Virginia Non-Tidal Wetland Condition Assessment 2016

This data set is a GIS-based landscape (Level one) assessment of the water quality and habitat benefits of non-tidal wetlands from the National Wetlands Inventory (NWI) in Virginia utilizing the 2016 National Land Cover Dataset (NLCD) and 2016 Tiger/Line roads. The model assessment uses remote sensing and GIS technology to characterize land use patterns and features around wetlands such as surrounding land cover and density of roads as well as individual wetland characteristics such as wetland size and type to determine the wetlands overall condition as related to habitat and water quality functions. The water quality analysis determines the percentages of different land covers and features within the contributing drainage area of the wetland. Habitat and water quality ecosystem services scoring is on a scale from less disturbed to more disturbed and labeled as Slightly Stressed, Somewhat Stressed, Somewhat Severely Stressed, and Severely Stressed

Comparison of bivalent and monovalent SARS-CoV-2 variant vaccines: the phase 2 randomized open-label COVAIL trial.

Vaccine protection against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection wanes over time, requiring updated boosters. In a phase 2, open-label, randomized clinical trial with sequentially enrolled stages at 22 US sites, we assessed safety and immunogenicity of a second boost with monovalent or bivalent variant vaccines from mRNA and protein-based platforms targeting wild-type, Beta, Delta and Omicron BA.1 spike antigens. The primary outcome was pseudovirus neutralization titers at 50% inhibitory dilution (ID50 titers) with 95% confidence intervals against different SARS-CoV-2 strains. The secondary outcome assessed safety by solicited local and systemic adverse events (AEs), unsolicited AEs, serious AEs and AEs of special interest. Boosting with prototype/wild-type vaccines produced numerically lower ID50 titers than any variant-containing vaccine against all variants. Conversely, boosting with a variant vaccine excluding prototype was not associated with decreased neutralization against D614G. Omicron BA.1 or Beta monovalent vaccines were nearly equivalent to Omicron BA.1 + prototype or Beta + prototype bivalent vaccines for neutralization of Beta, Omicron BA.1 and Omicron BA.4/5, although they were lower for contemporaneous Omicron subvariants. Safety was similar across arms and stages and comparable to previous reports. Our study shows that updated vaccines targeting Beta or Omicron BA.1 provide broadly crossprotective neutralizing antibody responses against diverse SARS-CoV-2 variants without sacrificing immunity to the ancestral strain. ClinicalTrials.gov registration: NCT05289037

Comparison of bivalent and monovalent SARS-CoV-2 variant vaccines: the phase 2 randomized open-label COVAIL trial.

Vaccine protection against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection wanes over time, requiring updated boosters. In a phase 2, open-label, randomized clinical trial with sequentially enrolled stages at 22 US sites, we assessed safety and immunogenicity of a second boost with monovalent or bivalent variant vaccines from mRNA and protein-based platforms targeting wild-type, Beta, Delta and Omicron BA.1 spike antigens. The primary outcome was pseudovirus neutralization titers at 50% inhibitory dilution (ID50 titers) with 95% confidence intervals against different SARS-CoV-2 strains. The secondary outcome assessed safety by solicited local and systemic adverse events (AEs), unsolicited AEs, serious AEs and AEs of special interest. Boosting with prototype/wild-type vaccines produced numerically lower ID50 titers than any variant-containing vaccine against all variants. Conversely, boosting with a variant vaccine excluding prototype was not associated with decreased neutralization against D614G. Omicron BA.1 or Beta monovalent vaccines were nearly equivalent to Omicron BA.1 + prototype or Beta + prototype bivalent vaccines for neutralization of Beta, Omicron BA.1 and Omicron BA.4/5, although they were lower for contemporaneous Omicron subvariants. Safety was similar across arms and stages and comparable to previous reports. Our study shows that updated vaccines targeting Beta or Omicron BA.1 provide broadly crossprotective neutralizing antibody responses against diverse SARS-CoV-2 variants without sacrificing immunity to the ancestral strain. ClinicalTrials.gov registration: NCT05289037

Comparison of bivalent and monovalent SARS-CoV-2 variant vaccines: the phase 2 randomized open-label COVAIL trial.

Acknowledgements: We thank all the participants in this trial; the members of the safety monitoring committee (K. Talaat, J. Treanor, G. Paulsen and D. Stablein), who provided thoughtful discussions resulting in the early trial design; and staff members at Moderna, Pfizer and Sanofi–GSK for their collaboration, scientific input and sharing of documents needed to implement the trial. The COVAIL trial has been funded in part with federal funds from the NIAID and the National Cancer Institute, NIH, under contract HHSN261200800001E 75N910D00024, task order no. 75N91022F00007, and in part by the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Government Contract no. 75A50122C00008 with Monogram Biosciences, LabCorp. This work was also supported in part with federal funds from the NIAID, NIH, under contract no. 75N93021C00012, and by the Infectious Diseases Clinical Research Consortium (IDCRC) through the NIAID, under award no. UM1AI148684. D.J.S., A.N., S.H.W. and S.T. were supported by the NIH—NIAID Centers of Excellence for Influenza Research and Response (CEIRR) contract no. 75N93021C00014 as part of the SAVE program. D.C.M. and A.E. were supported by the NIAID Collaborative Influenza Vaccine Innovation Centers (CIVICs) contract no. 75N93019C00050. Testing of neutralizing antibody titers by Monogram Biosciences, LabCorp has been funded in part with federal funds from the Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under contract no. 75A50122C00008. Testing for anti-N-specific antibody was conducted by Cerba Research under contract no. 75N93021D00021. The content of this paper is solely the responsibility of the authors and does not necessarily represent the official views of the NIH—NIAID.Vaccine protection against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection wanes over time, requiring updated boosters. In a phase 2, open-label, randomized clinical trial with sequentially enrolled stages at 22 US sites, we assessed safety and immunogenicity of a second boost with monovalent or bivalent variant vaccines from mRNA and protein-based platforms targeting wild-type, Beta, Delta and Omicron BA.1 spike antigens. The primary outcome was pseudovirus neutralization titers at 50% inhibitory dilution (ID50 titers) with 95% confidence intervals against different SARS-CoV-2 strains. The secondary outcome assessed safety by solicited local and systemic adverse events (AEs), unsolicited AEs, serious AEs and AEs of special interest. Boosting with prototype/wild-type vaccines produced numerically lower ID50 titers than any variant-containing vaccine against all variants. Conversely, boosting with a variant vaccine excluding prototype was not associated with decreased neutralization against D614G. Omicron BA.1 or Beta monovalent vaccines were nearly equivalent to Omicron BA.1 + prototype or Beta + prototype bivalent vaccines for neutralization of Beta, Omicron BA.1 and Omicron BA.4/5, although they were lower for contemporaneous Omicron subvariants. Safety was similar across arms and stages and comparable to previous reports. Our study shows that updated vaccines targeting Beta or Omicron BA.1 provide broadly crossprotective neutralizing antibody responses against diverse SARS-CoV-2 variants without sacrificing immunity to the ancestral strain. ClinicalTrials.gov registration: NCT05289037