Effects of Exposure to Per- and Polyfluoroalkyl Substances (PFAS) on Innate and Adaptive Immune Responses to Tetanus-diphtheria (Td) Vaccination Among Adults in a Community-based Panel Study

This clinical trial aims to investigate how exposure to Perfluorononanoic acid (PFNA), a type of per- and polyfluoroalkyl substance (PFAS), affects the immune response to the standard tetanus and diphtheria (Td) vaccine. The study focuses on participants from a community with known prior PFNA exposure through contaminated drinking water. The main question it aims to answer is:
* Does exposure to PFNA weaken the body's initial immune response, leading to lower levels of protective antibodies after vaccination?
Participants will:
* Receive Tetanus and Diphtheria (Td) booster vaccination
* Visit the study office 7 times over a 30-day period
* Have blood and saliva collected at each study visit

Start Date01 Sep 2024

Sponsor / Collaborator

Rutgers State University of New Jersey

NCT05077137

/ RecruitingPhase 1IIT

A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy

The purpose of this study is to determine the safety and feasibility of administering the Tetanus Diptheria Vaccine (Td) or Polio Boost Immunization (IPOL) to patients with metastatic melanoma who are receiving immune checkpoint inhibitor (IO) therapy per standard of care. Subjects will have the vaccine at cycle 4 of IO therapy and will have research blood and tissue samples collected prior to starting IO therapy, at cycle 4 prior to vaccine administration, and at 12-17 days post vaccine.

Start Date07 Sep 2021

Sponsor / Collaborator

Duke University

NCT02673255

/ CompletedPhase 1

Safety and Efficacy of Two Tetanus-Diphtheria Vaccines for a Donor Hyper Immunization Program

Many plasma donation centers have Tetanus immunization programs that are implemented in order to collect plasma with high levels of tetanus antibodies. The immunization program requires participants to receive multiple tetanus vaccinations over a period of time with the goal of hyper-immunizing them to tetanus. Their antibody-rich plasma is then used to manufacture a tetanus immunoglobulin product which helps with the prophylaxis and treatment of tetanus disease.
The Tetanus vaccine previously used for these programs is no longer being manufactured. Therefore, we must evaluate the safety and efficacy of a different vaccine when used for this purpose. The only other FDA approved Tetanus vaccines currently available for adults in the US are combination vaccines that also immunize against Diphtheria and/or Pertussis.
In this study, the investigators will evaluate two vaccines that are combinations of Tetanus and Diphtheria (Td). Investigators will not evaluate any vaccines containing Pertussis antigen. The vaccines to be evaluated are manufactured by MassBiologics and Sanofi Pasteur (Tenivac).
The package insert for these vaccines indicates they should be administered to previously vaccinated people once every 10 years. However, this study will evaluate whether they are safe and effective for dosing every 90 days.
The investigators hypothesize that at least 25% of study subjects will have a positive response to at least one of the five planned doses. Each vaccine will be evaluated separately.

Start Date22 Aug 2016

Sponsor / Collaborator

Biomat USA, Inc.

[+2]

100 Clinical Results associated with Tetanus and diphtheria toxoids adsorbed(Sanofi)

100 Translational Medicine associated with Tetanus and diphtheria toxoids adsorbed(Sanofi)

100 Patents (Medical) associated with Tetanus and diphtheria toxoids adsorbed(Sanofi)

Literatures (Medical) associated with Tetanus and diphtheria toxoids adsorbed(Sanofi)

01 Jun 2013·PediatricsQ2 · MEDICINE

Comparative Effectiveness of Acellular Versus Whole-Cell Pertussis Vaccines in Teenagers

Q2 · MEDICINE

Article

Author: Klein, Nicola P. ; Bartlett, Joan ; Baxter, Roger ; Fireman, Bruce ; Rowhani-Rahbar, Ali

BACKGROUND::

During the 1990s, the United States switched from combined diphtheria, tetanus toxoids, whole-cell pertussis (DTwP) vaccines to combined acellular pertussis (DTaP) vaccines because of safety concerns. After a 2010–2011 pertussis outbreak, we sought to evaluate whether disease risk in 10 to 17 year olds differed between those who previously received DTwP from those who received DTaP.

METHODS::

A case-control study among individuals born from 1994 to 1999 who received 4 pertussis-containing vaccines during the first 2 years of life at Kaiser Permanente Northern California (KPNC). We separately compared pertussis polymerase chain reaction (PCR)-positive cases with PCR-negative and KPNC-matched controls. We assessed risk of pertussis relative to vaccine type in early childhood (4 DTwPs, mixed DTwP/DTaP, or 4 DTaPs) by using conditional logistic regression stratified for calendar time and adjusted for gender, race, medical clinic, and receipt of reduced antigen content acellular pertussis (Tdap) vaccine.

RESULTS::

We compared 138 PCR-positive cases with 899 PCR-negative and 54 339 KPNC-matched controls. Teenagers who had received 4 DTwPs were much less likely to be pertussis PCR-positive than those who had received 4 DTaPs (odds ratio 5.63, 95% confidence interval 2.55–12.46) or mixed DTwP/DTaP vaccines (odds ratio 3.77, 95% confidence interval 1.57–9.07). Decreasing number of DTwP doses was significantly associated with increased pertussis risk (P < .0001).

CONCLUSIONS::

Teenagers who received DTwP vaccines in childhood were more protected during a pertussis outbreak than were those who received DTaP vaccines.

01 Feb 2013·Clinical infectious diseases : an official publication of the Infectious Diseases Society of AmericaQ1 · MEDICINE

Safety of a Tetanus-Diphtheria-Acellular Pertussis Vaccine When Used Off-Label in an Elderly Population

Q1 · MEDICINE

Article

Author: Steven J. Jacobsen ; Jim Nordin ; Hung Fu Tseng ; Lisa A. Jackson ; Jason Glanz ; Lina S. Sy ; Eric Weintraub ; James Donahue ; Roger Baxter ; Lei Qian ; Allison Naleway ; S. Michael Marcy

BACKGROUND:

Published data on the safety of tetanus-diphtheria-acellular pertussis vaccine (Tdap) in persons aged ≥65 years are limited. This study aims to examine a large cohort of Tdap users ≥65 years for evidence of increased risk of adverse events following vaccination.

METHODS:

A matched cohort study design and a self-controlled case series (SCCS) design were used. The study population was adults aged ≥65 years who received the Tdap or tetanus and diphtheria (Td) vaccine during 1 January 2006-31 December 2010 at 7 health maintenance organizations in the United States. Seven major groups of prespecified events were identified electronically by diagnostic codes.

RESULTS:

The study included 119 573 Tdap vaccinees and the same number of Td vaccinees. The results indicated that the risk of the prespecified events following Tdap was comparable to that following Td vaccination in this elderly population. There was a small increased rate of codes suggesting medically attended inflammatory or allergic events in 1-6 days following Tdap in the SCCS analysis (incidence rate ratio, 1.59 [95% confidence interval, 1.40-1.81]).

CONCLUSION:

Although there is a small increased risk of medically attended inflammatory or allergic events in 1-6 days following Tdap compared to other time periods, it is no more common than that following Td. This study provides empirical safety data suggesting that immunizing adults aged ≥65 years with Tdap to reduce the risk of pertussis in the elderly and their contacts should not have untoward safety consequences.

01 Aug 2012·VaccineQ3 · MEDICINE

A randomised, double-blind, non-inferiority clinical trial on the safety and immunogenicity of a tetanus, diphtheria and monocomponent acellular pertussis (TdaP) vaccine in comparison to a tetanus and diphtheria (Td) vaccine when given as booster vaccinations to healthy adults

Q3 · MEDICINE

Article

Author: Thierry-Carstensen, Birgit ; Soerensen, Charlotte ; Jensen, Anders Moerup ; Heilmann, Carsten ; Dalby, Tine ; Uhlving, Hilde Hylland ; Jordan, Karina

BACKGROUND:

Increasing incidence of pertussis in adolescents and adults has stimulated the development of safe and immunogenic acellular pertussis vaccines for booster vaccination of adolescents and adults.

PURPOSE:

To obtain clinical documentation of the safety and immunogenicity of a tetanus, diphtheria and monocomponent acellular pertussis combination vaccine (TdaP), when given as a booster vaccination to adults.

METHODS:

The trial was double-blind, controlled and randomised. 802 healthy adults, aged 18-55 years who had completed childhood vaccination with diphtheria, tetanus and whole cell pertussis vaccine (DTwP), were booster vaccinated with TdaP or Td. Blood samples were taken before and one month after the vaccination for serological analysis and adverse events were recorded during the one-month-follow-up period.

RESULTS:

The monocomponent acellular pertussis vaccine (aP) in the TdaP vaccine was immunogenic in adults with 92.0% of TdaP vaccinated subjects obtaining an anti-pertussis toxin (anti-PT) antibody booster response. TdaP was non-inferior to Td in eliciting seroprotective anti-tetanus and diphtheria antibody concentrations with more than 98% of subjects obtaining post-vaccination seroprotective concentrations (≥ 0.1 IU/mL). T and d booster response rates were 93.0% and 97.5%, respectively. The frequencies of solicited local adverse reactions were low and comparable between TdaP and Td vaccinees. In the TdaP group, 30.7% reported pain, 4.2% swelling and 2.0% erythema at the injection site. The most frequent solicited general symptoms were headache (20.4%), fatigue (17.0%) and myalgia (10.0%). In the Td group, 35.7% reported pain, 2.5% swelling and 3.2% erythema at the injection site, whereas headache, fatigue and myalgia were reported by 15.7%, 14.5% and 12.5%, respectively. In conclusion, TdaP Vaccine SSI was safe and immunogenic when given as a booster vaccination to adults.

News (Medical) associated with Tetanus and diphtheria toxoids adsorbed(Sanofi)

28 Jun 2022

·www.prnewswire.com

United States Human Vaccines Markets, 2018-2021 & Forecast to 2028: Approval/launches of the New Vaccines / Rising Focus on Immunization Programs / Increasing Investments and Government Support

DUBLIN, June 28, 2022 /PRNewswire/ -- The "United States Human Vaccines Market Size, Share, Top 45 Human Vaccines Brand In-depth Analysis, Emerging Trends, Current Analysis, Growth, Demand, Opportunity, and Forecast 2022 - 2028" report has been added to ResearchAndMarkets.com's offering. Amid the COVID-19 crisis, the United States human vaccines market is poised to grow by US$ 31,517 million by 2028, accelerating at a CAGR of 7% during the forecast period. The prominent factors that are expected to contribute to the growth of the United States human vaccines market: Increased Disease Awareness Approval/launches of the New Vaccines Rising Focus on Immunization Programs Increasing Investments and Government Support for the Vaccines Development The report contains a deep analysis of the United States human vaccines market size in terms of value. The report provides a clear insight into current and future developments of the United States vaccines market. The report also explores the detailed analysis, insights of the top 45 vaccines market assessment in the United States from 2018 to 2021, and forecasts to 2028. The report also details the latest information about the vaccine's pricing analysis, insights, and trends, and the regulatory framework of the United States human vaccines market. After conducting thorough research on the historical and current growth parameters, the growth prospects of the United States human vaccines market are obtained with maximum precision. This new 2022 market report provides a holistic analysis of the entire United States human vaccines market. The report offers the most up-to-date industry data on the actual market situation and future outlook for the United States' human vaccines market. The report also tracks and analyses competitive developments, including collaboration, partnership deals, distribution, exclusive and licensing agreements, new vaccine developments, and R&D activities in the market. The report also delivers an in-depth analysis of evolving market trends, drivers, and restraining forces that influence the growth of the market. The report also analyses detailed profiles of innovative and leading players with information on business overview, companies' vaccines portfolio, promising vaccines in the clinical development, and the newest developments The report will serve as a source for a 360-degree analysis, thoroughly integrating different models. This Newest and Comprehensive the United States Human Vaccines Market Research Report 2022 Delivers: Comprehensive Research Methodology of the United States Human Vaccines Market Detailed and Extensive Market Overview with Key Analyst Insights Insights about Market Determinants that are Stimulating the United States Human Vaccines Market To Analyze the Historical Growth in the Market Size of the United States Human Vaccines Market from 2018 to 2021 To Estimate and Forecast the Market Size of the United States Human Vaccines Market from 2022 to 2028 and Growth Rate until 2028 Detailed Insights of the Top 45 Human Vaccines Market Value Used in the U.S. with Six Years Forecast An Insightful Analysis of the Top 45 Vaccines Brand Market Share and Y-o-Y Growth Rate Delivers All-inclusive Insights on the Latest Pricing Analysis, Insights, and Trends Delivers an In-Depth Analysis of Evolving Market Trends, Drivers, and Restraints of the United States Human Vaccines Market An Insightful Investigation has been done on Promising Human Vaccines in the Clinical Development Delivers Comprehensive Insights into the Regulatory Framework of the United States Human Vaccines Market Tracks Competitive Developments, Approaches, Recent Industry Developments, Partnership, Collaboration Deals, Distribution, Exclusive, and Licensing Agreement A Comprehensive List of the Leading Companies along with the Analysis of their Current Vaccines Portfolio, Promising Human Vaccines in the Clinical Development, and Present Development The Report Helps Answer the Following Questions: What is the current scenario of the United States human vaccines market? What is the total market size and forecast (until 2028) of the United States human vaccines market? How big is the United States human vaccines market? At what CAGR is the U.S. human vaccines market projected to grow in the forecast period (2022-2028)? What are the leading human vaccines? What are their revenue potentials to 2028? Which human vaccine brand provides the highest market share? What is the regulatory framework in the United States vaccines market? What are the key factors driving the United States human vaccines market? What are the key challenges of the United States human vaccines market? What are the major deals and agreement happenings in the United States human vaccines market? What are the United States human vaccines pricing trends and analysis? What are the various human vaccines available in the United States? Who are the topmost market players? What are their happenings, current developments, and scenarios? How is the market predicted to develop in the future? Key Topics Covered: 1. Executive Summary 2. United States Human Vaccines Market Size and Forecast (2018 - 2028) 3. United States Human Vaccines Brand Market Share and Y-o-Y Growth (%), 2018 - 2028 4. Key Market Growth Drivers and Challenges in the United States Human Vaccines Market 4.1 Key Market Growth Drivers 4.2 Key Market Challenges 5. United States Top 45 Human Vaccines Market Value Analysis, Insights and Forecasts, 2018 - 2028 5.1 Daptacel 5.2 Quadracel 5.3 Kinrix 5.4 Vaxelis 5.5 IPOL 5.6 Vaqta 5.7 Havrix 5.8 Twinrix 5.9 Engerix B 5.10 PedvaxHIB 5.11 ActHIB 5.12 Hiberix 5.13 MenQuadfi 5.14 Tenivac 5.15 Imovax 5.16 FluMist Quadrivalent 5.17 Prevnar 13 5.18 Gardasil 9 5.19 Fluzone Quadrivalent 5.20 Flublok 5.21 Flucelvax Quadrivalent 5.22 Afluria Quadrivalent 5.23 Fluad 5.24 Varivax 5.25 Menactra 5.26 Proquad 5.27 Pneumovax 23 5.28 Fluarix 5.29 FluLaval 5.30 M-M-R II 5.31 Adacel 5.32 Boostrix 5.33 Bexsero 5.34 Menveo 5.35 Trumenba 5.36 Shingrix 5.37 Pentacel 5.38 Recombivax HB 5.39 Rotateq 5.40 Rotarix 5.41 Pediarix 5.42 Infanrix 5.43 Heplisav-B 5.44 TDVAX 5.45 BioThrax 5.46 Other Vaccines 6. United States Human Vaccines Pricing Analysis, Insights and Trends 7. Regulatory Framework of the United States Human Vaccines Market 8. Major Deals and Agreement Happenings in the Human Vaccines Market 8.1 Merger & Acquisitions 8.2 Collaboration Deals 8.3 Licensing Agreement 8.4 Exclusive Agreement 8.5 Distribution Agreement 8.6 Partnership Deals 9. Leading Companies in the United States Human Vaccines Market 9.1 Sanofi Pasteur 9.1.1 Business Overview 9.1.2 Human Vaccines Portfolio 9.1.3 Promising Human Vaccines in the Clinical Development 9.1.4 Recent Development 9.3 Merck 9.4 Pfizer 9.5 Seqirus (CSL Limited) 9.6 AstraZeneca 9.7 Dynavax Technologies Corporation 9.8 Emergent BioSolutions Inc. For more information about this report visit Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1904 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

VaccineAcquisition

100 Deals associated with Tetanus and diphtheria toxoids adsorbed(Sanofi)

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KEGG	Wiki	ATC	Drug Bank
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R&D Status

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Indication	Country/Location	Organization	Date
Diphtheria	United States	Sanofi Pasteur, Inc.	24 Feb 2000
Tetanus	United States	Sanofi Pasteur, Inc.	24 Feb 2000

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00601835 (CTgov)	Phase 4	Diphtheria \| Tetanus	3,651	Tetanus and Diphtheria Toxoids Adsorbed (+Td) Vaccine (Canadian Td Vaccine Group)	epkjxxluyc = icgyslvquu dfskqfqbjm (ffhatjwqly, qwuikqpyfx - sfarerapem) View more	-	18 Feb 2011
				Tetanus and Diphtheria Toxoids Adsorbed (+Td) Vaccine (United States Td Vaccine Group)	epkjxxluyc = wgowvgncss dfskqfqbjm (ffhatjwqly, ukyjonjnle - xhjxhvdqwg) View more

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