Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2025-12-17 @ 4:58 AM
Study NCT ID:
NCT04760730
Status:
None
Last Update Posted:
2022-10-26 00:00:00
First Post:
2021-02-17 00:00:00
Brief Title:
Safety and Immunogenicity Study in Adults of AZD1222 and rAd26-S Administered as Heterologous Prime Boost Regimen for the Prevention of Coronavirus Disease 2019 (COVID-19)
Sponsor:
R-Pharm
Organization:
R-Pharm
Study Overview
Official Title:
A Phase I/II Single-Blinded Randomised Safety and Immunogenicity Study in Adults of AZD1222 and rAd26-S Administered as Heterologous Prime Boost Regimen for the Prevention of COVID-19
Status:
None
Status Verified Date:
2022-10
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:
This is a prospective, single blinded randomised clinical study, designed to provide data on the heterologous prime boost use of AZD1222 and rAd26-S, to be administered one after the other interchangeably. This study aims to explore the immunogenicity and safety of combining these 2 different adenovirus vector vaccines in the prevention of coronavirus disease 2019 (COVID-19).
Participants will be healthy adults ≥ 18 years of age.
Approximately 100 participants will be randomised (1:1) to one of the following groups:
* Group A: 1 intramuscular (IM) injection of 5×10\^10 vp (nominal) of AZD1222 on Day 1 followed by rAd26-S (1.0±0.5) х 10\^11vp (nominal) on Day 29.
* Group B: 1 IM injection of rAd26-S (1.0±0.5) х 10\^11vp (nominal) on Day 1 followed by AZD1222 5×10\^10 vp (nominal) on Day 29.
Immunogenicity will be assessed for the duration of the study, including serologic quantification of severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) antigen specific antibody levels and antibody seroconversion rate, neutralising antibody assays and cellular immunity testing.
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 (Day 1 through Day 7 for first vaccination and Day 29 through Day 35 for second vaccination).
* Unsolicited AEs will be recorded for 29 days following each vaccination (ie, until Day 29 following the first vaccination and Day 57 following the second vaccination).
* Serious adverse events (SAEs) will be recorded from signing of the informed consent form through Day 180. However, the safety endpoint for SAEs will be assessed after the first vaccination (see Section 12.2).
* Adverse events of special interest (AESIs) will be recorded from first vaccination through Day 180.
This study is going to be conducted in the United Arab Emirates. All participants will remain on study for 6 months (180 days) following the first vaccination.
Participants will be healthy adults ≥ 18 years of age.
Approximately 100 participants will be randomised (1:1) to one of the following groups:
* Group A: 1 intramuscular (IM) injection of 5×10\^10 vp (nominal) of AZD1222 on Day 1 followed by rAd26-S (1.0±0.5) х 10\^11vp (nominal) on Day 29.
* Group B: 1 IM injection of rAd26-S (1.0±0.5) х 10\^11vp (nominal) on Day 1 followed by AZD1222 5×10\^10 vp (nominal) on Day 29.
Immunogenicity will be assessed for the duration of the study, including serologic quantification of severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) antigen specific antibody levels and antibody seroconversion rate, neutralising antibody assays and cellular immunity testing.
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 (Day 1 through Day 7 for first vaccination and Day 29 through Day 35 for second vaccination).
* Unsolicited AEs will be recorded for 29 days following each vaccination (ie, until Day 29 following the first vaccination and Day 57 following the second vaccination).
* Serious adverse events (SAEs) will be recorded from signing of the informed consent form through Day 180. However, the safety endpoint for SAEs will be assessed after the first vaccination (see Section 12.2).
* Adverse events of special interest (AESIs) will be recorded from first vaccination through Day 180.
This study is going to be conducted in the United Arab Emirates. All participants will remain on study for 6 months (180 days) following the first vaccination.
Detailed Description:
This is a prospective single blinded randomised clinical study designed to provide data on the heterologous prime boost use of AZD1222 and rAd26-S to be administered one after the other interchangeably This study aims to explore the immunogenicity and safety of combining these 2 different adenovirus vector vaccines in the prevention of coronavirus disease 2019 COVID-19
Participants will be healthy adults 18 years of age
Approximately 100 participants will be randomised 11 to one of the following groups
Group A 1 intramuscular IM injection of 51010 vp nominal of AZD1222 on Day 1 followed by rAd26-S 1005 х 1011vp nominal on Day 29
Group B 1 IM injection of rAd26-S 1005 х 1011vp nominal on Day 1 followed by AZD1222 51010 vp nominal on Day 29
Immunogenicity will be assessed for the duration of the study including serologic quantification of severe acute respiratory syndrome-coronavirus-2 SARS-CoV-2 antigen specific antibody levels and antibody seroconversion rate neutralising antibody assays and cellular immunity testing
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 Day 1 through Day 7 for first vaccination and Day 29 through Day 35 for second vaccination
Unsolicited AEs will be recorded for 29 days following each vaccination ie until Day 29 following the first vaccination and Day 57 following the second vaccination
Serious adverse events SAEs will be recorded from signing of the informed consent form through Day 180 However the safety endpoint for SAEs will be assessed after the first vaccination see Section 122
Adverse events of special interest AESIs will be recorded from first vaccination through Day 180
This study is going to be conducted in the United Arab Emirates All participants will remain on study for 6 months 180 days following the first vaccination
Participants will be healthy adults 18 years of age
Approximately 100 participants will be randomised 11 to one of the following groups
Group A 1 intramuscular IM injection of 51010 vp nominal of AZD1222 on Day 1 followed by rAd26-S 1005 х 1011vp nominal on Day 29
Group B 1 IM injection of rAd26-S 1005 х 1011vp nominal on Day 1 followed by AZD1222 51010 vp nominal on Day 29
Immunogenicity will be assessed for the duration of the study including serologic quantification of severe acute respiratory syndrome-coronavirus-2 SARS-CoV-2 antigen specific antibody levels and antibody seroconversion rate neutralising antibody assays and cellular immunity testing
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 Day 1 through Day 7 for first vaccination and Day 29 through Day 35 for second vaccination
Unsolicited AEs will be recorded for 29 days following each vaccination ie until Day 29 following the first vaccination and Day 57 following the second vaccination
Serious adverse events SAEs will be recorded from signing of the informed consent form through Day 180 However the safety endpoint for SAEs will be assessed after the first vaccination see Section 122
Adverse events of special interest AESIs will be recorded from first vaccination through Day 180
This study is going to be conducted in the United Arab Emirates All participants will remain on study for 6 months 180 days following the first vaccination
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