KCONVAC (inactivated SARS-CoV-2 Vaccine) / Shenzhen Kangtai - LARVOL DELTA

A head-to-head comparison of humoral and cellular immune responses of five COVID-19 vaccines in adults in China. (PubMed, Front Immunol) - "Here, SARS-CoV 2-specific immune responses to DNA vaccine (INO-4800), mRNA vaccine (BNT162b2), Adenovirus-vectored vaccine (CONVIDECIA), Protein subunit vaccine (Recombinant COVID- 19 Vaccine (Sf9 Cells)), Inactivated Vaccine (KCONVAC) were examined longitudinally in healthy adults between Jan 15, 2021 and July 5, 2021 for 6 months...BNT162b2 (mRNA vaccine) exhibits the highest antibody levels among the five vaccines evaluated, regardless of whether the target is the wild-type virus or its variants. However, its cellular immune response may be weaker compared to CONVIDECIA (adenovirus type 5 vector vaccine)."

Clinical • Head-to-Head • Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

CpG 684: an effective adjuvant for the inactivated COVID-19 vaccine in mice. (PubMed, Future Virol) - "CpG 684 also improved cellular immune response. CpG 684 is an effective adjuvant for inactivated COVID-19 vaccine."

Journal • Preclinical • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG

Hand-foot-vulva pustule After COVID-19 inactive vaccine (ISDS 2023) - "The patient was first diagnosed with palmoplantar pustulosis and was prescribed oral acitretin 30mg once daily and topical steroids for one month...Therefore, we chose tripterygium glycosides as an anti-inflammatory and doxycycline to inhibit neutrophil chemotaxis. After being adjusted to a new treatment, the patient recovered."

Dermatology • Immunology • Infectious Disease • Novel Coronavirus Disease • Ophthalmology • Psoriasis • Pustular Psoriasis • Urticaria • CRP

Immunogenicity and Safety of a SARS-CoV-2 Inactivated Vaccine KCONVAC in Chinese Children: Randomized, Double-blind, Placebo-controlled Phase 1 and 2 Trials. (PubMed, Pediatr Infect Dis J) - "Two doses of this study vaccine, KCONVAC, were well tolerated and immunogenic in children 3 to 17 years of age."

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

Immunogenicity and Safety of a SARS-CoV-2 Inactivated Vaccine KCONVAC in Chinese Children: Randomized, Double-blind, Placebo-controlled Phase 1 and 2 Trials. (PubMed, Pediatr Infect Dis J) - "Two doses of this study vaccine, KCONVAC, were well tolerated and immunogenic in children 3 to 17 years of age."

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

Comparison of the immunogenicity of nasal-spray rVSV vector, adenovirus vector, and inactivated COVID-19-based vaccines in rodent models. (PubMed, J Med Virol) - "Furthermore, the immune responses elicited by rVSV-based vaccine candidates via the i.n. route were significantly higher than those of two licensed vaccines: the inactivated vaccine KCONVAC delivered via the i.m. route and the adenovirus-based Vaxzevria delivered i.n. or i.m. We next assessed the booster efficacy of rVSV following two i.m. doses of KCONVAC. In summary, our results confirmed that two i.n. doses of rVSV-Beta elicited significantly higher humoral immune responses than commercial inactivated and adeno-based COVID vaccines in hamsters. As a heterologous booster dose, rVSV-Beta induced potent, persistent, and broad-spectrum humoral and mucosal neutralizing responses against all VOCs, highlighting its potential to be developed into a nasal-spray vaccine."

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

Insufficient epitope-specific T cell clones are responsible for impaired cellular immunity to inactivated SARS-CoV-2 vaccine in older adults. (PubMed, Nat Aging) - "Single-cell sequencing revealed that older adults had less T cell clone expansion specific to SARS-CoV-2, likely due to inadequate immune receptor repertoire size and diversity. Our study provides mechanistic insights for weaker response to inactivated vaccine by older adults and suggests the need for further vaccination optimization for the old population."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Omicron variants escape the persistent SARS-CoV-2-specific antibody response in 2-year COVID-19 convalescents regardless of vaccination. (PubMed, Emerg Microbes Infect) - "Furthermore, we revealed that inactivated vaccines (BBIBP-CorV, CoronaVac, or KCONVAC) could improve the plasma neutralization and help to maintain the broadly neutralizing antibodies at a certain level. Notably, with the time-dependent decline of antibody, 1-dose or 2-dose vaccination strategy seemed not to be enough to provide immune protection against the emerging variants. Overall, these results facilitated our understanding of SARS-CoV-2-induced antibody memory, contributing to the development of immunization strategy against SARS-CoV-2 variants for such a large number of COVID-19 survivors."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Effectiveness of Booster Doses of the SARS-CoV-2 Inactivated Vaccine KCONVAC against the Mutant Strains. (PubMed, Viruses) - "As the COVID-19 epidemic progresses with the emergence of different SARS-CoV-2 variants, it is important to know the effectiveness of inactivated SARS-CoV-2 vaccines against the variants...Fifty days post-boost, the KCONVAC-vaccinated CD8 T-cell level reached 1.23-, 2.59-, 2.53-, and 1.01-fold that of convalescents against ancestral, Delta, Omicron and other SARS-CoV-2 variants, respectively. Our data demonstrate the importance of KCONVAC boosters to broaden both humoral and cellular immune responses against SARS-CoV-2 variants."

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

Unravelling the enhanced vaccine immunity by heterologous KCONVAC/Ad5-nCoV COVID-19 vaccination. (PubMed, Signal Transduct Target Ther) - No abstract available

Journal • Infectious Disease • Novel Coronavirus Disease

Simultaneous quantification of spike and nucleocapsid protein in inactivated COVID-19 vaccine bulk by liquid chromatography-tandem mass spectrometry. (PubMed, J Chromatogr B Analyt Technol Biomed Life Sci) - "The amount of S and N proteins in 9 batches of inactivated COVID-19 vaccines were quantified, and their compositions relative to total protein content were consistent. We believe this method can be applied for quality evaluation of other S and/or N protein based COVID-19 vaccine, and could be extended to other viral vector, and protein subunit-based vaccines."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Phase Ⅱ Clinical Trial of SARS-CoV-2 Vaccine (Vero Cells), Inactivated in Healthy Population Aged 3 to 17 Years(COVID-19) (clinicaltrials.gov) - P2; N=480; Not yet recruiting; Sponsor: Shenzhen Kangtai Biological Products Co., LTD

New P2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Phase Ⅰ Clinical Trial of SARS-CoV-2 Vaccine (Vero Cells), Inactivated in Healthy Population Aged 3 to 17 Years(COVID-19) (clinicaltrials.gov) - P1; N=84; Not yet recruiting; Sponsor: Shenzhen Kangtai Biological Products Co., LTD

New P1 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Immunogenicity and safety of a SARS-CoV-2 inactivated vaccine in healthy adults: randomized, double-blind, and placebo-controlled phase 1 and phase 2 clinical trials. (PubMed, Chin Med J (Engl)) - "Both doses of KCONVAC are well tolerated and able to induce robust immune responses in healthy adults. These results support testing 5-μg vaccine in the 0/28 regimen in an upcoming phase 3 efficacy trial."

Clinical • Journal • P1 data • P2 data • Infectious Disease • Musculoskeletal Diseases • Novel Coronavirus Disease • Orthopedics • Respiratory Diseases

A Study to Evaluate the Efficacy, Safety and Immunogenicity of SARS-CoV-2 Vaccine (Vero Cells), Inactivated in Healthy Adults Aged 18 Years and Older (COVID-19) (clinicaltrials.gov) - P3; N=28000; Not yet recruiting; Sponsor: Shenzhen Kangtai Biological Products Co., LTD

New P3 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Shenzhen Kangtai Biological Products : China’s Kangtai starts mid-stage trial of its COVID-19 vaccine candidate (Market Screener) - "China's Shenzhen Kangtai Biological Products has begun a mid-stage human trial of its experimental coronavirus vaccine....The company plans to test the vaccine's safety and ability to trigger immune responses in a Phase 2 clinical trial expected to recruit 1,000 participants....The vaccine candidate uses an inactivated virus that cannot replicate in human cells....Trial has already started."

Trial status • Infectious Disease • Novel Coronavirus Disease

A Safety and Immunogenicity Study of Inactivated SARS-CoV-2 Vaccine (Vero Cells) in Healthy Population Aged 18 Years and Above(COVID-19) (clinicaltrials.gov) - P1; N=180; Active, not recruiting; Sponsor: Beijing Minhai Biotechnology Co., Ltd

Clinical • New P1 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IL2 • IL4 • IL5 • IL6

A Study to Evaluate Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccine (Vero Cells) in Healthy Population Aged 18 Years and Above(COVID-19) (clinicaltrials.gov) - P2; N=1000; Active, not recruiting; Sponsor: Beijing Minhai Biotechnology Co., Ltd

Clinical • New P2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases