| Author | Takuva, Simbarashe | |
| Author | Karuna, Shelly T. | |
| Author | Juraska, Michal | |
| Author | Rudnicki, Erika | |
| Author | Edupuganti, Srilatha | |
| Author | Anderson, Maija | |
| Author | La Grecca, Robert De | |
| Author | Gaudinski, Martin R. | |
| Author | Sehurutshi, Alice | |
| Author | Orrell, Catherine | |
| Author | Naidoo, Logashvari | |
| Author | Valencia, Javier | |
| Author | Villela, Larissa M. | |
| Author | Walsh, Stephen R. | |
| Author | Andrew, Philip | |
| Author | Karg, Carissa | |
| Author | Randhawa, April | |
| Author | Hural, John | |
| Author | Lorenzo, Margarita M. Gomez | |
| Author | Burns, David N. | |
| Author | Ledgerwood, Julie | |
| Author | Mascola, John R. | |
| Author | Cohen, Myron | |
| Author | Corey, Lawrence | |
| Author | Mngadi, Kathy | |
| Author | Mgodi, Nyaradzo M. | |
| Access date | 2024-05-22T00:11:18Z | |
| Available date | 2024-05-22T00:11:18Z | |
| Document date | 2022 | |
| Citation | TAKUVA, Simbarashe et al. Infusion Reactions After Receiving the Broadly Neutralizing Antibody VRC01 or Placebo to Reduce HIV-1 Acquisition: Results From the Phase 2b Antibody-Mediated Prevention Randomized Trials. Journal of Acquired Immune Deficiency Syndromes, v. 89, n. 4, p. 1-17, Apr. 2022. | |
| ISSN | 1525-4135 | |
| URI | https://www.arca.fiocruz.br/handle/icict/64175 | |
| Description | HVTN 703/HPTN 081 and HVTN 704/HPTN 085 Study Teams. | en_US |
| Sponsorship | AI068614, AI068635, AI068618, AI068619, and AI069412. Presented at Conference for Retroviruses and Opportunistic Infections; March 06–10, 2021. S.R.W. has received clinical trial funding from Janssen Vaccines. | |
| Language | eng | en_US |
| Publisher | Lippincott Williams & Wilkins | |
| Later version | https://www.arca.fiocruz.br/handle/icict/69321 | |
| Rights | open access | |
| Title | Infusion Reactions After Receiving the Broadly Neutralizing Antibody VRC01 or Placebo to Reduce HIV-1 Acquisition: Results From the Phase 2b Antibody-Mediated Prevention Randomized Trials | en_US |
| Type | Preprint | |
| DOI | 10.1097/QAI.0000000000002892 | |
| Abstract | Background: The antibody-mediated prevention (AMP) studies (HVTN 703/HPTN 081 and HVTN 704/HPTN 085) are harmonized phase 2b trials to assess HIV prevention efficacy and safety of intravenous infusion of anti-gp120 broadly neutralizing antibody VRC01. Antibodies for other indications can elicit infusion-related reactions (IRRs), often requiring premedication and limiting their application. We report on AMP study IRRs. Methods: From 2016 to 2018, 2699 HIV-uninfected, at-risk men and transgender adults in the Americas and Switzerland (704/085) and 1924 at-risk heterosexual women in sub-Saharan Africa (703/081) were randomized 1:1:1 to VRC01 10 mg/kg, 30 mg/kg, or placebo. Participants received infusions every 8 weeks (n = 10/participant) over 72 weeks, with 104 weeks of follow-up. Safety assessments were conducted before and after infusion and at noninfusion visits. A total of 40,674 infusions were administered. Results: Forty-seven participants (1.7%) experienced 49 IRRs in 704/085; 93 (4.8%) experienced 111 IRRs in 703/081 (P < 0.001). IRRs occurred more frequently in VRC01 than placebo recipients in 703/081 (P < 0.001). IRRs were associated with atopic history (P = 0.046) and with younger age (P = 0.023) in 703/081. Four clinical phenotypes of IRRs were observed: urticaria, dyspnea, dyspnea with rash, and "other." Urticaria was most prevalent, occurring in 25 (0.9%) participants in 704/085 and 41 (2.1%) participants in 703/081. Most IRRs occurred with the initial infusion and incidence diminished through the last infusion. All reactions were managed successfully without sequelae. Conclusions: IRRs in the AMP studies were uncommon, typically mild or moderate, successfully managed at the research clinic, and resolved without sequelae. Analysis is ongoing to explore potential IRR mechanisms. | en_US |
| Affilliation | Fred Hutchinson Cancer Research Center. Vaccine and Infectious Disease Division. Seattle, WA, USA / University of the Witwatersrand. Faculty of Health Sciences. Perinatal HIV Research Unit. Johannesburg, South Africa / University of Pretoria. Faculty of Health Sciences. School of Health Systems and Public Health. Pretoria, South Africa. | |
| Affilliation | Fred Hutchinson Cancer Research Center. Vaccine and Infectious Disease Division. Seattle, WA, USA. | |
| Affilliation | Fred Hutchinson Cancer Research Center. Vaccine and Infectious Disease Division. Seattle, WA, USA. | |
| Affilliation | Fred Hutchinson Cancer Research Center. Vaccine and Infectious Disease Division. Seattle, WA, USA. | |
| Affilliation | Emory University. Department of Medicine. Division of Infectious Disease. Atlanta, GA, USA. | |
| Affilliation | Fred Hutchinson Cancer Research Center. Vaccine and Infectious Disease Division. Seattle, WA, USA. | |
| Affilliation | Fred Hutchinson Cancer Research Center. Vaccine and Infectious Disease Division. Seattle, WA, USA. | |
| Affilliation | National Institutes of Health. National Institute of Allergy and Infectious Diseases. Vaccine Research Center. Bethesda, MD, USA. | |
| Affilliation | Botswana Harvard AIDS Institute. Gaborone, Botswana, South Africa. | |
| Affilliation | University of Cape Town. Institute of Infectious Disease and Molecular Medicine. Desmond Tutu HIV Center. Department of Medicine. Cape Town, South Africa. | |
| Affilliation | South African Medical Research Council. Durban, South Africa. | |
| Affilliation | Asociacion Civil Impacta Salud y Educacion. Lima, Peru. | |
| Affilliation | Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil. | |
| Affilliation | Brigham and Women's Hospital. Division of Infectious Diseases. Boston, MA, USA. | |
| Affilliation | Family Health International. Durham, NC, USA. | |
| Affilliation | Fred Hutchinson Cancer Research Center. Vaccine and Infectious Disease Division. Seattle, WA, USA. | |
| Affilliation | Fred Hutchinson Cancer Research Center. Vaccine and Infectious Disease Division. Seattle, WA, USA. | |
| Affilliation | Fred Hutchinson Cancer Research Center. Vaccine and Infectious Disease Division. Seattle, WA, USA. | |
| Affilliation | National Institutes of Health. National Institute of Allergy and Infectious Diseases. Division of AIDS. Bethesda, MD, USA. | |
| Affilliation | National Institutes of Health. National Institute of Allergy and Infectious Diseases. Division of AIDS. Bethesda, MD, USA. | |
| Affilliation | National Institutes of Health. National Institute of Allergy and Infectious Diseases. Vaccine Research Center. Bethesda, MD, USA. | |
| Affilliation | National Institutes of Health. National Institute of Allergy and Infectious Diseases. Vaccine Research Center. Bethesda, MD, USA. | |
| Affilliation | University of North Carolina. Department of Medicine. Chapel Hill, NC, USA. | |
| Affilliation | Fred Hutchinson Cancer Research Center. Vaccine and Infectious Disease Division. Seattle, WA, USA. | |
| Affilliation | Aurum Institute. Johannesburg, South Africa. | |
| Affilliation | University of Zimbabwe Clinical Trials Research Center. Harare, Zimbabwe. | |
| Subject | Infusion related reactions | en_US |
| Subject | Hypersensitivity | en_US |
| Subject | Broadly neutralizing antibodies | en_US |
| Subject | AMP study | en_US |
| Subject | VRC01 | en_US |
| Subject | HIV | en_US |
| e-ISSN | 1944-7884 | |
