Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2021
Safety and Efficacy of CR6261 in an Influenza A H1N1 Healthy Human Challenge Model.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02371668 (Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study in Healthy Volunteers to Evaluate the Efficacy and Safety of CR6261 in an H1N1 Influenza Healthy Human Challenge Model), which is not on this map. Cited by 34 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study in Healthy Volunteers to Evaluate the Efficacy and Safety of CR6261 in an H1N1 Influenza Healthy Human Challenge Model
Who cites it
34 citing papers in PubMed, 1 synthesis or guideline pooled it, 51 citations in OpenAlex.
- Raising the patient's voice in influenza research and care: a systematic review of patient-reported outcomes.BMC infectious diseases · 2026Pooled it
- A phase 1 study in healthy volunteers to investigate the safety, tolerability, and pharmacokinetics of VIR-2482: a monoclonal antibody for the prevention of severe influenza A illness.Antimicrobial agents and chemotherapy · 2024Trial
- Article
- Pre-existing cross-reactive immunity to highly pathogenic avian influenza 2.3.4.4b A(H5N1) virus in the United States.Nature communications · 2025Article
- Polyclonal and Monoclonal Antibodies for the Treatment and Prevention of Influenza.The Journal of infectious diseases · 2025Review
- Preferential apical infection and spread of human metapneumovirus highlights the importance of inhaled delivery of neutralizing monoclonal antibody to treat established infections.Proceedings of the National Academy of Sciences of the United States of America · 2025Article
- Non-neutralizing antibodies to influenza A matrix-protein-2-ectodomain are broadly effective therapeutics and resistant to viral escape mutations.Science advances · 2025Article
- Passive Immunization in the Prevention and Treatment of Viral Infections.European journal of immunology · 2025Review
- Fast and flu-rious: How to prevent and treat emerging influenza A viruses.PLoS pathogens · 2025Article
- Preventive effect of Lianhua Qingwen capsule on close contacts of seasonal influenza in residential environments: protocol for a multicenter, randomized, double-blind, placebo-controlled study.Journal of thoracic disease · 2025Article
- Intranasal administration of a panreactive influenza antibody reveals Fc-independent mode of protection.Scientific reports · 2025Article
- Antiviral strategies against influenza virus: an update on approved and innovative therapeutic approaches.Cellular and molecular life sciences : CMLS · 2025Review
- Potential Broad-Spectrum Antiviral Agents: A Key Arsenal Against Newly Emerging and Reemerging Respiratory RNA Viruses.International journal of molecular sciences · 2025Review
- How Broadly Neutralising Antibodies Are Redefining Immunity to Influenza.Antibodies (Basel, Switzerland) · 2025Review
- Monoclonal antibodies against influenza viruses: a clinical trials review.Frontiers in immunology · 2025Review
- Symptoms and adverse events in controlled human infection models.Frontiers in medicine · 2025Review
- Monoclonal Antibodies and Hyperimmune Immunoglobulins in the Next Pandemic.Current topics in microbiology and immunology · 2025Review
- Use of equine H3N8 hemagglutinin as a broadly protective influenza vaccine immunogen.NPJ vaccines · 2024Article
- How a paramyxovirus fusion/entry complex adapts to escape a neutralizing antibody.Nature communications · 2024Article
- Defining the balance between optimal immunity and immunopathology in influenza virus infection.Nature reviews. Immunology · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 3 institutions in 2 countries.
Funding
Abstract
backgroundIt is imperative to identify new targets for improved vaccines and therapeutics against influenza. One such target is the relatively conserved stalk region of the influenza A hemagglutinin (HA) surface protein.
methodsWe conducted a randomized, double-blind, phase 2, placebo-controlled trial of a monoclonal antibody that targets the HA stalk (CR6261) in a H1N1pdm09 healthy volunteer human challenge model. A single 50 mg/kg dose of CR6261 was infused 24 hours after challenge. The primary efficacy outcome was area under the curve (AUC) of viral RNA detection over time.
resultsNinety-one healthy volunteers were randomized and underwent influenza challenge; 49 received CR6261 and 42 received placebo. CR6261 had no statistically significant effect on AUC (AUC, 48.56 log [copies/mL] × days, interquartile range [IQR], 202 vs AUC, 25.53 log [copies/mL] × days, IQR, 155; P = .315) and no clinically significant effect on influenza disease measures including number of symptoms, duration of symptoms, or inFLUenza Patient-Reported Outcome (FLU-PRO) scores. Preexisting anti-NA antibody titers were most predictive of reduced influenza disease. CR6261 reached a mean peak serum concentration of 1 × 106 ng/mL 15 minutes after infusion and a mean peak of 5.97 × 102 ng/mL in the nasal mucosa 2-3 days after infusion.
conclusionsThe results of this study suggest that a monoclonal anti-stalk approach to prevent or treat influenza infection may be limited in efficacy. Future approaches should consider including and evaluating anti-stalk antibodies as part of a multifaceted strategy rather than as a stand-alone therapeutic. CLINICAL TRIALS REGISTRATION: NCT02371668.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.