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

COVID-19 Clinical Trial

— InVITE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05096091
• Other study ID #: InVITE 01
• Status: Active, not recruiting
• Start date: August 16, 2021
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5399
• Est. completion date: December 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Locations

Country	Name	City	State
Congo, The Democratic Republic of the	National Institute for Biomedical Research/Institut National de Recherche Biomédicale (INRB)	Gombe	Kinshasa
Guinea	Partnership for Clinical Research in Guinea/Partenariat de Recherche Clinique en Guinée (PREGUI)	Conakry
Indonesia	National Institute of Health Research and Development (NIHRD), Ministry of Health, Republic of Jakarta - RSU Kabupaten Tangerang	Tangerang
Liberia	Partnership for Research in Vaccines and Infectious Diseases in Liberia (PREVAIL) - Duport Road Health Center	Monrovia
Mali	University Clinical Research Center (UCRC) University of Sciences, Techniques and Technologies of Bamako	Bamako
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	Hospital Regional de Alta Especialidad "Ciudad Salud" HRAE-CS	Tapachula	Chiapas
Mongolia	Onom Foundation and Liver Center	Ulaanbaatar

Sponsors (8)

Lead Sponsor

Collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

Ina-Respond, Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo, Mexican Emerging Infectious Diseases Clinical Research Network, Onom Foundation and Liver Center, 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

Countries where clinical trial is conducted

Congo, The Democratic Republic of the,  Guinea,  Indonesia,  Liberia,  Mali,  Mexico,  Mongolia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Evaluate duration of immunogenicity	Measured by Anti-S Ab at different specific timepoints	1 day, 2 months, 10 months
Secondary	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.	1 day, 2 months, 10 months
Secondary	Characterize virus causing breakthrough infections using viral genomic sequencing.	Measured from sequencing to characterize SARS-CoV-2 variants	1 day
Secondary	Compare immunogenicity between different vaccines.	Measured by Anti-S Ab levels at 2 months post-vaccine regimen	2 months
Secondary	Evaluate infection rates after vaccination.	Measured by levels of anti-nucleocapsid Ab	1 day

External Links

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