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| Name | Class |
|---|---|
| Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo | OTHER |
| Partnership for Clinical Research in Guinea/Partenariat de Recherche Clinique en Guinée (PREGUI) | UNKNOWN |
| Partnership for Research on Ebola Virus in Liberia (PREVAIL) |
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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate duration of immunogenicity | Measured by Anti-S Ab at different specific timepoints | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Renee Ridzon, MD | National Institute of Allergy and Infectious Diseases (NIAID) | Study Director |
| Irini Sereti, MD | National Institute of Allergy and Infectious Diseases (NIAID) | Study Director |
| Sally Hunsberger, PhD | National Institute of Allergy and Infectious Diseases (NIAID) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute for Biomedical Research/Institut National de Recherche Biomédicale (INRB) | Gombe | Kinshasa City | Democratic Republic of the Congo |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38417612 | Result | 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. |
| Label | URL |
|---|---|
| SARS-CoV-2 seroprevalence in vaccine-naïve participants from the Democratic Republic of Congo, Guinea, Liberia, and Mali | View source |
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| NETWORK |
| University Clinical Research Center, Mali | OTHER |
| Onom Foundation and Liver Center | UNKNOWN |
| Mexican Emerging Infectious Diseases Clinical Research Network | NETWORK |
| Ina-Respond | OTHER |
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Blood, and nasal swabs
Measured by levels of Anti-S Ab in predefined subgroups. |
| 1 day, 2 months, 10 months |
| Characterize virus causing breakthrough infections using viral genomic sequencing. | Measured from sequencing to characterize SARS-CoV-2 variants | 1 day |
| Compare immunogenicity between different vaccines. | Measured by Anti-S Ab levels at 2 months post-vaccine regimen | 2 months |
| Evaluate infection rates after vaccination. | Measured by levels of anti-nucleocapsid Ab | 1 day |
| Partnership for Clinical Research in Guinea/Partenariat de Recherche Clinique en Guinée (PREGUI) | Conakry | Guinea |
| National Institute of Health Research and Development (NIHRD), Ministry of Health, Republic of Jakarta - RSU Kabupaten Tangerang | Tangerang | Indonesia |
| Partnership for Research in Vaccines and Infectious Diseases in Liberia (PREVAIL) - Duport Road Health Center | Monrovia | Liberia |
| University Clinical Research Center (UCRC) University of Sciences, Techniques and Technologies of Bamako | Bamako | Mali |
| Hospital Regional de Alta Especialidad "Ciudad Salud" HRAE-CS | Tapachula | Chiapas | Mexico |
| Hospital General Dr. Manuel Gea Gonzalez (HGMGG) | Mexico City | Mexico |
| Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (INCMNSZ), | Mexico City | Mexico |
| Instituto Nacional de Enfermedades Respiratorias (INER) | Mexico City | Mexico |
| Hospital General Dr. Aurelio Valdivieso (HGAV) | Oaxaca City | Mexico |
| Onom Foundation and Liver Center | Ulaanbaatar | 17011 | Mongolia |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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