Zika 2016
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Zika virus was first discovered in 1947 in Uganda. It is transmitted primarily via mosquito bites but can also be transmitted sexually or from mother to fetus. While most infections cause only mild symptoms, infection during pregnancy can lead to microcephaly and other birth defects. There is currently no vaccine or treatment, but researchers are developing DNA vaccines which may be available in 3-5 years. Two vaccine candidates are currently in phase 1 clinical trials.
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Zika 2016
- 1. Libby Daugherty, PharmD Candidate Todd Parker, Pharm.D., Preceptor Piedmont Atlanta Hospital APPE 2 – Infectious Disease July 22, 2016
- 2. Background Zika Virus is an arbovirus that was first discovered in Uganda in 1947 Named after the forest where it was first found in a rhesus monkey A member of the flavivirus family Dengue fever Yellow fever West Nile virus Zika is the zoonotic disease in humans caused by Zika Virus
- 3. History First detected in humans in Uganda and Tanzania in 1952 Sporadic infections across Africa until… First major outbreak on the island of Yap, Micronesia in 2007 Outbreaks have occurred in Africa, Southeast Asia and the Pacific Rim First recorded infection in the Western hemisphere was on Easter Island, Chile in 2014. Current outbreak in the Americas, the Caribbean, and the Pacific
- 5. Epidemiology Confirmed mosquito-borne transmissions in Puerto Rico, US Virgin Islands and American Samoa 1404 documented cases of Zika currently in the US as of July 20 Travel-associated: 1403 Sexually transmission: 15 One case of potential nosocomial transmission Still no evidence of mosquito-borne transmission in the US States 1 reported case of Zika-related microcephaly in the US 5 reported cases of Zika-related Guillain-Barré Syndrome
- 6. Transmission Mosquitos Aedes aegypti Aedes albopictus Congenital (mother to baby) Sexual intercourse Blood/organ donation Lab exposure/needlestick
- 8. Clinical Presentation Most people infected with Zika virus are asymptomatic (75-80%) Symptoms, when they occur, are usually mild Low-grade fever (37.8 – 38.5) Macropapular pruritic rash Arthralgia, especially of the hands and feet Non-purulent conjunctivitis Myalgia Headache Retro-orbital pain Asthenia Death is extremely rare
- 9. Complications Guillain-Barré Syndrome (GBS) Rare autoimmune disease Muscle weakness Paralysis A likely complication of Zika Virus infection Has been occurring more frequently than usual in countries affected by the current Zika outbreak. Could be a concern with both the disease and any potential vaccines Myelitis Meningeoencephalitis
- 10. Complications for Pregnant Women Miscarriage Stillbirth Birth Defects Microcephaly Ocular abnormalities CNS abnormalities Hydrops fetalis Impaired prenatal and postnatal growth Hearing loss
- 11. Diagnosis Suspected in patients with Typical clinical manifestations AND Relevant epidemiologic exposure OR Unprotected sexual contact with someone meeting the above criteria Definitive Diagnosis Real-time reverse-transcription polymerase chain reaction (rRT-PCR) testing for Zika viral RNA in serum or urine Depends on timing of presentation/onset of symptoms May not be necessary for people not at risk of pregnancy who live in Zika-affected countries Rule out other similar (more serious) infections like Dengue
- 12. Zika Virus RNA Source Active Virus Found Viral RNA Found Blood A few days to a week after onset. Up to 10 weeks in pregnancy. A few days to a week after onset. Up to 10 weeks in pregnancy. Urine At time of onset. 29 days after onset Semen 7 days after onset 62 days after onset Saliva While symptomatic 29 days after onset Female genital tract secretions 11 days after onset Also found in cerebrospinal fluid, amniotic fluid, and breast milk
- 13. Treatment There is no currently accepted treatment or cure for Zika Virus Provide supportive care Fluids for hydration Treat the symptoms Acetaminophen for fever/aches Avoid Aspirin and NSAIDs until Dengue fever is ruled out
- 14. Prevention of Mosquito Bites Avoid Mosquitos and Use Protection! CDC’s 6 Steps to Zika Prevention: Keep mosquitos outside Create a barrier between you and mosquitoes Wear insect repellent Protect your family Protect your partner Do your homework before traveling
- 15. Prevention of Sexual Transmission Use a condom or abstain from sex Women: Symptomatic At least 8 weeks after symptoms start Asymptomatic At least 8 weeks after returning from a Zika-affected country Men: Symptomatic At least 6 months after symptoms start Asymptomatic At least 8 weeks after returning from a Zika-affected country Pregnant partner For the duration of the pregnancy, even if asymptomatic. All Residents of Zika-Affected Countries: Use condoms or abstain from sex for the duration of the outbreak.
- 16. Vaccines There are no approved vaccines available for the prevention of Zika Virus. 18 companies and academic laboratories are currently in various stages of vaccine development. The usual course (a live attenuated virus) would not be safe to use in pregnant women who are the target vaccine population. DNA vaccines are the current focus Vaccine contains DNA that encodes for a benign part of the virus structure (like the membrane/capsule) Electroporation: Injection site is stimulated with a short electrical pulse that helps the DNA integrate into cells This is a new step that may increase the effectiveness of DNA vaccines which have not been very successful in the past Immune system generates antibodies against the viral capsule
- 17. Vaccines Two candidates are currently recruiting for Phase 1 clinical trials GLS-5700 GeneOne Life Science, Inc. Inovio Pharmaceuticals Estimated study completion date: November 2017 VRC-ZKADNA085-00-VP National Institute of Allergy and Infectious Diseases (NIAID) Estimated study completion date: December 2018 Timeline September 2015: Research began June 2106: Phase 1 Approval August 2016: Phase 1 Begins November 2016: Phase 1 Ends November 2017: Phase 1 Analysis Complete ???? - Phase 2 Approval/Study/Analysis ???? - Phase 3 Approval Study/Analysis ???? Commercialization/Monetization Agreements and Logistics ???? - Mass Production ???? - Distribution Best case scenario = 3-5 years before a vaccine is available and deliverable.
- 18. References Branswell, Helen. "Zika Vaccine Approved for Human Trials." STAT. N.p., 20 June 2016. Web. 22 July 2016. "Important Information Regarding Zika Virus." Zika Virus Investigational Study and Donor Self-Deferral Information Sheet to Reduce the Risk of Transfusion- Transmitted Zika Virus. American Red Cross, 2016. Web. 22 July 2016. LaBeaud, A. Desiree. "Zika Virus Infection: An Overview." Ed. Martin S. Hirsch and Elinor L. Baron. UpToDate. Wolters Kluwer, 19 July 2016. Web. 22 July 2016. Leonard, Kimberly. "Brain Damage Confirmed in Babies Born with Microcephaly from Zika." U.S. News & World Report. N.p., 13 Apr. 2016. Web. 22 July 2016. McCabe, Edward RB. "Zika Virus Infection: Pregnancy and Congenital Infection." Ed. Martin S. Hirsch, Charles J. Lockwood, Deborah Levine, Vanessa A. Barss, and Elinor L. Baron. UpToDate. Wolters Kluwer, 07 July 2016. Web. 22 July 2016. Mohney, Gillian. "Zika in Florida: Second Possible Case of Local Transmission Under Investigation, Officials Say." ABC News. ABC News Network, 21 July 2016. Web. 22 July 2016.
- 19. References Rasmussen, Sonja A., Denise J. Jamieson, Margaret A. Honein, and Lyle R. Petersen. "Zika Virus and Birth Defects — Reviewing the Evidence for Causality." New England Journal of Medicine N Engl J Med 374.20 (2016): 1981-987. Web. 22 July 2016. "Safety and Immunogenicity of a Zika Virus DNA Vaccine, VRC-ZKADNA085-00-VP, in Healthy Adults." ClinicalTrials.gov. National Institute of Allergy and Infectious Diseases (NIAID), 2016. Web. 22 July 2016. "Study of GLS-5700 in Healthy Volunteers." ClinicalTrials.gov. GeneOne Life Science, Inc., July 2016. Web. 22 July 2016. "A Study of INO-3112 DNA Vaccine With Electroporation in Patients With Cervical Cancer." ClinicalTrials.gov. Inovio Pharmaceuticals, Feb. 2016. Web. 22 July 2016. "Zika Virus." Centers for Disease Control and Prevention, 21 July 2016. Web. 22 July 2016.
- 20. Thank you for your attention!
Editor's Notes
- Arbovirus = transmitted by the bite from an infected arthropod Flaviviruses cause encephalopathy Flavus = yellow
- Regions above 6500 feet (2000 meters) are excluded from travel precautions, since the mosquitoes that transmit Zika virus are rare in these locations and the risk for mosquito-borne transmission of Zika virus is minimal
- Outbreak in French Polynesia in 2013/2014 which affected 2/3 of the population 3% of donated blood samples tested positive Red Cross has instituted Donor Self-Deferral for Zika virus Blood product donations are now screened for Zika virus
- Only 1 reported Zika-related death 1 = Puerto Rico = internal bleeding due to immune-mediated thrombocytopenia
- Microcephaly is a severe birth defect that is a sign of a problem with brain development. Microcephaly can occur because a baby’s brain has not developed properly during pregnancy or has stopped growing after birth. Recognizing that Zika is a cause of certain birth defects does not mean that every pregnant woman infected with Zika will have a baby with a birth defect. It means that infection with Zika during pregnancy increases the chances for these problems.
- Also found in cerebrospinal fluid Amniotic fluid Breast milk – no confirmed transmissions anywhere
- Keep mosquitos outside Screens/Bed Nets/Tents Air conditioning Sprays Remove standing water Create a barrier between you and mosquitoes Long sleeves and pants Clothing and equipment treated with Permethrin (not effective in Puerto Rico) Wear insect repellent DEET or Picaridin Cannot use on children < 2 months Not under clothing Apply after sunscreen Protect your family Clothing that covers all skin Crib/Stroller covers AVOID BEING BITTEN BY MOSQUITOS EVEN/ESPECIALLY IF YOU ALREADY HAVE/HAD ZIKA Zika is unique among most other arboviruses (except Dengue and Yellow Fever) in that human blood can reinfect vector mosquitos
- Unknown whether or not a woman can give Zika to a man during sexual contact
- DNA vaccines Uses only the DNA from infectious organisms (as opposed to attenuated ones) = improved antibody recognition Avoid the risk of using actual infectious organism Provide both humoral and cell-mediated imunity (vs. just humoral) Refrigeration is not required (bonus in many of the places this vaccine would be employed) DNA vaccines have not been very successful in the past However, promising improvements due to Electroporation
- Inovio is a company centered on DNA vaccine research and development Have not brought a vaccine to market yet But they do have 1 cervical cancer vaccine about to start Phase 3 (VGX-3100 SynCon® immunotherapy)