SCB-2019 / Sichuan Clover Biopharma, CEPI, Dynavax - LARVOL DELTA

Indirect effectiveness of a novel SAR-COV-2 vaccine (SCB-2019) in unvaccinated household contacts in the Philippines: a cluster randomised analysis. (PubMed, J Infect) - P2/3 | "SCB-2019 demonstrated bias-corrected indirect effectiveness against SARS-CoV-2 infection among HHC, even at a modest coverage level in the household (approximately 25%). Further research into the indirect effects of SARS-CoV-2 vaccines is needed to optimize the impact of limited doses in low and middle-income settings."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Interchangeability of different COVID-19 vaccine platforms as booster doses: A phase 3 study mimicking real-world practice. (PubMed, Vaccine) - P3 | "Protein, adenovirus-vector or mRNA vaccine boosters were equally well tolerated and immunogenic against ancestor SARS-CoV-2 and Omicron sub-lineages in fully primed adults with 0-2 prior boosters. BNT162b induced the highest immune responses but also the most rapid waning of antibodies 3 months after vaccination."

Journal • P3 data • Real-world • Real-world evidence • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Efficacy of adjuvant-associated COVID-19 vaccines against SARS-CoV-2 variants of concern in randomized controlled trials: A systematic review and meta-analysis. (PubMed, Medicine (Baltimore)) - "In this meta-analysis, it should be that full vaccination with ACVs has high efficacy against Alpha or Gamma variants and moderate efficacy against Beta and Delta variants. Notably, with the exception of the aluminum-adjuvanted vaccine, the other ACVs had moderate to high efficacy against the SARS-CoV-2 variant. This raises concerns about the effectiveness of ACVs booster vaccinations against Omicron."

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

SCB-2019 protein vaccine as heterologous booster of neutralizing activity against SARS-CoV-2 Omicron variants after immunization with other COVID-19 vaccines. (PubMed, Hum Vaccin Immunother) - "No vaccine-related serious adverse events were reported. Heterologous SCB-2019 boosting was well tolerated and elicited neutralizing responses against all tested SARS-COV-2 viruses including Omicron BA.1, BA.2, BA.4, BA.5, BF.7, BQ.1.1.3, and XBB1.5 sub-lineages that were non-inferior to homologous boosting with CoronaVac or Vaxzevria, but not homologous Comirnaty booster."

Journal • Fatigue • Infectious Disease • Novel Coronavirus Disease • Pain • Respiratory Diseases

Boosting with adjuvanted SCB-2019 elicits superior Fcγ-receptor engagement driven by IgG3 to SARS-CoV-2 spike. (PubMed, NPJ Vaccines) - "Individuals who were primed with 2 doses of the ChAdOx1 vaccine were equally divided into 4 groups and boosted with following formulations: Group 1: 9 μg SCB-2019 and Alhydrogel; Group 2: 9 μg SCB-2019, CpG 1018, and Alhydrogel; Group 3: 30 μg SCB-2019, CpG 1018, and Alhydrogel; Group 4: ChAdOx1. Moreover, from day 15 after vaccination, Group 3 exhibited higher IgG3 and FcγR binding across variants of concerns, including Omicron and its subvariants, compared to the ChAdOx1-boosted individuals. Overall, this highlights the potential of SCB-2019 as a cost-efficient boosting regimen effective across variants of concerns."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Vaccination is the most effective and best way to avoid the disease of COVID-19. (PubMed, Immun Inflamm Dis) - "Among the vaccines that stimulate the host's immune system with the help of DNA are: undergoing Phase 2/3 trials including INO-4800 (International Vaccine Institute; Inovio Pharmaceuticals), Symvivo, Canada-COVID19 (AnGes, Inc.); GX-19 (Genexine, Inc.). BNT162b2 and mRNA-1273 vaccines were made by BioNTech/Pfizer/Fosun Pharma group and Moderna/NIAID group, respectively, which are considered as types of RNA vaccines...Among the inactive viral vaccines, the following can be mentioned: CoronaVac (Sinovac) WIBP vaccine (Wuhan Institute of Biological Products, Sinopharm), BBIBPCorV (Beijing Institute of Biological Products, Sinopharm), BBV152/Covaxin (Bharat Biotech, ICMR, National Institute of Virology) And among the protein-based/subunit vaccines, the following can be counted: NVX-CoV2373: (Novavax); SCB-2019 vaccine (Clover Biopharmaceuticals AUS Pty Ltd.); Covax-19 (GeneCure Biotechnologies; Vaxine Pty Ltd.) mRNA vaccines, viral vector vaccines, and protein..."

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

Immunogenicity and Safety Study of SCB-2023 Vaccine as a Booster in Adults (clinicaltrials.gov) - P3 | N=0 | Withdrawn | Sponsor: Clover Biopharmaceuticals AUS Pty Ltd | N=600 ➔ 0 | Trial completion date: Sep 2024 ➔ Aug 2023 | Not yet recruiting ➔ Withdrawn | Trial primary completion date: Aug 2024 ➔ Aug 2023

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Infectious Disease • Novel Coronavirus Disease

Immunogenicity and Safety Study of SCB-2019 Vaccine as a Booster to COVID-19 Vaccine in Adults (clinicaltrials.gov) - P3 | N=1831 | Completed | Sponsor: Clover Biopharmaceuticals AUS Pty Ltd | Active, not recruiting ➔ Completed | Trial completion date: Feb 2024 ➔ Jun 2023

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

Superior boosting of neutralizing titers against Omicron SARS-CoV-2 variants by heterologous SCB-2019 vaccine vs a homologous booster in CoronaVac-primed adults. (PubMed, J Infect Dis) - "Boosting CoronaVac-immunized adults with full or half doses of SCB-2019 was well tolerated with superior immunogenicity than homologous boosting, particularly against newly emerged variants, supporting use of SCB-2019 for booster vaccination."

Journal • Fatigue • Infectious Disease • Novel Coronavirus Disease • Pain • Respiratory Diseases

Safety and Immunogenicity Dose-finding Study of Adjuvanted SCB-2020S Vaccine in Adults (clinicaltrials.gov) - P1 | N=153 | Completed | Sponsor: Clover Biopharmaceuticals AUS Pty Ltd | Active, not recruiting ➔ Completed | Trial completion date: Sep 2023 ➔ Apr 2023 | Trial primary completion date: Sep 2023 ➔ Sep 2022

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

Immunogenicity and Safety Study of SCB-2023 Vaccine as a Booster in Adults (clinicaltrials.gov) - P3 | N=600 | Not yet recruiting | Sponsor: Clover Biopharmaceuticals AUS Pty Ltd

New P3 trial • Infectious Disease • Novel Coronavirus Disease

SPECTRA: A Controlled Phase 2/3 Study of Adjuvanted Recombinant SARS-CoV-2 Trimeric S-protein Vaccine (SCB-2019) for the Prevention of COVID-19 (clinicaltrials.gov) - P2/3 | N=31454 | Completed | Sponsor: Clover Biopharmaceuticals AUS Pty Ltd | Active, not recruiting ➔ Completed

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

Safety and immunogenicity of SCB-2019, an adjuvanted, recombinant SARS-CoV-2 trimeric S-protein subunit COVID-19 vaccine in healthy 12-17 year-old adolescents. (PubMed, Hum Vaccin Immunother) - P2/3 | "SCB-2019 vaccine was highly immunogenic against SARS-CoV-2 prototype and variants in adolescents, especially in those with evidence of prior exposure, with comparable immunogenicity to young adults. Clinical trial registration: EudraCT 2020-004272-17; ClinicalTrials.gov NCT04672395."

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

Assessment of Immunogenicity, Safety and Reactogenicity of a Booster Dose of Various COVID-19 Vaccine Platforms in Individuals Primed With Several Regimes. (clinicaltrials.gov) - P3 | N=760 | Active, not recruiting | Sponsor: D'Or Institute for Research and Education

New P3 trial • Real-world • Real-world evidence • Infectious Disease • Novel Coronavirus Disease

Safety and Immunogenicity of SCB-2019 in Children <18 Years of Age (clinicaltrials.gov) - P2/3 | N=0 | Withdrawn | Sponsor: Clover Biopharmaceuticals AUS Pty Ltd | N=3820 ➔ 0 | Trial completion date: Jul 2024 ➔ Dec 2022 | Not yet recruiting ➔ Withdrawn | Trial primary completion date: Jul 2024 ➔ Dec 2022

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Immunogenicity and Safety Study of SCB-2019 Vaccine as a Booster to COVID-19 Vaccine in Adults (clinicaltrials.gov) - P3 | N=1831 | Active, not recruiting | Sponsor: Clover Biopharmaceuticals AUS Pty Ltd | Recruiting ➔ Active, not recruiting | Trial completion date: Oct 2023 ➔ Feb 2024 | Trial primary completion date: Mar 2023 ➔ Jun 2023

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

Six-month safety follow-up of an adjuvanted SARS-CoV-2 trimeric S-protein subunit vaccine (SCB-2019) in adults: A phase 2/3, double-blind, randomized study. (PubMed, Vaccine) - P2/3 | "SCB-2019 administered as a 2-dose series has an acceptable safety profile. No safety concerns were identified during the 6-month follow-up after the primary vaccination."

Journal • P2/3 data • Acute Respiratory Distress Syndrome • CNS Disorders • Immunology • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases

Immunogenicity of an adjuvanted SARS-CoV-2 trimeric S-protein subunit vaccine (SCB-2019) in SARS-CoV-2-naïve and exposed individuals in a phase 2/3, double-blind, randomized study. (PubMed, Vaccine) - P2/3 | "A single dose of SCB-2019 was immunogenic in SARS-CoV-2-exposed individuals, whereas two doses were required to induce immune response in SARS-CoV-2-naïve individuals. SCB-2019 elicited a cross-neutralizing response against emergent SARS-CoV-2 variants at antibody levels associated with clinical protection, underlining its potential as a booster."

Journal • P2/3 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Impact of vaccination with SCB-2019 COVID-19 vaccine on transmission of SARS-CoV-2 infection: a household contact study in the Philippines. (PubMed, Clin Infect Dis) - "In this prospective household contact study vaccination with SCB-2019 reduced SARS-CoV-2 transmission compared with placebo in households and in household members independently of whether index cases were symptomatic or not."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Immunogenicity and Safety Study of SCB-2019 Vaccine as a Booster to COVID-19 Vaccine in Adults (clinicaltrials.gov) - P3 | N=1822 | Recruiting | Sponsor: Clover Biopharmaceuticals AUS Pty Ltd | Trial completion date: Apr 2023 ➔ Oct 2023 | Trial primary completion date: Oct 2022 ➔ Mar 2023

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

Safety and Immunogenicity Dose-finding Study of Adjuvanted SCB-2020S Vaccine in Adults (clinicaltrials.gov) - P1 | N=153 | Active, not recruiting | Sponsor: Clover Biopharmaceuticals AUS Pty Ltd | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Homologous and Heterologous Boosting of the Chadox1-S1-S COVID-19 Vaccine With the SCB-2019 Vaccine Candidate: A Randomized, Controlled, Phase 2 Study. (PubMed, Open Forum Infect Dis) - P2 | "We assessed the immunogenicity and reactogenicity of booster doses of different formulations of aluminium hydroxide-adjuvanted SCB-2019 vaccine (9 μg of SCB-2019, with or without CpG-1018 adjuvant, or 30 μg of SCB-2019 with CpG-1018) in Brazilian adults primed with ChAdOx1-S vector vaccine. Boosting ChAdOx1-S-primed adults with SCB-2019 induced higher levels of antibodies against a wild-type strain and SARS-CoV-2 variants than a homologous ChAdOx1-S booster, with the highest responses being with the 30-μg SCB-2019 + CpG + aluminium hydroxide formulation. NCT05087368."

Journal • P2 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

SPECTRA: A Controlled Phase 2/3 Study of Adjuvanted Recombinant SARS-CoV-2 Trimeric S-protein Vaccine (SCB-2019) for the Prevention of COVID-19 (clinicaltrials.gov) - P2/3 | N=31454 | Active, not recruiting | Sponsor: Clover Biopharmaceuticals AUS Pty Ltd | Recruiting ➔ Active, not recruiting | Trial completion date: Jul 2022 ➔ Apr 2023

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

Safety and Immunogenicity of SCB-2019 in Children <18 Years of Age (clinicaltrials.gov) - P2/3 | N=3820 | Not yet recruiting | Sponsor: Clover Biopharmaceuticals AUS Pty Ltd | Initiation date: Jul 2022 ➔ Jan 2023

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

An Observer-blind, Cohort Randomized, Exploratory Phase 3 Study to Evaluate the Safety and Immunogenicity of Recombinant Covid-19 Vaccine, mRNA Covid-19 Vaccine and Recombinant SARS-CoV-2 Trimeric S-protein Subunit Vaccine as 4th Dose in Individuals Primed/ Boosted With Various Regimens (clinicaltrials.gov) - P3 | N=360 | Not yet recruiting | Sponsor: D'Or Institute for Research and Education

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