AUTHOR OF THIS BLOG

DR ANTHONY MELVIN CRASTO, WORLDDRUGTRACKER
Dec 112017
 

 

Applications and perspectives of nanomaterials in novel vaccine development

Med. Chem. Commun., 2018, Advance Article
DOI: 10.1039/C7MD00158D, Review Article
Yingbin Shen, Tianyao Hao, Shiyi Ou, Churan Hu, Long Chen
Vaccines show great potential for both prophylactic and therapeutic use in infections, cancer, and other diseases

Applications and perspectives of nanomaterials in novel vaccine development

* Corresponding authors

Abstract

Vaccines show great potential for both prophylactic and therapeutic use in infections, cancer, and other diseases. With the rapid development of bio-technologies and materials sciences, nanomaterials are playing essential roles in novel vaccine formulations and can boost antigen effectiveness by operating as delivery systems to enhance antigen processing and/or as immune-potentiating adjuvants to induce or potentiate immune responses. The effect of nanoparticles in vaccinology showed enhanced antigen stability and immunogenicity as well as targeted delivery and slow release. However, obstacles remain due to the lack of fundamental knowledge on the detailed molecular working mechanism and in vivo bio-effects of nanoparticles. This review provides a broad overview of the current improvements in nanoparticles in vaccinology. Modern nanoparticle vaccines are classified by the nanoparticles’ action based on either delivery system or immune potentiator approaches. The mechanisms of interaction of nanoparticles with the antigens and the immune system are discussed. Nanoparticle vaccines approved for use are also listed. A fundamental understanding of the in vivo bio-distribution and the fate of nanoparticles will accelerate the rational design of new nanoparticles comprising vaccines in the future.

Image result for Department of Food Science and Engineering, School of Science and Engineering, Jinan University

Department of Food Science and Engineering, School of Science and Engineering, Jinan University

//////////////nanomaterials, vaccine

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FDA approves vaccine Vaxchora to prevent cholera for travelers

 FDA 2016, VACCINE  Comments Off on FDA approves vaccine Vaxchora to prevent cholera for travelers
Jun 112016
 

 

 

06/10/2016 04:22 PM EDT
The U.S. Food and Drug Administration today approved Vaxchora, a vaccine for the prevention of cholera caused by serogroup O1 in adults 18 through 64 years of age traveling to cholera-affected areas. Vaxchora is the only FDA-approved vaccine for the prevention of cholera.

June 10, 2016

Release

The U.S. Food and Drug Administration today approved Vaxchora, a vaccine for the prevention of cholera caused by serogroup O1 in adults 18 through 64 years of age traveling to cholera-affected areas. Vaxchora is the only FDA-approved vaccine for the prevention of cholera.

Cholera, a disease caused by Vibrio cholerae bacteria, is acquired by ingesting contaminated water or food and causes a watery diarrhea that can range from mild to extremely severe. Often the infection is mild; however, severe cholera is characterized by profuse diarrhea and vomiting, leading to dehydration. It is potentially life threatening if treatment with antibiotics and fluid replacement is not initiated promptly. According to the World Health Organization, serogroup O1 is the predominant cause of cholera globally.

“The approval of Vaxchora represents a significant addition to the cholera-prevention measures currently recommended by the Centers for Disease Control and Prevention for travelers to cholera-affected regions,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.

While cholera is rare in the U.S., travelers to parts of the world with inadequate water and sewage treatment and poor sanitation are at risk for infection. Travelers to cholera-affected areas have relied on preventive strategies recommended by the CDC to protect themselves against cholera, including safe food and water practices and frequent hand washing.

Vaxchora is a live, weakened vaccine that is taken as a single, oral liquid dose of approximately three fluid ounces at least 10 days before travel to a cholera-affected area.

Vaxchora’s efficacy was demonstrated in a randomized, placebo-controlled human challenge study of 197 U.S. volunteers from 18 through 45 years of age. Of the 197 volunteers, 68 Vaxchora recipients and 66 placebo recipients were challenged by oral ingestion of Vibrio cholerae, the bacterium that causes cholera. Vaxchora efficacy was 90 percent among those challenged 10 days after vaccination and 80 percent among those challenged three months after vaccination.  The study included provisions for administration of antibiotics and fluid replacement in symptomatic participants. To prevent transmission of cholera into the community, the study included provisions for administration of antibiotics to participants not developing symptoms.

Two placebo-controlled studies to assess the immune system’s response to the vaccine were also conducted in the U.S. and Australia in adults 18 through 64 years of age. In the 18 through 45 year age group, 93 percent of Vaxchora recipients produced antibodies indicative of protection against cholera. In the 46 through 64 years age group, 90 percent produced antibodies indicative of protection against cholera. The effectiveness of Vaxchora has not been established in persons living in cholera-affected areas.

The safety of Vaxchora was evaluated in adults 18 through 64 years of age in four randomized, placebo-controlled, multicenter clinical trials; 3,235 study participants received Vaxchora and 562 received a placebo. The most common adverse reactions reported by Vaxchora recipients were tiredness, headache, abdominal pain, nausea/vomiting, lack of appetite and diarrhea.

The FDA granted the Vaxchora application fast track designation and priority review status. These are distinct programs intended to facilitate and expedite the development and review of medical products that address a serious or life-threatening condition. In addition, the FDA awarded the manufacturer of Vaxchora a tropical disease priority review voucher, under a provision included in the Food and Drug Administration Amendments Act of 2007. This provision aims to encourage the development of new drugs and biological products for the prevention and treatment of certain tropical diseases.

Vaxchora is manufactured by PaxVax Bermuda Ltd., located in Hamilton, Bermuda.

Company PaxVax Inc.
Description Live attenuated vaccine against Vibrio cholerae
Molecular Target
Mechanism of Action Vaccine
Therapeutic Modality Preventive vaccine: Viral vaccine
Latest Stage of Development Registration
Standard Indication Cholera
Indication Details Prevent cholera infection; Treat cholera
Regulatory Designation U.S. – Fast Track (Prevent cholera infection);
U.S. – Priority Review (Prevent cholera infection)

 

FDA Approves Vaxchora, PaxVax’s Single-Dose Oral Cholera Vaccine

Vaxchora™ is the only approved vaccine in the U.S. for protection against cholera

REDWOOD CITY, Calif.—-PaxVax, today announced that it has received marketing approval from the United States (U.S.) Food and Drug Administration (FDA) for Vaxchora, a single-dose oral, live attenuated cholera vaccine indicated for use in adults 18 to 64 years of age. Vaxchora is the only vaccine available in the U.S. for protection against cholera and the only single-dose vaccine for cholera currently licensed anywhere in the world.

FDA Approves Vaxchora, PaxVax’s Single-Dose Oral Cholera Vaccine

“FDA approval of a new vaccine for a disease for which there has been no vaccine available is an extremely rare event. The approval of Vaxchora is an important milestone for PaxVax and we are proud to provide the only vaccine against cholera available in the U.S.,” said Nima Farzan, Chief Executive Officer and President of PaxVax. “We worked closely with the FDA on the development of Vaxchora and credit the agency’s priority review program for accelerating the availability of this novel vaccine. In line with our social mission, we have also begun development programs focused on bringing this vaccine to additional populations such as children and people living in countries affected by cholera.”

“As more U.S. residents travel globally, there is greater risk of exposure to diseases like cholera,” added Lisa Danzig, M.D., Vice President, Clinical Development and Medical Affairs. “Cholera is an underestimated disease that is found in many popular global travel destinations and is thought to be underreported in travelers. Preventative measures such as food and water precautions can be challenging to follow effectively and until now, U.S. travelers have not had access to a vaccine to help protect against this potentially deadly pathogen.”

Cholera is an acute intestinal diarrheal infection acquired by ingesting contaminated water and food. Annually, millions of people around the world are impacted by this extremely virulent disease1 which can cause death in less than 24 hours if left untreated2. More than 80 percent of reported U.S. cases3 are associated with travel to one of the 69 cholera-endemic countries4 in Africa, Asia and the Caribbean. A recent report from the Centers for Disease Prevention and Control suggests that the true number of cholera cases in the U.S. is at least 30 times higher than observed by national surveillance systems5. The currently recommended intervention to prevent cholera infection is the avoidance of contaminated water and food, but studies have shown that 98 percent of travelers do not comply with these precautions when travelling6.

“This important FDA decision is the culmination of years of dedicated work by many researchers,” said Myron M. Levine, MD, DTPH, the Simon and Bessie Grollman Distinguished Professor at the University of Maryland School of Medicine (UM SOM). “For travelers to the many parts of the world where cholera transmission is occurring and poses a potential risk, this vaccine helps protect them from this disease. It is a wonderful example of how public-private partnerships can develop medicines from bench to bedside.” Dr. Levine is co-inventor of the vaccine, along with James B. Kaper, PhD, Chairman of the UM SOM Department of Microbiology and Immunology. In addition, the Center for Vaccine Development at UM SOM worked closely with PaxVax during the development of Vaxchora.

The attenuated cholera vaccine strain used in Vaxchora is CVD 103-HgR, which was in-licensed from the Center for Vaccine Development at UM SOM in 2010. Vaxchora is expected to be commercially available in Q3 2016. Vaxchora will be distributed through PaxVax’s U.S. marketing and sales organization, which currently commercializes Vivotif®, an FDA-approved oral typhoid fever vaccine.

 

 

About Vaxchora (Cholera Vaccine, Live, Oral)

Vaxchora is an oral vaccine indicated for active immunization against disease caused by Vibrio cholerae serogroup O1. Vaxchora is approved for use in adults 18 through 64 years of age traveling to cholera-affected areas. The effectiveness of Vaxchora has not been established in persons living in cholera-affected areas or in persons who have pre-existing immunity due to previous exposure to V. cholerae or receipt of a cholera vaccine. Vaxchora has not been shown to protect against disease caused by V. cholerae serogroup O139 or other non-O1 serogroups.

The FDA approval of Vaxchora is based on positive results from a 10 and 90-day cholera challenge trial, as well as two safety and immunogenicity trials in healthy adults that demonstrated efficacy of more than 90 percent at 10 days and 79 percent at 3 months post vaccination7. The most common adverse reactions were tiredness, headache, abdominal pain, nausea/vomiting, lack of appetite and diarrhea. More than 3,000 participants were enrolled in the Phase 3 clinical trial program that evaluated Vaxchora at sites in Australia and the United States.

For the full Prescribing Information, please visit www.vaxchora.com.

Young man drinking contaminated water. Close-up of vibrio cholerae bacteria.
A bacterial disease causing severe diarrhoea and dehydration, usually spread in water

About PaxVax

PaxVax develops, manufactures and commercializes innovative specialty vaccines against infectious diseases for traditionally overlooked markets such as travel. PaxVax has licensed vaccines for typhoid fever (Vivotif) and cholera (Vaxchora), and vaccines at various stages of research and clinical development for adenovirus, anthrax, hepatitis A, HIV, and zika. As part of its social mission, PaxVax is also working to make its vaccines available to broader populations most affected by these diseases. PaxVax is headquartered in Redwood City, California and maintains research and development and Good Manufacturing Practice (GMP) facilities in San Diego, California and Bern, Switzerland and other operations in Bermuda and Europe. More information is available at www.PaxVax.com.

References:

1 Centers for Disease Control and Prevention. Cholera: General Information. November 2014. http://www.cdc.gov/cholera/general. Accessed June 2016.

2 World Health Organization website. Cholera Fact Sheet. July 2015. http://www.who.int/mediacentre/factsheets/fs107/en/. Accessed June 2016.

3 Loharikar A et al. Cholera in the United States, 2001-2011: a reflection of patterns of global epidemiology and travel. Epidemiol Infect. 2015;143(4):695-703. doi:10.1017/S0950268814001186.

4 Ali M et al. Updated global burden of cholera in endemic countries. PLoS Negl Trop Dis. 2015; 9: e0003832 doi: 10.1371/journal.pntd.0003832.

5 Scallan E et al. Foodborne Illness Acquired in the United States –Major Pathogens. Emerg Infect Dis. 2011. http://dx.doi.org/10.3201/eid1701.P11101.

6 Kozicki M et al. Boil it, cook it, peel it or forget it’: does this rule prevent travellers’ diarrhoea?. Int J. Epidemiol. 1985; 14(1):169-72.

7 Chen WH et al. Single-Dose Live Oral Cholera Vaccine CVD 103-HgR Protects Against Human Experimental Infection with Vibrio cholerae O1 El Tor. Clinical Infectious Diseases 2016. 62 (11) 1329-1335. doi: 10.1093/cid/ciw145.

Contacts

PaxVax Inc.
Colin Sanford, 415-870-9188
colin.sanford@W2comm.com

/////FDA.  vaccine,  Vaxchora, choleram  travelers, PaxVax Bermuda Ltd.,Hamilton, Bermuda.

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AmVac begins Phase III trial of Gynevac vaccine for bacterial vaginosis

 Phase 3 drug, Uncategorized, VACCINE  Comments Off on AmVac begins Phase III trial of Gynevac vaccine for bacterial vaginosis
Jun 192014
 
AmVac begins Phase III trial of Gynevac vaccine for bacterial vaginosis
AmVac has commenced a Phase III study of its Gynevac to assess the safety and efficacy of the vaccine in bacterial vaginosis (BV) treatment.

AmVac has commenced a Phase III study of its Gynevac to assess the safety and efficacy of the vaccine in bacterial vaginosis (BV) treatment.

Image

Manufactured in accordance with the current GMP standards, the therapeutic vaccine is based on a blend of inactivated lactobacilli strains.

http://www.marketwatch.com/story/amvac-initiates-phase-iii-trial-with-its-lead-vaccine-gynevac-for-the-treatment-of-bacterial-vaginosis-2014-06-17

 

Love, cast in stone: Temples in India depicting erotic art

India is dotted with many glorious temples, but erotica on the walls of some arouses curiosity and even puzzles tourists. There are various theories about the reason for such vivid depiction of erotica–mass sex education, warding off natural calamities and the devdasi system. Due to the presence of 64 Yogini temples near Khajuraho, Padawali, Konarak/Lingaraj etc., scholars also attribute the erotic art to Tantric practices, which revolve around the ultimate union of the male and the female energy and forms referred to as Maithuna. Whatever the reason be, the brazenness or ethereal beauty of temple erotica will never cease to amaze us.

Khajuraho, Madhya Pradesh

Built by the Chandela Kings who were greatly influenced by Tantric traditions, this temple is said to represent the ultimate seductress.

While the fine sandstone statues built earlier have a well rounded finish, the ones made later are more angular. In his history of the Kamasutra, Mc Connachie describes the amorous sculptures as “the apogee of erotic art”, where the twisting, broad hipped and high breasted nymphs, fleshy apsaras and extravagantly interlocked maithunas run riot along the surface of stone.

The various scenes of passionate love making, in acrobatic postures that sometimes border on the physically impossible, strike viewers. Look out for the bold panels of multiple partners engaged with each other. For an interesting perspective on Khajuraho, watch the Sound and Light show. The best time to visit is during the Khajuraho Dance Festival in the first week of February.

Markandeshwar Temple, Maharashtra

Near the naxal district of Gadchiroli, the Markandeshwar temple complex, by the River Wainganga, showcases a sprinkling of erotic art. A couple performing ‘fellacio’ will raise eyebrows. Know to be built by danavas (evil forces) in one night, the temple is made from stone, and follows Hemadpanth architecture. The annual fair during Mahashivratri attracts devotees from far and wide every year. Hiring a car from Nagpur is recommended, unless you fancy hitch-hiking with villagers past moonlit fields or changing several buses and autos. If you’re stranded, look for the dharamshala near the temple.

Padawali Temple,  Madhya Pradesh

In Morena district near the Chambal Valley, once notorious for dacoits, lies the fortress of Padawali. Two stalwart lion statues greet you at its entrance. The temple inside has earned the reputation being a ‘Mini Khajuraho’ due to the prevalence of erotic art. The difference between big brother Khajuraho and Padawali Temple, is that the erotic art here seems less acrobatic and more ‘real life’ and ‘doable’. The carvings of maithunas in various positions, ranging from simple to difficult almost brings the Kamasutra to life.

Ranakpur Jain Temples, Rajasthan

This marble temple of superlative beauty is a ‘vision in white’ with its domes, shikharas and turrets. Over 1,444 intricately carved marble pillars hold up the temple and a monolithic marble rock depicting over 100 snakes catches the eye. Look out for a panel depicting several experimental love making scenes, in a line with a central queen-like figure seated on a throne, with an amorous midget on her lap. It’s interesting to note that not only Hindus, but even Jains decorated temples with erotic art. It hints at how nudity had a religious connect due to the ‘Digambara’ ideology or the Tantric cult.

Sun Temple,  Orissa 

When I first visited the Sun Temple at Konarak in Orissa, as a giggly 16-year-old , I was  taken aback by how the panels revealed way more about the ‘birds and bees’ than our biology classes had taught us. My second visit recently, helped me appreciate the beautiful erotic art better. The brazenness of the sculptures here gives Khajuraho stiff competition; one of the most scandalous panels is of a dog licking a woman’s genital area. I overheard a guide say, “this was considered a cure for sex related infections, as the dog’s saliva has antibiotic properties.” Scenes of polygamy, polyandry and lesbian love are blissfully abundant.

An architectural genius, this temple shows the Sun God on a colossal chariot drawn by seven horses. The word Konarak is a combination of Kona (corner) and Arka (Sun).  The temple was previously located closer to the sea, but the magnetic properties of its stone caused shipwrecks. This, along with the dark colour of its stones, earned it the tile of ‘The Black Pagoda’. An interesting study in contrast is the famous Jagannath Temple at Puri, also referred to as ‘The White Pagoda’ due to its whitewashed walls. If you are an art enthusiast you must visit the Konarak Archaeological Museum nearby that contains fallen sculptures from the temple.

Sun Temple, Gujarat

It is believed to be the place where Lord Rama conducted a yagna here to purify himself of the sin of killing a Brahmana-Ravana. Like Konarak, its architecture is such that the temple catches the first rays of the rising sun. The most striking feature of the temple is a perfectly designed Kama Kunda (water tank) meant for ablutions and for a reflection of the temple in the water. It has lateral stone steps leading down to the tank, allowing both direct and diagonal descent from all sides. Carvings of men and women in various acts of sex with small midget like creatures are prominent. However, due to erosion the detailing of the stone carvings is blurred in places.

Osian, Rajasthan

Amidst the sand dunes of Thar, Osian has a cluster of Hindu and Jain temples dating back to the 11 century AD. The Sachiya Mata temple dedicated to the resident Goddess has a gorgeous carved archway leading up to the shrine and has some beautiful depiction of erotic love locked couples, complete with details like the bed on which the couples lie.

Virupaksha Temple, Karnataka
On the banks of the Tungabhadra River, this temple with beautiful pillars and towered gateways dedicated to Lord Shiva in his avatar as Virupaksha. It is one of the oldest functioning temples since the 7th century AD. A  panel  that catches the eyes depicts a nude woman being ‘admired’ by men and women around her. It is best to visit the temple, during the Hampi festival in November. While in the area, also check out the erotic art on the pillars of the Achyutaraya temple.

Several other temples in South India like Belur, Halebidu, Somanathapura and Nugguhalli, the Badami and Banashankari temples of the Chalukya times and the Vijayanagar temples of Bhatkal and Lepakshi also have a profusion of erotic art. The Meenakshi temple of Madurai and Veeraranarayan temple of Gadag have erotic sculptures on their Gopuram. (Information about other temples with erotic art in South India taken from www.kamat.com)

No one has summed up the beauty of erotica on temple walls better than Tagore while he was referring to Konarak, ‘The language of man here is defeated by the language of stone.’

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European Commission approves Fluenz Tetra for the prevention of seasonal influenza in children

 VACCINE  Comments Off on European Commission approves Fluenz Tetra for the prevention of seasonal influenza in children
Dec 092013
 

Friday, 6 December 2013

AstraZeneca today announced that the European Commission (EC) has granted Marketing Authorisation to FluenzTM Tetra. Fluenz Tetra is a nasally administered four-strain live attenuated influenza vaccine for the prevention of influenza in children and adolescents from 24 months up to 18 years of age. The EC approval makes Fluenz Tetra the first and only intra-nasal four-strain influenza vaccine available in Europe.http://www.pharmalive.com/ec-approves-fluenz-tetra

 

 

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Vical and Astellas Announce Initiation of Phase 3 Trial of ASP0113 Cytomegalovirus Vaccine

 VACCINE  Comments Off on Vical and Astellas Announce Initiation of Phase 3 Trial of ASP0113 Cytomegalovirus Vaccine
Jun 272013
 

 

Illustration of the CMV life cycle from viral entry to egress of new infectious virions.

Jun 25, 2013,  Vical Incorporated and Astellas Pharma Inc. today announced the initiation of a multinational Phase 3 registration trial of ASP0113 (TransVax(TM)), in approximately 500 hematopoietic cell transplant (HCT) recipients. Vical and Astellas entered into exclusive worldwide license agreements in 2011 to develop and commercialize ASP0113, Vical’s investigational therapeutic vaccine designed to control cytomegalovirus (CMV) in transplant recipients. Astellas is conducting the trial, and Vical is providing development, regulatory and manufacturing support. The companies expect to begin a separate Phase 2 trial of ASP0113 in solid organ transplant (SOT) recipients later this year.

http://www.marketwatch.com/story/vical-and-astellas-announce-initiation-of-phase-3-trial-of-asp0113-cytomegalovirus-vaccine-2013-06-25

About ASP0113

ASP0113 is an investigational bivalent DNA vaccine containing plasmids (closed loops of DNA) encoding human CMV pp65 and gB antigens for induction of both cellular and humoral immune responses. ASP0113 is formulated with a proprietary poloxamer-based delivery system. ASP0113 has received orphan drug designation in the United States and Europe for HCT and SOT patients.

About CMV

CMV is a herpes virus that infects more than half of all adults in the United States by age 40, and is even more widespread in developing countries. A healthy immune system typically protects an infected person against CMV disease, but does not prevent or clear latent infection, and those whose immune systems are not fully functional are at high risk of CMV reactivation, potentially leading to severe illness or death. Those at greatest risk include transplant patients and infants born to mothers who first become infected during pregnancy. Vical is pursuing two distinct vaccine approaches for these separate market segments: ASP0113 for the transplant market and CyMVectin(TM) for the congenital disease market.

About Astellas

Astellas Pharma Inc., located in Tokyo, Japan, is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. Astellas has approximately 17,000 employees worldwide. The organization is committed to becoming a global category leader in Urology, Immunology (including Transplantation) and Infectious diseases, Oncology, Neuroscience and DM Complications and Kidney diseases. For more information on Astellas Pharma Inc., please visit www.astellas.com/en.

About Vical

Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. Potential applications of the company’s DNA delivery technology include DNA vaccines for infectious diseases or cancer, in which the expressed protein is an immunogen; cancer immunotherapeutics, in which the expressed protein is an immune system stimulant; and cardiovascular therapies, in which the expressed protein is an angiogenic growth factor. The company is developing certain infectious disease vaccines and cancer therapeutics internally. In addition, the company collaborates with major pharmaceutical companies and biotechnology companies that give it access to complementary technologies or greater resources. These strategic partnerships provide the company with mutually beneficial opportunities to expand its product pipeline and address significant unmet medical needs. Additional information on Vical is available at www.vical.com.

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