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

NCT05096091 | Completed

• 1 other identifier: InVITE 01
• Study Type: observational
• Target: 5,399
• Locations: 7 countries
• Sites: 11

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.

Conditions

COVID-19

Keywords

SARS-CoV-2 Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Evaluate duration of immunogenicity

  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).

  1 day, 2 months, 10 months

• Characterize virus causing breakthrough infections using viral genomic sequencing.

  1 day

• Compare immunogenicity between different vaccines.

  2 months

• Evaluate infection rates after vaccination.

  1 day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (11)

National Institute for Biomedical Research/Institut National de Recherche Biomédicale (INRB)

Gombe, Kinshasa City, Democratic Republic of the Congo

Location

Partnership for Clinical Research in Guinea/Partenariat de Recherche Clinique en Guinée (PREGUI)

Conakry, Guinea

Location

National Institute of Health Research and Development (NIHRD), Ministry of Health, Republic of Jakarta - RSU Kabupaten Tangerang

Tangerang, Indonesia

Location

Partnership for Research in Vaccines and Infectious Diseases in Liberia (PREVAIL) - Duport Road Health Center

Monrovia, Liberia

Location

University Clinical Research Center (UCRC) University of Sciences, Techniques and Technologies of Bamako

Bamako, Mali

Location

Hospital Regional de Alta Especialidad "Ciudad Salud" HRAE-CS

Tapachula, Chiapas, Mexico

Location

Hospital General Dr. Manuel Gea Gonzalez (HGMGG)

Mexico City, Mexico

Location

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (INCMNSZ),

Mexico City, Mexico

Location

Instituto Nacional de Enfermedades Respiratorias (INER)

Mexico City, Mexico

Location

Hospital General Dr. Aurelio Valdivieso (HGAV)

Oaxaca City, Mexico

Location

Onom Foundation and Liver Center

Ulaanbaatar, 17011, Mongolia

Location

Related Publications (1)

• 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.

  PMID: 38417612 RESULT

Related Links

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

Biospecimen

Retention: SAMPLES WITH DNA

Blood, and nasal swabs

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: October 27, 2021
• Study Start: August 16, 2021
• Primary Completion: August 19, 2025
• Study Completion: August 19, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1); ID (1); LI (1); ME (5); GU (1); MO (1); DE (1)