Oral fluid specimen collectionĪt each time point, one sample was collected using the OraSure ® Technologies Oral Specimen Collection Device (OSCD item number 3001-2870, OraSure ® Technologies, Bethlehem, PA) for SARS-CoV-2 IgG antibody detection), as previously described 2. A subset of the Pfizer/BioNTech cohort additionally provided a self-collected nasal swab fluid specimen for SARS-CoV-2 IgG antibody testing at every time point. Participants with a positive antibody test at the first time point or who missed more than one collection time point were excluded. Time pointsĮnrolled participants provided one self-collected oral fluid specimens for SARS-CoV-2 IgG antibody testing prior to or on the day of vaccination, as well as on days 5, 10, 15, and 20 following their first vaccination dose, and days 5, 10, 15, 20, 30, 60, and 90 following their second vaccination dose. Verbal informed consent was obtained from each subject prior to enrollment in the study. Vulnerable subjects (pregnant persons, nursing home residents or other institutionalized persons, prisoners, and persons without decisional capacity) were not eligible for enrollment in this study. Later recruitment took place among those who had received the first dose of the Pfizer/BioNTech COVID-19 vaccine. Initial recruitment took place among those who had received the first dose of the Moderna COVID-19 vaccine within the past 5 days. Enrollment was offered to subjects 18 years of age and older. Study enrollment was offered to healthcare workers at a COVID-19 testing site in San Dimas, California, USA, and interested healthy patients at vaccination sites in Riverside, California, USA and Round Rock, Texas, USA. In the present study, we aimed to assess whether (1) SARS-CoV-2 IgG antibodies targeting the spike protein are detectable in self-collected oral and nasal mucosal specimens following COVID-19 mRNA vaccination and (2) a quantitative assay could measure changes in SARS-CoV-2 IgG antibodies in oral and nasal mucosal fluid over time among vaccinated participants. Earlier work from our group demonstrated that an ELISA-based qualitative assay can reliably detect the presence of SARS-CoV-2 IgG antibodies targeting spike proteins S1 and S2 from self-collected oral mucosal specimens among participants previously infected with SARS-CoV-2 5. Prior studies have found that serum antibodies by mRNA-1273 persisted for at least 6 months following the recommended second vaccination dose 4. Vaccination against COVID-19 leads to the production of serum neutralizing antibodies 3. Mechanisms of protection against SARS-CoV-2 elicited from vaccines include humoral and cell-mediated immune responses 3. Prior research has found that vaccines for COVID-19 not only drastically decrease risk of hospitalization and death, but also prevent risk of acquisition and transmission of COVID-19 2. The rapid development and administration of highly effective vaccines for COVID-19 is a major triumph 1. Further research is needed to understand the duration of detectable oral or nasal mucosal antibodies and how antibody concentrations change with time. Oral or nasal mucosal antibody testing could be an inexpensive and less invasive alternative to serum antibody testing. There were no significant differences in oral mucosal antibody concentrations once participants were fully vaccinated in the Moderna and Pfizer/BioNTech vaccines. All participants developed detectable oral mucosal SARS-CoV-2 IgG antibodies by 15 days after the first vaccination dose. A subset of the cohort provided additional nasal mucosal specimens at every time point. Oral mucosal specimens were self-collected by participants prior to or on the day of vaccination, and on days 5, 10, 15, and 20 following each vaccination dose and 30, 60, and 90 days following the second vaccination dose. We enrolled 52 participants who received the Moderna vaccine and 80 participants who received the Pfizer/BioNTech vaccine. To assess the development of oral SARS-CoV-2 IgG antibodies among people who received either the Moderna or Pfizer/BioNTech COVID-19 vaccination series, we developed a novel SARS-CoV-2 IgG enzyme-linked immunosorbent assay (ELISA) to quantify the concentrations of oral and nasal mucosal SARS-CoV-2 IgG levels. Prior studies have found detectable SARS-CoV-2 IgG antibodies in oral mucosal specimens of participants with history of COVID-19. COVID-19 mRNA vaccines are highly effective at preventing COVID-19.
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