ABSTRACT
This phase 3 observer-blind, randomized, controlled study was conducted in adults [≥]18 years of age to assess the safety and immunogenicity of NVX-CoV2373 as a heterologous booster compared to BBIBP-CorV when utilized as a homologous booster. Approximately 1,000 participants were randomly assigned in a 1:1 ratio to receive a single dose of NVX-CoV2373 or BBIBP-CorV after prior vaccination with 2 or 3 doses of BBIBP-CorV. Solicited adverse events (AEs) were collected for 7 days after vaccination. Unsolicited AEs were collected for 28 days following the booster dose and serious adverse and adverse events of special interest (AESI) were collected throughout the study. For this interim analysis, anti-spike IgG and neutralizing antibodies against SARS-CoV-2 were measured at baseline, day 14, and day 28. The study achieved its primary non-inferiority endpoint and also demonstrated statistically higher neutralization responses of approximately 6-fold when NVX-CoV2373 was utilized as a heterologous booster compared with BBIBP-CorV as a homologous booster. Both vaccines had an acceptably low reactogenicity profile and no new safety concerns were found. Heterologous boosting with NVXCoV2373 was a highly immunogenic and safe vaccine regimen in those previously vaccinated with BBIBP-CorV.
Subject(s)
Drug-Related Side Effects and Adverse ReactionsABSTRACT
BACKGROUNDThe rising breakthrough infections caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants, especially Omicron and its sub-lineages, have raised an urgent need to develop broad-spectrum vaccines against coronavirus disease 2019 (COVID-19). We have developed a mosaic-type recombinant vaccine candidate, named NVSI-06-09, having immune potentials against a broad range of SARS-CoV-2 variants. METHODSAn ongoing randomized, double-blind, controlled phase 2 trial was conducted to evaluate the safety and immunogenicity of NVSI-06-09 as a booster dose in subjects aged 18 years and older from the United Arab Emirates (UAE), who had completed two or three doses of BBIBP-CorV vaccinations at least 6 months prior to the enrollment. The participants were randomly assigned with 1:1 to receive a booster dose of NVSI-06-09 or BBIBP-CorV. The primary outcomes were immunogenicity and safety against SARS-CoV-2 Omicron variant, and the exploratory outcome was cross-immunogenicity against other circulating strains. RESULTSA total of 516 participants received booster vaccination. Interim results showed a similar safety profile between NVSI-06-09 and BBIBP-CorV booster groups, with low incidence of adverse reactions of grade 1 or 2. For immunogenicity, by day 14 after the booster vaccination, the fold rises in neutralizing antibody geometric mean titers (GMTs) from baseline level elicited by NVSI-06-09 were remarkably higher than those by BBIBP-CorV against the prototype strain (19.67 vs 4.47-fold), Omicron BA.1.1 (42.35 vs 3.78-fold), BA.2 (25.09 vs 2.91-fold), BA.4 (22.42 vs 2.69-fold), and BA.5 variants (27.06 vs 4.73-fold). Similarly, the neutralizing GMTs boosted by NVSI-06-09 against Beta and Delta variants were also 6.60-fold and 7.17-fold higher than those boosted by BBIBP-CorV. CONCLUSIONSA booster dose of NVSI-06-09 was well-tolerated and elicited broad-spectrum neutralizing responses against SARS-CoV-2 prototype strain and immune-evasive variants, including Omicron and its sub-lineages. The immunogenicity of NVSI-06-09 as a booster vaccine was superior to that of BBIBP-CorV. (Funded by LIBP and BIBP of Sinopharm; ClinicalTrials.gov number, NCT05293548).
Subject(s)
Coronavirus Infections , Breakthrough Pain , COVID-19ABSTRACT
The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants with immune escape ability raises the urgent need for developing cross-neutralizing vaccines against the virus. NVSI-06-08 is a potential broad-spectrum recombinant COVID-19 vaccine that integrates the antigens from multiple SARS-CoV-2 strains into a single immunogen. Here, we evaluated the safety and immunogenicity of NVSI-06-08 as a heterologous booster dose in adults previously vaccinated with the inactivated vaccine BBIBP-CorV in a randomized, double-blind, controlled, phase 2 trial conducted in the United Arab Emirates (NCT05069129). Three groups of healthy adults over 18 years of age (600 participants per group) who had administered two doses of BBIBP-CorV 4-6-month, 7-9-month and >9-month earlier, respectively, were vaccinated with either a homologous booster of BBIBP-CorV or a heterologous booster of NVSI-06-08. The primary outcome was immunogenicity and safety of booster vaccinations. The exploratory outcome was cross-reactive immunogenicity against multiple SARS-CoV-2 variants of concerns (VOCs). The incidence of adverse reactions was low in both booster vaccinations, and the overall safety profile of heterologous boost was quite similar to that of homologous boost. Heterologous NVSI-06-08 booster was immunogenically superior to homologous booster of BBIBP-CorV. Both Neutralizing and IgG antibodies elicited by NVSI-06-08 booster were significantly higher than by the booster of BBIBP-CorV against not only SARS-CoV-2 prototype strain but also multiple VOCs. Especially, the neutralizing activity induced by NVSI-06-08 booster against the immune-evasive Beta variant was no less than that against the prototype strain, and a considerable level of neutralizing antibodies against Omicron (GMT: 367.67; 95%CI, 295.50-457.47) was induced by heterologous booster, which was substantially higher than that boosted by BBIBP-CorV (GMT: 45.03; 95%CI, 36.37-55.74). Our findings showed that NVSI-06-08 was safe and immunogenic as a booster dose following two doses of BBIBP-CorV, which was immunogenically superior to homologous boost with another dose of BBIBP-CorV. Our study also indicated that the design of hybrid antigen may provide an effective strategy for broad-spectrum vaccine developments.
Subject(s)
Coronavirus Infections , COVID-19ABSTRACT
Background: SARS‐CoV‐2 was first reported in December 2019. The severity of COVID-19 infection ranges from being asymptomatic to severe infection leading to death. The aim of the study is to describe the clinical characteristics and outcomes of hospitalized COVID-19 patients within the largest government healthcare facilities in the Emirate of Abu Dhabi, the capital of UAE. Methods: This paper is a retrospective cross-sectional study of all patients admitted to Abu Dhabi Healthcare services facilities (SEHA) between the period of March 1st until May 31st with a laboratory-confirmed test of SARS-CoV2, known as Coronavirus disease (COVID19). Variation in characteristics, comorbidities, laboratory values, length of hospital stay, treatment received and outcomes were examined. Data was collected from electronic health records available at SEHA health information system.Results: There were 9390 patients included; patients were divided into severe and non-severe groups. 721 (7.68%) patients required intensive care while the remaining majority (92.32 %) were mild-moderate cases. The mean age (41.8 years) is less than the mean age reported globally. Our population had a male predominance and variable representation of different nationalities. Three major comorbidities were noted, hypertension, diabetes mellitus and chronic kidney disease. The laboratory tests that were significantly different between the severe and the non-severe groups were LDH, Ferritin, CRP, neutrophil count, IL6 and creatinine level. The major antiviral therapies the patients have received were a combination of hydroxychloroquine and favipiravir. The overall in hospital mortality was 1.63% while severe group mortality rate was 19.56 %. The Death rate in the adults younger than 30 years was noted to be higher compared to elderly patients above 60 years, 2.3% and 0.9 % respectively. Conclusion: our analysis suggests that Abu Dhabi had a relatively low morbidity and mortality rate and a high recovery rate compared to published rates in China, Italy and The United States. The demographic of the population is younger and has an international representation. The country had the highest testing rate in relation to the population volume. We believe the early identification and younger demographic had affected the favorable comparative outcome in general with early identification of cases leading to a lower mortality rate.