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.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's enrollment of 5,399 is above the median of 268 across 3,208 observational studies indexed under COVID-19.
Browse COVID-19 studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Ran from Aug 2021 to primary completion in Aug 2025, 48 months.
How these figures are worked out, and which studies are left out of them.
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) →