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International Study on COVID-19 Vaccine to Assess Immunogenicity, Reactogenicity and Efficacy (InVITE) — InVITE  

COVID-19 Clinical Trial

Official title:
International Study on COVID-19 Vaccine to Assess Immunogenicity, Reactogenicity and Efficacy (InVITE)

Clinical Trial Summary

InVITE is funded by NIAID and is conducted in multiple international sites (approximately 20 sites across 7 countries). This is a study of adults who receive locally available COVID-19 vaccines through local vaccination programs. Persons will be enrolled within one day (before or after) of receipt of a COVID-19 vaccine. The study will enroll participants who receive COVID-19 vaccination at local clinics and/or study sites.

Clinical Trial Description

This is a multicenter study of COVID-19 vaccine immunogenicity and durability, and breakthrough serious acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infections in people who receive a COVID-19 vaccine through their country's national vaccination programs. Participants will be enrolled upon signing the informed consent within a day of receipt of a COVID-19 vaccine (before or after). The study team will not be administering the vaccine; receipt of vaccine will be provided through each country's vaccine program. Blood specimens will be collected to measure the immune response to the vaccine. Participants may be asked to contact study staff at any time during the study for evaluation if they develop symptoms consistent with SARS-CoV-2 infection, at which time they will be counseled about the need for a medical evaluation that may include collection of an upper airway swab for diagnosis (and research) and a blood sample for research. Infections will be confirmed by molecular or antigen (Ag) testing at the time of symptoms, and swabs will be collected and stored for viral sequencing and analyses. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05096091
Study type Observational
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status Active, not recruiting
Phase
Start date August 16, 2021
Completion date December 2025
View Details
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