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High Frequency of Chronic Urticaria Following an Investigational HIV-1 BG505 MD39.3 Trimer mRNA Vaccine in a Phase 1, Randomized, Open-Label Clinical Trial (HVTN 302).

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Title: High Frequency of Chronic Urticaria Following an Investigational HIV-1 BG505 MD39.3 Trimer mRNA Vaccine in a Phase 1, Randomized, Open-Label Clinical Trial (HVTN 302).
Authors: Riddler SA; Division of Infectious Diseases, Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania (S.A.R.)., Moodie Z; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington (Z.M., B.D.F., H.L., S.G., K.M., M.Anderson, J.M., M.P.L., A.S.W.D., M.J.M., J.G.K., L.C.)., Clark J; Department of Medicine, Division of Infectious Diseases, David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, California (J.C.)., Yen C; Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, Maryland (C.Y., M.Allen)., Allen M; Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, Maryland (C.Y., M.Allen)., Furch BD; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington (Z.M., B.D.F., H.L., S.G., K.M., M.Anderson, J.M., M.P.L., A.S.W.D., M.J.M., J.G.K., L.C.)., Lu H; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington (Z.M., B.D.F., H.L., S.G., K.M., M.Anderson, J.M., M.P.L., A.S.W.D., M.J.M., J.G.K., L.C.)., Grant S; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington (Z.M., B.D.F., H.L., S.G., K.M., M.Anderson, J.M., M.P.L., A.S.W.D., M.J.M., J.G.K., L.C.)., Mondal K; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington (Z.M., B.D.F., H.L., S.G., K.M., M.Anderson, J.M., M.P.L., A.S.W.D., M.J.M., J.G.K., L.C.)., Anderson M; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington (Z.M., B.D.F., H.L., S.G., K.M., M.Anderson, J.M., M.P.L., A.S.W.D., M.J.M., J.G.K., L.C.)., Maenza J; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington (Z.M., B.D.F., H.L., S.G., K.M., M.Anderson, J.M., M.P.L., A.S.W.D., M.J.M., J.G.K., L.C.)., Lemos MP; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington (Z.M., B.D.F., H.L., S.G., K.M., M.Anderson, J.M., M.P.L., A.S.W.D., M.J.M., J.G.K., L.C.)., Woodward Davis AS; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington (Z.M., B.D.F., H.L., S.G., K.M., M.Anderson, J.M., M.P.L., A.S.W.D., M.J.M., J.G.K., L.C.)., Walsh SR; Division of Infectious Diseases, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts (S.R.W., L.R.B.)., Sobieszczyk ME; Division of Infectious Diseases, Aaron Diamond AIDS Research Center, Department of Medicine, Vagelos College of Physicians & Surgeons, Columbia University Irving Medical Center, New York, New York (M.E.S.)., Frank I; School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania (I.F.)., Goepfert P; Division of Infectious Diseases, University of Alabama at Birmingham, Birmingham, Alabama (P.G.)., Stephenson KE; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts (K.E.S.)., Baden LR; Division of Infectious Diseases, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts (S.R.W., L.R.B.)., Tieu HV; Division of Infectious Diseases, Department of Medicine, Vagelos College of Physicians and Surgeons, New York-Presbyterian Columbia University Irving Medical Center, and Lindsley F. Kimball Research Institute, New York Blood Center, New York, New York (H.-V.T.)., Keefer MC; Department of Medicine, University of Rochester School of Medicine & Dentistry, Rochester, New York (M.C.K.)., McElrath MJ; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington (Z.M., B.D.F., H.L., S.G., K.M., M.Anderson, J.M., M.P.L., A.S.W.D., M.J.M., J.G.K., L.C.)., Kublin JG; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington (Z.M., B.D.F., H.L., S.G., K.M., M.Anderson, J.M., M.P.L., A.S.W.D., M.J.M., J.G.K., L.C.)., Corey L; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington (Z.M., B.D.F., H.L., S.G., K.M., M.Anderson, J.M., M.P.L., A.S.W.D., M.J.M., J.G.K., L.C.).
Source: Annals of internal medicine [Ann Intern Med] 2025 Jul; Vol. 178 (7), pp. 963-974. Date of Electronic Publication: 2025 Apr 29.
Publication Type: Journal Article; Randomized Controlled Trial; Clinical Trial, Phase I; Multicenter Study
Journal Info: Publisher: American College of Physicians--American Society of Internal Medicine Country of Publication: United States NLM ID: 0372351 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1539-3704 (Electronic) Linking ISSN: 00034819 NLM ISO Abbreviation: Ann Intern Med Subsets: MEDLINE
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  Data: High Frequency of Chronic Urticaria Following an Investigational HIV-1 BG505 MD39.3 Trimer mRNA Vaccine in a Phase 1, Randomized, Open-Label Clinical Trial (HVTN 302).
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  Data: <searchLink fieldCode="AU" term="%22Riddler+SA%22">Riddler SA</searchLink>; Division of Infectious Diseases, Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania (S.A.R.).<br /><searchLink fieldCode="AU" term="%22Moodie+Z%22">Moodie Z</searchLink>; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington (Z.M., B.D.F., H.L., S.G., K.M., M.Anderson, J.M., M.P.L., A.S.W.D., M.J.M., J.G.K., L.C.).<br /><searchLink fieldCode="AU" term="%22Clark+J%22">Clark J</searchLink>; Department of Medicine, Division of Infectious Diseases, David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, California (J.C.).<br /><searchLink fieldCode="AU" term="%22Yen+C%22">Yen C</searchLink>; Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, Maryland (C.Y., M.Allen).<br /><searchLink fieldCode="AU" term="%22Allen+M%22">Allen M</searchLink>; Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, Maryland (C.Y., M.Allen).<br /><searchLink fieldCode="AU" term="%22Furch+BD%22">Furch BD</searchLink>; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington (Z.M., B.D.F., H.L., S.G., K.M., M.Anderson, J.M., M.P.L., A.S.W.D., M.J.M., J.G.K., L.C.).<br /><searchLink fieldCode="AU" term="%22Lu+H%22">Lu H</searchLink>; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington (Z.M., B.D.F., H.L., S.G., K.M., M.Anderson, J.M., M.P.L., A.S.W.D., M.J.M., J.G.K., L.C.).<br /><searchLink fieldCode="AU" term="%22Grant+S%22">Grant S</searchLink>; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington (Z.M., B.D.F., H.L., S.G., K.M., M.Anderson, J.M., M.P.L., A.S.W.D., M.J.M., J.G.K., L.C.).<br /><searchLink fieldCode="AU" term="%22Mondal+K%22">Mondal K</searchLink>; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington (Z.M., B.D.F., H.L., S.G., K.M., M.Anderson, J.M., M.P.L., A.S.W.D., M.J.M., J.G.K., L.C.).<br /><searchLink fieldCode="AU" term="%22Anderson+M%22">Anderson M</searchLink>; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington (Z.M., B.D.F., H.L., S.G., K.M., M.Anderson, J.M., M.P.L., A.S.W.D., M.J.M., J.G.K., L.C.).<br /><searchLink fieldCode="AU" term="%22Maenza+J%22">Maenza J</searchLink>; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington (Z.M., B.D.F., H.L., S.G., K.M., M.Anderson, J.M., M.P.L., A.S.W.D., M.J.M., J.G.K., L.C.).<br /><searchLink fieldCode="AU" term="%22Lemos+MP%22">Lemos MP</searchLink>; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington (Z.M., B.D.F., H.L., S.G., K.M., M.Anderson, J.M., M.P.L., A.S.W.D., M.J.M., J.G.K., L.C.).<br /><searchLink fieldCode="AU" term="%22Woodward+Davis+AS%22">Woodward Davis AS</searchLink>; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington (Z.M., B.D.F., H.L., S.G., K.M., M.Anderson, J.M., M.P.L., A.S.W.D., M.J.M., J.G.K., L.C.).<br /><searchLink fieldCode="AU" term="%22Walsh+SR%22">Walsh SR</searchLink>; Division of Infectious Diseases, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts (S.R.W., L.R.B.).<br /><searchLink fieldCode="AU" term="%22Sobieszczyk+ME%22">Sobieszczyk ME</searchLink>; Division of Infectious Diseases, Aaron Diamond AIDS Research Center, Department of Medicine, Vagelos College of Physicians & Surgeons, Columbia University Irving Medical Center, New York, New York (M.E.S.).<br /><searchLink fieldCode="AU" term="%22Frank+I%22">Frank I</searchLink>; School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania (I.F.).<br /><searchLink fieldCode="AU" term="%22Goepfert+P%22">Goepfert P</searchLink>; Division of Infectious Diseases, University of Alabama at Birmingham, Birmingham, Alabama (P.G.).<br /><searchLink fieldCode="AU" term="%22Stephenson+KE%22">Stephenson KE</searchLink>; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts (K.E.S.).<br /><searchLink fieldCode="AU" term="%22Baden+LR%22">Baden LR</searchLink>; Division of Infectious Diseases, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts (S.R.W., L.R.B.).<br /><searchLink fieldCode="AU" term="%22Tieu+HV%22">Tieu HV</searchLink>; Division of Infectious Diseases, Department of Medicine, Vagelos College of Physicians and Surgeons, New York-Presbyterian Columbia University Irving Medical Center, and Lindsley F. 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