WIBP-CorV / Sinopharm - LARVOL DELTA

Assessment of the factors affecting the clinical outcomes of infection and safety of vaccines against SARS-CoV-2 among Egyptian patients. (PubMed, BMC Infect Dis) - "Vaccination, particularly with BBIBP-CorV (Sinopharm), significantly reduces COVID-19 severity among Egyptians, despite various clinical presentations and hematological effects."

Clinical data • Journal • Retrospective data • Cardiovascular • Diabetes • Hematological Disorders • Infectious Disease • Metabolic Disorders • Novel Coronavirus Disease • Respiratory Diseases

Re-Evaluation and Retrospective Comparison of Serum Neutralization Induced by Three Different Types of Inactivated SARS-CoV-2 Vaccines. (PubMed, Vaccines (Basel)) - "These three distinct types of inactivated vaccines, namely BBIBP-CorV, WIBP-CorV, and CoronaVac, induced serum neutralization in most vaccinated populations but in a short-term and variant-evaded manner with no significant difference among these inactivated vaccines."

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

Evaluation of the Robustness Verification of Downstream Production Process for Inactivated SARS-CoV-2 Vaccine and Different Chromatography Medium Purification Effects. (PubMed, Vaccines (Basel)) - "The study demonstrated the remarkable robustness of the current downstream process for producing WIBP-CorV vaccines. This process can adapt to different batches of hydrolytic concentrated solutions and various chromatography media. The research is crucial for the production of inactivated SARS-CoV-2 vaccines and provides a potential template for purifying other viruses."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study to Evaluate The Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) in Healthy Population Aged 18 Years Old and Above (clinicaltrials.gov) - P3 | N=44101 | Completed | Sponsor: China National Biotec Group Company Limited | Recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Sequential Immunization of Two Doses of Inactivated COVID-19 Vaccine (Omicron) in Vaccinated Population Aged 18 Years and Above (clinicaltrials.gov) - P3 | N=1804 | Active, not recruiting | Sponsor: China National Biotec Group Company Limited | Recruiting ➔ Active, not recruiting | Trial completion date: Nov 2023 ➔ Mar 2024 | Trial primary completion date: Nov 2022 ➔ Jul 2023

Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

Cov-Peru: Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru (clinicaltrials.gov) - P3 | N=12000 | Completed | Sponsor: Universidad Peruana Cayetano Heredia | Active, not recruiting ➔ Completed | Trial completion date: Dec 2021 ➔ Apr 2023

Trial completion • Trial completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Efficacy and Safety of a Booster Vaccination with Two Inactivated SARS-CoV-2 Vaccines on Symptomatic COVID-19 Infection in Adults: Results of a Double-Blind, Randomized, Placebo-Controlled, Phase 3 Trial in Abu Dhabi. (PubMed, Vaccines (Basel)) - P3 | "This study evaluated the safety of the booster dose, which was well tolerated by participants. Booster doses given over six months after the completion of primary immunization can help to provide more-effective protection against COVID-19 in healthy people 18 years of age or older. At the same time, the anti-SARS-CoV-2 antibodies produced by the two groups of experimental vaccines exhibited extensive cross-neutralization against representative SARS-CoV-2 variants."

Journal • P3 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Inactivated whole-virion SARS-CoV-2 vaccines and long-term clinical outcomes in patients with coronary atherosclerosis disease in China: a prospective cohort study. (PubMed, Cardiovasc Res) - "Our results indicated no evidence of an increased ischemic or bleeding risk after vaccination with inactivated SARS-CoV-2 vaccine among Chinese patients with CAD, with limited statistical power."

Clinical data • Journal • Acute Coronary Syndrome • Atherosclerosis • Cardiovascular • Coronary Artery Disease • Dyslipidemia • Hematological Disorders • Infectious Disease • Ischemic stroke • Myocardial Infarction • Novel Coronavirus Disease • Respiratory Diseases • Venous Thromboembolism

SARS-CoV-2 evolves to reduce but not abolish neutralizing action. (PubMed, J Med Virol) - "Serum samples from 65 convalescent individuals and 20 WIBP-CorV vaccine recipients and four therapeutic monoclonal antibodies (mAbs) namely imdevimab, casirivimab, bamlanivimab, and etesevimab were used to evaluate the neutralization potency against the variants...Therefore, SARS-CoV-2 has evolved persistently with a strong ability to escape neutralization and prevailing against the established immune barrier. Our findings provide important clues to controlling the COVID-19 pandemic caused by new variants."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety, immunogenicity, and immune persistence of two inactivated COVID-19 vaccines replacement vaccination in China: An observational cohort study. (PubMed, Vaccine) - "Both primary series were immunogenic; immunogenicity of WIBP-CorV followed by BBIBP-CorV was not different than immunogenicity following two doses of BBIBP-CorV for two months after vaccination; safety profiles were acceptable for both regimens. BBIBP-CorV can be used to complete a primary series that started with WIBP-CorV."

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

Safety and Immunogenicity of COVID-19 Vaccination in Patients with Hepatocellular Carcinoma (CHESS-NMCID 2101): A Multicenter Prospective Study. (PubMed, J Med Virol) - "Totally, 74 patients were enrolled from 10 centers in China, and 37 (50.0%), 25 (33.8%), and 12 (16.2%) received the CoronaVac, BBIBP-CorV, and WIBP-CorV, respectively...Given that the potential benefits may outweigh the risks and the continuing emergences of novel severe acute respiratory syndrome coronavirus 2 variants, we suggest HCC patients to be vaccinated against COVID-19. Future validation studies are warranted."

Journal • Anorexia • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Infectious Disease • Novel Coronavirus Disease • Oncology • Pain • Respiratory Diseases • Solid Tumor

Safety and Immunogenicity of an Inactivated COVID-19 Vaccine, WIBP-CorV, in Healthy Children: Interim Analysis of a Randomized, Double-Blind, Controlled, Phase 1/2 Trial. (PubMed, Front Immunol) - "Taken together, our data demonstrate that WIBP-CorV is safe and well tolerated at all tested doses in participants aged 3-17 years, and elicited robust humoral responses against SARS-CoV-2 lasted for at least 6 months after the third vaccination. This study is ongoing and is registered with www.chictr.org.cn, ChiCTR2000031809."

Clinical • Journal • P1 data • P1/2 data • P2 data • Infectious Disease • Novel Coronavirus Disease • Pain • Respiratory Diseases

Immune response and safety to inactivated COVID-19 vaccine: a comparison between people living with HIV and HIV-naive individuals. (PubMed, AIDS Res Ther) - "Early humoral immune response to the inactivated COVID-19 vaccine was weaker and delayed among the PLWH population than that among HNC. This observation remained consistent regardless of a high CD4 count with effective antiretroviral therapy."

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

Association of neutralizing breadth against SARS-CoV-2 with inoculation orders of heterologous prime-boost vaccines. (PubMed, Med (N Y)) - "Our data provide clinical evidence of inoculation order-dependent expansion of neutralizing breadth against SARS-CoV-2 in recipients of heterologous prime-boost vaccination and call for further studies into its underlying mechanism."

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

Sequential Immunization of Two Doses of Inactivated COVID-19 Vaccine (Omicron) in Vaccinated Population Aged 18 Years and Above (clinicaltrials.gov) - P3 | N=1800 | Recruiting | Sponsor: China National Biotec Group Company Limited | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Novel Coronavirus Disease

Sequential Immunization of Two Doses of Inactivated COVID-19 Vaccine (Omicron) in Vaccinated Population Aged 18 Years and Above (clinicaltrials.gov) - P3 | N=1800 | Not yet recruiting | Sponsor: China National Biotec Group Company Limited

New P3 trial • Infectious Disease • Novel Coronavirus Disease

A Study to Evaluate The Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) in Healthy Population Aged 18 Years Old and Above (clinicaltrials.gov) - P3 | N=45000 | Recruiting | Sponsor: China National Biotec Group Company Limited | Trial completion date: Sep 2021 ➔ Jul 2022

Trial completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Covid-19 vaccines and variants of concern: A review. (PubMed, Rev Med Virol) - "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."

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

Evaluation of Immunogenicity, Safety and Antibody Persistence of COVID-19 Booster Vaccine (Produced in Wuhan) in Patients With Hypertension and/or Diabetes (clinicaltrials.gov) - P4; N=1440; Not yet recruiting; Sponsor: China National Biotec Group Company Limited

Clinical • New P4 trial • Diabetes • Hypertension • Infectious Disease • Metabolic Disorders • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

Evaluation of Immunogenicity and Safety of Combined Immunization of COVAX (Produced in Wuhan) and PPV23 / IIV4 (clinicaltrials.gov) - P4; N=1404; Active, not recruiting; Sponsor: China National Biotec Group Company Limited

Clinical • New P4 trial • Infectious Disease • Novel Coronavirus Disease • Pneumococcal Infections • Pneumonia • Respiratory Diseases

Evaluation of Immunogenicity and Safety of COVAX (Produced in Wuhan) in Patients With Hypertension and/or Diabetes (clinicaltrials.gov) - P4; N=1440; Not yet recruiting; Sponsor: China National Biotec Group Company Limited

Clinical • New P4 trial • Diabetes • Hypertension • Infectious Disease • Metabolic Disorders • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

Cov-Peru: Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru (clinicaltrials.gov) - P3; N=12000; Active, not recruiting; Sponsor: Universidad Peruana Cayetano Heredia; Recruiting ➔ Active, not recruiting; N=6000 ➔ 12000; Trial completion date: Sep 2021 ➔ Dec 2021

Clinical • Enrollment change • Enrollment closed • Trial completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases