This study is a non-randomized observation and comparison of immune response between bacteriologically confirmed TB patients under treatment cohort who received COVID-19 vaccine (n=54) vs healthy individuals (n=54).
Each participant will receive single or double doses of one of COVID-19 vaccines (Pfizer-BioNTech COVID-19 vaccine, AstraZeneca vaccine or Janssen Ad26.COV2.S COVID-19 vaccine) in the deltoid muscle of the non-dominant arm. Study Duration approximately 1 year. The main focus of this study is to compare the humoral and cellular immunological responses of the COVID-19 vaccines between bacteriologically confirmed TB patients under treatment vs healthy individuals.
This study is funded by the Wellcome Trust. The grant reference number is 220211/A/20/Z.

Start Date15 Apr 2023

Sponsor / Collaborator

University of Oxford

NCT05710289

/ WithdrawnNot Applicable

A Prospective Blood Collection Study to Assess the Immunogenicity of Homologous Booster Combinations of COVID-19 Vaccines Available Under Emergency Use Authorization Among Adults of 18 Years and Older.

The purpose of this study is to assess the immunogenicity of nationally available pre-defined homologous booster vaccination of a SARS-CoV-2 WHO EUA qualified vaccination in adults aged 18 years and older

Start Date01 Feb 2023

Sponsor / Collaborator

SK bioscience Co., Ltd.

[+1]

NCT06429020

/ CompletedNot ApplicableIIT

Sonography for COVID-19 Vaccines Related Reactive Lymphadenopathy: A Retrospective Study

This study aimed to provide vast clinical information to facilitate breast sonographic examination for participants who underwent recent SARS-CoV-2 vaccination.
Among different SARS-CoV-2 vaccines in the Asian Taiwanese population, reactive axillary lymphadenopathy was investigated through breast sonographic findings and clinical data analysis. The sample included participants with recent vaccinations by different brands approved in Taiwan.

Start Date01 Jan 2023

Sponsor / Collaborator

Chi Mei Medical Center

100 Clinical Results associated with COVID-19 Vaccine (ChAdOx1-S [recombinant])(AstraZeneca Plc)

100 Translational Medicine associated with COVID-19 Vaccine (ChAdOx1-S [recombinant])(AstraZeneca Plc)

100 Patents (Medical) associated with COVID-19 Vaccine (ChAdOx1-S [recombinant])(AstraZeneca Plc)

1,845

Literatures (Medical) associated with COVID-19 Vaccine (ChAdOx1-S [recombinant])(AstraZeneca Plc)

01 Apr 2026·JOURNAL OF MICROBIOLOGY IMMUNOLOGY AND INFECTION

Cellular and humoral immunity following two AZD1222 and two booster vaccinations in hemodialysis patients

Article

Author: Chang, Yu-Tzu ; Huang, Chieh-Hsin ; Wang, Jen-Ren ; Shieh, Chi-Chang ; Sun, Chien-Yao ; Wu, Jia-Ling ; Lin, Wei-Ren ; Ko, Wen-Chien ; Chen, Po-Lin ; Ling, Tsai-Chieh ; Chao, Chiao-Hsuan

BACKGROUND:

Dialysis patients are vulnerable to SARS-CoV-2 infection and subsequent complications. However, the vaccine-induced immunity, especially against new variants, following two AZD1222 and two booster doses in hemodialysis patients remain largely unknown.

METHODS:

In this observational cohort study, we monitored immune responses in 127 hemodialysis patients receiving the 3^rd and 4th vaccinations until three months after the 4th immunization. Humoral and cellular immunity were assessed by anti-SARS-CoV-2 receptor-binding domain(RBD) antibody, neutralizing antibodies against the ancestral virus, delta, omicron BA.1 and BA.2 and SARS-CoV-2 specific IFN-γ releasing assay (Covi-FERON).

RESULTS:

The primary series and the fourth dose predominantly consisted of two-dose AZD1222 and mRNA-1273, respectively. The most common vaccines chosen for the third dose was mRNA-1273(n = 84), following by BNT 162b2(n = 38). Anti-RBD antibody increased to 13803.8 and 18197U/ml after the 3^rd and 4th vaccination, respectively, but dropped to 8709.6U/ml three months after the fourth vaccination. One month after the fourth vaccination, 99 %,98 %,51.5 % and 93.9 % participants had neutralizing antibodies against the ancestral virus, delta, omicron BA.1 and BA.2, respectively. 87.9 % and 81.8 % patients reacted to the ancestral or alpha and beta or gamma spike antigens in Covi-FERON, respectively, after four vaccinations. Higher Covi-FERON reactions were associated with increased IL-2 and IL-4 secretion. In linear mixed effect models, mRNA-1273 as the third vaccination was associated higher anti-RBD antibody titers and higher neutralization against the ancestral virus and delta compared with BNT162b2 but with higher mild adverse events following vaccination.

CONCLUSIONS:

Two AZD1222 and two mRNA booster doses confer substantial humoral and cellular immunity against variants including omicron in hemodialysis patients.

01 Mar 2026·DRUG SAFETY

Statistical Methods for Multi-jurisdictional Australian Vaccine Safety Investigations of Rare Adverse Events

Article

Author: Ngeh, Sera ; Effler, Paul ; Morgan, Hannah J ; Clothier, Hazel J ; Buttery, Jim P ; Kattan, Gonzalo Sepulveda ; Cadby, Gemma ; Boyd, James H ; Bloomfield, Lauren ; Carcione, Dale

BACKGROUND:

In Australia, surveillance of adverse events following immunisation is primarily conducted by states and territories, with each jurisdiction only able to view and analyse reports originating from their own population. Distributed data models (aka federated data models) are a form of decentralised collaboration, with each site maintaining ownership of its data from end-to-end including data collection, storage and analysis. The primary benefit of this model is that it maintains independence and autonomy while enabling interdependence, collaboration and scalability.

OBJECTIVE:

We aimed to investigate statistical methods for a multi-jurisdictional collaboration when conducting a rigorous assessment of rare adverse events following immunisation at a national level.

METHODS:

Victoria and Western Australia have independently established routine data linkage for vaccine safety surveillance. A data collaboration model is proposed, whereby each jurisdiction can generate de-identified population-level data for adverse events following immunisation, using agreed case definitions and analytical methods. To demonstrate its utility, Victoria and Western Australia combined data from a self-controlled case series via a meta-analysis approach using aggregate data and a pooled approach using individual-level data to investigate the association between coronavirus disease 2019 vaccines and Guillain-Barré syndrome.

RESULTS:

There were 519 and 176 new Guillain-Barré syndrome International Classification of Diseases, Tenth Revision, Australian Modification coded admissions in Victoria and Western Australia, respectively, between 01/01/2020 and 31/12/2023. Combining data using a fixed-effect meta-analysis method (relative incidence: 2.64, 95% confidence interval 1.90, 3.66) and a pooled method (relative incidence: 2.45, 95% confidence interval 1.76, 3.41) confirmed the known increased incidence in the 42 days following a coronavirus disease 2019 Vaxzevria^® vaccination. Both methods resulted in a decreased standard error when compared with either state alone.

CONCLUSIONS:

This project represents an ongoing successful collaboration between two Australian jurisdictions using data linkage to investigate rare adverse events following immunisation and inform accurate benefit-risk analyses. The decision to use meta-analysis and pooled analysis methods should be considered on a case-by-case basis and may depend on data-sharing agreements, the ease of pooling potentially discordant data variables and underlying population characteristics.

01 Mar 2026·INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES

Assessing the association between COVID-19 vaccination and thrombotic thrombocytopenia syndrome (ATTEST Study): Analyses of English data, 2020-2022

Article

Author: Fan, Xuejuan ; Layton, Deborah ; Hinton, William ; Anand, Sneha ; Hobbs, F D Richard ; de Lusignan, Simon ; Mather, Lisa ; Lee, Andrew ; Kar, Debasish ; Ferreira, Filipa ; Byford, Rachel ; Joy, Mark ; Forbes, Anna ; Meza-Torres, Bernardo ; Ordóñez-Mena, José M ; Wimalaratna, Rashmi ; Jamie, Gavin ; Gu, Xinchun

OBJECTIVE:

COVID-19 vaccine surveillance detected thrombotic thrombocytopenia syndrome (TTS), a rare combination of thrombosis and thrombocytopenia, after COVID-19 vaccination. We evaluated TTS risk within 28 days of AZD1222 and BNT162b2 exposure.

METHODS:

Matched case-control (MCCS) and self-controlled case series (SCCS) studies used Oxford-Royal College of General Practitioners Research and Surveillance Centre data linked to immunization, hospitalization and death data. English patient records extracted from December 2, 2020 to October 31, 2022 were used to identify TTS cases and age, sex, and practice matched controls. Conditional logistic regression and conditional Poisson regression were used for MCCS and SCCS analyses, respectively.

RESULTS:

Of 666 TTS events identified, >90% happened without AZD1222/BNT162b2 exposure in the preceding 28 days. MCCS analyses showed no association between TTS and a composite of both first and second AZD1222 dose (adjusted odds ratio [aOR]: 1.45 [95% CI: 0.90-2.34]). Both studies showed increased TTS risk after AZD1222 first dose (MCCS, aOR: 2.12 [1.14-3.92]; SCCS, incidence rate ratio: 3.49 [2.22-5.49]). No association between TTS and BNT162b2 was observed.

CONCLUSION:

Consistent with previous studies, we found an association between TTS and receiving a first dose of AZD1222. There were no associations of TTS with AZD1222 second dose and BNT162b2 first or second doses.

174

News (Medical) associated with COVID-19 Vaccine (ChAdOx1-S [recombinant])(AstraZeneca Plc)

15 Jan 2026

·endpoints.news

New York sues former Emergent CEO for alleged insider trading during Covid vaccine struggles

New York prosecutors sued the former CEO of Emergent BioSolutions over alleged insider trading while the contract manufacturer struggled with contamination issues making AstraZeneca’s Covid-19 vaccine during the pandemic. The lawsuit , filed Thursday by Attorney General Letitia James, claims Robert Kramer had material non-public knowledge and sold more than $10 million in stock prior to the company’s problems coming to light in February 2021. The AG is seeking damages, disgorgement and costs from Kramer. James also announced a settlement with Emergent for approving the executive’s trades. The dispute hinges on the timing of a stock trading program Kramer put in place and what he knew about contamination issues at the Maryland facility where Emergent helped make AstraZeneca’s Covid vaccine. “Emergent noticed indices of contamination in Emergent’s AZD1222 vaccine drug substance, including elevated endotoxin and excess bioburden in multiple drug substance batches, as early as September 26, 2020,” James’ suit said. Kramer’s trading plan to dump shares became effective Nov. 13 of that year “before the public learned of these serious problems and ultimately traded before the material nonpublic information was disclosed and the stock price fell,” the suit says. The company’s shares, which had soared during the pandemic to a high of $134.46 on Aug. 5, 2020, dropped below $100 in February 2021 and currently trade at about $11 a share. As a result of Emergent’s settlement with James, the company agreed to pay $900,000 in penalties and improve its executive trading policies. A company spokesperson said Emergent will report to the New York AG for three years regarding trading plans adopted, modified or terminated by senior management and board members. The latest case isn’t Kramer’s first run-in with insider trading accusations. In 2019, he settled a 2016 suit over alleged possession of material non-public information regarding Emergent’s manufacture of an anthrax vaccine. As for the plant’s contamination issues, the FDA ordered a permanent halt to Emergent’s production of AstraZeneca’s Covid vaccine on April 4, 2021, after Emergent had completed only 28 commercially viable batches of the vaccine, with 13 more in progress. Emergent initially agreed to manufacture up to 95 vaccine batches by April 30, 2021, and 120 batches by June 30, 2021.

VaccinePatent InfringementmRNA

05 Aug 2025

·endpoints.news

AstraZeneca culls plans for Evusheld successor in the US following Covid evolution

AstraZeneca is no longer seeking FDA approval for its Covid-19 prevention antibody known as sipavibart, a company spokesperson confirmed to Endpoints News . The monoclonal antibody was meant to be a successor to AstraZeneca’s former blockbuster Evusheld, which was authorized in the US, EU and other countries to help prevent Covid in immunocompromised individuals. The FDA pulled Evusheld’s emergency authorization in January 2023 due to ineffectiveness against most circulating variants. As for sipavibart, it’s approved in other regions. Japan and the EU greenlit the antibody after it passed muster in a Phase 3 trial that read out in May 2024. It is known as Kavigale in those markets. In the 3,330-person trial, AstraZeneca said sipavibart helped curtail symptomatic Covid in immunocompromised individuals as compared to Evusheld or placebo. At the time, the drugmaker thought the antibody could potentially work in an “ evolving variant landscape .” The company attributed its decision to sideline sipavibart in the US to currently circulating variants. “Due to the high prevalence of SARS-CoV-2 variants that are resistant to sipavibart, we are not currently pursuing a BLA in the US in Covid-19 prophylaxis,” the AstraZeneca spokesperson said in an email. Chemical & Engineering News first reported the news on Tuesday. It marks another Covid-related setback for AstraZeneca. The company developed a vaccine with the University of Oxford, eventually delivering Vaxzevria to more than 180 countries. The pharmaceutical company later withdrew the shot globally last year. At the time, a spokesperson said “no future commercial demand for the vaccine is expected.” AstraZeneca is not completely out of Covid R&D. The pharma is working on an mRNA-VLP vaccine that’s in Phase 1 , according to its most recent quarterly results. Immunocompromised individuals have said they are looking for other prevention tools after the FDA revoked the authorizations of Evusheld and antibodies from other biotech and pharma companies . The antibodies had offered an alternative , or additional, method of protection alongside vaccines. Invivyd’s Pemgarda is authorized for emergency use for Covid prevention in the US. Meanwhile, other efforts have also stalled over the years. A startup called Aerium Therapeutics shuttered last year after Covid variants threw a wrench in its R&D plans.

Phase 3VaccineEmergency Use AuthorizationDrug ApprovalmRNA

20 Mar 2025

·investors.barinthusbio.com

Barinthus Bio Reports Full Year 2024 Financial Results and Updates on Corporate Developments

Strategic transformation ongoing, positioning the Company as a focused leader in immunology and inflammatory diseases Highly differentiated, potentially curative immunotherapy for celiac disease (VTP-1000) in the clinic, with first data expected in third quarter of 2025 Proprietary SNAP-TI platform promoting antigen-specific immune tolerance is anticipated to drive multiple future pipeline and partnership opportunities Strategic prioritization of resources expected to provide a cash runway into 2027 OXFORD, United Kingdom and GERMANTOWN, Md., March 20, 2025 (GLOBE NEWSWIRE) -- Barinthus Biotherapeutics plc (NASDAQ: BRNS) (“Barinthus Bio,” or the “Company”), an immunology and inflammation (I&I) company focused on developing therapies that promote immune tolerance with curative potential, today announced its financial results for the year ended December 31, 2024 and provided an overview of the Company’s business updates. “We’ve entered 2025 with a refreshed strategic focus on immunological and inflammatory diseases. Following our restructuring, we are strongly positioned to advance our highly differentiated lead asset,VTP-1000, (and the underlying SNAP-TI platform) in patients with celiac disease. Through design innovations enabling greater targeting of disease antigens, intramuscular administration and potentially improved tolerability, VTP-1000 has promise to be a leading therapy for the approximate 80 million people worldwide with celiac disease. We look forward to reporting single-ascending dose Phase 1 data for this program in the third quarter of this year.” said Bill Enright, Chief Executive Officer of Barinthus Bio. “VTP-1000 is based on our innovative SNAP-TI platform, which is differentiated based on its capacity to promote antigen-specific immune tolerance that specifically guides a patient's T cells to suppress unwanted inflammation and restore the natural state of immune non-responsiveness to healthy tissue without affecting immunity against cancer or infections. Given this mild and potentially curative approach to restoring balance to the immune system, we believe SNAP-TI is poised to drive multiple future pipeline and partnership opportunities for the company particularly for autoimmune diseases where broadly immunosuppressive drugs are not optimal." “Turning to our development candidates designated for partnering, we reported highly encouraging results from two Phase 2 trials in our chronic hepatitis B (“CHB”) program demonstrating that VTP-300 contributed to the achievement of undetectable HBsAg levels in eight participants, with two participants meeting functional cure criteria. Further Phase 2 data are anticipated in the second quarter of 2025, which are expected to strengthen VTP-300’s market positioning as a component of a functional cure for CHB.” 2024 Corporate MilestonesClinical developments Celiac Disease (VTP-1000) In April 2024, Barinthus Bio received clearance from the U.S. Food and Drug Administration and Australian regulatory authorities on an Investigational New Drug application to progress VTP-1000 in a first in human clinical trial in celiac disease. In September 2024, Barinthus Bio initiated the first-in-human, Phase 1 AVALON trial for VTP-1000 in celiac disease. The AVALON trial aims to enroll 42 participants with celiac disease and will be conducted in two parts: the first part, a randomized double-blind placebo controlled single ascending dose, followed by the second part, a randomized double-blind placebo-controlled multiple ascending dose and incorporating a controlled gluten challenge to assess the impact of VTP-1000 administration on patients’ exposure to gluten. Chronic Hepatitis B (VTP-300) In June 2024, Barinthus Bio presented interim data from the two Phase 2 trials of VTP-300, which achieved 19% undetectable HBsAg levels across both studies, indicating potential rates of functional cure. The majority of patients who were assessed reached very low levels of HBsAg and eligibility for nucleos(t)ide discontinuation. In October 2024, the Company completed enrollment of the Phase 2b HBV003 clinical trial for VTP-300 in CHB. In November 2024 Barinthus Bio reported positive updated interim data from the Phase 2b HBV003 clinical trial for VTP-300 showing that as of the data cut off, eight participants achieved complete HBsAg loss (defined as HBsAg levels below the lower limit of quantitation [

Phase 2Clinical ResultPhase 1Executive Change

100 Deals associated with COVID-19 Vaccine (ChAdOx1-S [recombinant])(AstraZeneca Plc)

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-	COVID-19 Vaccine (ChAdOx1-S [recombinant])(AstraZeneca Plc)	J07B	DB15656

R&D Status

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Indication	Country/Location	Organization	Date
COVID-19	United Kingdom	AstraZeneca PLC	30 Dec 2020

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04536051 (COV003, Pubmed \| Mayo Clin Proc Innov Qual Outcomes)	Phase 3	COVID-19	172	ChAdOx1 nCoV-19 (AZD1222)	coyhplugrf(zbscosdsbc) = oamuaepdeq sjjrcjgysu (rmnrttkcbw, 1.6 - 2.4) View more	Positive	01 Aug 2025
NCT05057897 (VICTORIA, CTgov)	Phase 4	COVID-19	34	AZD1222 (Immunocompromised Cohort)	gcfkcrbeqf(imrvmwbved) = ogojrgvtuw noixywjqar (habnenjtjf, xbldifejfd - zbymjybphg) View more	-	27 Jan 2025
				AZD1222 (Immunocompetent Cohort)	gcfkcrbeqf(imrvmwbved) = fnokumiahu noixywjqar (habnenjtjf, obymekxvfx - onpmtoktjx) View more
NCT04568031 (phase 1/2 trial, CTgov)	Phase 1/2	COVID-19	256	AZD1222 (Cohort C: AZD1222)	onjbpaawle = kuketijxud ceojaunemi (eclnwbmiok, gualythgwu - wefhfgwvut) View more	-	01 Mar 2024
				placebo+AZD1222 (Cohort C: Placebo)	onjbpaawle = wxocepbhsj ceojaunemi (eclnwbmiok, zbubkpadnx - qwgnfdgain) View more
Open Label Extension Study (ACR2022)	Not Applicable	anti-RBD antibody titers	36	Rituximab treated patients with 3rd vaccination with vector vaccine	rowfxfngvt(zxixqehnfo) = one serious adverse event not related to vaccination occurred dzrmpydltw (zxgaxonvpc )	Negative	13 Nov 2022
				Rituximab treated patients with 3rd vaccination with mRNA vaccine
ASN2022	Not Applicable	Hemodialysis complication Maintenance	130	Inactivated Vaccine (Sinovac (SV-SV))	wnrrhgitfv(xetvgggiiv) = frbbmvimla pufnskkyfk (xiipcbtioa )	Positive	03 Nov 2022
				AZD1222 (AZ-AZ)	wnrrhgitfv(xetvgggiiv) = yfgdtpjsnj pufnskkyfk (xiipcbtioa )
NCT04516746 (Pubmed) Manual	Phase 3	COVID-19	32,450	COVID-19 Vaccine	tkopqtmond(oihskpvstv) = sybauejzyx zttmgqzxon (qdyardrrry ) View more	Positive	15 Sep 2022
				Placebo	tkopqtmond(oihskpvstv) = ihvllnaswe zttmgqzxon (qdyardrrry ) View more
ISTH2022	Not Applicable	Thrombocytopenia	-	2nd dose AZD1222	qgixqclglw(ubcnhwadeo) = Three catastrophic cases including 2 fatalities occurred. Concomitant factors were present in all and influenced outcome severity. tilcnaikan (nepkjxavrp )	-	09 Jul 2022
EADV2022	Not Applicable	Herpes Zoster	11	AZD1222 COVID-19 mRNA vaccine	hzccdrrtpf(xyhfzsariy) = two patients developed VZV after the first dose of 253 Pfizer vaccine and both were proceeded to the second dose of vaccine without any complications lazcggdrlq (hucblazuge )	Positive	12 May 2022
NCT04516746 (AZD1222, CTgov)	Phase 3	COVID-19	32,450	AZD1222 (AZD1222)	zsxcjwxvqy = bsivdiftmj feaqjwqxrx (yppqopwaxw, zbtbglrxfp - swhvueyuhx) View more	-	01 Apr 2022
				Placebo (Placebo)	zsxcjwxvqy = sgazifdlck feaqjwqxrx (yppqopwaxw, hyggorpgvo - yehjnrqdro) View more
NCT04400838 (COV002, Pubmed \| Lancet)	Phase 2/3	COVID-19	560	ChAdOx1 nCoV-19 vaccine (ChAdOx1 nCoV-19)	fbrrbtympv(oyrdlhwqpn) = Local and systemic reactions were more common in participants given ChAdOx1 nCoV-19 than in those given the control vaccine, and similar in nature to those previously reported (injection-site pain, feeling feverish, muscle ache, headache), but were less common in older adults (aged ≥56 years) than younger adults. zdjppfgthd (bciwgykyxd ) View more	Positive	19 Dec 2021

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