Ignite Creation Date:
2024-05-06 @ 3:57 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04811664
Status:
COMPLETED
Last Update Posted:
2023-08-02
First Post:
2021-03-19
Brief Title:
A Study of SARS CoV-2 Infection and Potential Transmission in Individuals Immunized With Moderna COVID-19 Vaccine
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Controlled Study to Assess SARS CoV-2 Infection Viral Shedding and Subsequent Potential Transmission in Individuals Immunized With Moderna COVID-19 Vaccine
Status:
COMPLETED
Status Verified Date:
2023-07
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:
CoVPN 3006
Brief Summary:
The purpose of this study is to assess SARS CoV-2 infection viral shedding and subsequent potential transmission in individuals immunized with the Moderna COVID-19 vaccine
Detailed Description:
This study will evaluate the efficacy of the Moderna COVID-19 vaccine against SARS-CoV-2 infection as well as its effect on peak nasal viral load as a measure of infection and a proxy of infectiousness in adults aged 18-29
In the Main study up to 12000 participants will be randomized 11 to Immediate Vaccination Group 1 at Months 0 and 1 or Standard of Care Group 2 with vaccination given at Months 4 and 5 if not received off-study previously Up to an additional 6000 participants will be enrolled into the Vaccine Declined Group 3 and will also be offered vaccine at Months 4 and 5
Additional study visits for Group 1 will occur at Months 2 and 4 for Groups 2 and 3 at Months 0 and 2 Study visits may include medical history vaccine injections blood collection nasal swab SARS-CoV-2 screening COVID-19 symptom check and questionnaires
In addition to the main study participants the study will also evaluate infectiousness following close contacts with main study participants Study procedures for close contacts include questionnaires and blood samples for those who become SARS-CoV-2 infected study procedures will also include nasal swabs
In the Main study up to 12000 participants will be randomized 11 to Immediate Vaccination Group 1 at Months 0 and 1 or Standard of Care Group 2 with vaccination given at Months 4 and 5 if not received off-study previously Up to an additional 6000 participants will be enrolled into the Vaccine Declined Group 3 and will also be offered vaccine at Months 4 and 5
Additional study visits for Group 1 will occur at Months 2 and 4 for Groups 2 and 3 at Months 0 and 2 Study visits may include medical history vaccine injections blood collection nasal swab SARS-CoV-2 screening COVID-19 symptom check and questionnaires
In addition to the main study participants the study will also evaluate infectiousness following close contacts with main study participants Study procedures for close contacts include questionnaires and blood samples for those who become SARS-CoV-2 infected study procedures will also include nasal swabs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None