InVITE : International Study on COVID-19 Vaccine to Assess lmmunogenicity, Reactogenicity and Efficacy

ClinicalTrials.gov: NCT05096091
Collaborator: NIAID, NIH
Status: Completed

https://clinicaltrials.gov/study/NCT05096091

The InVITE study was a large, multisite observational cohort study that investigated the immunogenicity of COVID-19 vaccines administered as part of each study site’s national COVID-19 immunization program. A total of 5,400 adults were enrolled globally between August 2021 and June 2022, including 700 from Indonesia between August 2021 and March 2022. Participants were enrolled within one day of receiving either their initial COVID-19 vaccine or a booster vaccine at a local clinic or study site and followed for 10 to 22 months. Demographic information, clinical data, and medical histories, including prior history of COVID-19, were collected at baseline. Blood and dried blood spots were collected at each study visit to measure anti-SARS-CoV-2 antibody levels, and respiratory swabs were collected during interim COVID-19 symptomatic visits for RT-PCR and sequencing to understand vaccine breakthrough infections. Early access to COVID-19 vaccines in Indonesia resulted in most participants (68.6%) being enrolled during their booster vaccination, with nearly all having received an initial Sinovac inactivated virus vaccine (97.7%) followed by a booster mRNA vaccine (92.3%). Among the Indonesian participants, 100 experienced a total of 121 symptomatic episodes of suspected COVID-19 during the study.

INVITE SITES Ver 2

Associated Publications:

  • Design of an observational multi-country cohort study to assess immunogenicity of multiple vaccine platforms (InVITE). PLoS One. 2022 Sep 15;17(9):e0273914. doi: 10.1371/journal.pone.0273914. PMID: 36107966.
  • Challenges of conducting an international observational study to assess immunogenicity of multiple COVID-19 vaccines. PLOS Glob Public Health. 2023 Jun 20;3(6):e0001918. doi: 10.1371/journal.pgph.0001918. PMID: 37339111.

Associated Biorepository

Specimen Type Baseline Month 2 Month 10 Month 16 Month 22 Symptomatic Visits
Dried Blood Spot (DBS) 699 661 617 519 507 120
Serum 700 662 617 519 507 120
Swab in VTM N/A N/A N/A N/A N/A 120
Whole Blood 698 661 616 519 507 119