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Original Research
29 April 2025

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: Sharon A. Riddler, MD https://orcid.org/0000-0002-2545-7037, Zoe Moodie, PhD https://orcid.org/0000-0001-8701-2001, Jesse Clark, MD https://orcid.org/0000-0001-5862-6530, Catherine Yen, MD, Mary Allen, RN, BSN, MS https://orcid.org/0000-0001-8163-0714, Briana D. Furch, MD, Huiyin Lu, MS, … Show All … , Shannon Grant, MS, Kajari Mondal, PhD, Maija Anderson, RN, MN, Janine Maenza, MD, Maria P. Lemos, PhD https://orcid.org/0000-0002-3530-9310, Amanda S. Woodward Davis, PhD https://orcid.org/0000-0002-6901-8271, Stephen R. Walsh, MD https://orcid.org/0000-0002-0817-9370, Magdalena E. Sobieszczyk, MD, Ian Frank, MD https://orcid.org/0000-0002-7824-0106, Paul Goepfert, MD, Kathryn E. Stephenson, MD https://orcid.org/0000-0002-3440-4105, Lindsey R. Baden, MD, Hong-Van Tieu, MD, Michael C. Keefer, MD, M. Juliana McElrath, MD, James G. Kublin, MD, and Lawrence Corey, MD https://orcid.org/0000-0002-2179-2436Author, Article, & Disclosure Information
Publication: Annals of Internal Medicine
https://doi.org/10.7326/ANNALS-24-02701
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Visual Abstract. 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) The mRNA platform is under investigation in many vaccines, including HIV-1 vaccines. This study, a safety analysis of a phase 1, randomized, open-label trial, evaluated the safety and tolerability of 3 investigational HIV-1 trimer mRNA vaccines.
Visual Abstract. 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)
The mRNA platform is under investigation in many vaccines, including HIV-1 vaccines. This study, a safety analysis of a phase 1, randomized, open-label trial, evaluated the safety and tolerability of 3 investigational HIV-1 trimer mRNA vaccines.

Abstract

Background:

The mRNA platform is under investigation for many vaccines, including HIV-1 vaccines.

Objective:

To evaluate the safety and tolerability of 3 investigational HIV-1 trimer mRNA vaccines.

Design:

Safety analysis of mRNA vaccination in a phase 1, randomized, open-label trial. (ClinicalTrials.gov: NCT05217641)

Setting:

Ten research sites in the United States.

Participants:

108 volunteers aged 18 to 55 years without HIV-1.

Intervention:

Investigational HIV-1 BG505 MD39.3 trimer mRNA vaccines (gp140 soluble trimer, gp151 membrane-bound trimer, and gp151 CD4KO membrane-bound trimer) at doses of 100 and 250 mcg at 0, 2, and 6 months.

Measurements:

Solicited and unsolicited adverse reactions and events reported during the 12 months after the first vaccination.

Results:

Participants (n = 108) were randomly assigned to 6 vaccine groups. Mild to moderate local and systemic solicited events were common. Eighty participants reported 190 unsolicited adverse events (AEs); 30 were considered to be related to a study product. Most (73%) related AEs were mild, and the rest were moderate. Among related AEs, urticaria was reported by 7 of 108 participants (7% [95% CI, 3% to 13%]), 4 of whom had unresolved, intermittent urticaria at 12 months. In post hoc analyses, demographic characteristics, history of allergy or medication use, and COVID-19 were not associated with urticaria. In a comparison of participants with versus without urticaria, 100% (7 of 7; CI, 65% to 100%) versus 37% (37 of 101; CI, 28% to 46%) reported previous Moderna COVID-19 vaccination, 29% (2 of 7; CI, 8% to 64%) versus 76% (77 of 101; CI, 67% to 84%) reported previous Pfizer–BioNTech COVID-19 vaccination, and 0% (0 of 7; CI, 0% to 35%) versus 5% (5 of 101; CI, 2% to 11%) reported no previous mRNA COVID-19 vaccination.

Limitations:

Lack of a placebo group, open-label study, and post hoc evaluation of urticarial risk.

Conclusion:

Urticarial reactions associated with experimental HIV-1 mRNA vaccines were observed in this trial. Studies to investigate the mechanism and approaches to mitigate these reactions are underway to further advance HIV-1 vaccine research.

Primary Funding Source:

National Institutes of Health, National Institute of Allergy and Infectious Diseases.

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Supplemental Material

Supplemental Material
Study Protocol

References

1.
Mena Lora AJ, Long JE, Huang Y, et al; COVID-19 Prevention Network. Rapid development of an integrated network infrastructure to conduct phase 3 COVID-19 vaccine trials. JAMA Netw Open. 2023;6:e2251974. [PMID: 36689221] doi: 10.1001/jamanetworkopen.2022.51974
Crossref
PubMed
Google Scholar
2.
Steichen JM, Kulp DW, Tokatlian T, et al. HIV vaccine design to target germline precursors of glycan-dependent broadly neutralizing antibodies. Immunity. 2016;45:483-496. [PMID: 27617678] doi: 10.1016/j.immuni.2016.08.016
Crossref
PubMed
Google Scholar
3.
Escolano A, Steichen JM, Dosenovic P, et al. Sequential immunization elicits broadly neutralizing anti-HIV-1 antibodies in Ig knockin mice. Cell. 2016;166:1445-1458.e12. [PMID: 27610569] doi: 10.1016/j.cell.2016.07.030
Crossref
PubMed
Google Scholar
4.
Briney B, Sok D, Jardine JG, et al. Tailored immunogens direct affinity maturation toward HIV neutralizing antibodies. Cell. 2016;166:1459-1470.e11. [PMID: 27610570] doi: 10.1016/j.cell.2016.08.005
Crossref
PubMed
Google Scholar
5.
Pauthner M, Havenar-Daughton C, Sok D, et al. Elicitation of robust tier 2 neutralizing antibody responses in nonhuman primates by HIV envelope trimer immunization using optimized approaches. Immunity. 2017;46:1073-1088.e6. [PMID: 28636956] doi: 10.1016/j.immuni.2017.05.007
Crossref
PubMed
Google Scholar
6.
Pauthner MG, Nkolola JP, Havenar-Daughton C, et al. Vaccine-induced protection from homologous tier 2 SHIV challenge in nonhuman primates depends on serum-neutralizing antibody titers. Immunity. 2019;50:241-252.e6. [PMID: 30552025] doi: 10.1016/j.immuni.2018.11.011
Crossref
PubMed
Google Scholar
7.
Szabó GT, Mahiny AJ, Vlatkovic I. COVID-19 mRNA vaccines: platforms and current developments. Mol Ther. 2022;30:1850-1868. [PMID: 35189345] doi: 10.1016/j.ymthe.2022.02.016
Crossref
PubMed
Google Scholar
8.
Chapin-Bardales J, Gee J, Myers T. Reactogenicity following receipt of mRNA-based COVID-19 vaccines. JAMA. 2021;325:2201-2202. [PMID: 33818592] doi: 10.1001/jama.2021.5374
Crossref
PubMed
Google Scholar
9.
Polack FP, Thomas SJ, Kitchin N, et al; C4591001 Clinical Trial Group. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. N Engl J Med. 2020;383:2603-2615. [PMID: 33301246] doi: 10.1056/NEJMoa2034577
Crossref
PubMed
Google Scholar
10.
Baden LR, El Sahly HM, Essink B, et al. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. N Engl J Med. 2021;384:403-416. [PMID: 33378609] doi: 10.1056/NEJMoa2035389
Crossref
PubMed
Google Scholar
11.
Abraham N, Spruin S, Rossi T, et al. Myocarditis and/or pericarditis risk after mRNA COVID-19 vaccination: a Canadian head to head comparison of BNT162b2 and mRNA-1273 vaccines. Vaccine. 2022;40:4663-4671. [PMID: 35750537] doi: 10.1016/j.vaccine.2022.05.048
Crossref
PubMed
Google Scholar
12.
Gargano JW, Wallace M, Hadler SC, et al. Use of mRNA COVID-19 vaccine after reports of myocarditis among vaccine recipients: update from the Advisory Committee on Immunization Practices - United States, June 2021. MMWR Morb Mortal Wkly Rep. 2021;70:977-982. [PMID: 34237049] doi: 10.15585/mmwr.mm7027e2
Crossref
PubMed
Google Scholar
13.
Dooling K, Gargano JW, Moulia D, et al. Use of Pfizer–BioNTech COVID-19 vaccine in persons aged ≥16 years: recommendations of the Advisory Committee on Immunization Practices - United States, September 2021. MMWR Morb Mortal Wkly Rep. 2021;70:1344-1348. [PMID: 34555007] doi: 10.15585/mmwr.mm7038e2
Crossref
PubMed
Google Scholar
14.
Oster ME, Shay DK, Su JR, et al. Myocarditis cases reported after mRNA-based COVID-19 vaccination in the US from December 2020 to August 2021. JAMA. 2022;327:331-340. [PMID: 35076665] doi: 10.1001/jama.2021.24110
Crossref
PubMed
Google Scholar
15.
Kocatürk E, Muñoz M, Elieh-Ali-Komi D, et al. How infection and vaccination are linked to acute and chronic urticaria: a special focus on COVID-19. Viruses. 2023;15:1585. [PMID: 37515272] doi: 10.3390/v15071585
Crossref
PubMed
Google Scholar
16.
Bianchi M, Turner HL, Nogal B, et al. Electron-microscopy-based epitope mapping defines specificities of polyclonal antibodies elicited during HIV-1 BG505 envelope trimer immunization. Immunity. 2018;49:288-300.e8. [PMID: 30097292] doi: 10.1016/j.immuni.2018.07.009
Crossref
PubMed
Google Scholar
17.
Zuberbier T, Abdul Latiff AH, Abuzakouk M, et al. The international EAACI/GA²LEN/EuroGuiDerm/APAAACI guideline for the definition, classification, diagnosis, and management of urticaria. Allergy. 2022;77:734-766. [PMID: 34536239] doi: 10.1111/all.15090
Crossref
PubMed
Google Scholar
18.
Ryan C, Li K, Bennett R, et al. Chronic urticaria after Moderna COVID-19 vaccine boosters: a case series. JAAD Case Rep. 2024;45:27-30. [PMID: 38379871] doi: 10.1016/j.jdcr.2023.11.037
Crossref
PubMed
Google Scholar
19.
Results from “A Clinical Trial to Evaluate the Safety and Immunogenicity of BG505 MD39.3, BG505 MD39.3 gp151, and BG505 MD39.3 gp151 CD4KO HIV Trimer mRNA Vaccines in Healthy, HIV-uninfected Adult Participants.” ClinicalTrials.gov ID: NCT05217641. Accessed at https://clinicaltrials.gov/study/NCT05217641?tab=results on 16 April 2025.
Google Scholar
20.
Division of AIDS, National Institute of Allergy and Infectious Diseases. Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events. Corrected Version 2.1. July 2017. Accessed at https://rsc.niaid.nih.gov/sites/default/files/daidsgradingcorrectedv21.pdf on 7 November 2022.
Google Scholar
21.
Agresti A, Coull BA. Approximate is better than “exact” for interval estimation of binomial proportions. Am Stat. 1998;52:119-126. doi: 10.2307/2685469
Crossref
Google Scholar
22.
Rothman KJ, Greenland S. Modern Epidemiology. Lippincott Williams & Wilkins; 1998.
Google Scholar
23.
Haldane JB. The estimation and significance of the logarithm of a ratio of frequencies. Ann Hum Genet. 1956;20:309-311. [PMID: 13314400] doi: 10.1111/j.1469-1809.1955.tb01285.x
Crossref
PubMed
Google Scholar
24.
International AIDS Vaccine Initiative. IAVI statement on mRNA HIV vaccine candidate trials. 2 March 2024. Accessed at www.iavi.org/features/iavi-statement-on-mrna-hiv-vaccine-candidate-trials on 11 February 2025.
Google Scholar
25.
Weller K, Groffik A, Church MK, et al. Development and validation of the Urticaria Control Test: a patient-reported outcome instrument for assessing urticaria control. J Allergy Clin Immunol. 2014;133:1365-1372. [PMID: 24522090] doi: 10.1016/j.jaci.2013.12.1076
Crossref
PubMed
Google Scholar
26.
Zuberbier T, Aberer W, Asero R, et al; World Allergy Organization. The EAACI/GA(2) LEN/EDF/WAO guideline for the definition, classification, diagnosis, and management of urticaria: the 2013 revision and update. Allergy. 2014;69:868-887. [PMID: 24785199] doi: 10.1111/all.12313
Crossref
PubMed
Google Scholar
27.
Maurer M, Weller K, Bindslev-Jensen C, et al. Unmet clinical needs in chronic spontaneous urticaria. A GA²LEN task force report. Allergy. 2011;66:317-330. [PMID: 21083565] doi: 10.1111/j.1398-9995.2010.02496.x
Crossref
PubMed
Google Scholar
28.
Strahan A, Ali R, Freeman EE. Chronic spontaneous urticaria after COVID-19 primary vaccine series and boosters. JAAD Case Rep. 2022;25:63-66. [PMID: 35637698] doi: 10.1016/j.jdcr.2022.05.012
Crossref
PubMed
Google Scholar
29.
Pitlick MM, Joshi AY, Gonzalez-Estrada A, et al. Delayed systemic urticarial reactions following mRNA COVID-19 vaccination. Allergy Asthma Proc. 2022;43:40-43. [PMID: 34983709] doi: 10.2500/aap.2022.43.210101
Crossref
PubMed
Google Scholar
30.
McMahon DE, Amerson E, Rosenbach M, et al. Cutaneous reactions reported after Moderna and Pfizer COVID-19 vaccination: a registry-based study of 414 cases. J Am Acad Dermatol. 2021;85:46-55. [PMID: 33838206] doi: 10.1016/j.jaad.2021.03.092
Crossref
PubMed
Google Scholar
31.
Shah R, Tsao L, Zheng J, et al. Urticarial and eczematous eruptions following mRNA COVID-19 vaccination in patients with and without chronic urticaria and atopic dermatitis. J Allergy Clin Immunol. 2022;149:AB175.
Crossref
Google Scholar
32.
Craffert V, Day C, Peter J. New-onset chronic spontaneous urticaria post–COVID-19 vaccination—South African case series. J Allergy Clin Immunol Glob. 2023;2:100154. [PMID: 37781658] doi: 10.1016/j.jacig.2023.100154
Crossref
PubMed
Google Scholar
33.
Pitlick MM, Sitek AN, Kinate SA, et al. Polyethylene glycol and polysorbate skin testing in the evaluation of coronavirus disease 2019 vaccine reactions: early report. Ann Allergy Asthma Immunol. 2021;126:735-738. [PMID: 33775902] doi: 10.1016/j.anai.2021.03.012
Crossref
PubMed
Google Scholar
34.
Wolfson AR, Robinson LB, Li L, et al. First-dose mRNA COVID-19 vaccine allergic reactions: limited role for excipient skin testing. J Allergy Clin Immunol Pract. 2021;9:3308-3320.e3. [PMID: 34166844] doi: 10.1016/j.jaip.2021.06.010
Crossref
PubMed
Google Scholar
35.
Arroliga ME, Dhanani K, Arroliga AC, et al. Allergic reactions and adverse events associated with administration of mRNA-based vaccines. A health-care system experience. Allergy Asthma Proc. 2021;42:395-399. [PMID: 34474708] doi: 10.2500/aap.2021.42.210069
Crossref
PubMed
Google Scholar
36.
Grieco T, Ambrosio L, Trovato F, et al. Effects of vaccination against COVID-19 in chronic spontaneous and inducible urticaria (CSU/CIU) patients: a monocentric study. J Clin Med. 2022;11:1822. [PMID: 35407429] doi: 10.3390/jcm11071822
Crossref
PubMed
Google Scholar
37.
Martinez-Ortega JI, Hernandez F de JP. Chronic spontaneous urticaria following COVID-19 vaccination: a case report and discussion on allergic reactions and vaccine safety. Cureus. 2023;15:e44860. [PMID: 37809203] doi: 10.7759/cureus.44860
Crossref
PubMed
Google Scholar
38.
Kocatürk E, Salameh P, Sarac E, et al. Urticaria exacerbations and adverse reactions in patients with chronic urticaria receiving COVID-19 vaccination: results of the UCARE COVAC-CU study. J Allergy Clin Immunol. 2023;152:1095-1106. [PMID: 37574079] doi: 10.1016/j.jaci.2023.07.019
Crossref
PubMed
Google Scholar
39.
Kartal D, Orujova S, Ertaş R. Clinical effects of COVID-19 vaccines on chronic spontaneous urticaria patients: a study on two Turkish centers. Front Med (Lausanne). 2023;10:1222126. [PMID: 37841021] doi: 10.3389/fmed.2023.1222126
Crossref
PubMed
Google Scholar
40.
Blumenthal KG, Greenhawt M, Phillips EJ, et al. An update in COVID-19 vaccine reactions in 2023: progress and understanding. J Allergy Clin Immunol Pract. 2023;11:3305-3318. [PMID: 37414339] doi: 10.1016/j.jaip.2023.06.057
Crossref
PubMed
Google Scholar
41.
Judd A, Samarakoon U, Wolfson AR, et al. Urticaria after COVID-19 vaccination and vaccine hesitancy. J Allergy Clin Immunol Pract. 2023;11:958-960. [PMID: 36581074] doi: 10.1016/j.jaip.2022.12.010
Crossref
PubMed
Google Scholar
42.
Duperrex O, Tommasini F, Muller YD. Incidence of chronic spontaneous urticaria following receipt of the COVID-19 vaccine booster in Switzerland. JAMA Netw Open. 2023;6:e2254298. [PMID: 36723944] doi: 10.1001/jamanetworkopen.2022.54298
Crossref
PubMed
Google Scholar
43.
Schwab J, Foglierini M, Pescosolido E, et al. Features of chronic urticaria after COVID-19 mRNA vaccine over time. Commun Med (Lond). 2024;4:254. [PMID: 39616213] doi: 10.1038/s43856-024-00656-y
Crossref
PubMed
Google Scholar
44.
Bianchi L, Hansel K, Biondi F, et al. Delayed urticaria after the third dose of mRNA COVID19 vaccine: a case series. Dermatol Ther. 2022;35:e15680. [PMID: 35770738] doi: 10.1111/dth.15680
Crossref
PubMed
Google Scholar
45.
Drivenes JL, Banerji A, Bygum A. Delayed onset urticaria and symptomatic dermographism following COVID-19 booster vaccination: a case series. Clin Transl Allergy. 2022;12:e12206. [PMID: 36434738] doi: 10.1002/clt2.12206
Crossref
PubMed
Google Scholar
46.
Pescosolido E, Muller YD, Sabaté-Brescó M, et al. Clinical and immunological data from chronic urticaria onset after mRNA SARS-CoV-2 vaccines. Clin Exp Allergy. 2022;52:1343-1346. [PMID: 35962744] doi: 10.1111/cea.14214
Crossref
PubMed
Google Scholar
47.
Prasad S, McMahon DE, Tyagi A, et al. Cutaneous reactions following booster dose administration of COVID-19 mRNA vaccine: a first look from the American Academy of Dermatology/International League of Dermatologic Societies registry. JAAD Int. 2022;8:49-51. [PMID: 35498758] doi: 10.1016/j.jdin.2022.04.004
Crossref
PubMed
Google Scholar
48.
Anvari S, Samarakoon U, Fu X, et al. Urticaria and/or angioedema secondary to mRNA COVID-19 vaccines: updates from a United States case registry. Allergy. 2023;78:283-286. [PMID: 35842747] doi: 10.1111/all.15447
Crossref
PubMed
Google Scholar
49.
Hahn WO, Parks KR, Shen M, et al. HIV BG505 SOSIP.664 trimer with 3M-052-AF/alum induces human autologous tier-2 neutralizing antibodies. medRxiv. 2024:2024.05.08.24306957. [PMID: 38766048] doi: 10.1101/2024.05.08.24306957
Crossref
PubMed
Google Scholar
50.
Fierro C, Brune D, Shaw M, et al. Safety and immunogenicity of a messenger RNA-based cytomegalovirus vaccine in healthy adults: results from a phase 1 randomized clinical trial. J Infect Dis. 2024;230:e668-e678. [PMID: 38478705] doi: 10.1093/infdis/jiae114
Crossref
PubMed
Google Scholar
51.
Shaw CA, Essink B, Harper C, et al. Safety and immunogenicity of an mRNA-based RSV vaccine including a 12-month booster in a phase 1 clinical trial in healthy older adults. J Infect Dis. 2024;230:e647-e656. [PMID: 38385566] doi: 10.1093/infdis/jiae081
Crossref
PubMed
Google Scholar
52.
Shaw CA, Mithani R, Kapoor A, et al. Safety, tolerability, and immunogenicity of an mRNA-based respiratory syncytial virus vaccine in healthy young adults in a phase 1 clinical trial. J Infect Dis. 2024;230:e637-e646. [PMID: 38298125] doi: 10.1093/infdis/jiae035
Crossref
PubMed
Google Scholar
53.
Wilson E, Goswami J, Baqui AH, et al; ConquerRSV Study Group. Efficacy and safety of an mRNA-based RSV PreF vaccine in older adults. N Engl J Med. 2023;389:2233-2244. [PMID: 38091530] doi: 10.1056/NEJMoa2307079
Crossref
PubMed
Google Scholar

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Information & Authors

Information

Published In

cover image Annals of Internal Medicine
Annals of Internal Medicine

History

Published online: 29 April 2025

Keywords

  1. Adverse events
  2. Allergy and immunology
  3. COVID-19
  4. Infectious diseases
  5. mRNA vaccines
  6. Safety
  7. Signs and symptoms
  8. Skin
  9. Urticaria
  10. Vaccines

Copyright

© 2025 American College of Physicians.

Authors

Affiliations

Sharon A. Riddler, MD* https://orcid.org/0000-0002-2545-7037
Division of Infectious Diseases, Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania (S.A.R.)
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Zoe Moodie, PhD* https://orcid.org/0000-0001-8701-2001
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.)
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Jesse Clark, MD https://orcid.org/0000-0001-5862-6530
Department of Medicine, Division of Infectious Diseases, David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, California (J.C.)
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Catherine Yen, MD
Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, Maryland (C.Y., M.Allen)
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Mary Allen, RN, BSN, MS https://orcid.org/0000-0001-8163-0714
Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, Maryland (C.Y., M.Allen)
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Briana D. Furch, MD
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.)
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Huiyin Lu, MS
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.)
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Shannon Grant, MS
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.)
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Kajari Mondal, PhD
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.)
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Maija Anderson, RN, MN
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.)
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Janine Maenza, MD
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.)
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Maria P. Lemos, PhD https://orcid.org/0000-0002-3530-9310
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.)
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Amanda S. Woodward Davis, PhD https://orcid.org/0000-0002-6901-8271
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.)
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Stephen R. Walsh, MD https://orcid.org/0000-0002-0817-9370
Division of Infectious Diseases, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts (S.R.W., L.R.B.)
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Magdalena E. Sobieszczyk, MD
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.)
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Ian Frank, MD https://orcid.org/0000-0002-7824-0106
School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania (I.F.)
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Paul Goepfert, MD
Division of Infectious Diseases, University of Alabama at Birmingham, Birmingham, Alabama (P.G.)
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Kathryn E. Stephenson, MD https://orcid.org/0000-0002-3440-4105
Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts (K.E.S.)
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Lindsey R. Baden, MD
Division of Infectious Diseases, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts (S.R.W., L.R.B.)
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Hong-Van Tieu, MD
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.)
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Michael C. Keefer, MD
Department of Medicine, University of Rochester School of Medicine & Dentistry, Rochester, New York (M.C.K.).
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M. Juliana McElrath, MD
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.)
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James G. Kublin, MD
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.)
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Lawrence Corey, MD https://orcid.org/0000-0002-2179-2436
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.)
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Acknowledgment: The authors thank the study participants, the HVTN 302 protocol team, the clinical research site staff, and the Community Advisory Board members at the 10 enrolling HVTN sites for their contributions to the successful conduct of this study. They also thank Jennifer Han at the Seattle site for helpful discussions and Evgenii Morgan, David Sierra, and Stephanie Weaver for their contributions to the optimization of the IgE protocol for staining.
Financial Support: The trial was funded through the National Institute of Allergy and Infectious Diseases of the National Institutes of Health under grants UM1 AI068614 (HVTN Leadership and Operations Core), UM1 AI068635 (HVTN Statistical and Data Management Center), UM1 AI068618 (HVTN Laboratory Center), UM1 AI069412 (Brigham and Women’s Hospital and Beth Israel Deaconess Medical Center), UM1 AI069452 (University of Alabama at Birmingham), 6 UM1 AI068614 and subaward 0001110283 (University of California, Los Angeles), 5 UM1 AI069470 18 (Columbia University College of Physicians and Surgeons), 5 UM1 AI069470 (Columbia University - New York Blood Center), 5 UM1 AI069534 18 (University of Pennsylvania), UM1 AI069494 and UL1 TR001857 (University of Pittsburgh), UM1 AI069481 (Seattle CTU), UM1 AI069511 (University of Rochester), and UM1 AI144462 (Scripps Consortium for HIV/AIDS Vaccine Development [CHAVD]). The vaccine was manufactured by Moderna Inc. and provided by IAVI. Data were collected and analyzed by the HVTN Data and Statistical Management team. Study products were provided by IAVI (on behalf of Scripps CHAVD), New York, New York. IND 027679 is held by DAIDS. The histopathology laboratory work was funded by the HVTN Laboratory Center (UM1 AI068618 [principal investigator: Dr. McElrath). This research was also supported by the Experimental Histopathology and Cellular Imaging Shared Resource RRID:SCR_022609 of the Fred Hutch/University of Washington/Seattle Children's Cancer Consortium (P30 CA0l5704).
Disclosures: Disclosure forms are available with the article online.
Data Sharing Statement: Data are publicly available at https://dataverse.harvard.edu/dataverse/hvtn302.
Corresponding Author: Sharon A. Riddler, MD, Division of Infectious Diseases, Department of Medicine, University of Pittsburgh, 3520 Fifth Avenue, Suite 510, Pittsburgh, PA 15213; e-mail, [email protected].
Author Contributions: Conception and design: Z. Moodie, J. Clark, C. Yen, J.G. Kublin, L. Corey.
Analysis and interpretation of the data: S.A. Riddler, Z. Moodie, J. Clark, C. Yen, M. Allen, B.D. Furch, H. Lu, S. Grant, M.P. Lemos, K.E. Stephenson, J.G. Kublin, L. Corey.
Drafting of the article: S.A. Riddler, Z. Moodie, C. Yen, M. Allen, B.D. Furch, M. Anderson, M.P. Lemos, A.S. Woodward Davis, S.R. Walsh, K.E. Stephenson, H.-V. Tieu, J.G. Kublin.
Critical revision for important intellectual content: S.A. Riddler, Z. Moodie, J. Clark, C. Yen, M. Allen, S.R. Walsh, M.E. Sobieszczyk, K.E. Stephenson, M.J. McElrath, J.G. Kublin, L. Corey.
Final approval of the article: S.A. Riddler, Z. Moodie, J. Clark, C. Yen, M. Allen, B.D. Furch, H. Lu, S. Grant, K. Mondal, M. Anderson, J. Maenza, M.P. Lemos, A.S. Woodward Davis, S.R. Walsh, M.E. Sobieszczyk, I. Frank, P. Goepfert, K.E. Stephenson, L.R. Baden, H.-V. Tieu, M.C. Keefer, M.J. McElrath, J.G. Kublin, L. Corey.
Provision of study materials or patients: S.A. Riddler, J. Maenza, S.R. Walsh, I. Frank, P. Goepfert, K.E. Stephenson, M.C. Keefer, M.J. McElrath.
Statistical expertise: Z. Moodie.
Obtaining of funding: P. Goepfert, M.J. McElrath, J.G. Kublin, L. Corey.
Administrative, technical, or logistic support: B.D. Furch, A.S. Woodward Davis, M.J. McElrath, J.G. Kublin.
Collection and assembly of data: S.A. Riddler, J. Clark, B.D. Furch, H. Lu, S. Grant, M. Anderson, J. Maenza, A.S. Woodward Davis, S.R. Walsh, M.E. Sobieszczyk, I. Frank, K.E. Stephenson, H.-V. Tieu, M.C. Keefer, M.J. McElrath.
This article was published at Annals.org on 29 April 2025.
*
Drs. Riddler and Moodie contributed equally to this work.

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Sharon A. Riddler, Zoe Moodie, Jesse Clark, et al. 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). Ann Intern Med. [Epub 29 April 2025]. doi:10.7326/ANNALS-24-02701

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