NVX-CoV2373 vaccine protects cynomolgus macaque upper and lower airways against SARS-CoV-2 challenge

Abstract

Highlights Full-length SARS-CoV-2 prefusion spike with Matrix-M™ (NVX-CoV2373) vaccine. Induced hACE2 receptor blocking and neutralizing antibodies in macaques. Vaccine protected against SARS-CoV-2 replication in the nose and lungs. Absence of pulmonary pathology in NVX-CoV2373 vaccinated macaques.

Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine

“…Of note, preclinical testing of mRNA-1273 and other SARS-CoV-2 vaccines in advanced clinical evaluation has shown a Th1-skewed vaccine response and no pathologic lung infiltrates. 15 , 26-28 Whether mRNA-1273 vaccination results in enhanced disease on exposure to the virus in the long term is unknown.…”

SARS-CoV-2: vaccines in the pandemic era

“…The vaccine induced CD4 + and CD8 + T cell responses and the formation of Th cell germinal centers. Immunogenicity and protection were also tested in cynomolgus monkeys, and the results revealed effective protection of the upper and lower respiratory tracts from viral infection, with no evidence of lung disease [ 51 ]. These results support the ongoing phase 1/2 clinical trial for NVX-CoV2373.…”

“…450 pseudotyped virus neutralisation 534 18–55 1 dose standard dose 40 10 18–55 0/28 5 × 10 10 vp 450.9 Phase 3: ISRCTN89951424, NCT04516746, NCT04540393, CTRI/2020/08/027170 Sputnik-V Gamaleya rAd26 + rAd5 S-full length N.A. Phase 1 [48] 9 18–60 1 dose rAd26 (Fro, Lyo): 1 × 10 11 vp 4.29, 3.67 32.96 Microneutralization assay 9 18–60 1 dose rAd5 (Fro, Lyo): 1 × 10 11 vp 6.3, 10.8 Phase 2 [48] 20 18–60 0/21 (rAd26)/ (rAd5): (Fro, Lyo): 1 × 10 11 vp 49.25, 45.95 Phase 3: NCT04530396, NCT04564716 Recombinant protein vaccine NVX-CoV2373 Novavax Protein Subunit S-full length (pre-fusion) Mice [ 50 ] Monkeys [ 51 ] (Challenge: Yes) Phase 1 [ 49 ]: 131 18–60 0/21 5 μg,25 μg 3906, 3305 983 Microneutralization assay Phase 3: 2020–004123-16 NCT04611802 EpiVacCorona Vector Peptide SARS-CoV-2 protein N.A. Phase 1: NCT04527575 14 18–60 0/21 No published results 86 18–60 0/21 Inactivated vaccine Inactivated vaccine Wuhan Institute of Biological Products Inactivated …”

Development of SARS-CoV-2 vaccines: challenges, risks, and the way forward

“…83 Seven NHP trials of the candidate SARS-CoV-2 vaccines in the macaque challenge model have been published so far. [84][85][86][87][88][89][90] They include three adjuvanted inactivated vaccines (PiCoVacc by Sinovac, BBIBP-CorV, and BBV152 by BBIL), two nonreplicating adenovirus vector vaccines (ChAdOx1nCOV-19 by AstraZeneca and Ad26COVS1 by Janssen), one mRNA vaccine (mRNA-1273 by Moderna), and one protein subunit, nanoparticle vaccine (NVX CoV2373 by Novavax) [84][85][86][87][88][89][90] .…”

“…5 Few of the vaccine developers have taken an alternative approach: they completed the animal studies of their candidates in parallel with ongoing human trials. [83][84][85][86] Umbrella clinical trials This approach could be used to test several candidates under a single study protocol to compare findings of different trials by standardizing decisions like criteria for recruitment and endpoints selection. There could be other logistical benefits also, such as having a single placebo arm for different trials to cut down on the cost and the overall size of the trials.…”