An observational study in COVID-19, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 11 sites in 7 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-18.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Observational
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.
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 participants will be people who are about to receive or have already received a Coronavirus disease 2019 (COVID-19) vaccine through the local vaccination program.
Exclusion Criteria:
1. To characterize immunogenicity (by measurement of anti-Spike [S] antibody [Ab]) of available COVID-19 vaccines in the overall study population, in each of the countries and in defined subgroups
Measured by amount of Anti-S Ab at 2 months after completion of vaccine regimen.
Time frame: 2 months
Evaluate duration of immunogenicity
Measured by Anti-S Ab at different specific timepoints
Time frame: 1 day, 2 months, 10 months
Evaluate immunogenicity in predefined subgroups (by age, body mass index [BMI], comorbidities, HIV, breakthrough infection, or evidence of prior infection with SARS-CoV-2).
Measured by levels of Anti-S Ab in predefined subgroups.
Time frame: 1 day, 2 months, 10 months
Characterize virus causing breakthrough infections using viral genomic sequencing.
Measured from sequencing to characterize SARS-CoV-2 variants
Time frame: 1 day
Compare immunogenicity between different vaccines.
Measured by Anti-S Ab levels at 2 months post-vaccine regimen
Time frame: 2 months
Evaluate infection rates after vaccination.
Measured by levels of anti-nucleocapsid Ab
Time frame: 1 day
Plan to share: No
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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National Institute of Allergy and Infectious Diseases (NIAID)