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

Yue, Shuai; Yang, Yang; Yang, Sen; Pan, Zhiwei; Yang, Xiaofan; Gao, Leiqiong; Zhou, Jing; Li, Zhirong; Hu, Li; Tang, Jianfang; Wu, Qing; Lei, Shun; Qin, Tian; Wang, Yifei; Hao, Yaxing; Xu, Lifan; Huang, Qizhao; Zhu, Bo; Chen, Yaokai; Chen, Xiangyu; Ye, Lilin

doi:10.1093/cid/ciac448

Cited by 24 publications

(23 citation statements)

References 27 publications

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“…Compared to the 0~5% of deposition fractions to these two regions using conventional nasal inhalers, the new protocol managed to deliver 31% of the dose to the nasopharynx alone ( Figure 6 c). This significant enhancement in posterior nose delivery can pave the way for mucosal immunization, for which low doses to the target using conventional methods have been a bottleneck to their wide clinical application, even though many nasally inhaled vaccines have been actively developed during the pandemic in the past 2 years [ 29 , 30 , 31 , 32 , 33 ].…”

Section: Discussionmentioning

confidence: 99%

A Supine Position and Dual-Dose Applications Enhance Spray Dosing to the Posterior Nose: Paving the Way for Mucosal Immunization

et al. 2023

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Delivering vaccines to the posterior nose has been proposed to induce mucosal immunization. However, conventional nasal devices often fail to deliver sufficient doses to the posterior nose. This study aimed to develop a new delivery protocol that can effectively deliver sprays to the caudal turbinate and nasopharynx. High-speed imaging was used to characterize the nasal spray plumes. Three-dimensional-printed transparent nasal casts were used to visualize the spray deposition within the nasal airway, as well as the subsequent liquid film formation and translocation. Influencing variables considered included the device type, delivery mode, release angle, flow rate, head position, and dose number. Apparent liquid film translocation was observed in the nasal cavity. To deliver sprays to the posterior nose, the optimal release angle was found to be 40° for unidirectional delivery and 30° for bidirectional delivery. The flow shear was the key factor that mobilized the liquid film. Both the flow shear and the head position were important in determining the translocation distance. A supine position and dual-dose application significantly improved delivery to the nasopharynx, i.e., 31% vs. 0% with an upright position and one-dose application. It is feasible to effectively deliver medications to the posterior nose by leveraging liquid film translocation for mucosal immunization.

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Section: Discussionmentioning

confidence: 99%

A Supine Position and Dual-Dose Applications Enhance Spray Dosing to the Posterior Nose: Paving the Way for Mucosal Immunization

et al. 2023

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“…At 48 and 72 h after nasal spray, the protective effectiveness was 60% and 20%, respectively. They concluded that a nasal spray of the 35B5 formulation provides excellent 24-h protection from SARS-CoV-2 variations, such as the alpha, beta, delta, or omicron forms [ 107 ].…”

Section: Efficacy Evaluation Of Nasal Vaccinesmentioning

confidence: 99%

Nasal sprays for treating COVID-19: a scientific note

et al. 2023

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Clinical management of COVID-19 has been a daunting task. Due to the lack of specific treatment, vaccines have been regarded as the first line of defence. Innate responses and cell-mediated systemic immunity, including serum antibodies, have been the primary focus of practically all studies of the immune response to COVID-19. However, owing to the difficulties encountered by the conventional route, alternative routes for prophylaxis and therapy became the need of the hour. The first site invaded by SARS-CoV-2 is the upper respiratory tract. Nasal vaccines are already in different stages of development. Apart from prophylactic purposes, mucosal immunity can be exploited for therapeutic purposes too. The nasal route for drug delivery offers many advantages over the conventional route. Besides offering a needle-free delivery, they can be self-administered. They present less logistical burden as there is no need for refrigeration. The present article focuses on various aspects of nasal spray for eliminating COVID-19.

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“…Preliminary but interesting evidence has also been provided that an anti-SARS-CoV-2 neutralizing monoclonal antibodies (mAbs)-based nasal spray may provide good protection against SARS-CoV-2 infection. In a small-scale clinical trial, Lin et al explored the efficacy of a single nasal spray containing the anti-SARS-CoV-2 35B5 mAb, which was tested in 30 healthy volunteers [ 55 ]. It was found that the mAB 35B5 concentration in a nasal mucosal specimens remained significant up to 72 h after spray administration (1 mg/mL 35B5 mAb diluted in 50% Dulbecco’s phosphate-buffered saline with 50% glycerol), concomitantly conveying up to 24–48 h efficient in vitro neutralization of several SARS-CoV-2 variants of concern (VOCs), including Omicron.…”

Section: The Role Of Mucosal Protection In Preventing Sars-cov-2 Infe...mentioning

confidence: 99%

Improving Nasal Protection for Preventing SARS-CoV-2 Infection

Nocini

Henry

Mattiuzzi³

et al. 2022

Biomedicines

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Airborne pathogens, including SARS-CoV-2, are mainly contracted within the airway pathways, especially in the nasal epithelia, where inhaled air is mostly filtered in resting conditions. Mucosal immunity developing after SARS-CoV-2 infection or vaccination in this part of the body represents one of the most efficient deterrents for preventing viral infection. Nonetheless, the complete lack of such protection in SARS-CoV-2 naïve or seronegative subjects, the limited capacity of neutralizing new and highly mutated lineages, along with the progressive waning of mucosal immunity over time, lead the way to considering alternative strategies for constructing new walls that could stop or entrap the virus at the nasal mucosa surface, which is the area primarily colonized by the new SARS-CoV-2 Omicron sublineages. Among various infection preventive strategies, those based on generating physical barriers within the nose, aimed at impeding host cell penetration (i.e., using compounds with mucoadhesive properties, which act by hindering, entrapping or adsorbing the virus), or those preventing the association of SARS-CoV-2 with its cellular receptors (i.e., administering anti-SARS-CoV-2 neutralizing antibodies or agents that inhibit priming or binding of the spike protein) could be considered appealing perspectives. Provided that these agents are proven safe, comfortable, and compatible with daily life, we suggest prioritizing their usage in subjects at enhanced risk of contagion, during high-risk activities, as well as in patients more likely to develop severe forms of SARS-CoV-2 infection.

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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

Cited by 24 publications

References 27 publications

A Supine Position and Dual-Dose Applications Enhance Spray Dosing to the Posterior Nose: Paving the Way for Mucosal Immunization

A Supine Position and Dual-Dose Applications Enhance Spray Dosing to the Posterior Nose: Paving the Way for Mucosal Immunization

Nasal sprays for treating COVID-19: a scientific note

Improving Nasal Protection for Preventing SARS-CoV-2 Infection

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