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Background and Objectives <p>The PROVENT study demonstrated the efficacy and safety of a single 300-mg dose of AZD7442 (tixagevimab/cilgavimab) for pre-exposure prophylaxis of COVID-19 in at-risk individuals. Here we report an analysis of repeat dosing of intramuscular AZD7442 300&#xa0;and 600&#xa0;mg from the PROVENT sub-study.</p> Methods <p>The sub-study enrolled eligible participants from the parent study, creating four sub-study groups. Group 1 received AZD7442 300 mg in PROVENT followed by one 300-mg dose in the sub-study (10–14 months apart). Group 2 received placebo in PROVENT followed by two AZD7442 300-mg doses 6 months apart in the sub-study. Group 3a received AZD7442 300 mg in PROVENT followed by one 300-mg dose and two 600-mg doses 6&#xa0;months apart in the sub-study. Group 3b received placebo in PROVENT followed by one 300-mg dose and two 600-mg doses 6 months apart in the sub-study. The primary endpoint was safety. Secondary endpoints included pharmacokinetics and anti-drug antibody (ADA) responses.</p> Results <p>Adverse events (AEs) and serious AEs (SAEs) were reported in 75.7–81.5% and 13.2–16.8% of participants, respectively. AZD7442-related AEs, SAEs, and AEs of special interest occurred in 1.4–5.3%, 0–0.2%, and 0–5.3% of participants, respectively, and 3.9–6.7% experienced ≥ 1 cardiac and/or thromboembolic SAE. AZD7442 serum concentrations were dose-dependent with minimal accumulation following redosing, and 4.1–10.7% had treatment-emergent ADAs to AZD7442.</p> Conclusions <p>AZD7442 safety, pharmacokinetic, and ADA response profiles were similar regardless of repeat dosing schedule, and consistent with single-dose study data. These results may support future use of long-acting antibodies.</p> ClinicalTrials.gov Registration <p>NCT04625725.</p>

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Safety and Pharmacokinetics of Repeat Dosing of Long-Acting SARS-CoV-2 Antibodies Tixagevimab/Cilgavimab (AZD7442): Results from the PROVENT Sub-study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年1月16日

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  • Andrew Ustianowski,
  • Myron J. Levin,
  • Stephane De Wit,
  • Odile Launay,
  • Bernard Veekmans,
  • Tommy Rampling,
  • James G. Sullivan,
  • Mark Vishnepolsky,
  • Priyantha Wijewardane,
  • Yousef Fawadleh,
  • Huixia Zhang,
  • Meng Li,
  • Dilki Wickramarachchi,
  • Audrey Sharbaugh,
  • Rohini Beavon,
  • Jesse Thissen,
  • Lauren Hirao,
  • Vitalina Dzutseva,
  • Seth Seegobin,
  • Katie Streicher,
  • Alexandre Kiazand,
  • Mark T. Esser,
  • Lee-Jah Chang,
  • John L. Perez,
  • Taylor S. Cohen

摘要

Background and Objectives

The PROVENT study demonstrated the efficacy and safety of a single 300-mg dose of AZD7442 (tixagevimab/cilgavimab) for pre-exposure prophylaxis of COVID-19 in at-risk individuals. Here we report an analysis of repeat dosing of intramuscular AZD7442 300 and 600 mg from the PROVENT sub-study.

Methods

The sub-study enrolled eligible participants from the parent study, creating four sub-study groups. Group 1 received AZD7442 300 mg in PROVENT followed by one 300-mg dose in the sub-study (10–14 months apart). Group 2 received placebo in PROVENT followed by two AZD7442 300-mg doses 6 months apart in the sub-study. Group 3a received AZD7442 300 mg in PROVENT followed by one 300-mg dose and two 600-mg doses 6 months apart in the sub-study. Group 3b received placebo in PROVENT followed by one 300-mg dose and two 600-mg doses 6 months apart in the sub-study. The primary endpoint was safety. Secondary endpoints included pharmacokinetics and anti-drug antibody (ADA) responses.

Results

Adverse events (AEs) and serious AEs (SAEs) were reported in 75.7–81.5% and 13.2–16.8% of participants, respectively. AZD7442-related AEs, SAEs, and AEs of special interest occurred in 1.4–5.3%, 0–0.2%, and 0–5.3% of participants, respectively, and 3.9–6.7% experienced ≥ 1 cardiac and/or thromboembolic SAE. AZD7442 serum concentrations were dose-dependent with minimal accumulation following redosing, and 4.1–10.7% had treatment-emergent ADAs to AZD7442.

Conclusions

AZD7442 safety, pharmacokinetic, and ADA response profiles were similar regardless of repeat dosing schedule, and consistent with single-dose study data. These results may support future use of long-acting antibodies.

ClinicalTrials.gov Registration

NCT04625725.