scholarly journals Complete protection by a single-dose skin patch–delivered SARS-CoV-2 spike vaccine

2021 ◽  
Vol 7 (44) ◽  
Author(s):  
Christopher L. D. McMillan ◽  
Jovin J. Y. Choo ◽  
Adi Idris ◽  
Aroon Supramaniam ◽  
Naphak Modhiran ◽  
...  
2021 ◽  
Author(s):  
Christopher L.D. McMillan ◽  
Jovin J.Y. Choo ◽  
Adi Idris ◽  
Aroon Supramaniam ◽  
Naphak Modhiran ◽  
...  

SARS-CoV-2 has infected over 160 million people and resulted in more than 3.3 million deaths, and we still face many challenges in the rollout of vaccines. Here, we use the high-density microarray patch to deliver a SARS-CoV-2 spike subunit vaccine directly to the skin. We show the vaccine, dry-coated on the patch is thermostable, and delivery of spike via HD-MAP induced greater cellular and antibody immune responses, with serum able to potently neutralize clinically relevant isolates including those from the B.1.1.7 and B.1.351 lineages. Finally, a single dose of HD-MAP-delivered spike provided complete protection from a lethal virus challenge, demonstrating that HD-MAP delivery of a SARS-CoV-2 vaccine is superior to traditional needle-and-syringe vaccination and has the potential to greatly impact the ongoing COVID-19 pandemic.


npj Vaccines ◽  
2019 ◽  
Vol 4 (1) ◽  
Author(s):  
Fangfang Dong ◽  
Dandan Li ◽  
Dan Wen ◽  
Suhua Li ◽  
Chaoyue Zhao ◽  
...  

2019 ◽  
Vol 8 (1) ◽  
pp. 575-578 ◽  
Author(s):  
Florine E. M. Scholte ◽  
Jessica R. Spengler ◽  
Stephen R. Welch ◽  
Jessica R. Harmon ◽  
JoAnn D. Coleman-McCray ◽  
...  

2019 ◽  
Vol 13 (6) ◽  
pp. e0007462 ◽  
Author(s):  
Neeltje van Doremalen ◽  
Teresa Lambe ◽  
Sarah Sebastian ◽  
Trenton Bushmaker ◽  
Robert Fischer ◽  
...  

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 589-589
Author(s):  
S. Yuki ◽  
H. Nakatsumi ◽  
M. Tateyama ◽  
Y. Uehata ◽  
M. Kudo ◽  
...  

589 Background: Indisetron is a 5-HT3 receptor antagonist which shows also 5-HT4 antagonistic activity, that had approved in 2004 by Japan's PMDA. There are no recommendations of prophylactic regimens for preventing nausea and vomiting induced by FOLFOX therapy. To explore the optimal dose period of indisetron tablets during mFOLFOX6, we designed the study to compare the antiemetic efficacy and safety of 3-day regimen of indisetron with a single dose regimen. Methods: Advanced colorectal cancer patients who were treated with mFOLFOX6 (+/- bevacizumab) as first-line chemotherapy were enrolled in this study. They were randomly assigned to Group A (3-day of indisetron) or Group B (a single dose of indisetron). Dexamethazone (8mg) was also administered intravenously in both groups before administering of oxaliplatin. The follow-up period was 5 days from the start of chemotherapy. The primary endpoint was complete protection from vomiting, and secondary endpoints were complete protection from nausea, no use of rescue therapy, and severe adverse events. Results: Of 45 patients enrolled in this trial, 42 (93.3%) were assessable. The proportions of patients with complete protection from vomiting were 85.7% in Group A, and 81.0% in Group B (p=1.000; Fisher's exact test). The proportions of patients with complete protection from nausea were 47.6% in each group (p=1.000; chi-square test). The no rescue therapy rates were 66.7% in Group A, and 57.1% in Group B (p=0.525; chi-square test). No severe adverse events were observed in both groups. Conclusions: We suggested that the efficacy of a single dose of indisetron might be equivalent of 3-day regimen for preventing from nausea and vomiting induced by mFOLFOX6. [Table: see text]


1989 ◽  
Vol 7 (11) ◽  
pp. 1693-1700 ◽  
Author(s):  
F Roila ◽  
M Tonato ◽  
C Basurto ◽  
M Picciafuoco ◽  
S Bracarda ◽  
...  

Despite treatment, emesis remains a major problem with cisplatin (CDDP) chemotherapy. Reasons for variability in antiemetic response among patients and in subsequent cycles are largely unknown and toxicity is sometimes severe. We have, therefore, carried out a multicenter, double-blind randomized trial comparing a combination of high-dose metoclopramide (MTC) (1 mg/kg x 4) and methylprednisolone (P) (treatment A) with a shorter but higher single-dose schedule of metoclopramide (3 mg/kg x 2) combined with dexamethasone (DEX) and diphenhydramine (DIP) to prevent extrapyramidal reactions (treatment B). Three hundred sixty-seven consecutive patients treated with various chemotherapy combinations containing CDDP were studied. Complete protection from vomiting/nausea was, at first cycle, 72.5%/79.5% with treatment B and 55.8%/65.1% with treatment A, a statistically significant difference (P less than .002/P less than .005). In subsequent cycles, protection from emesis significantly decreased with no difference between the two treatments. Multifactorial analysis shows that women, younger patients, outpatients, and patients who experienced emesis in previous cycles were at higher risk of suffering nausea and/or vomiting. Both regimens were well tolerated, but patients treated with treatment B had significantly less extrapyramidal reactions (1.7%/6.1%, P = .053). Treatment B is preferred due to its greater efficacy and lower incidence of extrapyramidal reactions. Trials on antiemetic therapy should take into account the important variables able to influence the efficacy of treatment. There is still a need for improving prevention of emesis in CDDP-treated patients.


2004 ◽  
Vol 78 (6) ◽  
pp. 3196-3199 ◽  
Author(s):  
Anjeanette Roberts ◽  
Jon D. Reuter ◽  
Jean H. Wilson ◽  
Stuart Baldwin ◽  
John K. Rose

ABSTRACT We generated an attenuated, recombinant vesicular stomatitis virus (VSV) expressing high levels of the cottontail rabbit papillomavirus (CRPV) L1 protein from an upstream site in the VSV genome. Rabbits vaccinated once with this VSV-L1 recombinant produced high levels of anti-L1 antibody and were completely protected against papilloma formation after challenge with CRPV. In contrast, animals vaccinated only once with a VSV vector expressing lower levels of L1 from a downstream site in the VSV genome generated lower levels of L1 antibody and demonstrated only incomplete protection from papilloma formation after challenge. We conclude that the level of L1 protein expression is critical in generating complete immunity with a single-dose vaccine.


2004 ◽  
Vol 22 (4) ◽  
pp. 725-729 ◽  
Author(s):  

Purpose Different doses and schedules of dexamethasone, combined with a 5-HT3 antagonist, are used to prevent acute emesis induced by anthracyclines, carboplatin, or cyclophosphamide. Therefore, we planned a randomized, double-blind, dose finding study aimed to identify the preferred dose and schedule of dexamethasone. Patients and Methods All consecutive chemotherapy-naive patients enrolled onto study were randomly assigned to receive for the prevention of acute emesis, during the first 24 hours, one of the following dexamethasone regimens, in combination with ondansetron 8 mg intravenously (IV): for arm A, 8 mg IV before chemotherapy plus 4 mg orally every 6 hours for four doses, starting at the same time of the chemotherapy; for arm B, 24 mg IV single dose before chemotherapy; and for arm C, 8 mg IV single dose before chemotherapy. All patients received from day 2 to 5 oral dexamethasone 4 mg bid. Results A total of 587 patients were enrolled, and 585 were assessed according to the intention-to-treat principle (195 patients in each arm). The rate of complete protection from acute vomiting and nausea, respectively, was not significantly different among the three groups (arm A, 84.6% and 66.7%; arm B, 83.6% and 56.9%; arm C, 89.2% and 61.0%), nor was the rate of complete protection from delayed vomiting and nausea, respectively (arm A, 81.0% and 46.7%; arm B, 81.3% and 45.1%; arm C, 79.8% and 46.1%). The incidence of delayed vomiting and nausea was strictly dependent on the presence of acute vomiting and nausea. Adverse events were mild and not significantly different among the three groups. Conclusion Dexamethasone 8 mg single dose IV before chemotherapy, in combination with a 5-HT3 antagonist, should be considered the preferred dose to prevent acute emesis induced by anthracyclines, carboplatin, or cyclophosphamide.


Vaccines ◽  
2021 ◽  
Vol 9 (12) ◽  
pp. 1457
Author(s):  
Priscila Diniz Lopes ◽  
Cintia Hiromi Okino ◽  
Filipe Santos Fernando ◽  
Caren Pavani ◽  
Viviane Casagrande Mariguela ◽  
...  

Efficient vaccines are the main strategy to control the avian coronavirus (AvCoV), although several drawbacks related to traditional attenuated and inactivated vaccines have been reported. These counterpoints highlight the importance of developing new alternative vaccines against AvCoV, especially those able to induce long-lasting immune responses. This study evaluated and compared two inactivated vaccines formulated with AvCoV BR-I variants, one composed of chitosan nanoparticles (AvCoV-CS) and the second by Montanide oily adjuvant (AvCoV-O). Both developed vaccines were administered in a single dose or associated with the traditional Mass attenuated vaccine. The AvCoV-CS vaccine administered alone or associated with the Mass vaccine was able to induce strong humoral and cell-mediated immune (CMI) responses and complete protection against IBV virulent infection, wherein single administration was characterized by high IgA antibody levels in the mucosa, whereas when associated with the Mass vaccine, the serum IgG antibody was predominantly observed. On the other hand, single administration of the oily vaccine presented poor humoral and CMI responses and consequently incomplete protection against virulent challenge, but when associated with the Mass vaccine, immune responses were developed, and complete protection against infection was observed. Both of our experimental vaccines were able to induce full protection against virulent IBV challenge. A single dose of AvCoV-CS vaccine was sufficient to achieve complete protection, while AvCoV-O required a previous priming by a Mass strain to complete the protection.


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