Zifivax (ZF2001) / Chinese Academy of Medical Sciences, Chongqing Zhifei - LARVOL DELTA

Immunogenicity of a recombinant subunit COVID-19 vaccine: A prospective, multi-centre, longitudinal study in Chinese Alzheimer's disease patients. (PubMed, Hum Vaccin Immunother) - "Vaccination correlated with reduced severe illness, increased survival rates and extended survival times after Omicron BTI. The findings highlight the immunogenicity and suggest a certain degree of protective effectiveness of the recombinant subunit COVID-19 vaccine (Zifivax) in AD patients."

Journal • Observational data • Alzheimer's Disease • CNS Disorders • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A High-Throughput Broad Neutralizing Antibody Assay for Detecting SARS-CoV-2 Variant Immunity in Population. (PubMed, ACS Infect Dis) - "Notably, the levels of NAbs against most of the SARS-CoV-2 variants are much lower in the decreased immunity of HIV patients (CD4+ 500 cells/μL), indicating that maintenance of the immune system is crucial for NAb production. Altogether, our high-throughput proteomics platform represents a powerful tool for the detection of bNAbs in the population and may inform the development of more effective COVID-19 vaccines and vaccination strategies in the future."

Journal • Human Immunodeficiency Virus • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4

COVID-19 vaccination pharmacovigilance in Khojaly district, Uzbekistan: an epidemiological evaluation. (PubMed, Front Public Health) - "The COVID-19 vaccination surveillance system in Khojaly recorded AEFIs, but we identified gaps in AEFI reporting and knowledge among providers. Improving the AEFI registry and training providers on standard operating procedures for identifying, reporting, and investigating AEFI could improve vaccine safety surveillance."

Adverse events • Journal • Allergy • Infectious Disease • Novel Coronavirus Disease

Mass Cytometry Analysis of High-Dimensional Single-Cell Immune Profiles in ZF2001-Vaccinated Patients Infected with SARS-CoV-2. (PubMed, Infect Drug Resist) - "These changes suggested that the vaccine was effectively modulating the immune response. Our results provided a detailed single-cell profile of the immune response to SARS-CoV-2 infection in vaccinated patients, highlighting significant changes in immune cell kinetics indicative of an active innate and adaptive immune cell response."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4 • CD8 • SDC1

Efficacy, immunogenicity, and safety of heterologous boosting with a novel chimera Chinese mRNA (RQ3013) SARS-CoV-2 vaccine: A randomized, double-blind, active-controlled trial. (PubMed, Hum Vaccin Immunother) - "All SAEs were not related to the vaccination. These findings suggest that a chimeric mRNA vaccine design involving multiple antigenic epitopes provides broader protection across subvariants and variants of SARS-CoV-2 than the subunit vaccine ZF2001."

Clinical • Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Repeated-dose toxicity and immunogenicity evaluation of a recombinant subunit COVID-19 vaccine (ZF2001) in rats. (PubMed, Front Cell Infect Microbiol) - "In addition, histological examination revealed recoverable inflammatory changes in quadricep muscles and adjacent lymph nodes at the vaccine injection site. In summary, our systematic toxicology study proves the safety, tolerability and immunogenicity of the ZF2001 vaccine, which further supports the results of clinical trials of ZF2001."

Journal • Preclinical • Hematological Disorders • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Boosting with Omicron-specific mRNA vaccine or historical SARS-CoV-2 vaccines elicits discriminating immune responses against Omicron variants. (PubMed, Acta Pharm Sin B) - "Moreover, the protective efficacies of the vaccines in booster vaccinations are highly related to GC reactions in secondary lymphatic organs. In summary, these findings provide timely important information on prime-boost regimens and future vaccine design."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Comparative efficacy of leading COVID-19 vaccines: A network meta-analysis. (PubMed, Indian J Med Res) - "The statistically significant direct estimates were obtained by Spikevax [VE: 93.29 (91.31, 95.27); P<0.05], Pfizer BioNTech [VE: 92.07 (90.03, 94.12); P<0.05], Sputnik [VE: 91.60 (85.60, 97.60); P<0.05], Novavax [VE: 88.99 (83.55, 94.42); P<0.05], Sinovac [VE: 83.50 (65.40, 101.60); P<0.05], Covifenz [VE: 77.27 (68.48, 86.06); P<0.05], Zifivax [VE: 75.94 (70.86, 81.02); P<0.05], Covishield [VE: 72.34 (67.12, 77.56); P<0.05], S-Trimer [VE: 71.61 (56.23, 86.98); P<0.05], Covaxin [VE: 70.81 (65.33, 76.29); P<0.05], Soberna [VE: 69.70 (56.50, 82.90); P<0.05], Zydus Cadila [VE: 66.60 (47.60, 85.60); P<0.05], CVnCoV [VE: 63.70 (52.20, 75.20); P<0.05], Convidecia [VE: 57.50 (39.70, 75.30); P <0.05], and Jcovden [VE : 52.42 (47.28, 57.57); P<0.05]. Spikevax emerged triumphant with an unparalleled P score of 0.95, solidifying its status as a top ranking prevention tool against the COVID-19 in our investigation. Our analysis reveals a..."

Clinical • Journal • Retrospective data • Review • Infectious Disease • Novel Coronavirus Disease

Waning neutralizing antibodies through 180 days after homologous and heterologous boosters of inactivated COVID-19 vaccine. (PubMed, Front Public Health) - "In summary, neutralizing antibody levels significantly waned 180 days after the third vaccine dose, with the most pronounced decline occurring within the initial 90 days. Heterologous boosting with Convidecia demonstrated a more robust, durable, and broad humoral immune response compared to boosting with inactivated vaccines or Zifivax, suggesting that adenovirus vector vaccines possess a special advantage in the realm of vaccine development for preventing infectious diseases."

Clinical • Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Immunogenicity and safety of SARS-CoV-2 recombinant protein vaccine (CHO cell) LYB001 as a heterologous booster following two- or three-dose inactivated COVID-19 vaccine in adults aged ≥18 years: interim results of a randomized, active-controlled, double-blinded, phase 3 trial. (PubMed, Expert Rev Vaccines) - P3 | "LYB001 is highly immunogenic and retains a well-characterized safety profile in adults aged ≥18 years. www.clinicaltrials.gov, identifier is NCT05664932."

Journal • P3 data • P3 data: top line • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

EXPLORING THE POTENTIAL LINK: ISCHEMIC STROKE INCIDENCE FOLLOWING COVID-19 VACCINATION (WSC 2024) - "Like other types of vaccines, COVID-19 vaccines have their own local and systemic side effects, as well as other systemic complications, including neurological ones...Results A total of 1,585,014 people have been completed the full course of vaccination (minimum age 18 years, maximum 85 years) and 6,796,188 doses of vaccines have been used (Oxford/AstraZeneca 240,144 doses, ZF2001 3,411,125 doses, Sputnik V 257,593 doses, Moderna 1,132 121 doses, Pfizer/BioNTech 1,441,627 doses, Sinovac 251,146 doses, Sputnik Light 51,141 doses, Johnson&Johnson 11,291 doses)...Conclusions Given the risk of neurological complications is extremely rare (0.001%), vaccination is the only way to protect against COVID-19. At a time when the COVID-19 infection has enormous complications not only in the nervous system, but also in other systems, even death."

Cardiovascular • Hematological Disorders • Infectious Disease • Ischemic stroke • Novel Coronavirus Disease • Thrombosis

Response to comment on 'Clinical characteristics and risk factors for ZF2001 fully vaccinated inpatients with COVID-19: A retrospective cohort study'. (PubMed, Hum Vaccin Immunother) - No abstract available

Journal • Retrospective data • Infectious Disease • Novel Coronavirus Disease

Protective RBD-dimer vaccines against SARS-CoV-2 and its variants produced in glycoengineered Pichia pastoris. (PubMed, PLoS Pathog) - "In a murine model, we demonstrated that the yeast-produced RBD-dimer induces robust and protective antibody responses, which is suitable for boosting immunization. This study developed the yeast system for producing SARS-CoV-2 RBD-dimer immunogens, providing a promising platform and pipeline for the future continuous updating and production of SARS-CoV-2 vaccines."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Integrative multi-omics reveal associations between gut microbiome and immune response against COVID-19 vaccine in the elderly (IDDF 2024) - "Multi-omics analyses showed lower immunosenescence in the high response group, accompanied by increased intestinal B.dentium and B.pseudocatenulatum as well as PCs. The potential utility of Bifidobacterium and phosphatidylcholines (PCs) as functional foods to enhance COVID-19 vaccination efficacy in immunosenescent elders requires further investigation."

Clinical • Infectious Disease • Novel Coronavirus Disease • CD4 • CD8 • TRB

Letter to the editor to 'Clinical characteristics and risk factors for ZF2001 fully vaccinated inpatients with COVID-19: A retrospective cohort study'. (PubMed, Hum Vaccin Immunother) - No abstract available

Journal • Retrospective data • Infectious Disease • Novel Coronavirus Disease

Factors influencing antibody response after COVID-19 recombinant protein vaccination in adults: A cross-sectional observational study, in Chongqing, China. (PubMed, Hum Vaccin Immunother) - "Conversely, the -interval between 1 and 2 dose and frequently of tea were positive associations with antibody response (β = 0.1369, 95% CI: 0.0463 to 0.2275, β = 0.0830, 95% CI: 0.0106 to 0.1554, P = 0.0032, P = 0.0247). Overall, the ZF2001 vaccine-induced antibody response was influenced by a multifactor that may provide a reference for the development of personalized antigen vaccines and vaccination strategies in the future."

Journal • Observational data • Cardiovascular • Diabetes • Hypertension • Infectious Disease • Metabolic Disorders • Novel Coronavirus Disease • Respiratory Diseases

ASSESSING THE POTENTIAL NEUROLOGICAL IMPACT OF COVID-19 VACCINES: AN IN-DEPTH EXAMINATION OF REPORTED COMPLICATIONS (EAN 2024) - " A total of 1,585,014 people have been completed the full course of vaccination (minimum age 18 years, maximum 85 years) and 6,796,188 doses of vaccines have been used (Oxford/AstraZeneca 240,144 doses, ZF2001 3,411,125 doses, Sputnik V 257,593 doses, Moderna 1,132 121 doses, Pfizer/BioNTech 1,441,627 doses, Sinovac 251,146 doses, Sputnik Light 51,141 doses, Johnson&Johnson 11,291 doses)... Given the risk of neurological complications is extremely rare (0.001%), vaccination is the only way to protect against COVID-19. At a time when the COVID-19 infection has enormous complications not only in the nervous system, but also in other systems, even death."

Cardiovascular • CNS Disorders • Hematological Disorders • Infectious Disease • Ischemic stroke • Multiple Sclerosis • Novel Coronavirus Disease • Otorhinolaryngology • Thrombosis

Clinical characteristics and risk factors for ZF2001 fully vaccinated inpatients with COVID-19: A retrospective cohort study. (PubMed, Hum Vaccin Immunother) - "This study supports the substantial clinical benefits of the ZF2001 vaccine for COVID-19 patients. Additionally, age over 65, elevated WBC count, reduced lymphocyte count, and higher blood levels of BUN, LDH, D-dimer, and procalcitonin may be used as predictive factors for disease progression in fully vaccinated COVID-19 inpatients."

Journal • Retrospective data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety, immunogenicity and protective effect of sequential vaccination with inactivated and recombinant protein COVID-19 vaccine in the elderly: a prospective longitudinal study. (PubMed, Signal Transduct Target Ther) - "To clarify these issues, this prospective study followed up 157 elderly and 73 young participants for 16 months and compared the safety, immunogenicity, and efficacy of two doses of the inactivated vaccine BBIBP-CorV followed by a booster dose of the recombinant protein vaccine ZF2001...The antibody levels in the elderly increased significantly after breakthrough infection but were still lower than those in the young. Our data suggest that multiple booster vaccinations at short intervals to maintain high antibody levels may be an effective strategy for protecting the elderly against COVID-19."

Journal • Observational data • Infectious Disease • Novel Coronavirus Disease

Immunogenicity and safety of a recombinant Omicron BA.4/5-Delta COVID-19 vaccine ZF2202-A in Chinese adults. (PubMed, Vaccine) - "The novel bivalent vaccine ZF2202-A demonstrated satisfactory immunogenicity and safety against Omicron variants as booster dose in adults with prior vaccination of COVID-19 vaccines."

Clinical • Journal • Dermatology • Fatigue • Infectious Disease • Novel Coronavirus Disease • Pain • Pruritus • KEAP1

Safety and immunogenicity of the SARS-CoV-2 LYB001 RBD-based VLP vaccine (CHO cell) phase 1 in Chinese adults: a randomized, double-blind, positive-parallel-controlled study. (PubMed, Expert Rev Vaccines) - P1 | "Therefore, further larger-scale clinical studies are warranted. This trial was registered with ClinicalTrials.gov (NCT05552573)."

Clinical • Journal • P1 data • P1 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Immunogenicity and safety of a recombinant COVID-19 vaccine (ZF2001) as heterologous booster after priming with inactivated vaccine in healthy children and adolescents aged 3-17 years: an open-labeled, single-arm clinical trial. (PubMed, BMC Infect Dis) - P=N/A | "On day 14 post-booster, a third dose booster of the ZF2001 provided a substantial increase in antibody responses in minors, and the overall occurrence rate of adverse reactions after heterologous vaccination was low and all adverse reactions were mild or moderate. The results showed that the ZF2001 heterologous booster had high immunogenicity and good safety profile in children and adolescents, and can elicit a certain level of neutralizing antibodies against Omicron.Trial registration NCT05895110 (Retrospectively registered, First posted in ClinicalTrials.gov date: 08/06/2023)."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Proteomic and cellular characterization of Omicron breakthrough infections and a third homologous or heterologous boosting vaccination in a longitudinal cohort. (PubMed, Mol Cell Proteomics) - "Breakthrough infections can trigger more intensive inflammatory chemokine responses than vaccination. T-cell and innate immune activation have been shown to be closely related to enhanced antibody levels after vaccination and therefore might be potential targets for vaccine adjuvant design."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IL17A

Neutralization of EG.5, EG.5.1, BA.2.86, and JN.1 by antisera from dimeric receptor-binding domain subunit vaccines and 41 human monoclonal antibodies. (PubMed, Med) - P=N/A | "Our data showed that the currently dominating sub-variant, JN.1, showed increased immune evasion compared to BA.2.86 and EG.5.1, which is highly concerning. This study provides a timely risk assessment of the interested sub-variants and the basis for updating COVID-19 vaccines."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Broad-spectrum Delta-BA.2 tandem-fused heterodimer mRNA vaccine delivered by lipopolyplex. (PubMed, PLoS Pathog) - "Here, based on a similar dimeric RBD design as our previous ZF2001 vaccine, we developed a novel broad-spectrum COVID-19 mRNA vaccine, SWIM516, with chimeric Delta-BA.2 RBD dimer delivered by lipopolyplex (LPP)...When challenged with Delta or Omicron live virus, vaccinated hACE2 transgenic mice and rhesus macaques were both protected, displaying significantly reduced viral loads and markedly relieved pathological damages. We believe the SWIM516 vaccine qualifies as a candidate for the next-generation broad-spectrum COVID-19 vaccine."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases