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Comparison of bivalent and monovalent SARS-CoV-2 variant vaccines: the phase 2 randomized open-label COVAIL trial.
Branche AR, Rouphael NG, Diemert DJ, Falsey AR, Losada C, Baden LR, Frey SE, Whitaker JA, Little SJ, Anderson EJ, Walter EB, Novak RM, Rupp R, Jackson LA, Babu TM, Kottkamp AC, Luetkemeyer AF, Immergluck LC, Presti RM, Bäcker M, Winokur PL, Mahgoub SM, Goepfert PA, Fusco DN, Malkin E, Bethony JM, Walsh EE, Graciaa DS, Samaha H, Sherman AC, Walsh SR, Abate G, Oikonomopoulou Z, El Sahly HM, Martin TCS, Kamidani S, Smith MJ, Ladner BG, Porterfield L, Dunstan M, Wald A, Davis T, Atmar RL, Mulligan MJ, Lyke KE, Posavad CM, Meagher MA, Stephens DS, Neuzil KM, Abebe K, Hill H, Albert J, Telu K, Mu J, Lewis TC, Giebeig LA, Eaton A, Netzl A, Wilks SH, Türeli S, Makhene M, Crandon S, Montefiori DC, Makowski M, Smith DJ, Nayak SU, Roberts PC, Beigel JH; COVAIL Study Group. Branche AR, et al. Nat Med. 2023 Sep;29(9):2334-2346. doi: 10.1038/s41591-023-02503-4. Epub 2023 Aug 28. Nat Med. 2023. PMID: 37640860 Free PMC article. Clinical Trial.
Immunogenicity of a 2-Dose Regimen of Moderna mRNA Beta/Omicron BA.1 Bivalent Variant Vaccine Boost in a Randomized Clinical Trial.
Rouphael NG, Branche AR, Diemert DJ, Falsey AR, Losada C, Baden LR, Frey SE, Whitaker JA, Little SJ, Kamidani S, Walter EB, Novak RM, Rupp R, Jackson LA, Babu TM, Kottkamp AC, Luetkemeyer AF, Immergluck LC, Presti RM, Bäcker M, Winokur PL, Mahgoub SM, Goepfert PA, Fusco DN, Atmar RL, Posavad CM, Netzl A, Smith DJ, Telu K, Mu J, McQuarrie LJ, Makowski M, Makhene MK, Crandon S, Montefiori DC, Roberts PC, Beigel JH; Coronavirus Variant Immunologic Landscape Trial (COVAIL) Study Team. Rouphael NG, et al. J Infect Dis. 2023 Dec 20;228(12):1662-1666. doi: 10.1093/infdis/jiad323. J Infect Dis. 2023. PMID: 37561027 Clinical Trial.
Risk of Severe Acute Respiratory Syndrome Coronavirus 2 Acquisition Is Associated With Individual Exposure but Not Community-Level Transmission.
Friedman-Klabanoff DJ, Fitzpatrick MC, Deming ME, Agrawal V, Sitar S, Schaafsma T, Brown E, Neuzil KM, Barnabas RV, Laufer MK; Hydroxychloroquine COVID-19 Postexposure Prophylaxis Study Team. Friedman-Klabanoff DJ, et al. J Infect Dis. 2022 Aug 24;226(2):225-235. doi: 10.1093/infdis/jiac029. J Infect Dis. 2022. PMID: 35134185 Free PMC article. Clinical Trial.
Implementation of a fully remote randomized clinical trial with cardiac monitoring.
Mayfield JJ, Chatterjee NA, Noseworthy PA, Poole JE, Ackerman MJ, Stewart J, Kissinger PJ, Dwyer J, Hosek S, Oyedele T, Paasche-Orlow MK, Paolino K, Friedman PA, Waters C, Moreno J, Leingang H, Heller KB, Morrison SA, Krows ML, Barnabas RV, Baeten J, Johnston C; COVID-19 Early Treatment Team; Sridhar AR. Mayfield JJ, et al. Commun Med (Lond). 2021 Dec 20;1:62. doi: 10.1038/s43856-021-00052-w. eCollection 2021. Commun Med (Lond). 2021. PMID: 35604806 Free PMC article.
Hydroxychloroquine as Postexposure Prophylaxis to Prevent Severe Acute Respiratory Syndrome Coronavirus 2 Infection : A Randomized Trial.
Barnabas RV, Brown ER, Bershteyn A, Stankiewicz Karita HC, Johnston C, Thorpe LE, Kottkamp A, Neuzil KM, Laufer MK, Deming M, Paasche-Orlow MK, Kissinger PJ, Luk A, Paolino K, Landovitz RJ, Hoffman R, Schaafsma TT, Krows ML, Thomas KK, Morrison S, Haugen HS, Kidoguchi L, Wener M, Greninger AL, Huang ML, Jerome KR, Wald A, Celum C, Chu HY, Baeten JM; Hydroxychloroquine COVID-19 PEP Study Team. Barnabas RV, et al. Ann Intern Med. 2021 Mar;174(3):344-352. doi: 10.7326/M20-6519. Epub 2020 Dec 8. Ann Intern Med. 2021. PMID: 33284679 Free PMC article. Clinical Trial.