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Page 1
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. Among authors: ladner bg. 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.
Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine.
Baden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R, Diemert D, Spector SA, Rouphael N, Creech CB, McGettigan J, Khetan S, Segall N, Solis J, Brosz A, Fierro C, Schwartz H, Neuzil K, Corey L, Gilbert P, Janes H, Follmann D, Marovich M, Mascola J, Polakowski L, Ledgerwood J, Graham BS, Bennett H, Pajon R, Knightly C, Leav B, Deng W, Zhou H, Han S, Ivarsson M, Miller J, Zaks T; COVE Study Group. Baden LR, et al. N Engl J Med. 2021 Feb 4;384(5):403-416. doi: 10.1056/NEJMoa2035389. Epub 2020 Dec 30. N Engl J Med. 2021. PMID: 33378609 Free PMC article. Clinical Trial.
Efficacy of the mRNA-1273 SARS-CoV-2 Vaccine at Completion of Blinded Phase.
El Sahly HM, Baden LR, Essink B, Doblecki-Lewis S, Martin JM, Anderson EJ, Campbell TB, Clark J, Jackson LA, Fichtenbaum CJ, Zervos M, Rankin B, Eder F, Feldman G, Kennelly C, Han-Conrad L, Levin M, Neuzil KM, Corey L, Gilbert P, Janes H, Follmann D, Marovich M, Polakowski L, Mascola JR, Ledgerwood JE, Graham BS, August A, Clouting H, Deng W, Han S, Leav B, Manzo D, Pajon R, Schödel F, Tomassini JE, Zhou H, Miller J; COVE Study Group. El Sahly HM, et al. N Engl J Med. 2021 Nov 4;385(19):1774-1785. doi: 10.1056/NEJMoa2113017. Epub 2021 Sep 22. N Engl J Med. 2021. PMID: 34551225 Free PMC article. Clinical Trial.
SARS-CoV-2 Variant Vaccine Boosters Trial: Preliminary Analyses.
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, Rostad CA, 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, Lewis TC, Giebeig LA, Eaton A, Netzl A, Wilks SH, Türeli S, Makhene M, Crandon S, Lee M, Nayak SU, Montefiori DC, Makowski M, Smith DJ, Roberts PC, Beigel JH; COVAIL Study Group. Branche AR, et al. Among authors: ladner bg. medRxiv [Preprint]. 2022 Jul 15:2022.07.12.22277336. doi: 10.1101/2022.07.12.22277336. medRxiv. 2022. PMID: 35898343 Free PMC article. Preprint.
Bivalent and Monovalent SARS-CoV-2 Variant Vaccine Boosters Improve coverage of the known Antigenic Landscape: Results of the COVID-19 Variant Immunologic Landscape (COVAIL) Trial.
Branche A, Rouphael N, Diemert D, Falsey A, Losada C, Baden LR, Frey S, Whitaker J, Little S, Anderson E, Walter E, Novak R, Rupp R, Jackson L, Babu T, Kottkamp A, Luetkemeyer A, Immergluck L, Presti R, Backer M, Winokur P, Mahgoub S, Goepfert P, Fusco D, Malkin E, Bethony J, Walsh E, Graciaa D, Samaha H, Sherman A, Walsh S, Abate G, Oikonomopoulou Z, El Sahly H, Martin T, Kamidani S, Smith M, Ladner B, Porterfield L, Dunstan M, Wald A, Davis T, Atmar R, Mulligan M, Lyke K, Posavad C, Meagher M, Stephens D, Neuzil K, Abebe K, Hill H, Albert J, Telu K, Mu J, Lewis T, Giebeig L, Eaton A, Netzl A, Wilks S, Tureli S, Makhene M, Crandon S, Montefiori D, Makowski M, Smith D, Nayak S, Roberts P, Beigel J. Branche A, et al. Res Sq [Preprint]. 2023 May 5:rs.3.rs-2653179. doi: 10.21203/rs.3.rs-2653179/v1. Res Sq. 2023. Update in: Nat Med. 2023 Sep;29(9):2334-2346. doi: 10.1038/s41591-023-02503-4 PMID: 37205592 Free PMC article. Updated. Preprint.
Clinical and Demographic Factors Associated With COVID-19, Severe COVID-19, and SARS-CoV-2 Infection in Adults: A Secondary Cross-Protocol Analysis of 4 Randomized Clinical Trials.
Theodore DA, Branche AR, Zhang L, Graciaa DS, Choudhary M, Hatlen TJ, Osman R, Babu TM, Robinson ST, Gilbert PB, Follmann D, Janes H, Kublin JG, Baden LR, Goepfert P, Gray GE, Grinsztejn B, Kotloff KL, Gay CL, Leav B, Miller J, Hirsch I, Sadoff J, Dunkle LM, Neuzil KM, Corey L, Falsey AR, El Sahly HM, Sobieszczyk ME, Huang Y; COVID-19 Prevention Network (CoVPN). Theodore DA, et al. JAMA Netw Open. 2023 Jul 3;6(7):e2323349. doi: 10.1001/jamanetworkopen.2023.23349. JAMA Netw Open. 2023. PMID: 37440227 Free PMC article.
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 Free PMC article. Clinical Trial.
Risk of COVID-19 after natural infection or vaccination.
Rick AM, Laurens MB, Huang Y, Yu C, Martin TCS, Rodriguez CA, Rostad CA, Maboa RM, Baden LR, El Sahly HM, Grinsztejn B, Gray GE, Gay CL, Gilbert PB, Janes HE, Kublin JG, Huang Y, Leav B, Hirsch I, Struyf F, Dunkle LM, Neuzil KM, Corey L, Goepfert PA, Walsh SR, Follmann D, Kotloff KL; NIAID-funded COVID-19 Prevention Network (CoVPN). Rick AM, et al. EBioMedicine. 2023 Oct;96:104799. doi: 10.1016/j.ebiom.2023.104799. Epub 2023 Sep 20. EBioMedicine. 2023. PMID: 37738833 Free PMC article. Clinical Trial.
SARS-CoV-2 Viral Load in the Nasopharynx at Time of First Infection Among Unvaccinated Individuals: A Secondary Cross-Protocol Analysis of 4 Randomized Trials.
Fisher LH, Kee JJ, Liu A, Espinosa CM, Randhawa AK, Ludwig J, Magaret CA, Robinson ST, Gilbert PB, Hyrien O, Kublin JG, Rouphael N, Falsey AR, Sobieszczyk ME, El Sahly HM, Grinsztejn B, Gray GE, Kotloff KL, Gay CL, Leav B, Hirsch I, Struyf F, Dunkle LM, Neuzil KM, Corey L, Huang Y, Goepfert PA, Walsh SR, Baden LR, Janes H; COVID-19 Prevention Network (CoVPN). Fisher LH, et al. JAMA Netw Open. 2024 May 1;7(5):e2412835. doi: 10.1001/jamanetworkopen.2024.12835. JAMA Netw Open. 2024. PMID: 38780941 Free PMC article.
Neutralizing Antibody Immune Correlates for a Recombinant Protein Vaccine in the COVAIL Trial.
Fong Y, Dang L, Zhang B, Fintzi J, Chen S, Wang J, 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, Yu C, Magaret CA, Molitor C, Borate B, Babu TM, Kottkamp AC, Luetkemeyer AF, Immergluck LC, Presti RM, Bäcker M, Winokur PL, Mahgoub SM, Goepfert PA, Fusco DN, Atmar RL, Posavad CM, Mu J, Makowski M, Makhene MK, Nayak SU, Roberts PC, Follmann D, Gilbert PB; Coronavirus Variant Immunologic Landscape Trial (COVAIL) Study Team. Fong Y, et al. Clin Infect Dis. 2024 Sep 26:ciae465. doi: 10.1093/cid/ciae465. Online ahead of print. Clin Infect Dis. 2024. PMID: 39325506