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

NCT ID: NCT05096091

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5399 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-16

Study Completion Date

2025-08-19

Brief Summary

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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

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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

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COVID-19

Keywords

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SARS-CoV-2 Infection

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo

OTHER

Sponsor Role collaborator

Partnership for Clinical Research in Guinea/Partenariat de Recherche Clinique en Guinée (PREGUI)

UNKNOWN

Sponsor Role collaborator

Partnership for Research on Ebola Virus in Liberia (PREVAIL)

NETWORK

Sponsor Role collaborator

University Clinical Research Center, Mali

OTHER

Sponsor Role collaborator

Onom Foundation and Liver Center

UNKNOWN

Sponsor Role collaborator

Mexican Emerging Infectious Diseases Clinical Research Network

NETWORK

Sponsor Role collaborator

Ina-Respond

OTHER

Sponsor Role collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Renee Ridzon, MD

Role: STUDY_DIRECTOR

National Institute of Allergy and Infectious Diseases (NIAID)

Irini Sereti, MD

Role: STUDY_DIRECTOR

National Institute of Allergy and Infectious Diseases (NIAID)

Sally Hunsberger, PhD

Role: STUDY_DIRECTOR

National Institute of Allergy and Infectious Diseases (NIAID)

Locations

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National Institute for Biomedical Research/Institut National de Recherche Biomédicale (INRB)

Gombe, Kinshasa City, Democratic Republic of the Congo

Site Status

Partnership for Clinical Research in Guinea/Partenariat de Recherche Clinique en Guinée (PREGUI)

Conakry, , Guinea

Site Status

National Institute of Health Research and Development (NIHRD), Ministry of Health, Republic of Jakarta - RSU Kabupaten Tangerang

Tangerang, , Indonesia

Site Status

Partnership for Research in Vaccines and Infectious Diseases in Liberia (PREVAIL) - Duport Road Health Center

Monrovia, , Liberia

Site Status

University Clinical Research Center (UCRC) University of Sciences, Techniques and Technologies of Bamako

Bamako, , Mali

Site Status

Hospital Regional de Alta Especialidad "Ciudad Salud" HRAE-CS

Tapachula, Chiapas, Mexico

Site Status

Hospital General Dr. Manuel Gea Gonzalez (HGMGG)

Mexico City, , Mexico

Site Status

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (INCMNSZ),

Mexico City, , Mexico

Site Status

Instituto Nacional de Enfermedades Respiratorias (INER)

Mexico City, , Mexico

Site Status

Hospital General Dr. Aurelio Valdivieso (HGAV)

Oaxaca City, , Mexico

Site Status

Onom Foundation and Liver Center

Ulaanbaatar, , Mongolia

Site Status

Countries

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Democratic Republic of the Congo Guinea Indonesia Liberia Mali Mexico Mongolia

References

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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.

Reference Type RESULT
PMID: 38417612 (View on PubMed)

Related Links

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https://pubmed.ncbi.nlm.nih.gov/38417612/

SARS-CoV-2 seroprevalence in vaccine-naïve participants from the Democratic Republic of Congo, Guinea, Liberia, and Mali

Other Identifiers

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InVITE 01

Identifier Type: -

Identifier Source: org_study_id