Delving into the Latest Updates on PF-6425090 with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine

Synonyms

Clostridium difficile vaccine, Toxoid-based Clostridium difficile vaccine

+ [1]

Target

TcdA x toxB

Mechanism

TcdA inhibitors(TcdA inhibitors), toxB inhibitors(Toxin B inhibitors)

Therapeutic Areas

Infectious Diseases

Active Indication-

Inactive Indication

Clostridium difficile colitisClostridium difficile infection

Originator Organization

Pfizer Inc.

Active Organization-

Inactive Organization

Pfizer Inc.

Drug Highest PhasePendingPhase 3

First Approval Date-

Regulation-

Gene Sequence

Sequence Code 4709750

Sequence Code 4709758

This study will investigate a Clostridium difficile vaccine in adults 50 years of age and older. In half the adults, all 3 doses given are the Clostridium difficile vaccine, and in half the adults, 2 of the 3 doses are the Clostridium difficile vaccine with the other dose containing no active ingredients. The study will look at the subjects' immune response to the vaccine and assess the safety and tolerability of a 2-dose regimen of Clostridium difficile vaccine compared to a 3-dose regimen of Clostridium difficile vaccine.

Start Date01 Apr 2019

Sponsor / Collaborator

Pfizer Inc.

NCT03579459 / CompletedPhase 3

A PHASE 3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE LOT CONSISTENCY, SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A CLOSTRIDIUM DIFFICILE VACCINE IN HEALTHY ADULTS 65 TO 85 YEARS OF AGE

This study will investigate a Clostridium difficile vaccine in healthy adults 65 to 85 years of age, who will each receive 3 doses of vaccine. The study will assess the lot consistency, safety, and tolerability of the vaccine, and also look at the subjects' immune response to the vaccine.

Start Date31 Jul 2018

Sponsor / Collaborator

Pfizer Inc.

NCT03090191 / CompletedPhase 3

A PHASE 3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF A CLOSTRIDIUM DIFFICILE VACCINE IN ADULTS 50 YEARS OF AGE AND OLDER

The Clover trial is evaluating an investigational vaccine that may help to prevent Clostridium difficile infection. Participants in the study are adults 50 years of age and older, who are at risk of developing Clostridium difficile infection. The study will assess whether the vaccine prevents the disease, and whether it is safe and well tolerated.
Each subject will receive 3 doses of Clostridium difficile vaccine or placebo and be followed for up to 3 years after vaccination for potential Clostridium difficile infection.

Start Date29 Mar 2017

Sponsor / Collaborator

Pfizer Inc.

100 Clinical Results associated with PF-6425090

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100 Translational Medicine associated with PF-6425090

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100 Patents (Medical) associated with PF-6425090

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17

Literatures (Medical) associated with PF-6425090

01 Jan 2024·Advances in Experimental Medicine and Biology

Clostridioides difficile Infections: Prevention and Treatment Strategies

Review

Author: Vandenplas, Yvan ; Levy, Elvira Ingrid ; Dinleyici, Meltem ; Dinleyici, Ener

Clostridioides difficile is the most common causative agent of antibiotic-associated diarrhea. This spore forming, obligate anaerobic, gram-positive bacillus is becoming responsible for an increasing number of infections worldwide, both in community and in hospital settings, whose severity can vary widely from an asymptomatic infection to a lethal disease. While discontinuation of antimicrobial agents and antibiotic treatment of the infection remain the cornerstone of therapy, more recent fecal microbiota transplantation has also been valid as a therapy. The use of probiotics, especially Saccharomyces boulardii CNCM I-745 have become valid forms of prevention therapy. Although there are studies in adults with microbiota-targeted new generation therapies and Clostridium difficile vaccines, there are no data in the paediatric age group yet.

01 Dec 2023·Vaccine

A phase 3 study evaluating the lot consistency, immunogenicity, safety, and tolerability of a Clostridioides difficile vaccine in healthy adults 65 to 85 years of age

Article

Author: Lockhart, Stephen P ; Kitchin, Nicholas ; Brock, Linda ; Lamberth, Erik ; Shah, Rupal ; Zhang, Haiying ; Pride, Michael W ; Webber, Chris ; Christensen, Shane ; Gao, Qi ; Bouguermouh, Salim ; Ilangovan, Kumar ; Gruber, William C ; Anderson, Annaliesa S

BACKGROUNDA toxoid-based Clostridioides difficile vaccine is currently in development. Here, we report lot-to-lot consistency, immunogenicity, safety, and tolerability of 3 C difficile vaccine doses in healthy older adults.METHODSThis phase 3, placebo-controlled study randomized (1:1:1:1) healthy adults 65 to 85 years of age to 1 of 3 C difficile vaccine lots or placebo. Participants received C difficile vaccine (200 μg total toxoid) or placebo (Months 0, 1, 6). The primary immunogenicity objective was lot-to-lot consistency (2-sided 95 % CIs within 0.5 and 2 for comparisons of geometric mean concentration [GMC] ratios) for toxins A- and B-specific neutralizing antibody levels 1 month after Dose 3. Safety outcomes included local reactions and systemic events ≤7 days after vaccination, adverse events (AEs), and serious AEs (SAEs).RESULTSOf 1317 enrolled participants, 1218 completed the study. C difficile vaccine immunogenicity was consistent across lots, with neutralizing antibody responses 1 month after Dose 3 for both toxin A (GMC [95 % CI]: lot 1, 878.8 [786.3, 982.2]; lot 2, 873.0 [779.2, 978.1]; lot 3, 872.9 [782.6, 973.5]) and toxin B (lot 1, 5823.9 [5041.0, 6728.4]; lot 2, 5462.8 [4733.4, 6304.7]; lot 3, 5426.0 [4724.4, 6231.8]). Two-sided 95 % CIs for GMC ratios were within 0.5 and 2 for toxins A and B, indicating lot-to-lot consistency was achieved. C difficile vaccine was well tolerated, with similar rates of local reactions and systemic events among vaccine lots. AE and SAE rates were similar across C difficile vaccine (36.5 % and 4.5 %, respectively) and placebo (35.3 % and 6 %).CONCLUSIONSThree doses (Months 0,1,6) of toxoid-based C difficile vaccine induced robust neutralizing antibody responses and were well tolerated in healthy participants 65 to 85 years of age. Lot-to-lot consistency was excellent, indicating the manufacturing process for this C difficile vaccine formulation was well controlled.CLINICAL TRIAL REGISTRATIONClinicalTrials.gov identifier: NCT03579459.

01 Feb 2023·Drugs

Emerging Options for the Prevention and Management of Clostridioides difficile Infection

Review

Author: Gonzales-Luna, Anne J ; Carlson, Travis J ; Garey, Kevin W

Agents in development for the prevention or treatment of Clostridioides difficile infection can be split into three broad categories: antibiotics, microbiome restoration, and vaccines. Given the extensive list of agents currently in development, this narrative review will focus on agents that have progressed into late-stage clinical trials, defined as having a Phase III clinical trial registered on ClinicalTrials.gov. These agents include one antibiotic (ridinilazole), three live biotherapeutic products (LBPs) (CP101, RBX2660, and SER109), and two toxoid vaccines (PF06425090 and a second toxoid vaccine). As new prevention and treatment strategies enter the market, clinicians and administrators will need knowledge of these products to make rational decisions on how best to adopt them into clinical practice.

100 Deals associated with PF-6425090

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Clostridium difficile infection	Phase 3	SE	Pfizer Inc.	29 Mar 2017
Clostridium difficile infection	Phase 3	PL	Pfizer Inc.	29 Mar 2017
Clostridium difficile infection	Phase 3	FR	Pfizer Inc.	29 Mar 2017
Clostridium difficile infection	Phase 3	US	Pfizer Inc.	29 Mar 2017
Clostridium difficile infection	Phase 3	CZ	Pfizer Inc.	29 Mar 2017
Clostridium difficile infection	Phase 3	GB	Pfizer Inc.	29 Mar 2017
Clostridium difficile infection	Phase 3	TW	Pfizer Inc.	29 Mar 2017
Clostridium difficile infection	Phase 3	SK	Pfizer Inc.	29 Mar 2017
Clostridium difficile infection	Phase 3	PT	Pfizer Inc.	29 Mar 2017
Clostridium difficile infection	Phase 3	FI	Pfizer Inc.	29 Mar 2017

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03918629 (CTgov)	Phase 3	Clostridium difficile colitis	1,994	Clostridium Difficile Vaccine (2-Dose Clostridium Difficile Vaccine)	otpciezfxq(qeigujekrz) = bvhawxxqag vpjqosshvh (ecmkdovslt, edhyloqttg - qamyvjkqrv) View more	-	10 Jan 2024
				Clostridium Difficile Vaccine (3-Dose Clostridium Difficile Vaccine)	otpciezfxq(qeigujekrz) = wjuabfdwge vpjqosshvh (ecmkdovslt, uhjspupybr - wdydlodqqv) View more
EASL2023	Not Applicable	Nonalcoholic Steatohepatitis \| Metabolic dysfunction-associated steatotic liver disease	-	Clostridium difficile (CDI and NASH)	(vtoyacwjgc) = gkterrlige mwhntbkecv (gxgmxmdxlq )	-	21 Jun 2023
				Clostridium difficile (CDI and NAFLD)	(vtoyacwjgc) = veynbhgier mwhntbkecv (gxgmxmdxlq )
NCT03090191 (CLOVER, CTgov)	Phase 3	Clostridium difficile infection	17,535	Clostridium difficile vaccine (Clostridium Difficile Vaccine)	sgjmjajxuu(rmcndufynv) = keubxrnekv frjtbsaekg (uximvzheiv, wssvlellvq - wtzelpeywu) View more	-	13 Feb 2023
				Placebo (Placebo)	sgjmjajxuu(rmcndufynv) = dpqgmiiaes frjtbsaekg (uximvzheiv, shapckdrjg - vnnwitedrd) View more
NCT03579459 (CTgov)	Phase 3	Clostridium difficile colitis	1,317	placebo	rifrulnoxb(bufowokjwu) = fhskdxnjxi ywofhzkjka (iupqdcmaxz, qzgzxyegyn - ttrzaskbmx) View more	-	19 Jan 2023
NCT03090191 (CLOVER, BusinessWire) Manual	Phase 3	Clostridium difficile infection	17,500	PF-6425090	(wvdxyrizqy) = Local and systemic reactions were mild to moderate, with mostly pain at the injection site with higher incidence after the second and third doses. The number of participants reporting overall adverse events (AEs), serious AEs (SAEs), withdrawals and deaths were similar between the two groups. iexgsjwcaf (nuhcohafil )	Negative	01 Mar 2022
				Placebo
NCT02117570 (CTgov)	Phase 2	Clostridium difficile colitis	185	Placebo	vlewiluolv(qsilrdcecq) = hmnfnuymhw wbrumawfoi (bqhopzhyjv, dbwkkggqzy - aubpnqcdmi) View more	-	30 Jan 2017