who are negative according to the test results will be hospitalized for the administration of their second dose.
İe., On the 28th day, the first two volunteers from the low-dose group (two volunteers who received the low-dose vaccine on the first day) will be administered the 2nd dose of vaccine. On the thirtieth day, the first two volunteers from the high-dose group (two volunteers who received the high-dose vaccine on the first day) will be administered the 2nd vaccine dose. After the evaluation and approval of the clinical and laboratory data of the 4 volunteers whose second dose applications were completed by the safety committee, second dose administrations to the rest of volunteers will be continued from the 35th day.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel arm, double blind study with no control arm. Two doses of vaccine will be administered and the randomization will be performed for dose levels.
| Arm | Type | Receives |
|---|---|---|
| Low dose arm | Experimental | Biological: Adeno-viral vector vaccineLow dose (5x1010 VP, i.m.); CoVacHGMix (with equal amounts of CoVacHGA1320, CoVacHGB420, CoVacHGC720 and CoVacHGD1480 adenoviral vector mix, as 0.5 solution) Intramuscular injection, two injections 28 days apart |
| High dose arm | Experimental | Biological: Adeno-viral vector vaccineHigh dose (1x1011 VP, i.m.); CoVacHGMix (with equal amounts of CoVacHGB420, CoVacHGC720 and CoVacHGD1480 adenoviral vector mix, as 1.0 solution) Intramuscular injections, two injections 28 days apart |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- I-1 Healthy volunteers of both sexes aged 18-59 years I-2 Able to give signed informed consent, I-3 Will be able to comply with the study protocol for approximately 6 months (depending on the group), I-4 HIV, Hepatitis B and C tests are negative, I-5 Body temperature below 37.2oC I-6 COVID-19 IgG and IgM antibodies negative and no history of symptomatic disease, I-7 Those who have not previously received any COVID-19 vaccines I-8 Negative qPCR SARS-CoV-2 result in nasopharynx or sputum samples, I-9 Body mass index between 18-35 kg/m2, I-10 Abnormal finding in complete blood count, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, urea, creatinine and fasting blood sugar between the normal reference values or detected in any laboratory parameter is Grade 1 according to the opinion of the investigator volunteers not older (>Grade 1) I-11 Good general health (history and physical examination within 14 days prior to enrollment in the study), I-12 if female, healthy volunteers who are not pregnant or who can use appropriate contraception within 30 days before vaccine injection and within 6 months after vaccination will be included in the study.
- I-13 Male volunteers who can use appropriate contraception within 6 months after vaccine injection will be included in the study.
Key exclusion criteria (2 listed)
- E-1. Subjects with a history of seizures, encephalopathy or psychosis, E-2. Subjects who have a known allergy to any vaccine or are allergic to any component of the vaccine to be administered, E-3. Pregnant or lactating women, women who have a positive pregnancy test or plan to become pregnant within the next 6 months.
- E-4. Subjects whose body temperature is above 37.2oC at the time of vaccination or who have signs of active infection, E-5. Subjects with a positive history of SARS (SARS-CoV-1) (based on voluntary declaration), E-6.Subjects with severe cardiovascular disease (arrhythmia, conduction block, myocardial infarction, uncontrolled hypertension), E-7. Subjects with serious chronic diseases (asthma, diabetes, thyroid diseases, etc.), E-8. Subjects with congenital or acquired angioedema, E-9. Subjects with a diagnosis of immunodeficiency, E-10. Subjects with a diagnosis of bleeding diathesis, E-11. Subjects who take immunosuppressive treatment, those who take anti-allergic treatment, those who take cytotoxic treatment, those who take inhaled corticosteroids (except for allergic rhinitis or topical steroid ointments), E-12. Subjects who received blood and blood product transfusion in the last 4 months, E-13. Subjects who participated in any vaccine study or took experimental drugs within 1 month before starting the study, E-14. Subjects who received any live vaccines in the 1 month prior to the study E-15. Subjects who received inactivated vaccine within 14 days of starting the study E-16. Subjects receiving active tuberculosis treatment, E-17. Subjects with a personal or family history of thrombosis and thromboembolism, persons prone to thrombosis E-18. According to the researcher's evaluation, those who have any condition (medical, psychological, social, etc.) that may impair the volunteer's compliance with the study will be excluded from the study.
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 |
|---|---|---|
| Adeno-viral vector vaccineThe vaccine will be injected intramuscularly, as two doses 28 days apart. Two different dosages will be given to volunteers (low dose: 5x1010 and high dose: 1x1011) | Biological | High dose arm, Low dose arm |
Primary outcome
Incidence of Adverse Events
Time frame: Day1 to 168 days after vaccination
Adverse events
1 secondary outcome
Immunogenicity
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2022.
- 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.
Ekmel Olcay, MD principal investigator
Ankara City Hospital Bilkent
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 Adeno-viral vector vaccine in people with COVID-19, run by Ankara City Hospital Bilkent 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 6 Sep 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 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ekmel Olcay, MD (90533 733 5535, ekmelolcay@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (time frame: Day1 to 168 days after vaccination). 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 6 Sep 2022.