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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: COVID-19

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.

• Study Type: Observational
• Enrollment (Actual): 5399

Contacts and Locations

Study Locations

• Congo, The Democratic Republic of the
  • Kinshasa
    • Gombe, Kinshasa, Congo, The Democratic Republic of the
      • National Institute for Biomedical Research/Institut National de Recherche Biomédicale (INRB)
• Guinea
  • Conakry, Guinea
    • Partnership for Clinical Research in Guinea/Partenariat de Recherche Clinique en Guinée (PREGUI)
• Indonesia
  • Tangerang, Indonesia
    • National Institute of Health Research and Development (NIHRD), Ministry of Health, Republic of Jakarta - RSU Kabupaten Tangerang
• Liberia
  • Monrovia, Liberia
    • Partnership for Research in Vaccines and Infectious Diseases in Liberia (PREVAIL) - Duport Road Health Center
• Mali
  • Bamako, Mali
    • University Clinical Research Center (UCRC) University of Sciences, Techniques and Technologies of Bamako
• Mexico
  • Mexico City, 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)
  • Oaxaca, Mexico
    • Hospital General Dr. Aurelio Valdivieso (HGAV)
  • Chiapas
    • Tapachula, Chiapas, Mexico
      • Hospital Regional de Alta Especialidad "Ciudad Salud" HRAE-CS
• Mongolia
  • Ulaanbaatar, Mongolia, 17011
    • Onom Foundation and Liver Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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).	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

Collaborators and Investigators

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborators: Ina-Respond; Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo; University Clinical Research Center, Mali; Partnership for Clinical Research in Guinea/Partenariat de Recherche Clinique en Guinée (PREGUI); Partnership for Research on Ebola Virus in Liberia (PREVAIL); Onom Foundation and Liver Center; Mexican Emerging Infectious Diseases Clinical Research Network
• Investigators: Study Director: 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)

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2021
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: October 26, 2021
• First Submitted That Met QC Criteria: October 26, 2021
• First Posted (Actual): October 27, 2021

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: SARS-CoV-2 Infection
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: InVITE 01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No