Delving into the Latest Updates on Tetanus toxoid helper peptide(NCI) with Synapse

Overview

Basic Info

Drug Type

Therapeutic vaccine

Synonyms-

Target-

Mechanism

Immunostimulants

Therapeutic Areas

NeoplasmsDigestive System DisordersEndocrinology and Metabolic Disease+ [4]

Active Indication-

Inactive Indication

Conjunctival NeoplasmsFallopian Tube CarcinomaMelanoma, Cutaneous Malignant+ [3]

Originator Organization

National Cancer Institute

Active Organization-

Inactive Organization

National Cancer Institute

Drug Highest PhaseDiscontinuedPhase 2

First Approval Date-

Regulation-

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RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving vaccine therapy and chemotherapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well giving vaccine therapy together with paclitaxel and carboplatin works in treating patients who are undergoing surgery for stage III or stage IV ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.

Start Date13 Apr 2006

Sponsor / Collaborator

University of Virginia

[+1]

NCT00404339 / CompletedPhase 1IIT

Adjuvant p53 Peptide Loaded DC-Based Therapy for Subjects With Squamous Cell Cancer of the Head and Neck (A Phase I Safety and Immunogenicity Trial)

RATIONALE: Vaccines made from a person's dendritic cells mixed with peptides may help the body build an effective immune response to kill tumor cells.
PURPOSE: This randomized phase I trial is studying the side effects of vaccine therapy in treating patients with head and neck cancer.

Start Date01 Sep 2005

Sponsor / Collaborator

University of Pittsburgh

[+1]

100 Clinical Results associated with Tetanus toxoid helper peptide(NCI)

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100 Translational Medicine associated with Tetanus toxoid helper peptide(NCI)

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100 Patents (Medical) associated with Tetanus toxoid helper peptide(NCI)

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14

Literatures (Medical) associated with Tetanus toxoid helper peptide(NCI)

01 Nov 2022·Vaccine

A phase II, single-center, randomized, double-blind, parallel control clinical study evaluating the immunogenicity and safety of a two-dose schedule of serogroups ACYW meningococcal polysaccharide conjugate vaccine

Article

Author: Meng, Qiuyan ; Wu, Jigang ; Liu, Gang ; Wei, Dingkai ; Li, Zhi ; Li, Yanan ; Mo, Zhaojun ; Mo, Yi ; Chen, Junji

BACKGROUNDThis was a single-center, randomized, double-blind, parallel control study evaluating the immunogenicity and safety of a two-dose schedule of serogroups ACYW meningococcal polysaccharide conjugate vaccine with tetanus toxoid (TT) conjugate protein, in infants and toddlers of 3-35 months old.METHOD720 participants were stratified according to the age of 3-5 months old, 6-11 months old, and 12-35 months old and randomly assigned with an equal ratio to two different dose groups, i.e., 40- and 20-μg doses. Blood samples were taken from all participants before the first vaccination and 30 days after the full-course vaccination to detect the serogroups ACYW meningococcal antibodies. All adverse events occurred within 30 days after vaccination of each dose, and serious adverse events occurred within six months after full-course vaccination were collected for safety evaluation. This study was registered at the China drug trial registration with the identifier CTR 20182031.RESULTSAfter 30 days of full-course vaccination, 92.78 % (95 % CI: 85.70 %-100.00 %) showed the immune response against all serogroups in both high-dose and low-dose groups by rabbit serum bactericidal antibody assay (rSBA) and the geometric mean titer (GMT) of all serogroups showed a high level (74.6-505.8, 95 % CI: 56.4-615.7). However, no significant difference between different dose groups was observed (P > 0.05). The common local and systemic adverse events in both groups were redness (3 %-7%), and fever (26 %-65 %), respectively. In addition, the grade 3 adverse event related to the vaccine was fever (1.67 %-12.50 %). No serious adverse event was reported to be associate with the vaccination.CONCLUSIONThe serogroups ACYW meningococcal polysaccharide conjugate vaccine was safe and effective in the population aged 3-35 months. The vaccine efficacy and safety of the 20-μg dose group were not less than that of the 40-μg dose group.

01 Jan 2022·International Journal of Cancer

A pilot trial of vaccination with Carcinoembryonic antigen and Her2/neu peptides in advanced colorectal cancer

Article

Author: Meneveau, Max O. ; Chianese‐Bullock, Kimberly A. ; Friel, Charles M. ; Petroni, Gina ; Kane, William J. ; Squeo, Gabriella C. ; Foley, Eugene F. ; Lynch, Kevin T. ; Olson, Walter C. ; Slingluff, Craig L.

AbstractCheckpoint‐blockade therapy (CBT) is approved for select colorectal cancer (CRC) patents, but additional immunotherapeutic options are needed. We hypothesized that vaccination with carcinoembryonic antigen (CEA) and Her2/neu (Her2) peptides would be immunogenic and well tolerated by participants with advanced CRC. A pilot clinical trial (NCT00091286) was conducted in HLA‐A2+ or ‐A3+ Stage IIIC‐IV CRC patients. Participants were vaccinated weekly with CEA and Her2 peptides plus tetanus peptide and GM‐CSF emulsified in Montanide ISA‐51 adjuvant for 3 weeks. Adverse events (AEs) were recorded per NIH Common Terminology Criteria for Adverse Events version 3. Immunogenicity was evaluated by interferon‐gamma ELISpot assay of in vitro sensitized peripheral blood mononuclear cells and lymphocytes from the sentinel immunized node. Eleven participants were enrolled and treated; one was retrospectively found to be ineligible due to HLA type. All 11 participants were included in AEs and survival analyses, and the 10 eligible participants were evaluated for immunogenicity. All participants reported AEs: 82% were Grade 1‐2, most commonly fatigue or injection site reactions. Two participants (18%) experienced treatment‐related dose‐limiting Grade 3 AEs; both were self‐limiting. Immune responses to Her2 or CEA peptides were detected in 70% of participants. Median overall survival (OS) was 16 months; among those enrolled with no evidence of disease (n = 3), median OS was not reached after 10 years of follow‐up. These data demonstrate that vaccination with CEA or Her2 peptides is well tolerated and immunogenic. Further study is warranted to assess potential clinical benefits of vaccination in advanced CRC either alone or in combination with CBT.

01 May 2021·Journal for ImmunoTherapy of CancerQ2 · MEDICINE

Immunogenicity in humans of a transdermal multipeptide melanoma vaccine administered with or without a TLR7 agonist

Q2 · MEDICINE

ArticleOA

Author: Grosh, William W ; Olson, Walter C ; Salerno, Elise P ; Smolkin, Mark ; Slingluff, Craig L ; Meneveau, Max O ; Petroni, Gina R ; Woodson, Elizabeth ; Patterson, James W ; Deacon, Donna ; Lynch, Kevin T ; Chianese-Bullock, Kimberly A

BackgroundExperimental cancer vaccines are traditionally administered by injection in subcutaneous tissue or muscle, commonly with adjuvants that create chronic inflammatory depots. Injection of melanoma-derived peptides induces T cell responses; however, the depots that form following injection may inhibit optimization of the immune response. In skin, epidermal Langerhans cells (LC) are a dominant source of professional antigen presenting cells. We hypothesized that: (1) applying melanoma-derived peptides topically, in proximity to LC, could be immunogenic and safe, with low vaccine-site toxicity and (2) topical toll-like receptor 7 (TLR7) agonist would increase immunogenicity of the peptide vaccine.MethodsTwelve melanoma peptides plus a tetanus helper peptide were combined with granulocyte macrophage colony stimulating factor (GM-CSF) and were administered topically on days 1, 8, and 15, to 28 patients randomized to one of four adjuvant preparations: (1) incomplete Freund’s adjuvant (IFA); (2) IFA plus a TLR7 agonist (imiquimod) administered on days 0, 7, 14; (3) dimethyl sulfoxide (DMSO) or (4) DMSO+ imiquimod administered on day 0, 7, 14. Every 3 weeks thereafter (x 6), the peptides were combined with GM-CSF and were injected into the dermis and subcutis in an emulsion with IFA. Toxicities were recorded and immune responses assayed by ELIspot.ResultsCD8+T cell responses to transdermal vaccination in DMSO occurred in 83% of participants in group 3 and 86% in group 4, and responses to vaccination in IFA were observed in 29% of participants in group 1 and 14% in group 2. Overall, 61% of participants had CD4+T cell immune responses to the tetanus peptide, with large, durable responses in groups 3 and 4. Five of seven participants in group 4 had a severe rash, one that was dose limiting. Ten-year overall survival was 67% and disease-free survival was 44%.ConclusionsThese data provide proof of principle for immunogenicity in humans of transdermal immunization using peptides in DMSO. Further study is warranted into the pharmacokinetics and immunobiology of TLR agonists as vaccine adjuvants during transcutaneous application. Overall survival is high, supporting further investigation of this immunization approach.

100 Deals associated with Tetanus toxoid helper peptide(NCI)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Conjunctival Neoplasms	Phase 2	US	National Cancer Institute	31 May 2008
Uveal Melanoma	Phase 2	US	National Cancer Institute	31 May 2008
Fallopian Tube Carcinoma	Phase 2	US	National Cancer Institute	29 Feb 2008
Ovarian Cancer	Phase 2	US	National Cancer Institute	29 Feb 2008
Primary peritoneal carcinoma	Phase 2	US	National Cancer Institute	29 Feb 2008
Melanoma, Cutaneous Malignant	Phase 2	US	National Cancer Institute	01 Mar 2005

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00118274 (CTgov)	Phase 1/2	Melanoma, Cutaneous Malignant	170	multi-epitope melanoma peptide vaccine+tetanus toxoid helper peptide (Arm I)	mkqczwqfhu(kdzbpjbzle) = ipvvmrmkjo exiwxuboqv (sjfckehqjl, ttylirlavi - icxqocznks) View more	-	20 Apr 2021
				multi-epitope melanoma peptide vaccine+cyclophosphamide+tetanus toxoid helper peptide (Arm II)	mkqczwqfhu(kdzbpjbzle) = rgbgekczld exiwxuboqv (sjfckehqjl, zmpxzlwwrc - snjsyspzni) View more