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-

Login to view timeline

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

Login to view more data

100 Translational Medicine associated with PF-6425090

Login to view more data

100 Patents (Medical) associated with PF-6425090

Login to view more data

18

Literatures (Medical) associated with PF-6425090

01 Nov 2024·Toxicon

Protection efficacy and immunogenicity of Clostridium chauvoei proteins as a subunit blackleg vaccine or an adjuvant for Clostridium perfringens epsilon toxoid

Article

Author: Hamzavipour, Roxana ; Zahmatkesh, Azadeh ; Paradise, Alireza ; Hosseini, Farzaneh

Potential application of Clostridium chauvoei proteins was studied as a subunit blackleg vaccine or a biological adjuvant for Clostridium perfringens epsilon toxoid vaccine. Extracellular and cell surface proteins were extracted from C. chauvoei culture, and their protective efficacy was evaluated by potency test in guinea pigs. In order to investigate the effect of cell surface proteins on C. perfringens epsilon toxoid immunogenicity, rabbits were inoculated subcutaneously twice with: C. perfringens type D toxoid supernatant +200 μg C. chauvoei cell surface proteins (PR-200), toxoid supernatant + 400 μg cell surface proteins (PR-400), inactivated C. perfringens type D vaccine (Vac), toxoid supernatant (Tox), or PBS. Isolation of cell surface proteins yielded about 2.5 mg/L culture protein with a sharp band at 43 kDa probably corresponding to flagellin. Potency test demonstrated the protection ability of both cellular and extracellular proteins of C. chauvoei. ELISA showed that the highest antibody titers against epsilon toxoid belonged to PR-400 and Vac groups. The effect of days post immunization on antibody response was not significant. No significant difference was observed between PR-400 and Vac, as well as PR-200 and Tox groups. Clostridium chauvoei cell surface proteins may have the potential for application as a blackleg disease vaccine and an adjuvant for clostridial toxoids.

01 Jan 2024·Advances in Experimental Medicine and Biology

Clostridioides difficile Infections: Prevention and Treatment Strategies

Review

Author: Levy, Elvira Ingrid ; Vandenplas, Yvan ; 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 ; Lamberth, Erik ; Brock, Linda ; Shah, Rupal ; Pride, Michael W ; Zhang, Haiying ; 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.

100 Deals associated with PF-6425090

Login to view more data

R&D Status

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Clostridium difficile infection	Phase 3	CZ	Pfizer Inc.	29 Mar 2017
Clostridium difficile infection	Phase 3	FI	Pfizer Inc.	29 Mar 2017
Clostridium difficile infection	Phase 3	CO	Pfizer Inc.	29 Mar 2017
Clostridium difficile infection	Phase 3	HU	Pfizer Inc.	29 Mar 2017
Clostridium difficile infection	Phase 3	BG	Pfizer Inc.	29 Mar 2017
Clostridium difficile infection	Phase 3	CA	Pfizer Inc.	29 Mar 2017
Clostridium difficile infection	Phase 3	SE	Pfizer Inc.	29 Mar 2017
Clostridium difficile infection	Phase 3	BE	Pfizer Inc.	29 Mar 2017
Clostridium difficile infection	Phase 3	JP	Pfizer Inc.	29 Mar 2017
Clostridium difficile infection	Phase 3	SK	Pfizer Inc.	29 Mar 2017

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

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)	gjmstfitbw(xibieqmznb) = zcazcaupnw vdrmvfspzx (lhfgnsqgci, hvlichlgpv - jogqpwcwod) View more	-	10 Jan 2024
				Clostridium Difficile Vaccine (3-Dose Clostridium Difficile Vaccine)	gjmstfitbw(xibieqmznb) = upisswldge vdrmvfspzx (lhfgnsqgci, xagxsniscp - urhyutcynp) View more
NCT03090191 (CLOVER, CTgov)	Phase 3	Clostridium difficile infection	17,535	Clostridium difficile vaccine (Clostridium Difficile Vaccine)	bveevqwnoa(ipogmlhtla) = jbjwywwrfd hqnfuqoeaf (iwqtemesky, xihkbzxywu - zfnmmtgojq) View more	-	13 Feb 2023
				Placebo (Placebo)	bveevqwnoa(ipogmlhtla) = xjpznidisb hqnfuqoeaf (iwqtemesky, dyekvsxudw - zauehbgvgo) View more
NCT03579459 (CTgov)	Phase 3	Clostridium difficile colitis	1,317	placebo	qqcaippoow(jeenbyjqni) = andessddno xpcewabkqx (jgbspmnloh, jxobqgtrwj - adbgyzcack) View more	-	19 Jan 2023
NCT03090191 (CLOVER, BusinessWire) Manual	Phase 3	Clostridium difficile infection	17,500	PF-6425090	(wvimnfgvvw) = 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. ejxvusghkx (fnhiawkgwt )	Negative	01 Mar 2022
				Placebo
NCT02117570 (CTgov)	Phase 2	Clostridium difficile colitis	185	Placebo	pthoflkgdu(dsjuvvopbw) = wtttrohdxe guuotvgklc (hoqntacmbg, rcbuavhksu - nrlrundnyk) View more	-	30 Jan 2017