Ignite Creation Date:
2024-05-06 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04686773
Status:
COMPLETED
Last Update Posted:
2022-06-03
First Post:
2020-12-25
Brief Title:
Open-label Non-randomized Non-comparative Phase II Study of Safety and Immunogenicity of Combination of AZD1222 and rAd26-S for COVID-19 Prevention
Sponsor:
R-Pharm
Organization:
R-Pharm
Study Overview
Official Title:
Open-label Non-randomized Non-comparative Phase II Study in Adult Subjects to Assess Safety and Immunogenicity of Combination of AZD1222 a Non-replicating ChAdOx1 Vector Vaccine and rAd26-S a Recombinant Adenovirus Type 26 Component of Gam-COVID-Vac Vaccine for COVID-19 Prevention
Status:
COMPLETED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to assess safety and immunogenicity of heterologous booster vaccine containing combination of AZD1222 and rAd26-S one of components of Gam-COVID-Vac vaccine in adult subjects aged 18 years old to prevent COVID-19 spread
Detailed Description:
This clinical study is a prospective single-center open-label non-comparative non-randomized single-arm study It will enroll adult subjects aged 18 years old with absence of active COVID-19 infection to be verified by the results of reverse transcription polymerase chain reaction RT-PCR
100 subjects meeting inclusion criteria are expected to be screened 100 of them meeting eligibility criteria will receive one intramuscular injection of AZD1222 vaccine at 51010 viral particles nominal dose and at least 90 subjects per one intramuscular injection of rAd26-S at 1005 11011 viral particles with a 4-week interval on study days 1 and 29 respectively
Duration of the subject participation in the study will be 6 months 18010 days from the day of administration of the first dose of AZD1222 vaccine 10 visits are scheduled for each subject 8 of them being obligatory personal visits to the study site
Safety will be assessed for the duration of the study as follows
Solicited adverse events AEs local and systemic will be assessed for 7 days following each vaccination ie on days 1-7 after the first vaccination and on study days 29-35 to account for AEs after second vaccination at the study visits and based on the results of Subject Diary review
Unsolicited AEs will be recorded within 29 days after administration of each dose of AZD1222rAd26-S vaccine ie on days 1-29 and on days 29 to 57
Serious adverse events SAEs will be recorded from signing of the informed consent form through Day 180
Adverse events of special interest AESI will be documented from the first vaccination until day 180
Immunogenicity will also be assessed throughout the study and include serological assay of levels of antibodies specific for Severe acute respiratory syndrome coronavirus 2 SARS-CoV-2 antigen as well as level of seroconversion tests for neutralising antibodies
At least 100 subjects are expected to receive at least one dose of the study product in 1 study site on the territory of Republic Azerbaijan
100 subjects meeting inclusion criteria are expected to be screened 100 of them meeting eligibility criteria will receive one intramuscular injection of AZD1222 vaccine at 51010 viral particles nominal dose and at least 90 subjects per one intramuscular injection of rAd26-S at 1005 11011 viral particles with a 4-week interval on study days 1 and 29 respectively
Duration of the subject participation in the study will be 6 months 18010 days from the day of administration of the first dose of AZD1222 vaccine 10 visits are scheduled for each subject 8 of them being obligatory personal visits to the study site
Safety will be assessed for the duration of the study as follows
Solicited adverse events AEs local and systemic will be assessed for 7 days following each vaccination ie on days 1-7 after the first vaccination and on study days 29-35 to account for AEs after second vaccination at the study visits and based on the results of Subject Diary review
Unsolicited AEs will be recorded within 29 days after administration of each dose of AZD1222rAd26-S vaccine ie on days 1-29 and on days 29 to 57
Serious adverse events SAEs will be recorded from signing of the informed consent form through Day 180
Adverse events of special interest AESI will be documented from the first vaccination until day 180
Immunogenicity will also be assessed throughout the study and include serological assay of levels of antibodies specific for Severe acute respiratory syndrome coronavirus 2 SARS-CoV-2 antigen as well as level of seroconversion tests for neutralising antibodies
At least 100 subjects are expected to receive at least one dose of the study product in 1 study site on the territory of Republic Azerbaijan
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None