Archive for the ‘Zika virus’ Category
Echocardiography evaluation of a group of Brazilian babies with Zika-related birth defects found three times the expected rate of congenital heart disease (CHD), but only one infant had symptoms and most had minor septal defects that weren’t hemodynamically significant.Saturday, April 22nd, 2017
Cavalcanti DD, Alves LV, Furtado GJ, Santos CC, Feitosa FG, Ribeiro MC, et al. (2017) Echocardiographic findings in infants with presumed congenital Zika syndrome: Retrospective case series study. PLoS ONE 12(4): e0175065. https://doi.org/10.1371/journal.pone.0175065
Friday, March 31, 2017
Study will evaluate NIH’s experimental DNA vaccine.
Vaccinations have begun in a multi-site Phase 2/2b clinical trial testing an experimental DNA vaccine designed to protect against disease caused by Zika infection. The vaccine was developed by government scientists at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). NIAID is leading the trial, which aims to enroll at least 2,490 healthy participants in areas of confirmed or potential active mosquito-transmitted Zika infection, including the continental United States and Puerto Rico, Brazil, Peru, Costa Rica, Panama and Mexico. The two-part trial, called VRC 705, further evaluates the vaccine’s safety and ability to stimulate an immune response in participants, and assesses the optimal dose for administration. It also will attempt to determine if the vaccine can effectively prevent disease caused by Zika infection.
Most people with Zika infection have either no or only mild symptoms, such as fever, rash, joint pain and conjunctivitis (red eyes). However, when Zika infection occurs during pregnancy, the pregnant woman can pass the virus to her fetus, which can result in a range of fetal defects known collectively as congenital Zika syndrome. Currently there is no licensed vaccine to prevent disease caused by Zika infection, which is mainly transmitted via the bite of infected Aedes aegypti mosquitoes but also can be transmitted sexually.
“We are pleased to have advanced rapidly one of NIAID’s experimental Zika vaccines into this next stage of testing in volunteers. We expect this study will yield valuable insight into the vaccine’s safety and ability to prevent disease caused by Zika infection,” said NIAID Director Anthony S. Fauci, M.D. “A safe and effective Zika vaccine is urgently needed to prevent the often-devastating birth defects that can result from Zika virus infection during pregnancy. Evidence also is accumulating that Zika can cause a variety of health problems in adults as well. This trial marks a significant milestone in our efforts to develop countermeasures for a pandemic in progress.”
Scientists at NIAID’s Vaccine Research Center (VRC) developed the NIAID Zika virus investigational DNA vaccine. It entered early-stage human testing in 2016 following extensive testing in animal models. Initial findings indicate the vaccine is safe and able to induce a neutralizing antibody response against Zika virus. The Phase 2/2b trial aims to gain more safety and immune response data and determine if this immune response protects against disease caused by natural Zika infection.
The Zika vaccine platform is based on a strategy VRC scientists used previously to develop a West Nile virus vaccine candidate. The Zika vaccine candidate being tested in this study contains a small circular piece of DNA called a plasmid into which scientists have inserted genes that encode two proteins found on the surface of the Zika virus. Once injected into muscle, the encoded proteins assemble into particles that mimic Zika virus and trigger the body’s immune system to respond. The vaccine does not contain infectious material, so it cannot cause Zika infection.
The trial is being led by protocol co-chairs Julie E. Ledgerwood, D.O., chief of VRC’s Clinical Trials Program, and Grace L. Chen, M.D., deputy chief of the same program.
The trial consists of two studies: part A and part B. Part A will build on ongoing Phase 1 trials to further evaluate the vaccine’s safety and ability to stimulate an immune response, specifically in populations where Zika could be endemic. It will also help determine the optimal dose and injection sites for administration. Part A will enroll 90 healthy men and non-pregnant women ages 18-35 years at three sites in Houston, Miami and San Juan, Puerto Rico. All participants will receive the investigational vaccine intramuscularly at three separate clinic visits each four weeks apart. Participants will be randomly assigned to receive either a standard dose or a high dose of the investigational vaccine at all three visits, and will be followed for about 32 weeks total.
Part B of the trial will enroll at least 2,400 healthy men and non-pregnant women ages 15-35 years. This part of the trial aims to determine if the vaccine can effectively protect against Zika-related disease when someone is naturally exposed to the virus. Sites will include the three locations from part A (Houston, Miami and San Juan) as well as two additional sites in San Juan, two sites in Costa Rica, and one site each in Peru, Brazil, Panama and Mexico. Additional sites might be added in the future. Participants will be randomly assigned to receive either the investigational vaccine or a placebo at three separate clinic visits each four weeks apart. The trial is double-blind, meaning neither the study investigators nor the participants will know who receives the investigational vaccine.
Part B participants will be followed for nearly two years, during which time they will undergo assessments for adverse events and symptoms of Zika infection. Trial participants in both parts will be counseled on how to protect against Zika infection. Investigators will compare the rates of confirmed cases of Zika in the placebo group and the vaccinated group to determine if the investigational vaccine protects against disease caused by Zika infection.
Each site will have a principal investigator responsible for ensuring daily review of safety data as they become available. A protocol safety review team that includes the protocol chairs and other medical officers at NIAID will review safety data reports weekly. The NIAID Intramural Data and Safety Monitoring Board will also review cumulative study data at least twice per year. The study is currently expected to be completed by 2019.
For more information about the trial, visit Questions and Answers: VRC 705: Phase 2/2b Trial Testing the NIAID Zika Virus Investigational DNA Vaccine.
NIAID conducts and supports research — at NIH, throughout the United States, and worldwide — to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.
About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
NIH…Turning Discovery Into Health®
“….And doctors and researchers are just starting to grasp the medical consequences of Zika. Besides the alarmingly small heads characteristic of microcephaly, many babies have a long list of varied symptoms, leading experts to rename their condition “congenital Zika syndrome.” They can have seizures, breathing problems, trouble swallowing, weakness and stiffness in muscles and joints preventing them from even lifting their heads, clubbed feet, vision and hearing problems, and ferocious irritability.
Some have passed their first birthdays, but have neurological development closer to that of 3-month-old infants, doctors say. Some microcephaly cases appear so dire that experts liken them to a previously rare variant called “fetal brain disruption sequence.” And new issues keep cropping up, including hydrocephalus,…..”
WHO, the United States Centers for Disease Control and Prevention and the European Centre for Disease Prevention and Control have developed a new Zika virus classification scheme. The classification serves to categorize the presence of and potential for vector-borne ZIKV transmission and to inform public health recommendations. Based on the defined criteria and expert review, some countries, territories and subnational areas were reclassified and some were classified for the first time.
Category 1: Area with new introduction or re-introduction with ongoing transmission
- A laboratory-confirmed autochthonous, vector-borne case of ZIKV infection in a country /territory/subnational area where there is no evidence of virus circulation before 2015, whether it is detected and reported by the country /territory/subnational area where infection occurred, or by another country by diagnosis of a returning traveller; or
- A laboratory-confirmed autochthonous, vector-borne case of ZIKV infection in a country/territory/subnational area where transmission has been previously interrupted, whether it is detected and reported by the country where infection occurred, or by another country by diagnosis of a returning traveller.
Category 2: Area either with evidence of virus circulation before 2015 or area with ongoing transmission that is no longer in the new or re-introduction phase, but where there is no evidence of interruption
This category takes into account those countries with known historical laboratory evidence of ZIKV circulation prior to 2015, based on the literature as well as all ZIKV surveillance data whether detected and reported by the country where infection occurred or by another country reporting a confirmed case in a returning traveller. Countries in this category may have seasonal variations in transmission. These countries may also experience outbreaks of ZIKV disease.
Laboratory criteria to ascertain the presence of ZIKV in past studies are:
- Detection of the virus in humans, mosquitoes or animals; and/or
- Serologic confirmation of ZIKV infection with tests conducted after 1980, and considered as confirmed infection on expert review based on testing for all appropriate cross-reactive flaviviruses and utilization of comprehensive testing methodologies. Because of testing and interpretation limitations with serological data antedating 1980, they were not used for classification purposes.
Category 3: Area with interrupted transmission and with potential for future transmission
The minimum timeline for determining transition to an interrupted state is 12 months after the last confirmed case, and no cases identified in travellers. For countries with a high capacity for diagnostic testing, consistent timely reporting of diagnostic results, a comprehensive arboviral surveillance system and/or a temperate climate or island setting, the interruption of vector-borne transmission is defined as the absence of ZIKV infection 3 months after the last confirmed case. Countries where interruption is epidemiologically likely to have occurred should provide surveillance data to WHO to support the assessment by expert review.
Category 4: Area with established competent vector but no known documented past or current transmission
All countries/territories/subnational areas where the main competent vector (A. aegypti) is established, but which have not had a documented, autochthonous, vector-borne case of ZIKV infection. This category also includes a subgroup of countries/ territories /subnational areas where ZIKV transmission may occur because of a shared border with a neighbouring Category 2 country, by belonging to the same ecological zone and having evidence of dengue virus transmission. In this subgroup, a first laboratory-confirmed, autochthonous vector-borne case of ZIKV infection may not necessarily indicate new introduction (Category 1), but rather previously unknown and undetected transmission (Category 2), and these countries/territories/subnational areas will be reclassified accordingly.
Mar 10 CDC travel advisory for Angola
Mar 10 CDC travel advisory for Guinea-Bissau
Mar 10 CDC travel advisory for Maldives
Mar 10 CDC travel advisory for Solomon Islands
- Countries, territories and subnational areas reporting vector-borne Zika virus (ZIKV) infections for the first time since 1 February:
- Countries and territories reporting microcephaly and other central nervous system malformations potentially associated with ZIKV infection for the first time since 1 February:
- Mexico, Saint Martin
- Countries and territories reporting Guillain-Barré syndrome cases associated with ZIKV infection for the first time since 1 February:
- Curaçao, Trinidad and Tobago
- WHO, the United States Centers for Disease Control and Prevention and the European Centre for Disease Prevention and Control have developed a new Zika virus classification scheme. The classification serves to categorize the presence of and potential for vector-borne ZIKV transmission and to inform public health recommendations. Based on the defined criteria and expert review, some countries, territories and subnational areas were reclassified and some were classified for the first time.
- In line with WHO’s transition to a sustained programme to address the long-term nature of the disease and its consequences, this is the final WHO Zika situation report. WHO will continue to publish the Zika classification table (Table 1) on a regular basis as well as periodic situation analysis.
March 02, 2017
Department of Health Daily Zika Update
Tallahassee, Fla. — In an effort to keep Florida residents and visitors safe and aware about the status of the Zika virus, the department issues a Zika virus update when there is a confirmed locally acquired case of Zika.
There are no new travel-related cases to report today. Please visit our website to see the full list of travel-related cases by county and year. The department updates the travel-related case chart online each weekday.
There are three locally acquired cases being reported today. Two are cases that had samples collected in October as part of our ongoing investigation and the department just received confirmatory testing back from CDC. These two cases have been added to the 2016 chart.
The third case reported no symptoms, but screening conducted after blood donation in January showed evidence of a past infection. The department concluded our investigation of this case yesterday. This individual had multiple exposures in Miami-Dade County and likely contracted Zika in 2016. Because the individual was asymptomatic, it is difficult to determine when infection occurred. Since the first positive sample was collected in January, this is considered our first locally reported case of Zika in 2017. Florida still does not have any identified areas with ongoing, active Zika transmission.
The total number of Zika cases reported in Florida for 2016 is 1,384. The total number of Zika cases reported in Florida for 2017 is 18.
|Infection Type||Infection Count|
|Travel-Related Infections Of Zika||1076|
|Locally Acquired Infections Of Zika||276|
|Pregnant Women With Lab-Evidence Of Zika||264|
|Infection Type||Infection Count|
|Travel-Related Infections Of Zika||13|
|Locally Acquired Infections Of Zika||1|
|Pregnant Women With Lab-Evidence Of Zika||4|
Florida no longer has any identified areas with active Zika transmission, but we will continue to see isolated cases of local transmission so it is important for residents and visitors in Miami-Dade County to remain vigilant about mosquito bite protection.
It is important for people to remember to take proper precautions to prevent mosquito bites while traveling to areas with widespread Zika transmission. The CDC list of these locations is available here.
One case does not mean ongoing active transmission is taking place. DOH conducts a thorough investigation by sampling close contacts and community members around each case to determine if additional people are infected. If DOH finds evidence that active transmission is occurring in an area, the media and the public will be notified.
The department has conducted Zika virus testing for more than 12,700 people statewide. Florida currently has the capacity to test 4,653 people for active Zika virus and 5,152 for Zika antibodies. At Governor Scott’s direction, all county health departments now offer free Zika risk assessment and testing to pregnant women.
The CDC advises pregnant women should consider postponing travel to Miami-Dade County. If you are pregnant and must travel or if you live or work in Miami-Dade County, protect yourself from mosquito bites by wearing insect repellent, long clothing and limiting your time outdoors.
According to CDC guidance, providers should test all pregnant women who lived in, traveled to or whose partner traveled to Miami-Dade County after Aug. 1, 2016. Pregnant women in Miami-Dade County can contact their medical provider or their local county health department to be tested and receive a Zika prevention kit. Additionally, the department is working closely with the Healthy Start Coalition of Miami-Dade County to identify pregnant women in Miami-Dade County to ensure they have access to resources and information to protect themselves. CDC recommends that a pregnant woman with a history of Zika virus and her provider should consider additional ultrasounds.
Pregnant women can contact their local county health department for Zika risk assessment and testing hours and information. A Zika risk assessment will be conducted by county health department staff and blood and/or urine samples may be collected and sent to labs for testing. It may take one to two weeks to receive results.
Florida has been monitoring pregnant women with evidence of Zika regardless of symptoms. The total number of pregnant women who have been or are being monitored is 264.
On Feb. 12, Governor Scott directed the State Surgeon General to activate a Zika Virus Information Hotline for current Florida residents and visitors, as well as anyone planning on traveling to Florida in the near future. The number for the Zika Virus Information Hotline is 1-855-622-6735.
The department urges Floridians to drain standing water weekly, no matter how seemingly small. A couple drops of water in a bottle cap can be a breeding location for mosquitoes. Residents and visitors also need to use repellents when enjoying the Florida outdoors.
For more information on DOH action and federal guidance, please click here.
For resources and information on Zika virus, click here.
About the Florida Department of Health
The department, nationally accredited by the Public Health Accreditation Board, works to protect, promote and improve the health of all people in Florida through integrated state, county and community efforts.
“…..A prospective case series of 87 infants with laboratory-confirmed congenital Zika syndrome (CZS) at the epicenter of the Brazilian Zika epidemic in Pernambuco state is presented. Mothers were interviewed for symptoms of possible Zika virus (ZIKV) infection during pregnancy and fetal ultrasounds were obtained. Infant cerebrospinal fluid (CSF) samples were tested for ZIKV specific antibodies and sera were screened for other congenital infections. Neuroimaging and ophthalmologic evaluations were also performed. Sixty six mothers (76%) reported symptoms of ZIKV infection during gestation. Fetal ultrasounds were available from 90% of the mothers and all demonstrated brain structural abnormalities. All the CSF samples tested positive for ZIKV IgM. The majority of infants (89%) were term, the mean birth weight was 2577±260g and the mean head circumference was 28.1±1.8 cm. Severe microcephaly, defined as head circumference below 3 SD for sex and gestational age, was found in 72 (82%) infants. All infants had an abnormal neurological exam and 18 (20.7%) had arthrogryposis. The main abnormalities detected in CT scans were calcifications (99%), followed by ventricular enlargement (94%), cortical hypogyration (81%), and less commonly, cerebellar hypoplasia (52%). Unilateral diaphragm paralysis was identified in three infants. Maternal young age, term infant, small for gestational age and the presence of ophthalmologic abnormalities were significantly associated with a smaller head circumference Z score. Our findings, based on laboratory-confirmed ZIKV infection, add valuable evidence for the understanding of CZS.”
AGS-v: An investigational vaccine that triggers an immune response to mosquito saliva rather than to a specific virus or parasite carried by mosquitoesWednesday, February 22nd, 2017
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has launched a Phase 1 clinical trial to test an investigational vaccine intended to provide broad protection against a range of mosquito-transmitted diseases, such as Zika, malaria, West Nile fever and dengue fever, and to hinder the ability of mosquitoes to transmit such infections. The study, which is being conducted at the NIH Clinical Center in Bethesda, Maryland, will examine the experimental vaccine’s safety and ability to generate an immune response.
The investigational vaccine, called AGS-v, was developed by the London-based pharmaceutical company SEEK, which has since formed a joint venture with hVIVO in London. The consulting group Halloran has provided regulatory advice to both companies.
Unlike other vaccines targeting specific mosquito-borne diseases, the AGS-v candidate is designed to trigger an immune response to mosquito saliva rather than to a specific virus or parasite carried by mosquitoes. The test vaccine contains four synthetic proteins from mosquito salivary glands. The proteins are designed to induce antibodies in a vaccinated individual and to cause a modified allergic response that can prevent infection when a person is bitten by a disease-carrying mosquito.
“Mosquitoes cause more human disease and death than any other animal,” said NIAID Director Anthony S. Fauci, M.D. “A single vaccine capable of protecting against the scourge of mosquito-borne diseases is a novel concept that, if proven successful, would be a monumental public health advance.”
Led by Matthew J. Memoli, M.D., director of the Clinical Studies Unit in NIAID’s Laboratory of Infectious Diseases, the clinical trial is expected to enroll up to 60 healthy adults ages 18 to 50 years. Participants will be randomly assigned to receive one of three vaccine regimens. The first group will receive two injections of the AGS-v vaccine, 21 days apart. The second group will receive two injections of AGS-v combined with an adjuvant, 21 days apart. The adjuvant is an oil and water mixture commonly added to vaccines to enhance immune responses. The third group will receive two placebo injections of sterile water 21 days apart. Neither the study investigators nor the participants will know who is assigned to each group.
Participants will be asked to return to the clinic twice between vaccinations and twice after the second vaccination to undergo a physical exam and to provide blood samples. Study investigators will examine the blood samples to measure levels of antibodies triggered by vaccination.
Each participant also will return to the Clinical Center approximately 21 days after completing the vaccination schedule to undergo a controlled exposure to biting mosquitoes. The mosquitoes will not be carrying viruses or parasites, so the participants are not at risk of becoming infected with a mosquito-borne disease. Five to 10 female Aedes aegypti mosquitoes from the insectary in NIAID’s Laboratory of Malaria and Vector Research will be put in a feeding device that will be placed on each participant’s arm for 20 minutes. The mosquitoes will bite the participants’ arms through the netting on the feeding devices.
Afterward, investigators will take blood samples from each participant at various time points to see if participants experience a modified response to the mosquito bites as a result of AGS-v vaccination.
Investigators also will examine the mosquitoes after the feeding to assess any changes to their life cycle. Scientists suspect that the mosquitoes who take a blood meal from ASG-v-vaccinated participants may have altered behavior that could lead to early death or a reduced ability to reproduce. This would indicate that the experimental vaccine could also hinder disease transmission by controlling the mosquito population.
All participants will be asked to return to the clinic for follow-up visits every 60 days for five months following the mosquito feeding. A final clinic visit to assess long-term safety will take place approximately 10 months after the mosquito feeding. Throughout the trial, an independent Data and Safety Monitoring Board will review study data to evaluate participant safety and the overall conduct of the study. A medical monitor from NIAID’s Office of Clinical Research Policy and Regulatory Operations will also perform routine safety assessments.
The study is expected to be completed by summer 2018. For more information about the trial, see ClinicalTrials.gov using the trial identifier NCT03055000.