Evaluating the Safety, Reactogenicity, and Immunogenicity of Intradermal Fractional Dose IPV (fIPV) in Combination With the Novel Mucosal Adjuvant, dmLT

This is a single site, phase 1 study of dmLT as a mucosal adjuvant to control fecal viral shedding when used in combination with intradermally administered fractional dose trivalent IPV (fIPV). It will be a 2-arm, randomized, double-blind controlled trial of intradermal fIPV versus fIPV+dmLT in healthy adults with a monovalent oral polio vaccine (OPV) challenge administered as a test of mucosal immunity. A maximum of 30 healthy subjects will be recruited, all of whom will have received IPV only as part of their primary childhood immunization series (cohort 1); they will be randomized 2:1 to receive fIPV-dmLT or fIPV alone. A maximum of 27 participants will be recruited from an earlier pilot study population exposed to fIPV+/-dmLT and will provide follow-up samples for immunologic studies only (cohort 2).

Start Date01 Apr 2022

Sponsor / Collaborator

University of Vermont

[+1]

NCT04639375

/ Unknown statusPhase 4

A Proof-of-concept Study of Poliovirus Vaccine (IPV) Activity to Induce an Immune Response That Cross-reacts With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2)

A total of 300 healthy volunteers between the ages of 18 and 80 with no previous history of COVID-19 will be entered into the study and will receive IPV by injection on Day 1. Blood specimens collected pre-inoculation will be tested for cross-reactivity to poliovirus and SARS-CoV-2 by Western blot. An additional specimen will be collected on Day 28 post-inoculation and, likewise tested for cross-reactivity to poliovirus and SARS-CoV-2.
The number of subjects with an immune response to SARS-CoV-2 antigens following inoculation with IPV will be summarized.

Start Date15 Nov 2020

Sponsor / Collaborator

E Mo Biology, Inc.

NCT02775942

/ CompletedPhase 2IIT

Safety and Immunogenicity of an Inactivated Poliomyelitis Vaccine (IPOVAC) in Vietnamese Children

A dose escalating study with 3 different dosing regimens of the studied vaccine (IPOVAC- POLYVAC-Vietnam) and a licensed vaccine (IMOVAC-Sanofi Pasteur- France) is conducted in Vietnamese children, aged 2 months and above to assess the safety and immunogenicity. Two hundred and forty children are enrolled and placed randomly into 4 groups (60 children/group), each of which receive 3 doses of vaccine subcutaneously, at 4 week interval. Safety issues included immediate reaction at the site of injection and systemic reaction within 30 min of administration, within 7 days after each dose, unexpected event occur within 30 days of each dose, SAE (from start of dose 1 to 30 days after dose 3), blood cell count, urea, ALT,AST. Immunogenicity outcomes include seroconversion of neutralising antibodies for each of vaccine serotypes.

Start Date01 Nov 2015

Sponsor / Collaborator

National Institute of Hygiene & Epidemiology

100 Clinical Results associated with Poliovirus vaccine inactivated(Sanofi)

100 Translational Medicine associated with Poliovirus vaccine inactivated(Sanofi)

100 Patents (Medical) associated with Poliovirus vaccine inactivated(Sanofi)

Literatures (Medical) associated with Poliovirus vaccine inactivated(Sanofi)

01 Jun 2024·PEDIATRICS

Vaccine Coverage at 36 Months and 7 Years by Parental Birth Country, Washington State

Article

Author: Bell, Teal R. ; Ibrahim, Anisa ; Matheson, Jasmine ; Tasslimi, Azadeh ; DeBolt, Charla ; Moore, Tyler P.

BACKGROUND AND OBJECTIVES:

Ensuring equitable vaccination access for immigrant communities is critical for guiding efforts to redress health disparities, but vaccine coverage data are limited. We evaluated childhood vaccination coverage by parental birth country (PBC) through the linkage of Washington State Immunization Information System data and birth records.

METHODS:

We conducted a retrospective cohort evaluation of children born in Washington from January 1, 2006 to November 12, 2019. We assessed up-to-date vaccination coverage status for measles, mumps, and rubella (MMR), diphtheria, tetanus, and pertussis (DTaP), and poliovirus vaccines at ages 36 months and 7 years. Children with ≥1 parent(s) born in selected non-US countries were compared with children with 2 US-born parents, using Poisson regression models to provide prevalence ratios.

RESULTS:

We identified 902 909 eligible children, of which 24% had ≥1 non-US-born parent(s). Vaccination coverage at 36 months by PBC ranged from 41.0% to 93.2% for ≥1 MMR doses and ≥3 poliovirus doses and 32.6% to 86.4% for ≥4 DTaP doses. Compared with children of US-born parents, the proportion of children up to date for all 3 vaccines was 3% to 16% higher among children of Filipino-, Indian-, and Mexican-born parents and 33% to 56% lower among children of Moldovan-, Russian-, and Ukrainian-born parents. Within-PBC coverage patterns were similar for all vaccines with some exceptions. Similar PBC-level differences were observed at 7 years of age.

CONCLUSIONS:

The linkage of public health data improved the characterization of community-level childhood immunization outcomes. The findings provide actionable information to understand community-level vaccination determinants and support interventions to enhance vaccine coverage.

01 Dec 2022·Vaccine: X

Development of an animal component free production process for Sabin inactivated polio vaccine

Article

Author: van 't Oever, Aart G ; van der Pol, Leo A ; Bakker, Wilfried A M ; Thomassen, Yvonne E ; Suarez-Zuluaga, Diego A

Inactivated polio vaccine production using attenuated Sabin strains (sIPV) instead of wild type polio viruses (cIPV) is an initiative encouraged by the World Health Organization. This use of attenuated viruses is preferred as it reduces risks related to potential outbreaks during IPV production. Previously, an sIPV production process was set up based on the cIPV production process. Optimizing this process while using only animal component free (ACF) substances allows reduction of operational costs and mitigates risks of adverse effects related with animal derived compounds. Here, development of a process for production of sIPV using only ACF compounds, is described. The upstream process required a change in cell growth medium from serum-containing medium to ACF medium, while virus production media remained the same as the already used M199 medium was free of animal components. In the downstream process multiple modifications in existing unit operations were made including addition of a diafiltration step prior to inactivation. After optimizing each unit operation, robustness of the whole process was demonstrated using design of experiments (DoE) methodology. By using DoE we were able to vary different process parameters across unit operations to assess the impact on our quality attributes. The developed process was robust as the observed variation for quality attributes due to differences in process parameters remained within specification. The resulting pilot process showed not only to be robust, but also to have a considerable higher product yield when compared to the serum containing sIPV process. Product yields are now comparable to the cIPV process based on using wild type polio viruses. Moreover, the potency of the produced vaccine was comparable that of cIPV vaccine. The developed ACF sIPV process can be transferred to vaccine manufacturers at the end-of pre-clinical development phase, at lab- or pilot scale, before production of clinical trial material.

01 Dec 2022·Beni-Suef University journal of basic and applied sciences

Intelligent system based comparative analysis study of SARS-CoV-2 spike protein and antigenic proteins in different types of vaccines

Article

Author: Touati, Rabeb ; Elngar, Ahmed A

Abstract:

Background:

Coronaviruses, members of the Coronavirinae subfamily in the Coronaviridae family, are enveloped and positive-stranded RNA viruses that infect animals and humans, causing intestinal and respiratory infections. Coronavirus disease 2019 (COVID-19) is caused by a novel coronavirus, named Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). This disease appeared, for the first time (December 2019), in China and has spread quickly worldwide causing a large number of deaths. Considering the global threat, the World Health Organization (WHO) has declared, in March 2020, COVID-19 as a pandemic. Many studies suggest the great effect of the existing vaccines to protect against symptomatic cases of death by the COVID-19 virus. This paper, proposes to compare the main antigenic proteins sequences of the existing vaccines with Spike (S) protein of the SARS-CoV-2 genome. Our choice of S protein is justified by the major role that plays it in the receptor recognition and membrane fusion process based on an intelligent system. Herein, we focus on finding a correlation between S protein and compulsory vaccines in the countries that have a less death number by COVID-19 virus. In this work, we have used a combination of coding methods, signal processing, and bioinformatic techniques with the goal to localize the similar patterns between the S gene of the SARS-Cov-2 genome and 14 investigated vaccines.

Results:

A total of 8 similar sequences which have a size more than 6 amino acids were identified. Further, these comparisons propose that these segments can be implicated in the immune response against COVID-19, which may explain the wide variation by country in the severity of this viral threat.

Conclusions:

Our in silico study suggests a possible protective effect of Poliovirus, HIB, Hepatitis B, PCV10, Measles, Mumps, and Rubella (MMR) vaccines against COVID-19.

News (Medical) associated with Poliovirus vaccine inactivated(Sanofi)

10 Apr 2024

·www.pharmaindustrial-india.com

Sanofi Receives Nod for IMOVAX-Polio in India

Sanofi has gained approval for IMOVAX-Polio, an alternative injectable vaccine. According to a report, this new vaccine will replace the Inactivated Polio Vaccine (IPV) ShanIP in India. IMOVAX-Polio is an alternative IPV vaccine that has been used in more than 100 countries for over 40 years, a Sanofi India spokesperson commented. The vaccine has the same composition/formulation as ShanIPV, the spokesperson added. “We wish to assure all stakeholders that there will be no shortage of IPV vaccines in India on our account, towards safeguarding the nation’s status of remaining polio-free. We remain fully committed to fulfilling our public health mission in India,” the spokesperson noted. To ensure that there is no interruption to the availability of IPV vaccines, the French firm has already obtained approvals for IMOVAX-Polio. “Sanofi has had to adapt its strategy and portfolio to these (emerging) trends. Accordingly, Sanofi Healthcare India Pvt Ltd (SHIPL) announced that by the end of 2023, it will discontinue ShanIPV, which was only filled and packaged at our factory in Hyderabad, India,” the spokesperson added. Launched in India in 2015, ShanIPV is a trivalent inactivated injectable vaccine. Under the government’s immunisation program, the vaccine was injected in two stages at six weeks and 14 weeks of age. Sanofi and Serum Institute of India are the leading suppliers of IPV vaccines in India. The French drugmaker is also planning to enhance its presence in the diabetes segment and grow its consumer healthcare business after spinning it off into a new entity while also looking at local production of its various best-in-class products in India. Sanofi has a pipeline of 12 different products lined up for launch in India.

Drug ApprovalVaccine

10 Apr 2024

·www.pharmaindustrial-india.com

Sanofi Receives Nod for IMOVAX-Polio in India

Drug ApprovalVaccine

04 Apr 2024

·www.fiercepharma.com

Sanofi pledges to keep polio vaccine supplies afloat in India after new approval

“We wish to assure all stakeholders that there will be no shortage of IPV vaccines in India on our account,” a Sanofi India spokesperson told Fierce Pharma on Thursday. After press reports flagged the possibility of an inactivated polio vaccine (IPV) shortage in India, Sanofi says it's ready to supply the nation with a newly approved shot. Thursday, after the company gained an approval for a new polio vaccine, IMOVAX-Polio, Sanofi issued an assurance that it will be able to keep providing sufficient supplies. The developments come quickly on the heels of an Economic Times report alleging that a shortage crisis was looming following Sanofi’s decision to shut down certain vaccine manufacturing operations in the country. Last September, Sanofi revealed plans to discontinue its previous polio shot in India. Still, to hear Sanofi tell it, India shouldn’t be concerned. The company’s local branch remains “dedicated to supporting India’s public health program for polio,” a Sanofi India spokesperson told Fierce Pharma on Thursday. “To ensure that there is no interruption to the availability of IPV vaccines, we have already obtained approvals for our product IMOVAX-Polio,” she added. Regarding the company’s decision to discontinue its previous polio shot, Sanofi India’s spokesperson pointed to the rapidly shifting healthcare environment in the country following the COVID-19 pandemic. Amid rising demand for production capacity in India, Sanofi last year opted to discontinue its older polio shot. The company's spokesperson noted that the shot was only filled and packaged at the company’s factory in Hyderabad, while the antigens themselves were manufactured in France. Sanofi and its Indian affiliate Shantha Biotechnics pledged to supply polio vaccines for India’s universal immunization program through UNICEF back in 2015. Sanofi got its hands on Shantha in 2009 when the French drugmaker’s vaccine division agreed to pay 550 million euros ($784 million) for the Merieux Alliance’s controlling stake in the Indian shot maker. Elsewhere in India, Sanofi last week called on local drugmakers Cipla and Dr. Reddy’s Laboratories to help sell its central nervous system (CNS) drugs and vaccines in country. Cipla is slated to market six Sanofi CNS medicines, including the leading epilepsy therapy Frisium, which Sanofi will continue to own, import and manufacture. Dr. Reddy’s, for its part, is on deck to sell five Sanofi vaccines in the country.

VaccineDrug Approval

100 Deals associated with Poliovirus vaccine inactivated(Sanofi)

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Indication	Country/Location	Organization	Date
Poliomyelitis	United States	Sanofi Winthrop Industrie SA	04 Feb 2000
Poliomyelitis	United States	Sanofi Pasteur SA	04 Feb 2000

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01686503 (IDIPV, CTgov)	Phase 2	HIV Infections \| Poliomyelitis	231	IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose (2/5 Dose Intradermal IPV)	vsodgubvvk(ssmdjkzhwu) = jmmzuxavuf hnxzskzgqb (olyzfprhno, rzqqzvqkdd - nwmijgcofn) View more	-	05 Feb 2015
				IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose (Full Dose Intramuscular IPV)	vsodgubvvk(ssmdjkzhwu) = ormapdpbfh hnxzskzgqb (olyzfprhno, sltpfsujif - mvpjckzvts) View more
NCT00514709 (CTgov)	Phase 3	Diphtheria \| Hepatitis B \| Whooping Cough ... View more	1,843	DTaP-Hep B-PRP~T (Group 1: DTaP-Hep B-PRP~T + OPV)	kubtipiirk = ibnyoaugwp lubbgnpgbq (rveregodaq, ceobclhmps - ssrjrdumai) View more	-	14 Nov 2013
				Tritanrix-Hep B (Group 2: Tritanrix-Hep B/ Hib™ + OPV)	kubtipiirk = jdkeeyavou lubbgnpgbq (rveregodaq, xbukexfsze - somrfbxkat) View more
NCT00255047 (CTgov)	Phase 3	Diphtheria \| Whooping Cough \| Poliomyelitis	2,167	Pentacel®: DTaP-IPV/Hib combined (Study Group 2: Pentacel®)	ptupioosxp = rajkkarpap jrkjcvtfgh (kebnsmyurf, umeiglmjjo - mfumedrxrh) View more	-	10 Nov 2010
				DTaP-IPV+ActHIB (Study Group 3: DTaP-IPV and ActHIB®)	ptupioosxp = exoobiqzny jrkjcvtfgh (kebnsmyurf, xbxjrponcv - ilkyzzrfvq) View more

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