582. Risk Factors for Progression to Hospitalization in Adolescents Presenting with Mild or Moderate COVID-19

Abstract Background Most adolescents (age 12-17 years) with COVID-19 have mild disease. However, certain comorbidities may be risk factors for disease progression, and hospitalization rates for this age group have increased. Adolescents and adults with mild to moderate COVID-19 are eligible for monoclonal antibody therapy. To identify subgroups likely to benefit from this intervention, we evaluated the relationship between comorbidities and need for hospitalization in US adolescents presenting with mild to moderate COVID-19. Methods We analyzed presence of comorbidities and need for hospitalization within 28 days of diagnosis for adolescents in the PIDTRAN registry, a multicenter retrospective cohort of US pediatric patients with COVID-19. Comorbidities assessed included obesity, chronic kidney disease (CKD), diabetes (DM), immunosuppressive disease or treatment (IS), sickle cell disease (SCD), congenital/acquired heart disease (CHD), neurologic disease/neurodevelopmental disorders (ND), medical-related technology dependence (MTD), and pulmonary disease requiring daily inhaled corticosteroids (PD). We used multivariable logistic regression to determine race/ethnicity-adjusted associations between comorbidities and hospitalization. Results 1574 patients met inclusion criteria, of whom 180 (11.4%) were hospitalized within 28 days of COVID-19 diagnosis. In a race/ethnicity-adjusted model, the following comorbidities were independently associated with increased odds of hospitalization: IS (OR 10.8 [95%CI 5.4 – 21.7]); CKD (OR 5.1 [95%CI 1.0 – 25.6]); DM (OR 4.2 [95%CI 1.7 – 10.6]); SCD (OR 3.4 [95%CI 1.1 – 10.6]). ND (OR 3.0 [95%CI 1.7 – 5.4]); and obesity (OR 2.0 [95%CI 1.1 – 3.9]). Notably, CHD, MTD, and PD were not independently associated with hospitalization. There was no effect modification of race/ethnicity on the association between obesity or DM and hospitalization. Table 1: Characteristics of adolescents in our cohort Figure 1. Association between comorbidities and hospitalization. Model 1: comorbidities only. Model 2: comorbidities, adjusted for race/ethnicity. Abbreviations: CKD – chronic kidney disease; SCD – sickle cell disease; ICS – inhaled corticosteroids. Conclusion IS, CKD, DM, SCD, ND, and obesity were associated with increased odds of hospitalization in adolescents presenting with mild to moderate COVID-19. Adolescents with these comorbidities should be prioritized for consideration of treatment with monoclonal antibodies. Disclosures Gabriella S. Lamb, MD, MPH, Nothing to disclose

. Sociodemographic Characteristics of Adults Conclusion. Although some unvaccinated individuals seemingly perceived the SARS-CoV-2 vaccine offered some protection, research should continue to evaluate the implications of vaccine hesitancy on the COVID-19 pandemic response as we prepare for the upcoming respiratory season.
Disclosures. Natasha B. Halasa, MD, MPH, Genentech (Other Financial or Material Support, I receive an honorarium for lectures -it's a education grant, supported by genetech)Quidel (Grant/Research Support, Other Financial or Material Support, Donation of supplies/kits)Sanofi (Grant/Research Support, Other Financial or Material Support, HAI/NAI testing) Natasha B. Halasa, MD, MPH, Genentech (Individual(s) Involved: Self): I receive an honorarium for lectures -it's a education grant, supported by genetech, Other Financial or Material Support, Other Financial or Material Support; Sanofi (Individual(s) Involved: Self): Grant/Research Support, Research Grant or Support

Risk Factors for Progression to Hospitalization in Adolescents Presenting with Mild or Moderate COVID-19
Melanie Dubois, MD 1 ; Jeffrey Campbell, MD 2 ; Gabriella S. Lamb, MD, MPH 2 ; Gabriella S. Lamb, MD, MPH 2 ; Mari M. Nakamura, MD, MPH 3 ; 1 Boston Children's Hospital, Harvard Medical School, Boston, MA; 2 Boston Children's Hospital, Boston, MA; 3 Boston Children's Hospital, Harvard medical school, Jamaica Plain, MA Session: P-25. COVID-19 Vaccines Background. Most adolescents (age 12-17 years) with COVID-19 have mild disease. However, certain comorbidities may be risk factors for disease progression, and hospitalization rates for this age group have increased. Adolescents and adults with mild to moderate COVID-19 are eligible for monoclonal antibody therapy. To identify subgroups likely to benefit from this intervention, we evaluated the relationship between comorbidities and need for hospitalization in US adolescents presenting with mild to moderate COVID-19.
Methods. We analyzed presence of comorbidities and need for hospitalization within 28 days of diagnosis for adolescents in the PIDTRAN registry, a multicenter retrospective cohort of US pediatric patients with COVID-19. Comorbidities assessed included obesity, chronic kidney disease (CKD), diabetes (DM), immunosuppressive disease or treatment (IS), sickle cell disease (SCD), congenital/ acquired heart disease (CHD), neurologic disease/neurodevelopmental disorders (ND), medical-related technology dependence (MTD), and pulmonary disease requiring daily inhaled corticosteroids (PD). We used multivariable logistic regression to determine race/ethnicity-adjusted associations between comorbidities and hospitalization.
Results. 1574 patients met inclusion criteria, of whom 180 (11.4%) were hospitalized within 28 days of COVID-19 diagnosis. In a race/ethnicity-adjusted model, the following comorbidities were independently associated with increased odds of hospitalization: IS  . Notably, CHD, MTD, and PD were not independently associated with hospitalization. There was no effect modification of race/ethnicity on the association between obesity or DM and hospitalization.  Background. Peru started its national vaccination campaign in February 2021 using Sinopharm vaccine, targeting healthcare personnel on its initial phase. Although the immunogenicity of this vaccine was tested in clinical trials, there are no studies that evaluated the humoral response post vaccination in Peru.
Methods. We conducted a cross sectional study, which objective was to evaluate the humoral immunogenicity triggered by the Sinopharm vaccine in Peruvian physicians. We collected demographic and epidemiologic data via an electronic. The SARS-CoV-2 spike protein S1/S2 antibodies were measured by chemiluminescense (Liaison®). A positive test was defined as >15 U/ml, which has correlation of 95% with neutralizing antibodies measured by plaque reduction neutralizing test.
Results. 92 participants were enrolled in the study. The epidemiologic characteristics are described in table 1. The mean level of antibodies measured at least 2 weeks from the second vaccine dose was 67.5 ± 70.5 U/ml. 85.7% of the study cohort had positive S1/S2 antibodies. In the univariate analysis, an imperfect negative correlation was found between the level of antibodies and participants' age (r= -0.24; regression F test 5.25; p = 0.0242). A weak negative correlation was observed between the antibody titer and the time elapsed from the second vaccine dose and the day of antibody measurement (r= -0.17). A higher antibody level post vaccine was found in individuals who worked in COVID units (105.5 U / mL vs 58.2 U / mL; p = 0.0125), and in participants with history of COVID (216.5 U / mL vs 81.2 U / mL; p = < 0.0000). Hypertension was associated with lower antibody titers (36.9 U / mL vs. 74.6; p = 0.0464). In the multivariate analysis, working in COVID units, having previous COVID infection and shorter time from second vaccine dose and day of antibody measurement were associated with higher antibody levels post vaccine (table 2).

Conclusion.
Our study showed that the time elapsed from the second vaccine dose and the day of antibody measurement, having previous COVID-19 infection and working in COVID -19 units may help to predict higher antibody titers post vaccine. Larger studies to evaluate the humoral response post Sinopharm vaccine and its clinical implications are still needed in Peru.
Disclosures Background. COVI-VAC TM is an intra-nasal live-attenuated SARS-COV-2 synthetic viral vaccine being developed for the prevention of COVID-19. COVI-VAC is attenuated through deletion of the furin cleavage site and introduction of 283 silent deoptimizing mutations that maintain viral amino acid sequence but result in significant attenuation due to slow translation in the human host cell. Notably, COVI-VAC includes all viral antigens and is not limited to spike. COVI-VAC has demonstrated attenuation, immunogenicity and single dose protection in both Syrian golden hamster and non-human primate models.
Methods. 48 healthy young adults were enrolled in an inpatient quarantine setting to one of 3 dose escalating cohorts and randomized to COVI-VAC or saline placebo given as nose drops, as a single 0.5mL dose or 2 doses 28 days apart. Endpoints included solicited and unsolicited adverse events, serum cytokines, viral shedding and sequence stability, mucosal and serum antibody responses and IFN ELISpot. Subjects will be followed for 1 year for late safety events and durability of immune response.
Results. Dosing is complete. There has been no trend in solicited reactogenicity events, and all unsolicited adverse events reported to date have been mild. There have been no SAEs or Grade 3 or 4 events. Vaccine virus from anonymized subjects was shed at levels lower than that likely to result in onward transmission, and the deoptimized sequence of the shed virus remained unchanged compared to the original vaccine sequence. Unblinded data including immunogenicity will be available prior to the IDWeek meeting.
Conclusion. COVI-VAC appears safe and well tolerated in healthy young adults. Vaccination resulted in minimal viral shedding without sequence instability. Safety and shedding data supports continued development in a wider Phase 2/3 population.