The main goal of this study is to compare the Haemophilus influenzae type b antibody response in American Indian / Alaska Native (AI/AN) infants to two licensed vaccines: Vaxelis and PedvaxHIB.

Start Date27 Jan 2022

Sponsor / Collaborator

Johns Hopkins Bloomberg School of Public Health

[+1]

NCT01545375

/ CompletedPhase 2

Study to Determine Protective Efficacy Against Otitis Media and Assess Safety of an Investigational Pneumococcal Vaccine 2189242A in Healthy Infants

The purpose of this study is to 1) demonstrate the protective efficacy against acute otitis media (AOM), 2) assess safety of the GlaxoSmithKline (GSK) Biologicals' pneumococcal vaccine GSK2189242A in Native American infants aged less than 24 months, living in the southwestern US, in and around the Navajo and White Mountain Apache reservations, and 3) evaluate the impact on acute lower respiratory tract infections (ALRI) up to the second year of life.

Start Date21 May 2012

Sponsor / Collaborator

GSK Plc

NCT01337167

/ CompletedPhase 3

A Phase III Randomized, Open-Label, Active-Comparator Controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V419 in Infants When Given at 2, 4, and 6 Months Concomitantly With Prevnar 13™ and RotaTeq™

This is a study to assess the safety, tolerability, and immunogenicity of V419 (PR5I) when administered as an infant series at 2, 4, and 6 months of age followed by a toddler dose of DAPTACEL™, Prevnar 13™ and PedvaxHIB™ at 15 months of age. The study will determine whether subjects who receive V419 have a similar immune response to the vaccine compared to subjects who receive licensed component vaccine controls.

Start Date19 Apr 2011

Sponsor / Collaborator

Merck Sharp & Dohme Corp.

[+1]

100 Clinical Results associated with Haemophilus B conjugate vaccine (Merck Sharp & Dohme)

100 Translational Medicine associated with Haemophilus B conjugate vaccine (Merck Sharp & Dohme)

100 Patents (Medical) associated with Haemophilus B conjugate vaccine (Merck Sharp & Dohme)

Literatures (Medical) associated with Haemophilus B conjugate vaccine (Merck Sharp & Dohme)

01 Oct 2024·Pediatrics

Haemophilus influenzae Type b Vaccine Immunogenicity in American Indian/Alaska Native Infants

Article

Author: Keck, James ; Clichee, Demetria ; Hurley, Chloe ; Thomas, Mary ; Hammitt, Laura L. ; Farrenkopf, Brooke Amara ; Beaudry, Jeanette ; Damon, Shawnell ; Weatherholtz, Robert ; Miernyk, Karen ; Christensen, Loretta ; Zeger, Scott ; Jackson, Bianca D. ; Singleton, Rosalyn ; VanDeRiet, Dan ; Simons, Brenna ; Zylstra, Sarah ; Luna, Juan ; Steinberg, Jonathan ; Chukwuma, Uzo

OBJECTIVESAmerican Indian and Alaska Native (AI/AN) infants historically experienced a disproportionate burden of invasive Haemophilus influenzae type b (Hib) disease, especially early in life. PedvaxHIB vaccine is preferentially recommended for AI/AN infants because it elicits protective antibody levels postdose 1. Vaxelis, a hexavalent vaccine that contains the same Hib conjugate as PedvaxHIB but at lower concentration, is recommended for US children, but postdose 1 Hib immunogenicity data are needed to inform whether a preferential recommendation should be made for AI/AN infants.METHODSWe conducted a phase IV randomized, open-label, noninferiority trial comparing postdose 1 immunogenicity of Vaxelis to PedvaxHIB in AI/AN infants. Participants were randomized to receive a primary series of PedvaxHIB or Vaxelis. Serum samples collected 30 days postdose 1 were tested for anti-Hib immunoglobulin G antibody by enzyme-linked immunosorbent assay. The anti-Hib immunoglobulin G geometric mean concentration (GMC) ratio (Vaxelis/PedvaxHIB) was estimated by constrained longitudinal data analysis. Noninferiority was defined a priori as the lower bound of the 95% confidence interval (CI) of the GMC ratio ≥0.67.RESULTSA total of 327 of the 333 infants enrolled in the study were included in the per-protocol analysis. The postdose 1 anti-Hib GMC was 0.41 µg/mL (95% CI 0.33–0.52) in the Vaxelis group (n = 152) and 0.39 µg/mL (95% CI 0.31–0.50) in the PedvaxHIB group (n = 146). The constrained longitudinal data analysis GMC ratio was 1.03 (95% CI 0.76–1.39).CONCLUSIONSPostdose 1 immunogenicity of Vaxelis was noninferior to PedvaxHIB. Our findings support the use of Vaxelis in AI/AN children, a population with elevated risk of Hib disease.

01 Jul 2023·Journal for ImmunoTherapy of Cancer

Pattern recognition receptor agonists in pathogen vaccines mediate antitumor T-cell cross-priming

Article

Author: Kim, Kristy ; Brown, Brian D ; Merad, Miriam ; Rose, Samuel A ; Yellin, Michael ; Pantsulaia, Gvantsa ; Oreper, Daniel ; Svensson-Arvelund, Judit ; Marsh, Henry ; Jhunjhunwala, Suchit ; Upadhyay, Ranjan ; Moussion, Christine Carine ; Brody, Joshua D ; Aleynick, Mark

BackgroundCancer immunotherapies are generally effective in patients whose tumors contain a priori primed T-cells reactive to tumor antigens (TA). One approach to prime TA-reactive T-cells is to administer immunostimulatory molecules, cells, or pathogens directly to the tumor site, that is, in situ vaccination (ISV). We recently described an ISV using Flt3L to expand and recruit dendritic cells (DC), radiotherapy to load DC with TA, and pattern recognition receptor agonists (PRRa) to activate TA-loaded DC. While ISV trials usingsyntheticPRRa have yielded systemic tumor regressions, the optimal method to activate DCs is unknown.MethodsTo discover optimal DC activators and increase access to clinical grade reagents, we assessed whether viral or bacterial components found in common pathogen vaccines are an effective source ofnatural PRRa(naPRRa). Using deep profiling (155-metric) of naPRRa immunomodulatory effects and gene editing of specific PRR, we defined specific signatures and molecular mechanisms by which naPRRa potentiate T-cell priming.ResultsWe observed that vaccine naPRRa can be even more potent in activating Flt3L-expanded murine and human DCs than synthetic PRRa, promoting cross-priming of TA-reactive T-cells. We developed a mechanistically diverse naPRRa combination (BCG, PedvaxHIB, Rabies) and noted more potent T-cell cross-priming than with any single naPRRa. The naPRRa triplet—as part of Flt3L-primed ISV—induced greater intratumoral CD8 T-cell infiltration, T-cells reactive to a newly defined tumorous neoantigen, durable tumor regressions.ConclusionsThis work provides rationale for the translation of pathogen vaccines as FDA-approved clinical-grade DC activators which could be exploited as immune-stimulants for early phase trials.

02 May 2023·Vaccine

Newborn medication adherence and childhood under-immunization in military beneficiaries.

Article

Author: Vereen, Rasheda J ; Aden, James K ; Drumm, Caitlin M

BACKGROUNDThe American Academy of Pediatrics recommends birth doses of vitamin K, erythromycin ointment, and the hepatitis B vaccine, but the relationship between birth medication administration and childhood immunization compliance is understudied. The objective of this study is to evaluate rates of newborn medication administration, and risk factors for refusal in military beneficiaries and determine the relationship between medication refusal and under-immunization at 15 months.METHODSA retrospective chart review was completed for all term and late preterm infants born at Brooke Army Medical Center, San Antonio, TX, from January 1, 2016, to December 31, 2019. The electronic medical record was queried for birth medication administration, maternal age, active-duty status, rank, and birth order. Childhood immunization records were extracted for all patients who continued care at our facility. A patient was considered completely immunized if they had received at least 22 vaccines by 15 months: three doses of the hepatitis B vaccine [Pediarix^TM], two doses of the rotavirus vaccine [Rotarix^TM], four doses of the DTAP vaccine [Pediarix^TM and Acel-Immune^TM], three doses of Haemophilus influenza B vaccine [Pedvaxhib^TM], four doses of pneumococcal [Prevnar 13^TM], three doses of IPV [Pediarix^TM], one dose of measles, mumps, and rubella [MMR^TM], one dose of varicella [Varivax^TM] and one dose of hepatitis A vaccine [Harvix^TM].RESULTSSeven thousand one hundred and forty infants were included; 99.3% received vitamin K, 98.8% received erythromycin ointment, and 93.8% received the hepatitis B vaccine. Refusal of the erythromycin ointment and hepatitis B vaccine was associated with older maternal age and higher birth order. Childhood immunization records were available for 607 infants; 7.2% (n = 44) were under-immunized by 15 months, with no infants being non-immunized. Refusal of the hepatitis B vaccine (RR: 2.9 (CI 1.16-7.31)) only at birth was associated with a higher risk of being under-immunized.CONCLUSIONSRefusal of the hepatitis B vaccine in the nursery is associated with a risk of being under-immunized in childhood. Obstetric and pediatric providers should be aware of this association for appropriate family counseling.

News (Medical) associated with Haemophilus B conjugate vaccine (Merck Sharp & Dohme)

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

01 May 2008

·www.pharmatimes.com

FDA sends warning letter to Merck & Co over vaccines plant

Merck & Co’s week of woe has continued with the news that US regulators have told the firm to correct what are described as “numerous manufacturing deficiencies” at its main vaccines plant. The US Food and Drug Administration has issued a warning letter to Merck having conducted an inspection of the firm’s West Point, Pennsylvania facility between November 26, 2007 and January 17 this year. The agency’s investigators say they documented “significant deviations from current good manufacturing practice” at the plant in the manufacture of vaccine products, bulk drug substances and drug components. The products manufactured at the West Point site include Merck & Co’s cervical cancer vaccine Gardasil and ProQuad, its combination jab against measles, mumps, rubella and chicken pox. Also produced at the facility are the Haemophilus influenzae type B vaccine PedvaxHIB and ComVax for haemophilius b and hepatitis B and 1.2 million doses of these two jabs were voluntarily recalled in December because Merck said it could not assure sterility of those specific vaccine lots. The warning letter, which is posted on the FDA’s website in a heavily edited form, has been issued because Merck's response to the FDA’s initial inspection report was "inadequate to address the serious deviations noted”. Most of the myriad complaints appear to deal with procedural errors but the agency stresses it "does not believe that the issues identified will affect the safety of the vaccines" made at the facility. Merck says that it is committed to working with the FDA to address these issues, adding that it does not distribute contaminated products and is confident in their “quality, effectiveness and safety”. The letter comes in a week when Merck’s stock has taken a bashing after the FDA rejected applications firstly for a proposed fixed combination of Singulair (montelukast) and S-P’s Claritin (loratadine) as a treatment for allergic rhinitis and secondly for its new cholesterol compound MK-0524A (extended-release niacin/laropiprant).

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100 Deals associated with Haemophilus B conjugate vaccine (Merck Sharp & Dohme)

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Indication	Country/Location	Organization	Date
Haemophilus Infections	United States	Merck Sharp & Dohme LLC	20 Dec 1989

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04978818 (CTgov)	Phase 4	Haemophilus Infections	333	PedvaxHIB (PedvaxHIB Arm)	fkviqjwzuh(yyobwwuaez) = yzhpqjhfld skuugayext (wpxhtipslo, qaapqkmfpa - lthfjwshex) View more	-	24 Jun 2024
				Vaxelis (Vaxelis)	fkviqjwzuh(yyobwwuaez) = kbmnxechvf skuugayext (wpxhtipslo, lfndpooavx - ojltxijezk) View more
NCT01545375 (CTgov)	Phase 2	Streptococcal Infections \| Infection of ear \| Otitis Media	1,806	Pneumococcal vaccine GSK2189242A+PedvaxHIB®+Prevnar 13® (dPly-PhtD Group)	lfloavamyg(fhbmkiyhrp) = coetobnowo amxtwbaniy (kvxyjuqstj, jbceecstsb - lnhnyygpbt) View more	-	12 Sep 2017
				Placebo+PedvaxHIB®+Prevnar 13® (Control Group)	lfloavamyg(fhbmkiyhrp) = suybyafgcg amxtwbaniy (kvxyjuqstj, xmewirqruh - oeowkdtqtf) View more
NCT01337167 (V419-005, CTgov)	Phase 3	Bacterial Infections \| Virus Diseases	1,473	DAPTACEL™+V419+PedvaxHIB™+RotaTeq™+Prevnar 13™ (V419)	zvqukdlimn(esfwtjrvha) = zhxzxfjfik mmktopndyk (lcdxtotogx, cxeteorcey - llqrttdihm) View more	-	16 Mar 2016
				ActHIB™+DAPTACEL™+PENTACEL™+Recombivax HB vaccine+RotaTeq™+Prevnar 13™ (Control)	zvqukdlimn(esfwtjrvha) = tjxqcgeahx mmktopndyk (lcdxtotogx, azhbtrzkca - gecldvlezx) View more
NCT00289913 (V251-068, CTgov)	Phase 4	Hepatitis A \| Tetanus	1,274	Infanrix+PedvaxHIB+VAQTA (VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1))	bztwflznby(mjfakokucb) = ccqwxuefef kfyaoqafsd (mgudmspbnc, jfuxhfnphi - aamhgydqwr) View more	-	07 Jul 2011
				Infanrix+PedvaxHIB+VAQTA (PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1))	bztwflznby(mjfakokucb) = nzrtaxrxtg kfyaoqafsd (mgudmspbnc, exelcwrkhw - qosiuidtch) View more

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Haemophilus B conjugate vaccine (Merck Sharp & Dohme)

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