Clinical trial NCT05096091: International Study on COVID-19 Vaccine to Assess Immunogenicity, Reactogenicity and Efficacy (InVITE)
Official title: International Study on COVID-19 Vaccine to Assess Immunogenicity, Reactogenicity and Efficacy (InVITE)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: COVID-19
Keywords: SARS-CoV-2 Infection
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
name: Partnership for Clinical Research in Guinea/Partenariat de Recherche Clinique en Guinée (PREGUI)
name: Partnership for Research on Ebola Virus in Liberia (PREVAIL)
name: University Clinical Research Center, Mali
name: Onom Foundation and Liver Center
name: Mexican Emerging Infectious Diseases Clinical Research Network
name: Ina-Respond
First posted: 2021-10-27
Enrollment: 5399
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
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
timeFrame: 2 months
Secondary outcomes:
measure: Evaluate duration of immunogenicity
timeFrame: 1 day, 2 months, 10 months
measure: Evaluate immunogenicity in predefined subgroups (by age, body mass index [BMI], comorbidities, HIV, breakthrough infection, or evidence of prior infection with SARS-CoV-2).
timeFrame: 1 day, 2 months, 10 months
measure: Characterize virus causing breakthrough infections using viral genomic sequencing.
timeFrame: 1 day
measure: Compare immunogenicity between different vaccines.
timeFrame: 2 months
measure: Evaluate infection rates after vaccination.
timeFrame: 1 day
Other outcomes:
Locations:
city: Gombe
country: Congo, The Democratic Republic of the
facility: National Institute for Biomedical Research/Institut National de Recherche Biomédicale (INRB)
state: Kinshasa
city: Conakry
country: Guinea
facility: Partnership for Clinical Research in Guinea/Partenariat de Recherche Clinique en Guinée (PREGUI)
city: Tangerang
country: Indonesia
facility: National Institute of Health Research and Development (NIHRD), Ministry of Health, Republic of Jakarta - RSU Kabupaten Tangerang
city: Monrovia
country: Liberia
facility: Partnership for Research in Vaccines and Infectious Diseases in Liberia (PREVAIL) - Duport Road Health Center
city: Bamako
country: Mali
facility: University Clinical Research Center (UCRC) University of Sciences, Techniques and Technologies of Bamako
city: Tapachula
country: Mexico
facility: Hospital Regional de Alta Especialidad "Ciudad Salud" HRAE-CS
state: Chiapas
city: Mexico City
country: Mexico
facility: Hospital General Dr. Manuel Gea Gonzalez (HGMGG)
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (INCMNSZ),
city: Mexico City
country: Mexico
facility: Instituto Nacional de Enfermedades Respiratorias (INER)
city: Oaxaca
country: Mexico
facility: Hospital General Dr. Aurelio Valdivieso (HGAV)
city: Ulaanbaatar
country: Mongolia
facility: Onom Foundation and Liver Center
Study officials:
affiliation: National Institute of Allergy and Infectious Diseases (NIAID)
name: Renee Ridzon, MD
role: STUDY_DIRECTOR
affiliation: National Institute of Allergy and Infectious Diseases (NIAID)
name: Irini Sereti, MD
role: STUDY_DIRECTOR
affiliation: National Institute of Allergy and Infectious Diseases (NIAID)
name: Sally Hunsberger, PhD
role: STUDY_DIRECTOR
References:
citation: 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.