Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2023
Nasal Spray of Neutralizing Monoclonal Antibody 35B5 Confers Potential Prophylaxis Against Severe Acute Respiratory Syndrome Coronavirus 2 Variants of Concern: A Small-Scale Clinical Trial.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.
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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.
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Who cites it
18 citing papers in PubMed.
- Colostrum from MERS-CoV seropositive camels for MERS prophylaxis and SARS-CoV-2 infection, a placebo controlled randomized trial.Scientific reports · 2025Trial
- Human monoclonal antibody F61 nasal spray effectively protected high-risk populations from SARS-CoV-2 variants during the COVID-19 pandemic from late 2022 to early 2023 in China.Emerging microbes & infections · 2024Trial
- Respiratory mucosal immunity: Biological functions, diseases, prevention and therapy.Genes & diseases · 2026Review
- Intranasal monoclonal antibodies do not prevent respiratory infection in a randomized, controlled experimental infection trial.npj drug discovery · 2025Article
- Fc-binding nanodisc restores antiviral efficacy of antibodies with reduced neutralizing effects against evolving SARS-CoV-2 variants.Journal of nanobiotechnology · 2025Article
- Monoclonal Antibody Therapies Against SARS-CoV-2: Promises and Realities.Current topics in microbiology and immunology · 2025Review
- Safety and Intranasal Retention of a Broad-Spectrum Anti-SARS-CoV-2 Monoclonal Antibody SA55 Nasal Spray in Healthy Volunteers: A Phase I Clinical Trial.Pharmaceutics · 2024Article
- Neutralization of SARS-CoV-2 and Intranasal Protection of Mice with a nanoCLAMP Antibody Mimetic.ACS pharmacology & translational science · 2024Article
- Daily intranasal palivizumab to prevent respiratory syncytial virus infection in healthy preterm infants: a phase 1/2b randomized placebo-controlled trial.EClinicalMedicine · 2023Article
- Use of a point-of-care test to rapidly assess levels of SARS-CoV-2 nasal neutralising antibodies in vaccines and breakthrough infected individuals.Scientific reports · 2023Article
- Delivery of biologics: Topical administration.Biomaterials · 2023Review
- Real-world effectiveness of an intranasal spray A8G6 antibody cocktail in the post-exposure prophylaxis of COVID-19.Signal transduction and targeted therapy · 2023Article
- Respiratory delivery of passive immunotherapies for SARS-CoV-2 prophylaxis and therapy.Human vaccines & immunotherapeutics · 2023Review
- Broad-spectrum pan-genus and pan-family virus vaccines.Cell host & microbe · 2023Review
- Nasal sprays for treating COVID-19: a scientific note.Pharmacological reports : PR · 2023Review
- A Supine Position and Dual-Dose Applications Enhance Spray Dosing to the Posterior Nose: Paving the Way for Mucosal Immunization.Pharmaceutics · 2023Article
- Mendelian randomization analysis identified tumor necrosis factor as being associated with severe COVID-19.Frontiers in pharmacology · 2023Article
- Improving Nasal Protection for Preventing SARS-CoV-2 Infection.Biomedicines · 2022Article
Corrections and comments
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Authors and funding
22 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants of concern (VOCs), especially the Delta and Omicron variants, have been reported to show significant resistance to approved neutralizing monoclonal antibodies (mAbs) and vaccines. We previously identified a mAb named 35B5 that harbors broad neutralization to SARS-CoV-2 VOCs. Herein, we explored the protection efficacy of a 35B5-based nasal spray against SARS-CoV-2 VOCs in a small-scale clinical trial.
methodsWe enrolled 30 healthy volunteers who were nasally administered the modified 35B5 formulation. At 12, 24, 48, and 72 hours after nasal spray, the neutralization efficacy of nasal mucosal samples was assayed with pseudoviruses coated with SARS-CoV-2 spike protein of the wild-type strain or the Alpha, Beta, Delta, or Omicron variants.
resultsThe nasal mucosal samples collected within 24 hours after nasal spray effectively neutralized SARS-CoV-2 VOCs (including Delta and Omicron). Meanwhile, the protection efficacy was 60% effective and 20% effective at 48 and 72 hours after nasal spray, respectively.
conclusionsA single nasal spray of 35B5 formation conveys 24-hour effective protection against SARS-CoV-2 VOCs, including the Alpha, Beta, Delta, or Omicron variants. Thus, 35B5 nasal spray might be potential in strengthening SARS-CoV-2 prevention, especially in high-risk populations. CLINICAL TRIALS REGISTRATION: 2022-005-02-KY.
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