FDA Fast Tracks Development of PaxVax Vaccine for Chikungunya

MedicalResearch.com Interview with:

Lisa Danzig, MD Chief Medical Office PaxVax

Dr. Danzig

Lisa Danzig, MD
Chief Medical Office
PaxVax

MedicalResearch.com: Would you briefly explain what is meant by Chikungunya infection?  Whom does it primarily affect?  How is it transmitted and what the  complications?

Response: Chikungunya is caused by the chikungunya virus (CHIKV), an arthropod-borne virus (arbovirus) spread by infected mosquitos.

Infection with chikungunya virus results in severe, often debilitating joint pain in infected patients, known as arthralgia. Symptoms can include intense discomfort in joints, such as the wrists, fingers, ankles, and feet, in the knees and in the hips or shoulders. Those affected can also frequently suffer from headaches, fever, and severe muscle pain, rashes on the torso and limbs and swelling in one or more cervical lymph nodes. Individuals who are at a higher risk for contracting chikungunya include infants, elderly and those with chronic conditions.

The virus is a small, spherical, enveloped, positive-strand RNA virus. The virus is transmitted by the Aedes aegypti and Aedes albopictus mosquito, which originated in Africa, first spreading to Asia and recently expanding to the western hemisphere.  Outbreaks are rapid and widespread.  In February 2005 a major outbreak of chikungunya occurred in the islands of the Indian Ocean after which over 1.9 million cases have been reported in India, Indonesia, Maldives, Myanmar and Thailand.

Chikungunya spread has been identified in 45 countries in the Americas alone with more than 1.7 million suspected cases reported to the Pan American Health Organization since 2015, increasing the incidence of the disease and risk to U.S. travelers. In 2016 there were approximately 60,000 cases of chikungunya across India. Beyond the Indian subcontinent, the Caribbean, Central America and South America, inhabitants and travelers visiting sub-Saharan Africa and Southeast Asia are also at risk.

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End of Honeymoon Period Means Whooping Cough Can Resurge

MedicalResearch.com Interview with:

This Gram-stained photomicrograph depicts numbers of Bordetella pertussis bacteria, which is the etiologic pathogen for pertussis, also known as whooping cough.

This Gram-stained photomicrograph depicts numbers of Bordetella pertussis bacteria, which is the etiologic pathogen for pertussis, also known as whooping cough.
CDC image

Matthieu Domenech de Cellès PhD
Department of Ecology and Evolutionary Biology
University of Michigan, Ann Arbor, MI, USA.
Biostatistics, Biomathematics, Pharmacoepidemiology, and Infectious Diseases Unit
Institut Pasteur, Inserm,
University of Versailles St-Quentin-en-Yvelines,
Versailles, France.

MedicalResearch.com: What is the background for this study? What are the main findings?

 

Response: Our main motivation was to elucidate an apparent paradox: Why has the US experienced a resurgence of pertussis (whooping cough) since the mid-1970s, despite persistently high vaccine coverage? A variety of hypotheses have been proposed to explain this resurgence, but most attention has focused on the potential shortcomings of the new generation of pertussis vaccines (called acellular pertussis vaccines). However, there remains considerable uncertainty about the degree and the mechanisms of protection conferred by pertussis vaccines.

Via a collaboration with the local department of public health, we used detailed surveillance data in the state of Massachusetts to test a number of hypotheses about pertussis vaccines. We found that, although pertussis vaccines are imperfect (in the sense that they do not provide lifelong, 100% protection to 100% of children vaccinated), they are still highly efficacious. Specifically, we estimated that vaccine protection wanes over time, but slowly, with about 85% of children still protected 10 years after vaccination. Despite this high vaccine efficacy, we showed that the resurgence of pertussis was, in fact, to be expected. What happens is that the introduction of routine vaccination leads to an overall reduction in transmission, not only in vaccinated children but also in the population at large. Accordingly, those who escaped vaccination as children (as a consequence of incomplete vaccine coverage or imperfect vaccine protection) increasingly age having also avoided natural infection. As a result, the number of individuals susceptible to contract pertussis gradually increases. Because such people are the “fuel” of epidemics, this sets the stage for pertussis’ resurgence, with increasing incidence among older individuals.

This overall effect is called the “end-of-honeymoon” and means that resurgence is therefore a predictable consequence of incomplete vaccination with efficacious, but imperfect, vaccines. Importantly, these results show that recent trends do not necessarily reflect recent changes in the epidemiology of pertussis. Rather, they may be interpreted as a legacy of past immunization practices, with long-to-manifest effects. This is a significant shift of perspective about pertussis epidemiology.  Continue reading

New SHINGRIX Vaccine Induces Stronger Immune Protection Against Shingles in Elderly

MedicalResearch.com Interview with:

Herpes Zoster or Shingles of chest Wikipedia

Herpes Zoster or Shingles of chest
Wikipedia

Anthony. L. Cunningham, MD
The Westmead Institute for Medical Research
Westmead, NSW
University of Sydney, Sydney,  

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: This study examines the reasons why the HZ subunit vaccine candidate (HZ/su vaccine) consisting of a single viral protein, varicella-zoster glycoprotein E, and and adjuvant (immunostimulant) combination AS01B is so effective as a vaccine to prevent shingles (>90%), especially in those over the age of 70 years and 80 years, as published in recent trials i.e. it combats the declining immunity in the aging which usually restricts vaccine efficacy to under 60% in these age groups.  Continue reading

New Vaccine Administered To Newborns Protects Against Rotavirus Gastroenteritis

MedicalResearch.com Interview with:

This illustration provides a 3D graphical representation of a number of Rotavirus virions set against a black background. Note the organism’s characteristic wheel-like appearance, which is visible when viewed under the electron microscope. It’s this morphology that gives the Rotavirus its name, which is derived from the Latin rota, meaning "wheel". Rotaviruses are nonenveloped, double-shelled viruses, making them quite stable in the environment. CDC- PHIL collection: Illustrator: Alissa Eckert, MS

This illustration provides a 3D graphical representation of a number of Rotavirus virions set against a black background. Note the organism’s characteristic wheel-like appearance, which is visible when viewed under the electron microscope. It’s this morphology that gives the Rotavirus its name, which is derived from the Latin rota, meaning “wheel”. Rotaviruses are nonenveloped, double-shelled viruses, making them quite stable in the environment.
CDC- PHIL collection: Illustrator: Alissa Eckert

Professor Julie Bines
Inaugural Victor and Loti Smorgon Professor of Paediatrics and Deputy Head of Department of Paediatrics University of Melbourne.
Murdoch Childrens Research Institute 

MedicalResearch.com: What is the background for this study? Would you briefly explain the significance of Rotavirus infections?

Diarrhoea is one of the leading causes of child illness and death, and rotavirus is the most common cause of severe diarrhoea. Globally rotaviruses cause approximately 215,000 deaths in children under five years. This disease doesn’t discriminate – it infects children worldwide under the age of five – irrespective of what environment you live in.

The rotavirus vaccines that are currently available work very well in places like Australia, the US and Europe but they don’t seem to work as well in low income settings in Africa and Asia where severe gastroenteritis is common and many children die.

In a world-first clinical trial conducted in Indonesia, the oral RV3-BB vaccine was administered to babies within their first five days of life. Current rotavirus vaccines can only be administered to children older than six weeks, which leaves newborn babies particularly vulnerable to rotavirus infection. In lower resource settings, birth is often the best contact between mother, baby and health services.

The oral RV3-BB vaccine was developed from the human neonatal rotavirus strain RV3 identified in the stool of healthy newborn babies. It does not naturally cause diarrhoea like other rotaviruses. The RV3-BB vaccine program aims to take advantage of the characteristics of this novel strain to target a birth dose vaccination strategy.  Continue reading

One Step Closer To Vaccine Against Heroin Addiction

MedicalResearch.com Interview with:
“Syringe and Vaccine” by NIAID is licensed under CC BY 2.0Candy Hwang, Ph.D.

The Scripps Research Institute
La Jolla, CA 92037

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Our heroin vaccine is designed to stimulate antibodies to recognize and bind heroin, preventing passage of drug molecules to the brain. By essentially blocking the “high” from heroin, we believe this will assist recovering addicts from relapsing. Last year, we reported a heroin vaccine that was shown to be effective in both mouse and non-human primate models. In this current study, we were interested in enhancing our heroin vaccine by exploring different vaccine components and dosages.

Once we discovered the most promising vaccine formulations, we wanted to see if our vaccines would be stable under different storage conditions. We found that our heroin vaccine was shelf stable under different temperatures and as a powder or in liquid form, meaning that the vaccine will remain stable for transport and storage. The best vaccine formulation from these studies showed protection against lethal doses of heroin.

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Cochrane Reviews Efficacy of Vaccination To Prevent Flu In Healthy Adults

MedicalResearch.com Interview with:
“#influenza” by J.S. Zolliker is licensed under CC BY 2.0Dr. Vittorio Demicheli

Servizio Regionale di Riferimento per l’Epidemiologia
SSEpi-SeREMI, Azienda Sanitaria Locale ASL AL
Alessandria, Piemonte, Italy

MedicalResearch.com: What is the background for this study? What are the main findings? 

Response: The consequences of influenza in adults are mainly time off work. Only vaccination of pregnant women is recommended internationally, while mass vaccination of healthy adults is still matter of debate.

The aim of this Cochrane Review is to assist informed decision making summarizing research that looks at the effects of immunizing healthy adults with influenza vaccines during influenza seasons.

The review process found 52 clinical trials of over 80,000 adults. Only around 15% of the included studies were well designed and conducted. We focused on reporting of results from 25 studies that looked at inactivated vaccines. Injected influenza vaccines probably have a small protective effect against influenza and influenza-like illness (ILI_ (moderate-certainty evidence), as 71 people would need to be vaccinated to avoid one influenza case, and 29 would need to be vaccinated to avoid one case of ILI. Vaccination may have little or no appreciable effect on hospitalizations (low-certainty evidence) or number of working days lost. Continue reading

Potential Universal Influenza Vaccine Uses Nanoparticle Technology

MedicalResearch.com Interview with:
“Syringe and Vaccine” by NIAID is licensed under CC BY 2.0Dr. Lei Deng PhD

Postdoctoral researcher
Institute for Biomedical Sciences at Georgia State University

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Influenza A viruses evade human herd immunity by genetic hypervariation. Annual influenza epidemics are estimated to cause about 3 to 5 million cases of severe illness, and about 290,000 to 650,000 deaths. Vaccination is still the most effective way to prevent diseases, but current influenza vaccines provide limited protections against mismatched circulating virus strains. This drives scientists to develop universal influenza vaccines that can induce broad immune responses against all influenza A virus infections.

We used biochemistry and nanotechnology to generate a double-layered protein nanoparticle universal influenza vaccine. The layered nanoparticle contains genetically modified influenza virus components without irrelevant carry/structural proteins and chemicals and confers strong and long-lasting immunity in laboratory mice against H1N1, H3N2, H5N1 and H7N9 infections. We also explain the protection mechanism of antibody dependent cell-mediated cytotoxicity (ADCC) and antibody dependent cell-mediated phagocytosis (ADCP) play the main role in the immune protection.  Continue reading

Trumenba Vaccine Helps Protect Against Meningococcal B Infections in Adolescents and Young Adults

MedicalResearch.com Interview with:

Judith Absalon, M.D., M.P.H Senior Director, Vaccines Clinical Research  Pfizer Pharmaceuticals

Dr. Judith Absalon

Judith Absalon, M.D., M.P.H
Senior Director, Vaccines Clinical Research
Pfizer Pharmaceuticals

MedicalResearch.com: What is the background for these two studies?

Response: Invasive serogroup B meningococcal disease (MenB) is uncommon, yet serious, is unpredictable and can strike at any age, including healthy teenagers and young adults, with potentially long-lasting and devastating consequences, including death. The data from these two Phase 3 studies, one in adolescents (Study 1009) and one young adults (Study 1016), highlight that Trumenba can help protect teens and young adults against meningococcal group B disease.

Additionally, these two large Phase 3 studies confirmed the results of earlier studies and supported the transition from Accelerated to Traditional Approval in the US; were pivotal for approvals in Europe, Australia, and Canada earlier this year; and add to the growing portfolio of research for TRUMENBA.

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Tetravalent Vaccine Proves Promising In Protecting Children From Dengue

MedicalResearch.com Interview with:
Vianney Tricou DPhil
Takeda Vaccines Pte Ltd
Singapore

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Dengue fever is a painful, debilitating mosquito-borne disease caused by any one of the four closely related dengue virus serotypes. Forty percent of the world’s population lives under the threat of dengue, with approximately 390 million infections and 20,000 deaths occurring globally each year. Dengue virus can infect people of all ages and is a leading cause of serious illness among children in some countries in Latin America and Asia. Takeda is developing a dengue vaccine candidate to safely protect children and adults living in, or traveling to, endemic areas against all four dengue virus serotypes, regardless of previous dengue virus exposure. 

Takeda’s tetravalent dengue vaccine candidate (TAK-003) is based on a live, attenuated dengue serotype 2 virus, which provides the genetic ‘backbone’ for all four vaccine viruses. Takeda’s ongoing Phase 2 DEN-204 study was designed to assess the safety and immunogenicity of different dose schedules of TAK-003 in approximately 1,800 healthy children and adolescents ages two through 17 years living in dengue-endemic countries in Latin America and Asia. Participants of the DEN-204 trial received either one primary dose of TAK-003, two primary doses of TAK-003 administered three months apart, one primary dose of TAK-003 followed by a booster dose one year later, or a placebo. Eighteen-month interim data showed that that TAK-003 is associated with a reduction in the incidence of dengue in the study participants. Data also showed that TAK-003 induced sustained antibody responses against all four serotypes of dengue virus, regardless of previous dengue exposure and dosing schedule.

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TDAP Vaccine During Pregnancy Prevents Whooping Cough In Young Babies

MedicalResearch.com Interview with:
Tami H Skoff Centers for Disease Control and Prevention Atlanta, Georgia
Tami H Skoff
Centers for Disease Control and Prevention
Atlanta, Georgia

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Infants are at greatest risk for severe pertussis (whooping cough) morbidity and mortality, especially during the first months of life before infant immunizations begin.  CDC and the Advisory Committee on Immunization Practices (ACIP) currently recommend that women receive a dose of Tdap during the third trimester of each pregnancy.  This recommendation has been in place since 2012.  By getting Tdap, pregnant women pass critical short-term protection to their unborn babies. This helps protect babies until they are old enough to start getting their own whooping cough vaccines at 2 months of age.

The purpose of our study was to evaluate the effectiveness of maternal Tdap during pregnancy at preventing whooping cough in infants <2 months of age.

In our evaluation, Tdap administration during the third trimester of pregnancy prevented more than 3 in 4 (78%) infant cases.  Additionally, Tdap vaccination during pregnancy was even more effective (90%) at preventing whooping cough serious enough that the baby had to get treatment in a hospital.

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