Breaking News
August 14, 2018 - Wearable devices and ‘mhealth’ technology emerge as promising tools for better health
August 14, 2018 - Phase 2 Clinical Data Published Showing Summit’s Ridinilazole Preserved Gut Microbiome of Patients with CDI
August 14, 2018 - Cardiac progenitor cells undergo a cell fate switch to build coronary arteries
August 14, 2018 - Revealed: The molecular mechanism underlying hypertrophic cardiomyopathy, or “workaholic heart”
August 14, 2018 - New technology shows potential to streamline the analysis of proteins
August 14, 2018 - Rethinking the stroke rule ‘time is brain’
August 14, 2018 - Incidence of coronary artery compression in children may be more common than previously thought
August 14, 2018 - Study helps to better understand disease caused by Alpha-1 antitrypsin deficiency
August 14, 2018 - AI platform identifies acute neurological illnesses faster than human diagnosis
August 14, 2018 - American College of Rheumatology receives grants to support development of lupus clinical trials
August 14, 2018 - New study explains why women get more migraines than men
August 14, 2018 - American Heart Association Urges Screen Time Limits for Youth
August 14, 2018 - Brief interventions during routine care reduce alcohol use among men with HIV
August 14, 2018 - New genome analysis could identify people at higher risk of common deadly diseases
August 14, 2018 - NIH grant for Mount Sinai to study use of inhaled corticosteroids for treatment of sickle cell disease
August 14, 2018 - Daicel supplies free nanodiamond samples to international researchers
August 14, 2018 - Switching anti-psychotic drugs in first-episode schizophrenia patients does not improve clinical outcomes
August 14, 2018 - Study to examine whether modulating gut bacteria can improve cardiac function in heart failure patients
August 14, 2018 - AI technology could hold key to improving health services
August 14, 2018 - One out of two children not getting enough nutrients needed for their health
August 14, 2018 - Mono-antiplatelet therapy after aortic heart valve replacements may work as well as two drugs
August 14, 2018 - Aid-in-dying patient chooses his last day
August 14, 2018 - Exercise Really Can Chase Away the Blues, to a Point
August 14, 2018 - Surgical mesh implants may cause autoimmune disorders
August 14, 2018 - Researchers develop revolutionary zebrafish model to gain more insight into bone diseases
August 14, 2018 - Researchers discover secret communication hotline between breast cancers and normal cells
August 14, 2018 - Study examines how a person adapts to visual field loss after stroke
August 14, 2018 - Researchers show how specialized nucleic acid-based nanostructures could help target cancer cells
August 14, 2018 - Reducing opioid prescriptions for one operation can also spill over to other procedures
August 14, 2018 - E-cigarettes not so safe but still better than cigarettes
August 14, 2018 - Researchers find link between common ‘harmless’ virus and cardiovascular damage
August 14, 2018 - Initiation of PIMs associated with higher risk of fracture-specific hospitalizations and mortality
August 14, 2018 - Genetically modified mosquitoes and special bed nets help tackle deadly diseases
August 14, 2018 - Advances in treating hep C lead to new option for transplant patients
August 14, 2018 - Study finds quality of doctor-patient discussions about lung cancer screening to be ‘poor’
August 14, 2018 - MSU researchers uncover the effects of aging on regenerative ability of kidneys
August 14, 2018 - Better conditioning, throwing mechanics can help reduce elbow injuries in young baseball pitchers
August 14, 2018 - Brain game doesn’t offer brain gain
August 14, 2018 - Reproductive choices facing women with disabilities require careful consideration
August 14, 2018 - Scientists pinpoint the cause of a rare childhood seizure disorder
August 14, 2018 - Lumpectomy plus radiation associated with reduced risk of breast cancer death, study finds
August 14, 2018 - UAB study shows how ion channel differentiates newborn and mature neurons in the brain
August 14, 2018 - Experts highlight key knowledge gaps that need to be addressed in Ebola vaccine research
August 14, 2018 - Discovery could lead to new drugs against infection and inflammation
August 14, 2018 - Infection Prevention Differs Between Small, Large Hospitals
August 14, 2018 - Mom still matters—In study, young adults tended to prioritize parents over friends
August 14, 2018 - Deep brain stimulation might benefit those with severe alcoholism, preliminary studies show
August 14, 2018 - Study finds increased rate of repeat pregnancies in women with intellectual and developmental disabilities
August 14, 2018 - Lighter sedation fails to reduce risk of postoperative delirium in older patients
August 13, 2018 - Asking better questions about person’s memory could improve doctors’ understanding of patients
August 13, 2018 - U.S. Trauma Doctors Push for Stricter Gun Controls
August 13, 2018 - Asthma and flu: a double whammy
August 13, 2018 - 5 Questions: Donna Zulman on engaging high-need patients in intensive outpatient programs | News Center
August 13, 2018 - Behavioral Nudges Lead to Drop in Prescriptions of Potent Antipsychotic
August 13, 2018 - Potential New Class of Drugs May Reduce Cardiovascular Risk by Targeting Gut Microbes
August 13, 2018 - How to get your kids to eat better
August 13, 2018 - The importance of hearing your patients
August 13, 2018 - Transmission of F. tularensis unlikely to happen through the food chain
August 13, 2018 - Researchers discover epigenetic mechanism underlying ischemic cardiomyopathy
August 13, 2018 - Adolescent health programs receive only a tiny share of international aid, finds research
August 13, 2018 - Fracture risk increases by 30% after gastric bypass, study shows
August 13, 2018 - Quality-improvement project to standardize feeding practices helps micro preemies gain weight
August 13, 2018 - Long-term cannabinoid exposure impairs memory, study shows
August 13, 2018 - New intervention to reduce risk of HIV in young transgender women
August 13, 2018 - Japan human trial tests iPS cell treatment for Parkinson’s
August 13, 2018 - Altered nitrogen metabolism may contribute to emergence of new cancer mutations
August 13, 2018 - Cycling provides greatest health benefits, study finds
August 13, 2018 - Scientists discover biomarker for kidney cancer
August 13, 2018 - New test predicts the risk of serious disease before symptoms appear
August 13, 2018 - Cianna Medical receives FDA 510(k) clearance to extend indication of SCOUT reflector for use in soft tissue localization
August 13, 2018 - Ground-breaking discovery offers new hope for treatment of Alzheimer’s, other neurological diseases
August 13, 2018 - Medical nutrition therapy provided by RDNs benefits patients with chronic kidney disease
August 13, 2018 - Prenatal Tdap vaccination not linked with increased risk of autism in children, study shows
August 13, 2018 - One-Third of Canadian Patients Get Hip Fx Repair Within 24 Hours
August 13, 2018 - ANA (Antinuclear Antibody) Test: MedlinePlus Lab Test Information
August 13, 2018 - Traffic jams in the brain
August 13, 2018 - NIH awards $6.5 million to establish multi-institution biomedical technology resource center
August 13, 2018 - New marker in the blood could help predict person’s risk of developing kidney cancer
August 13, 2018 - New biomarker may provide clues to create diagnostic tool for hypoglycemia-associated autonomic failure
August 13, 2018 - Oxidative Stress Hampers Blood Vessel Dilation in Men
Investigational ZPIV vaccine found to be safe and immunogenic in trial participants

Investigational ZPIV vaccine found to be safe and immunogenic in trial participants

image_pdfDownload PDFimage_print

The investigational Zika purified inactivated virus (ZPIV) vaccine was well-tolerated and induced an immune response in participants, according to initial results from three Phase 1 clinical trials. Scientists at the Walter Reed Army Institute of Research (WRAIR), part of the U.S. Department of Defense, are developing the vaccine as well as leading one of the trials. WRAIR also is co-funding the trials together with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The results will appear on Dec. 4 in The Lancet.

“A vaccine is urgently needed to help prevent Zika infection, which can cause birth defects and other developmental abnormalities in babies born to infected women, as well as a constellation of other health problems in infected adults and children,” says NIAID Director Anthony S. Fauci, M.D. “We are encouraged by initial clinical trial results that indicate the ZPIV vaccine is safe and immunogenic, data that support additional clinical testing of the vaccine to determine its ability to prevent Zika virus infection.”

The ZPIV vaccine candidate contains whole Zika virus particles that have been inactivated and therefore cannot replicate and cause disease in humans. However, because the protein shell of the inactivated virus remains intact, it can be recognized by the immune system.

Of the 67 adult participants in the initial studies, 55 received the investigational vaccine and 12 received a placebo. The investigational vaccine was administered with an adjuvant (a compound that helps induce a stronger immune response) containing aluminum salts. All participants received two intramuscular injections of the same dose four weeks apart. The trial was double-blinded, meaning neither the investigators nor the participants knew who received a placebo.

Investigators tested participants’ blood samples periodically and detected antibodies to Zika virus in more than 90 percent of individuals who received the experimental vaccine, within four weeks after the last dose.

While Zika experts have not precisely determined the concentration of antibodies needed to protect against congenital infection, animal model studies are helping to provide useful insights. Researchers investigated the possible mechanism of vaccine protection by transferring the vaccinated participants’ antibodies into mice and then purposely infecting the mice with Zika virus. Results indicate the antibodies provided robust protection against Zika viremia (detectable virus in the blood).

“Zika remains a threat to U.S. military personnel and families of service members. We aim to develop a vaccine to protect the military, as well as the global community,” said Col. Nelson Michael, Zika program leader at the Walter Reed Army Institute of Research.

The vaccinations were administered at three sites: the WRAIR Clinical Trial Center in Silver Spring, Maryland; the Center for Virology and Vaccine Research, part of Beth Israel Deaconess Medical Center and Harvard Medical School in Boston; and the Center for Vaccine Development at the Saint Louis University School of Medicine, a NIAID-funded Vaccine and Treatment Evaluation Unit (VTEU). The VTEU network can rapidly enroll large cohorts of volunteers and has conducted hundreds of clinical trials, many of which have contributed to vaccine licensure.

Additional research on the candidate vaccine will examine dosing, schedule and prior immunity. Specifically, WRAIR is examining the impact of pre-existing immunity by vaccinating participants with a yellow fever or Japanese encephalitis vaccine before beginning the ZPIV vaccine regimen. Those viruses, like Zika, are members of the flavivirus family. An additional study at Ponce Health Sciences University in Puerto Rico includes participants who already have been exposed naturally to a flavivirus, such as dengue. Saint Louis University seeks to identify the optimal ZPIV vaccine dose by assigning participants to receive a high, moderate or low dose, whereas Beth Israel Deaconess Medical Center is testing various dosing schedules.

NIAID is developing additional Zika vaccine candidates, including an experimental DNA vaccine, which is currently in Phase 2 trials at sites in the United States, Central, and South America. In addition, NIAID is helping to develop an investigational mRNA Zika vaccine (a gene-based platform similar to DNA vaccines) and a live-attenuated vaccine candidate designed to protect against Zika and all four strains of dengue virus.

Source:

https://www.niaid.nih.gov/news-events/trials-show-inactivated-zika-virus-vaccine-safe-and-immunogenic

Tagged with:

About author

Related Articles