The CoVacHGMix adenoviral vector vaccine is a new vaccine developed to protect againstSARS-CoV-2 and is a Phase I study designed based on adaptive clinical trial standards. Inthis Phase I study, it is aimed to test the safety and efficacy of the investigationalproduct at 2 different dose levels (low: 5x1010 and high: 1x1011) in volunteers aged18-59 years. Vaccination will be performed as two doses: on days 0 and 28. In line withadaptive design standards, Phase I will be transferred to Phase II. In this phase, 2different dose levels will be tested, and the dose and application forms in Phase II willbe determined according to the results of Phase I. One of the aims of the study is tocollect sufficient data to determine the final dose and method of administration to beapplied in the phase III study and clinic.
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.
Biological: Adeno-viral vector vaccine
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)
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Ankara City Hospital, Bilkent
Ankara, Bilkent, Turkey
Investigator: Ekmel Olcay, MD
Contact: 905337335535
ekmelolcay@gmail.com
Ekmel Olcay, MD
90533 733 5535
ekmelolcay@gmail.com
Bedia Dinc, MD
905053540776
bediadinc@gmail.com
Ekmel Olcay, MD, Principal Investigator
Ankara City Hospital Bilkent