Jcovden (COVID-19 vaccine (Ad26.COV2-S [recombinant])) / J&J - LARVOL DELTA

Sisonke Boost: Sisonke 2 - A COVID-19 Vaccine Boost Open Label Study. (clinicaltrials.gov) - P3 | N=500000 | Completed | Sponsor: Wits Health Consortium (Pty) Ltd | Recruiting ➔ Completed | Phase classification: P3b ➔ P3

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

Implications for future pandemics from a living systematic review and critical evaluation of observational studies of the effectiveness of COVID-19 vaccination against the Omicron variant. (PubMed, Vaccine) - "Reliable evidence on COVID-19 vaccine effectiveness during the period of Omicron variant predominance was essential to inform global vaccination strategies...Weekly searches covering seven databases up to 31 December 2022 sought evidence for WHO-approved vaccine platforms, including mRNA vaccines (BNT162b2, mRNA-1273), adenoviral vector vaccines (ChAdOx1-S, SII-ChAdOx1 nCoV-19, Ad26.COV2·S, Gam-COVID-Vac) and inactivated virus vaccines (CoronaVac, BBV-152)...Most results were judged to be at moderate risk of bias (361, 18%) or at serious risk of bias (1591, 78%) with the principal concern being confounding. We discuss implications for future pandemic preparedness, including the importance of standardized study protocols; robust data linkage between vaccination, testing and outcomes; and validated risk-of-bias frameworks for diverse observational designs."

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

Anti-PEG Antibodies From mRNA COVID-19 Vaccines Affect In Vitro Measurements of Pegylated Drug Levels. (PubMed, Clin Transl Sci) - "Elevated anti-PEG antibody titers with prolonged prevalence were detected in individuals who received the mRNA-1273 vaccine as compared to control samples...Serum from those who received the BNT162b2 or Ad26.COV2.S vaccines had anti-PEG antibody levels similar to control samples. Serum from individuals with elevated anti-PEG antibodies, regardless of study group, typically showed decreased detection of the pegylated drug, pegfilgrastim. This study demonstrates that anti-PEG antibodies have the potential to interfere with bioanalytical assays used for pharmacokinetic drug measurement during the development of pegylated pharmaceutical products, as well as during the establishment of comparability to pegylated reference products during development of biosimilar drug products."

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

Using tree-based scan statistics to assess vaccines for possible associations with Guillain-Barré syndrome in the Vaccine Safety Datalink. (PubMed, Vaccine) - "Conversely, there are no vaccines with a previously known association with GBS for which no signal was found. Tree-based data-mining holds promise for studying other outcomes suspected of association with vaccination, if case-finding algorithms are relatively specific, and allows detection of effects common to groups of related vaccines."

Journal • Herpes Zoster • Infectious Disease • Influenza • Novel Coronavirus Disease • Pertussis • Pneumococcal Infections • Respiratory Diseases • Tetanus

Comparative analysis of non-clinical and clinical safety assessment of COVID 19 vaccines. (PubMed, Regul Toxicol Pharmacol) - "Five authorized vaccines were included in the analysis: tozinameran (Comirnaty®), elasomeran (Spikevax®), ChAdOx1-S (Vaxzevria®), Ad26.COV2-S (Jcovden®), and the SARS-CoV-2-S protein with Matrix-M (Nuvaxovid®). These rare events were not predicted by non-clinical studies as expected. While non-clinical studies currently meet regulatory safety requirements, their predictive capacity could be enhanced by integrating a reactogenicity scoring system, harmonizing biomarker monitoring, and adding targeted parameters based on clinical evidence."

Journal • Cardiovascular • Hematological Disorders • Infectious Disease • Inflammation • Novel Coronavirus Disease • Respiratory Diseases • Thrombocytopenia

Potential association of cluster headache with certain COVID-19 vaccines: An assessment from the pharmacovigilance databases. (PubMed, Headache) - "Our study supports the possibility of a potential association between COVID-19 vaccines and cluster headache through an updated pharmacovigilance analysis. The signal appears to be more pronounced with the Vaxzevria vaccine."

Adverse events • Journal • CNS Disorders • Infectious Disease • Migraine • Novel Coronavirus Disease • Pain • Respiratory Diseases

Minor differences in the untranslated regions of measles vector additional transcription units are reflected by differential immunogenicity of encoded MERS-CoV Spike antigen. (PubMed, J Virol) - "Besides mRNA vaccines, also viral platform technologies, that is, the adenovirus-derived vaccines Vaxzevria and JCOVDEN, have proven to be of immense value during the COVID-19 pandemic...This knowledge allows the tailoring of vaccine vectors to fit specific target product profiles, for example, to build vectors which trigger an accentuated T cell or, alternatively, antibody response against an antigen of interest. Our study using the live-attenuated measles vaccine backbone as a promising example is therefore crucial in demonstrating that very minor differences in the vaccine backbone can alter the antigen expression profile of the vector-antigen system and impact the relative induction of T-cell or antibody responses against the added target antigen."

Journal • Infectious Disease • Measles • Novel Coronavirus Disease • Respiratory Diseases • IFNAR1

Early innate immune signatures correlate with Ad26.COV2.S vaccine durability and protective efficacy. (PubMed, bioRxiv) - "Similar correlates of immunogenicity were observed in a cohort of 25 adult healthy participants vaccinated with Ad26.COV2.S. Taken together, these findings highlight the importance of early activation of the innate immune system for Ad26.COV2.S vaccine immunogenicity and protective efficacy."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Thyroid Adverse Events Following mRNA COVID-19 Vaccination: A Dose-Specific Disproportionality Analysis Using VAERS, 2021-2024 (ENDO 2026) - "Exposure: BNT162b2 or mRNA-1273 monovalent/bivalent (XBB.1.5 not separately identifiable in VAX_NAME)...Sensitivity comparators: (a) non-COVID vaccines; (b) Janssen Ad26.COV2.S as active adenoviral-vector comparator...AI Use: ChatGPT was used only for language editing to improve clarity and grammar. All scientific content, data interpretation, and conclusions were generated and verified by the authors."

Adverse events • Late-breaking abstract • Endocrine Disorders • Grave’s Disease • Immunology • Infectious Disease • Novel Coronavirus Disease

Analysis of adverse events following COVID-19 vaccination and infection: A retrospective, comparative cohort study using a claims database from Discovery Health, a managed care organisation in South Africa. (PubMed, S Afr Med J) - "Across all age subgroups analysed, the risks associated with SARS-CoV-2 infection exceeded the increased risks following COVID-19 vaccination."

Adverse events • Journal • Retrospective data • Acute Kidney Injury • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Dermatology • Diabetes • Endometriosis • Eosinophilic Esophagitis • Epilepsy • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Glomerulonephritis • Gynecology • Hematological Disorders • Idiopathic Pulmonary Fibrosis • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Lupus Nephritis • Metabolic Disorders • Multiple Sclerosis • Myocardial Infarction • Myositis • Nephrology • Novel Coronavirus Disease • Otorhinolaryngology • Pain • Pancreatitis • Pulmonary Embolism • Renal Disease • Respiratory Diseases • Thrombocytopenia • Type 1 Diabetes Mellitus • Urticaria • Vertigo • Women's Health

Long-term cross-variant Fc-mediated immune responses against SARS-CoV-2 induced by a heterologous adenoviral/inactivated virus prime-boost vaccination strategy. (PubMed, NPJ Vaccines) - "We evaluated the immunogenicity and longevity of four vaccine regimens in adults from Mozambique and Madagascar: single-dose Ad26.COV2.S (Ad26.S), homologous BBIBP-CorV (BBIBP), and two heterologous combinations (BBIBP-Ad26.S and Ad26.S-BBIBP, in prime-boost order). Compared to the other regimens, antibody-dependent natural killer cell activation (ADNKA) emerged as a distinct characteristic of durable cross-variant immunity in Ad26.S-BBIBP recipients. These findings highlight that the Ad26.S-BBIBP regimen is immunologically advantageous, with Fc-mediated effector functions, particularly ADNKA, representing an important characteristic of its relatively durable and cross-strain protection even as neutralizing antibody titers decline."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

COVID-19 vaccination and immunoreactant deposition in non-autoimmune oral mucosal pathologies. (PubMed, Oral Surg Oral Med Oral Pathol Oral Radiol) - "Vaccines, known to reduce mortality, were granted emergency use authorization by the U.S. Food and Drug Administration, including BNT162b2 (Pfizer-BioNTech, 2 doses), mRNA-1273 (Moderna, 2 doses), and JNJ-78436735 (Janssen, 1 dose)...Of the 27 cases where the non-specific immunostaining was present, 25 (92.6%) were obtained from patients who had previously received vaccination, yielding an OR of 7.068 (95% CI, 1.712-31.27; Fischer's exact test P = 0.0042). Although the significance of the immunoreactant deposition remains unknown, this study provides a foundation for further exploration of oral mucosal immunity associated with COVID-19 vaccination and possibly other vaccines."

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

Humoral Immune Correlates Analysis of Four Vaccines Against SARS-CoV-2 in Rhesus Macaques. (PubMed, Res Sq) - "We assessed correlates of protection (COP) in a vaccine trial of 126 Rhesus macaques randomized to placebo or one of four vaccines (mRNA-1273 [Moderna], Ad26.COV2.S [Janssen], NVX-CoV2373 [Novavax], and CoV2 preS dTM+AS03 [Sanofi]) at varying doses and challenged with SARS-CoV-2 (USA-WA1/2020 strain)...Further, the observed viral load for animals receiving each vaccine showed good agreement to their predicted values modelled only using data from animals receiving the other three vaccines (agreement coefficients between 0.25-0.59). These analyses suggest that neutralizing titers and antibody binding levels are correlates of protection that predict reduction in viral load across these four different vaccines."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Early transcriptional responses following Ad26.COV2.S vaccination in individuals with prior SARS-CoV-2 infection. (PubMed, EBioMedicine) - "In this study in whole blood, innate and adaptive immune transcripts were upregulated as early as one and seven days post-Ad26.COV2.S, respectively. These findings add to the limited data on innate immune responses to adenovirus-based vaccines in a clinical setting and contribute to understanding the mechanisms behind the adaptive immune responses that may contribute to protective immunity."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A randomized, observer-blind, phase 1 study of immune responses to three human adenovirus type 26 vector-based vaccines. (PubMed, EBioMedicine) - "All three vaccine regimens induced specific immunogenic responses, were well tolerated, and triggered strong innate and antiviral immunity responses within 2 days post-vaccination, with no distinct immune signature observed across vaccines per transcriptomics/proteomics analyses."

Journal • P1 data • Infectious Disease • Respiratory Syncytial Virus Infections

Intranasal Replicating Adenovirus type 4-SARS-CoV-2 Recombinants Induce Superior Immune Response Durability and Efficacy in Preclinical Testing Compared to Standard Intramuscular Vaccines. (PubMed, bioRxiv) - "Although both IN Ad4-S and intramuscular (IM) vaccines (Ad26.CoV2.S and mRNA-1273) induced serum binding antibodies, only Ad4-S induced a robust mucosal response in the nasal cavity. Upon challenge, IN immunization also resulted in less weight loss, greater breadth and durability of restriction of viral replication, and less lung pathology than IM immunization up to 268 days after immunization. These data support the potential of the IN Ad4 vaccine platform to reduce transmission of SARS-CoV-2 and other respiratory viruses with pandemic potential."

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

Intranasal replicating adenovirus type 4-vectored SARS-CoV-2 vaccines induce durable and efficacious responses in preclinical testing. (PubMed, iScience) - "Although both IN Ad4-S and intramuscular (IM) vaccines (Ad26.CoV2.S and mRNA-1273) induced serum binding antibodies, only Ad4-S induced a robust nasal mucosal response. Upon challenge, IN immunization also resulted in less weight loss, greater breadth and durability of restriction of viral replication, and less lung pathology than IM immunization up to 268 days after immunization. These data support the potential of the IN Ad4 vaccine platform to reduce the transmission of SARS-CoV-2 and other respiratory viruses with pandemic potential."

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

CVTB: Immunogenicity of COVID-19 Vaccines in Tuberculosis Patients (clinicaltrials.gov) - P=N/A | N=133 | Recruiting | Sponsor: University of Oxford | Active, not recruiting ➔ Recruiting | Trial completion date: Dec 2025 ➔ Jun 2026 | Trial primary completion date: Dec 2025 ➔ Jun 2026

Enrollment open • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Antigen-specific IgG glycosylation profiles in hamsters and macaques following COVID-19 vaccination. (PubMed, iScience) - "In this study, we investigated the Fc glycosylation patterns of antigen-specific IgG in hamsters and rhesus macaques following immunization with Ad26.COV2.S COVID-19 vaccine...For example, we observed a transient afucosylated IgG response in both species, resembling the response previously reported in humans. These results indicate that IgG Fc glycosylation responses to vaccination in macaques and hamsters recapitulate key features of the human response, supporting their use as translational models for adenovirus vector-based vaccination studies."

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

Platelet Factor 4 Antibody Persistence and Long-term Pathogenicity in Vaccine-induced Immune Thrombotic Thrombocytopenia. (PubMed, J Thromb Haemost) - "VITT, unlike monoclonal gammopathy of thrombotic significance, appears to be an MGUS-negative state, but needs confirmation in larger studies. VITT antibodies can be comprised of lambda or kappa light chains, and some VITT patients exhibit persistent thrombocytopenia many years after the acute event."

Journal • Cardiovascular • Hematological Disorders • Hematological Malignancies • Monoclonal Gammopathy • Thrombocytopenia • Thrombosis

Incidence of Guillain-Barré Syndrome Following COVID-19 Vaccination and SARS-CoV-2 Infection: A Population-Based Cohort Study Using the Valencia Health System Integrated Database (Spain). (PubMed, Pharmaceuticals (Basel)) - "Two cohorts were defined: individuals receiving COVID-19 vaccines (mRNA-based vaccines (BNT162b2 [Pfizer-BioNTech] and mRNA-1273 [Moderna]) or non-virus-vectored (NVV) adenoviral vector-based vaccines (ChAdOx1-S [AstraZeneca] and Ad26.COV2.S [Janssen])) and individuals with laboratory-confirmed SARS-CoV-2 infection. Moreover, GBS appears to be more frequent after a COVID-19 infection than after vaccination. These findings highlight the importance of integrating pharmacoepidemiological analyses with pharmacovigilance data to contextualize rare but serious adverse events."

Journal • CNS Disorders • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Plus_Booster: Effectiveness, Immunogenicity and Safety of the Second Booster Dose of the Vaccine Against COVID-19 in the Elderly (clinicaltrials.gov) - P=N/A | N=260 | Completed | Sponsor: Federal University of Espirito Santo | Not yet recruiting ➔ Completed | N=490000 ➔ 260

Enrollment change • Trial completion • Infectious Disease • Novel Coronavirus Disease

A modified self-controlled case series on mortality risk following primary series doses of COVID-19 vaccines in U.S. Medicare beneficiaries aged 65 years and older. (PubMed, Vaccine) - "We did not observe an increased risk of mortality in U.S. older adults 4 weeks following a primary series dose of a COVID-19 vaccine."

Journal • Medicare • Reimbursement • US reimbursement • Infectious Disease • Novel Coronavirus Disease

Dose-dependent IFN programs in myeloid cells after mRNA and adenovirus COVID-19 vaccination. (PubMed, JCI Insight) - "However, to date, no study has directly compared immune responses to all 3 FDA-approved COVID-19 vaccines at single-cell multiomic resolution.METHODSWe longitudinally profiled SARS-CoV-2-naive adults (n = 31) vaccinated with BNT162b2, mRNA-1273, or Ad26.COV2.S, integrating plasma cytokines, antibody titers, and single-cell multiomic data (DOGMA-Seq).RESULTSWe discovered a distinct, transient IFN program termed ISG-dim, which emerged specifically 1-2 days after the first mRNA dose in approximately 10% of myeloid cells. This state was characterized by ISGF3 complex activation and its target genes (e.g., MX1, MX2, DDX58), with transcriptional and epigenetic profiles distinct from the robust IFN program observed after mRNA boosting or a single Ad26.COV2.S dose (ISG-high). In vitro stimulation of human monocytes showed that IFN-α alone recapitulates ISG-dim, whereas both IFN-α and IFN-γ are required for ISG-high.CONCLUSIONThese findings define dose-dependent IFN programming..."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • DDX58 • IFNA1 • IFNG • MX1

Immune Response to COVID-19 Vaccines: Updates in a Fast-Moving Scenario. (PubMed, Vaccines (Basel)) - "Far from being complete and exhaustive, this Special Issue provides the reader with fresh insights into several critical questions raised by or connected to the advent of COVID-19 vaccines. This introductory article provides an overview of their contribution, while offering a quick glance at the current state of the art."

Journal • Cardiovascular • Human Immunodeficiency Virus • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease • Rheumatology • Transplantation