Phase I Clinical Trial With New SARS-CoV-2 CoVacHGMix Type 5 Adenoviral Vector Vaccine

COVID-19 Clinical Trial

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

Status Recruiting

Clinical 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 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• COVID-19

• NCT number: NCT05526183
• Study type: Interventional
• Source: Ankara City Hospital Bilkent
• Contact: Ekmel Olcay, MD
• Phone: 90533 733 5535
• Email: ekmelolcay@gmail.com
• Status: Recruiting
• Phase: Phase 1
• Start date: January 21, 2022
• Completion date: March 1, 2023