RESUMO
Background: NVX-CoV2373, a Covid-19 vaccine was developed in the USA with â¼90% efficacy. The same vaccine is manufactured in India after technology transfer (called as SII-NVX-CoV2373), was evaluated in this phase 2/3 immuno-bridging study. Methods: This was an observer-blind, randomised, phase 2/3 study in 1600 adults. In phase 2, 200 participants were randomized 3:1 to SII-NVX-CoV2373 or placebo. In phase 3, 1400 participants were randomized 3:1 to SII-NVX-CoV2373 or NVX-CoV2373 (940 safety cohort and 460 immunogenicity cohort). Two doses of study products (SII-NVX-CoV2373, NVX-CoV2373 or placebo) were given 3 weeks apart. Primary objectives were to demonstrate non-inferiority of SII-NVX-CoV2373 to NVX-CoV2373 in terms of geometric mean ELISA units (GMEU) ratio of anti-S IgG antibodies 14 days after the second dose (day 36) and to determine the incidence of causally related serious adverse events (SAEs) through 180 days after the first dose. Anti-S IgG response was assessed using an Enzyme-Linked Immunosorbent Assay (ELISA) and neutralizing antibodies (nAb) were assessed by a microneutralization assay using wild type SARS CoV-2 in participants from the immunogenicity cohort at baseline, day 22, day 36 and day 180. Cell mediated immune (CMI) response was assessed in a subset of 28 participants from immunogenicity cohort by ELISpot assay at baseline, day 36 and day 180. The total follow-up was for 6 months. Trial registration: CTRI/2021/02/031554. Findings: Total 1596 participants (200 in Phase 2 and 1396 in Phase 3) received the first dose. SII-NVX-CoV2373 was found non-inferior to NVX-CoV2373 (anti-S IgG antibodies GMEU ratio 0.91; 95% CI: 0.79, 1.06). At day 36, there was more than 58-fold rise in anti-S IgG and nAb titers compared to baseline in both the groups. On day 180 visit, these antibody titers declined to levels slightly lower than those after the first dose (13-22 fold-rise above baseline). Incidence of unsolicited and solicited AEs was similar between the SII-NVX-CoV2373 and NVX-CoV2373 groups. No adverse event of special interest (AESI) was reported. No causally related SAE was reported. Interpretation: SII-NVX-CoV2373 induced a non-inferior immune response compared to NVX-CoV2373 and has acceptable safety profile. Funding: SIIPL, Indian Council of Medical Research, Novavax.
RESUMO
Human epidermal growth factor receptor 2/neu (HER2/neu) is known to serve as a prognostic and predictive biomarker in several cancers such as breast, gastric and ovarian cancers. In head and neck squamous cell carcinoma, HER2/neu expression is seen but in a fluctuated manner. Hence, its role as a prognostic factor in oral squamous cell carcinoma (OSCC) needs evaluation. To determine the HER 2/neu overexpression in OSCC patients and its association with clinical and pathological parameters. 74 patients of OSCC treated between 2016 and 2018 were included in the study. Immunohistochemistry was done on tissue samples from these patients and HER2/neu expression was measured. Both biopsy and resected specimens were considered for the study. Out of 74 patients, 47.3% (35) were operated and 52.7% (39) were not operated due to loss to follow-up. No significant association was found (p = 0.636, OR = 0.68, CI = 0.14-3.34) between lymphovascular invasion (LVI) and HER2/neu expression. Similar results were seen for perineural invasion (PNI) (p = 0.490, OR = 0.53, CI = 0.88-3.24), depth of invasion (p = 0.21), grade of tumor (p = 0.214), clinical-stage (p = 0.511) and pathological stage (p = 0.091). No significant association existed between HER2/neu expression and LVI, PNI, clinical-stage, the grade of tumor and the pathological stage of oral squamous cell carcinoma.