Zifivax (ZF2001) / Chinese Academy of Medical Sciences, Chongqing Zhifei 
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  • ||||||||||  Zifivax (ZF2001) / Chinese Academy of Medical Sciences, Chongqing Zhifei
    Clinical, Journal:  Immunogenicity and safety of a recombinant Omicron BA.4/5-Delta COVID-19 vaccine ZF2202-A in Chinese adults. (Pubmed Central) -  May 19, 2024   
    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. 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.
  • ||||||||||  SWIM816 / Stemirna Therap, Zifivax (ZF2001) / Chinese Academy of Medical Sciences, Chongqing Zhifei
    Journal:  Broad-spectrum Delta-BA.2 tandem-fused heterodimer mRNA vaccine delivered by lipopolyplex. (Pubmed Central) -  Apr 15, 2024   
    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.
  • ||||||||||  CoronaVac / Sinovac, Bio Farma Indonesia
    Journal:  Reduced neutralization and Fc effector function to Omicron subvariants in sera from SARS-CoV-1 survivors after two doses of CoronaVac plus one dose subunit vaccine. (Pubmed Central) -  Nov 1, 2023   
    Although previous study indicated that BNT162b2 messenger RNA vaccine induces potent cross-clade pan-sarbecovirus neutralizing antibodies in survivors of the infection by SARS-CoV-1, the neutralization activity and Fc-mediated effector functions of these cross-reactive antibodies elicited in SARS-CoV-1 survivors to Omicron subvariants still remain largely unknown...However, the induced antibodies exhibited both reduced neutralization and impaired Fc effector functions targeting multiple Omicron subvariants. Importantly, the data also support the notion that immune imprints resulted from SARS-CoV-1 infection may exacerbate the impairment of neutralization activity and Fc-mediated effector functions to Omicron subvariants and provided invaluable information to vaccination strategy in future.
  • ||||||||||  Zifivax (ZF2001) / Chinese Academy of Medical Sciences, Chongqing Zhifei
    Preclinical, Journal:  Immunogenicity and protective effects of recombinant bivalent COVID-19 vaccine in mice and rhesus macaques. (Pubmed Central) -  Aug 9, 2023   
    Rhesus macaque challenge experiments showed that this bivalent vaccine drastically decreased the lung viral load and reduced lung lesions in SARS-CoV-2 (the causative virus of COVID-19)-infected rhesus macaques. In summary, this bivalent vaccine showed immunogenicity and protective efficacy that was far superior to the monovalent recombinant protein vaccine against the prototype strain and provided an important basis for developing broad-spectrum COVID-19 vaccines.
  • ||||||||||  Zifivax (ZF2001) / Chinese Academy of Medical Sciences, Chongqing Zhifei
    Journal:  Robust and protective immune responses induced by heterologous prime-boost vaccination with DNA-protein dimeric RBD vaccines for COVID-19. (Pubmed Central) -  Jul 16, 2023   
    Priming with DNA-RBD-dimer followed by ZF2001 boosting induced higher levels of neutralizing antibodies than homologous vaccination with either DNA-RBD-dimer or ZF2001, elicited polyfunctional cellular immunity with a T 1-biased polarization, and efficiently protected mice against SARS-CoV-2 infection in the lung. This study demonstrated the robust and protective immune responses induced by the DNA-RBD-dimer candidate and provided a heterologous prime-boost approach with DNA-RBD-dimer and ZF2001.
  • ||||||||||  Qbrexza (glycopyrronium cloth) / Eli Lilly, Zifivax (ZF2001) / Chinese Academy of Medical Sciences, Chongqing Zhifei
    Clinical observation and analysis of skin reactions caused by COVID-19 vaccination () -  Jul 3, 2023 - Abstract #WCD2023WCD_3906;    
    Treatment measures are mostly mild regimens, such as oral antihistamines, compounded glycopyrrolate and topical weak to moderately potent corticosteroid creams. It is essential to recognize that these skin reactions, when followed by awareness, can alleviate patients' concerns about adverse reactions to COVID-19 vaccination and thus actively complete the vaccination
  • ||||||||||  Zifivax (ZF2001) / Chinese Academy of Medical Sciences, Chongqing Zhifei
    Trial completion, Trial completion date, Trial primary completion date:  ZF2001 Booster Immunization Clinical Trials of 6 Months After the Completion of Basic Immunization (clinicaltrials.gov) -  Jun 15, 2023   
    P1/2,  N=300, Completed, 
    It is essential to recognize that these skin reactions, when followed by awareness, can alleviate patients' concerns about adverse reactions to COVID-19 vaccination and thus actively complete the vaccination Active, not recruiting --> Completed | Trial completion date: Jul 2022 --> Dec 2022 | Trial primary completion date: Mar 2022 --> Aug 2022
  • ||||||||||  Zifivax (ZF2001) / Chinese Academy of Medical Sciences, Chongqing Zhifei
    Journal:  Rapid evaluation of heterologous chimeric RBD-dimer mRNA vaccine for currently-epidemic Omicron sub-variants as booster shot after inactivated vaccine. (Pubmed Central) -  May 1, 2023   
    Herein, we further explored the hetero-chimeric RBD-dimer mRNA vaccines and evaluated their broad-spectrum activities as booster jabs following two doses of inactivated vaccine (IV) in mice. Our data demonstrated that the chimeric vaccines significantly boosted neutralizing antibody levels and specific T-cell responses against the variants, and PT-Beta was superior to Delta-BA.1 RBD as a booster in mice, shedding light on the antigen design for the next-generation COVID-19 vaccines.
  • ||||||||||  Zifivax (ZF2001) / Chinese Academy of Medical Sciences, Chongqing Zhifei
    Trial completion:  Clinical Trial of Immunogenicity Bridging of a Recombinant New Coronavirus?COVID-19? Vaccine (CHO Cell) (clinicaltrials.gov) -  Apr 25, 2023   
    P2,  N=400, Completed, 
    Our data demonstrated that the chimeric vaccines significantly boosted neutralizing antibody levels and specific T-cell responses against the variants, and PT-Beta was superior to Delta-BA.1 RBD as a booster in mice, shedding light on the antigen design for the next-generation COVID-19 vaccines. Recruiting --> Completed
  • ||||||||||  Zifivax (ZF2001) / Chinese Academy of Medical Sciences, Chongqing Zhifei
    Journal:  Effect of adjuvanting RBD-dimer-based subunit COVID-19 vaccines with Sepivac SWE (Pubmed Central) -  Apr 19, 2023   
    SWE significantly increased antibody responses compared with aluminium hydroxide adjuvant and afforded greater neutralization breadth. These data highlight the advantage of emulsion-based adjuvants to elevate the protective immune response of protein subunit COVID-19 vaccines.
  • ||||||||||  BBIBP-CorV / Wuhan Institute of Virology, Sinopharm, Zifivax (ZF2001) / Chinese Academy of Medical Sciences, Chongqing Zhifei
    Journal:  Neutralization of SARS-CoV-2 omicron after BBIBP-CorV and ZF2001 booster vaccination. (Pubmed Central) -  Apr 4, 2023   
    These data highlight the advantage of emulsion-based adjuvants to elevate the protective immune response of protein subunit COVID-19 vaccines. No abstract available
  • ||||||||||  CoronaVac / Sinovac, Bio Farma Indonesia, Zifivax (ZF2001) / Chinese Academy of Medical Sciences, Chongqing Zhifei
    Coronavirus Disease Vaccination In Patients With Pulmonary Hypertension: A National Prospective Cohort Study (Walter E. Washington Convention Center, Area B, Hall C (Lower Level)) -  Mar 25, 2023 - Abstract #ATS2023ATS_6955;    
    A large-scale randomized controlled trial is warranted to confirm this finding. The final approval of the COVID-19 vaccination for patients with PH as a public health strategy is promising.
  • ||||||||||  CoronaVac / Sinovac, Bio Farma Indonesia, Zifivax (ZF2001) / Chinese Academy of Medical Sciences, Chongqing Zhifei
    Journal:  Durability of neutralization against Omicron subvariants after vaccination and breakthrough infection. (Pubmed Central) -  Feb 12, 2023   
    However, BQ.1.1 and XBB, followed by BA.2.75, are more resistant to neutralization, with neutralizing titer reductions of ?9- to 41-fold, ?16- to 63-fold, and ?4- to 25-fold, respectively. These data highlight additional vaccination in CoronaVac- or ZF2001-vaccinated individuals and provide insight into the durability of neutralization against Omicron subvariants.
  • ||||||||||  LYB001 / Luye Group
    Enrollment closed, Enrollment change:  Immunogenicity and Safety of COVID-19 Vaccine as a Booster Vaccination in Population Aged 18 Years and Above (clinicaltrials.gov) -  Jan 17, 2023   
    P3,  N=1200, Active, not recruiting, 
    These data highlight additional vaccination in CoronaVac- or ZF2001-vaccinated individuals and provide insight into the durability of neutralization against Omicron subvariants. Not yet recruiting --> Active, not recruiting | N=3600 --> 1200
  • ||||||||||  BBIBP-CorV / Wuhan Institute of Virology, Sinopharm, Zifivax (ZF2001) / Chinese Academy of Medical Sciences, Chongqing Zhifei, bebtelovimab (LY-CoV1404) / AbCellera, Eli Lilly
    Journal:  Neutralization sensitivity, fusogenicity, and infectivity of Omicron subvariants. (Pubmed Central) -  Dec 30, 2022   
    Not yet recruiting --> Active, not recruiting | N=3600 --> 1200 These findings have important public health implications and highlight the importance of repeated exposure to SARS-CoV-2 antigens to broaden the neutralizing antibody response against Omicron subvariants.
  • ||||||||||  Zifivax (ZF2001) / Chinese Academy of Medical Sciences, Chongqing Zhifei
    Preclinical, Journal:  Preclinical Toxicity and Immunogenicity of a COVID-19 Vaccine (ZF2001) in Cynomolgus Monkeys. (Pubmed Central) -  Dec 24, 2022   
    As expected, the vaccine can produce a strongly specific binding antibody and neutralizing antibodies in cynomolgus monkeys after inoculation. Taken together, our regulatory toxicology research proves the safety and immunogenicity of the ZF2001 vaccine, supporting its entry into large scale clinical trials.
  • ||||||||||  CoronaVac / Sinovac, Bio Farma Indonesia, Zifivax (ZF2001) / Chinese Academy of Medical Sciences, Chongqing Zhifei
    Journal:  Key mutations in the spike protein of SARS-CoV-2 affecting neutralization resistance and viral internalization. (Pubmed Central) -  Dec 16, 2022   
    In addition, F486L and Y508H significantly enhanced the utilization of human ACE2, suggesting a potentially elevated infectivity of these two mutants. In conclusion, our results show that some prevalent S mutations of SARS-CoV-2 reduced the protective efficacy of current vaccines and enhance the infectivity of the virus, indicating the necessity of vaccine renewal and providing direction for the development of new vaccines.
  • ||||||||||  BBIBP-CorV / Wuhan Institute of Virology, Sinopharm, Zifivax (ZF2001) / Chinese Academy of Medical Sciences, Chongqing Zhifei
    Journal:  Cellular basis of enhanced humoral immunity to SARS-CoV-2 upon homologous or heterologous booster vaccination analyzed by single-cell immune profiling. (Pubmed Central) -  Oct 23, 2022   
    Here, we investigated the durability of antibody responses and single-cell immune profiles following booster dose immunization, longitudinally over 6 months, in recipients of a homologous BBIBP-CorV/BBIBP-CorV or a heterologous BBIBP-CorV/ZF2001 regimen...The proper activation of cDC/Tfh/B cells was likely fueled by active energy metabolism, and glutaminolysis might also play a general role in promoting humoral immunity. Our study unveils the cellular mechanisms of booster-induced memory/adaptive humoral immunity and suggests potential strategies to optimize vaccine efficacy and durability in future iterations.
  • ||||||||||  Promune (agatolimod) / Pfizer, Zifivax (ZF2001) / Chinese Academy of Medical Sciences, Chongqing Zhifei
    Journal:  A Novel Single-Stranded RNA-Based Adjuvant Improves the Immunogenicity of the SARS-CoV-2 Recombinant Protein Vaccine. (Pubmed Central) -  Sep 30, 2022   
    L2, with adjuvant compatibility with RBD, elevated the antibody response to a level more than that achieved with Al, CpG 7909, or poly(I:C) as adjuvants in mice...Taken together, L2, used as an adjuvant, enhanced the immune response of the SARS-CoV-2 recombinant RBD protein vaccine in mice. These findings should provide a basis for the R&D of novel RNA-based adjuvants.
  • ||||||||||  Zifivax (ZF2001) / Chinese Academy of Medical Sciences, Chongqing Zhifei
    Trial completion, Trial primary completion date:  ZF2001 Booster Immunization Clinical Trials of 12 Months After the Completion of Basic Immunization (clinicaltrials.gov) -  Sep 29, 2022   
    P1/2,  N=300, Completed, 
    Recruiting --> Active, not recruiting Active, not recruiting --> Completed | Trial primary completion date: Mar 2022 --> Jul 2022
  • ||||||||||  Covaxin (BBV152 COVID Vaccine) / Bharat Biotech, Indian Council of Medical Research, Ocugen, Zifivax (ZF2001) / Chinese Academy of Medical Sciences, Chongqing Zhifei
    Clinical, Journal:  Efficacy of Approved Versus Unapproved Vaccines for Severe Acute Respiratory Syndrome Coronavirus 2 Infection in Randomized Blinded Clinical Trials. (Pubmed Central) -  Sep 14, 2022   
    Other vaccines have been developed, including Sinopharm, SinoVac, QazVac, Covaxin, Soberana, Zifivax, Medicago, Clover, and Cansino, but they are not approved in high-income countries...Differences in study design, endpoint definitions, variants, and infection prevalence may have influenced results. New patent-free vaccines could lower costs of worldwide SARS-CoV-2 vaccination campaigns significantly.
  • ||||||||||  Convidecia (Adenovirus Type 5 Vector) / CanSino, NPO Petrovax, Zifivax (ZF2001) / Chinese Academy of Medical Sciences, Chongqing Zhifei
    Observational data, Journal:  The acceptance to heterologous booster vaccination of COVID-19 vaccine among HCWs and targeted population: A cross-sectional study in central China. (Pubmed Central) -  Aug 22, 2022   
    The heterologous booster vaccination strategy on the COVID-19 vaccine could be widely accepted among HCWs, whereas its acceptance among targeted population was only moderate. Public authorities should make efforts to communicate the public about the effectiveness and safety of the heterologous booster vaccination which could help increase their willingness to get vaccinated.
  • ||||||||||  Zifivax (ZF2001) / Chinese Academy of Medical Sciences, Chongqing Zhifei
    Journal:  Omicron SARS-CoV-2 Neutralization from Inactivated and ZF2001 Vaccines. (Pubmed Central) -  Jul 24, 2022   
    Public authorities should make efforts to communicate the public about the effectiveness and safety of the heterologous booster vaccination which could help increase their willingness to get vaccinated. No abstract available
  • ||||||||||  Covovax (NVX-CoV2373) / Novavax, Takeda, Serum Institute of India, Sputnik-V (Gam-COVID-Vac Lyo) / Gamaleya Research Institute
    Review, Journal:  Covid-19 vaccines and variants of concern: A review. (Pubmed Central) -  Jul 10, 2022   
    All nine had an efficacy over 50% against symptomatic Covid-19 disease: NVX-CoV2373 (∼96%), BNT162b2 (∼95%), mRNA-1273 (∼94%), Sputnik V (∼92%), AZD1222 (∼81%), BBIBP-CorV (∼79%), Covaxin (∼78%), Ad26.CoV.S (∼66%) and CoronaVac (∼51%)...Promising Covid-19 vaccines such as WIBP-CorV, AD5-nCOV, ZyCoV-D, CVnCoV, EpiVacCorona and ZF2001 have advanced to clinical studies. This review describes the most relevant mutations in the SARS-CoV-2 spike protein, discusses VE against VOCs, presents rare adverse events after Covid-19 vaccination and introduces some promising Covid-19 vaccine candidates.
  • ||||||||||  Zifivax (ZF2001) / Chinese Academy of Medical Sciences, Chongqing Zhifei
    Journal:  Milk of Cow and Goat, Immunized by Recombinant Protein Vaccine ZF-UZ-VAC2001(Zifivax), Contains Neutralizing Antibodies Against SARS-CoV-2 and Remains Active After Standard Milk Pasteurization. (Pubmed Central) -  Jul 8, 2022   
    Here, we present the first experimental validation of the possibility for obtaining immune milk with neutralizing antibodies against SARS-CoV-2 from vaccinated cows and goat using approved recombinant protein human coronavirus vaccine, ZF-UZ-VAC2001, in the Republic of Uzbekistan...We showed an optimal regime for immune milk pasteurization at 62.5°C for 30 min, which retained specific neutralizing activity to SARS-CoV-2, potentially useful for passive immunization against coronavirus infection threats as an additive approach to the vaccination. This strategy, as a supportive approach to the vaccination, could also be applicable for directly reducing the effect of COVID-19 infection in gastrointestinal tract, supporting mucosal immunity.
  • ||||||||||  Zifivax (ZF2001) / Chinese Academy of Medical Sciences, Chongqing Zhifei
    Journal:  Protective prototype-Beta and Delta-Omicron chimeric RBD-dimer vaccines against SARS-CoV-2. (Pubmed Central) -  Jun 29, 2022   
    Again, the chimeric vaccine elicited broader sera neutralization of SARS-CoV-2 variants and conferred better protection against challenge by either Delta or Omicron SARS-CoV-2 in mice. The chimeric approach is applicable for rapid updating of immunogens, and our data supported the use of variant-adapted multivalent vaccine against circulating and emerging variants.
  • ||||||||||  Zifivax (ZF2001) / Chinese Academy of Medical Sciences, Chongqing Zhifei
    Clinical, Journal:  Efficacy and Safety of the RBD-Dimer-Based Covid-19 Vaccine ZF2001 in Adults. (Pubmed Central) -  Jun 8, 2022   
    P3
    In a large cohort of adults, the ZF2001 vaccine was shown to be safe and effective against symptomatic and severe-to-critical Covid-19 for at least 6 months after full vaccination. (Funded by the National Science and Technology Major Project and others; ClinicalTrials.gov number, NCT04646590.).
  • ||||||||||  CoronaVac / Sinovac, Bio Farma Indonesia, BBIBP-CorV / Wuhan Institute of Virology, Sinopharm, Zifivax (ZF2001) / Chinese Academy of Medical Sciences, Chongqing Zhifei
    Observational data, Journal:  Safety and Immunogenicity of Inactivated and Recombinant Protein SARS-CoV-2 Vaccines in Patients With Thyroid Cancer. (Pubmed Central) -  Jun 4, 2022   
    The regression time of SARS-CoV-2 IgG is significantly shorter in thyroid cancer patients than in healthy adults. Therefore, a booster vaccination dose may be earlier than the systematic strategy for thyroid cancer patients.