COVID-19InVITENCT05096091
International Study on COVID-19 Vaccine to Assess Immunogenicity, Reactogenicity and Efficacy (InVITE)
An observational study of COVID-19, run by National Institute of Allergy and Infectious Diseases (NIAID) at 11 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- How many people
- 5,399 participants
- Where
- 11 sitesin 7 countries
- Study dates
- 16 Aug 2021to 19 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 18 years of age or older.
- Ability to provide informed consent.
- Enrollment within one day (before or after) of receipt of COVID-19 vaccine.
- Willingness to be evaluated (including collection of blood and nasopharyngeal samples) during the prescribed study visits and/or during acute illness consistent with SARS-CoV-2 infection during the study period.
- Willingness to allow storage of biological samples for research testing as outlined in this protocol.
Who cannot join
- Any acute or chronic condition that, in the opinion of the investigator, is a contraindication to participation in this study; for example, acute febrile illness.
- Inability to comply with study visits.
Trial locations and contacts
11 sites in 7 countries.
11 sites in 7 countries
Mexico5 sites
Hospital General Dr. Manuel Gea Gonzalez (HGMGG)
Mexico City
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (INCMNSZ),
Mexico City
Instituto Nacional de Enfermedades Respiratorias (INER)
Mexico City
Hospital General Dr. Aurelio Valdivieso (HGAV)
Oaxaca City
Hospital Regional de Alta Especialidad "Ciudad Salud" HRAE-CS
Tapachula, Chiapas
Democratic Republic of the Congo1 site
National Institute for Biomedical Research/Institut National de Recherche Biomédicale (INRB)
Gombe, Kinshasa City
Guinea1 site
Partnership for Clinical Research in Guinea/Partenariat de Recherche Clinique en Guinée (PREGUI)
Conakry
Indonesia1 site
National Institute of Health Research and Development (NIHRD), Ministry of Health, Republic of Jakarta - RSU Kabupaten Tangerang
Tangerang
Liberia1 site
Partnership for Research in Vaccines and Infectious Diseases in Liberia (PREVAIL) - Duport Road Health Center
Monrovia
Mali1 site
University Clinical Research Center (UCRC) University of Sciences, Techniques and Technologies of Bamako
Bamako
About this study
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.
Read the detailed 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.
- Conditions
- COVID-19
- Keywords
- SARS-CoV-2 Infection
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Secondary outcomes (5)
Evaluate duration of immunogenicity
Measured by Anti-S Ab at different specific timepoints
Measured: 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.
Measured: 1 day, 2 months, 10 months
Characterize virus causing breakthrough infections using viral genomic sequencing.
Measured from sequencing to characterize SARS-CoV-2 variants
Measured: 1 day
Compare immunogenicity between different vaccines.
Measured by Anti-S Ab levels at 2 months post-vaccine regimen
Measured: 2 months
Evaluate infection rates after vaccination.
Measured by levels of anti-nucleocapsid Ab
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start16 Aug 2021
- Primary completion19 Aug 2025
- Study completion19 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 5,399 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Institut National de Recherche Biomedicale (INRB), Partnership for Clinical Research in Guinea/Partenariat de Recherche Clinique en Guinée (PREGUI), Partnership for Research on Ebola Virus in Liberia (PREVAIL), University Clinical Research Center, Mali, Onom Foundation and Liver Center, Mexican Emerging Infectious Diseases Clinical Research Network, Ina-Respond
- Responsible party
- Sponsor
- Investigators
- Renee Ridzon, MD, Study director, National Institute of Allergy and Infectious Diseases (NIAID)Irini Sereti, MD, Study director, National Institute of Allergy and Infectious Diseases (NIAID)Sally Hunsberger, PhD, Study director, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05096091
- Sponsor's protocol ID
- InVITE 01
- Acronym
- InVITE
- Status last verified
- Dec 2025
- First submitted
- 26 Oct 2021
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Laverdure S, Kazadi D, Kone K, Callier V, Dabitao D, Dennis D, Haidara MC, Hunsberger S, Mbaya OT, Ridzon R, Sereti I, Shaw-Saliba K; InVITE Study Team. SARS-CoV-2 seroprevalence in vaccine-naive participants from the Democratic Republic of Congo, Guinea, Liberia, and Mali. Int J Infect Dis. 2024 May;142:106985. doi: 10.1016/j.ijid.2024.106985. Epub 2024 Feb 28.
PubMed 38417612
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Study on COVID-19 Vaccine to Assess Immunogenicity, Reactogenicity and Efficacy (InVITE)
- ClinicalTrials.gov ID
- NCT05096091
- Acronym / sponsor ID
- InVITE / InVITE 01
- Conditions
- COVID-19
- Keywords
- SARS-CoV-2 Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,399 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Institut National de Recherche Biomedicale (INRB), Partnership for Clinical Research in Guinea/Partenariat de Recherche Clinique en Guinée (PREGUI), Partnership for Research on Ebola Virus in Liberia (PREVAIL), University Clinical Research Center, Mali, Onom Foundation and Liver Center, Mexican Emerging Infectious Diseases Clinical Research Network, Ina-Respond
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 19 Aug 2025 (actual)
- Study completion
- 19 Aug 2025 (actual)
- First posted
- 27 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 18 years of age or older.
- Ability to provide informed consent.
- Enrollment within one day (before or after) of receipt of COVID-19 vaccine.
- Willingness to be evaluated (including collection of blood and nasopharyngeal samples) during the prescribed study visits and/or during acute illness consistent with SARS-CoV-2 infection during the study period.
- Willingness to allow storage of biological samples for research testing as outlined in this protocol.
Key exclusion criteria (2 listed)
- Any acute or chronic condition that, in the opinion of the investigator, is a contraindication to participation in this study; for example, acute febrile illness.
- Inability to comply with study visits.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: 2 months
Measured by amount of Anti-S Ab at 2 months after completion of vaccine regimen.
5 secondary outcomes
Evaluate duration of immunogenicity
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).
Time frame: 1 day, 2 months, 10 months
Characterize virus causing breakthrough infections using viral genomic sequencing.
Time frame: 1 day
Compare immunogenicity between different vaccines.
Time frame: 2 months
Evaluate infection rates after vaccination.
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Results publication: PubMed 38417612Laverdure S, Kazadi D, Kone K, Callier V, Dabitao D, Dennis D, Haidara MC, Hunsberger S, Mbaya OT, Ridzon R, Sereti I, Shaw-Saliba K; InVITE Study Team. SARS-CoV-2 seroprevalence in vaccine-naive participants from the Democratic Republic of Congo, Guinea, Liberia, and Mali. Int J Infect Dis. 2024 May;142:106985. doi: 10.1016/j.ijid.2024.106985. Epub 2024 Feb 28.
- SARS-CoV-2 seroprevalence in vaccine-naïve participants from the Democratic Republic of Congo, Guinea, Liberia, and MaliLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renee Ridzon, MD study director
National Institute of Allergy and Infectious Diseases (NIAID)
Irini Sereti, MD study director
National Institute of Allergy and Infectious Diseases (NIAID)
Sally Hunsberger, PhD study director
National Institute of Allergy and Infectious Diseases (NIAID)
11 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by National Institute of Allergy and Infectious Diseases (NIAID) at 11 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Mexico, Democratic Republic of the Congo, Guinea, Indonesia, Liberia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05096091, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.