InVITE is funded by NIAID and is conducted in multiple international sites (approximately20 sites across 7 countries).This is a study of adults who receive locally available COVID-19 vaccines through localvaccination programs. Persons will be enrolled within one day (before or after) ofreceipt of a COVID-19 vaccine. The study will enroll participants who receive COVID-19vaccination 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.
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.
National Institute for Biomedical Research/Institut National de Recherche Biomédicale (INRB)
Gombe, Kinshasa, Congo, The Democratic Republic of the
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, Mexico
Onom Foundation and Liver Center
Ulaanbaatar, Mongolia