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Rotavirus & Rotavirus Vaccine By Dr. Asad Ramlawi DGPHC & PH Beithlehem / Palestine.

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Presentation on theme: "Rotavirus & Rotavirus Vaccine By Dr. Asad Ramlawi DGPHC & PH Beithlehem / Palestine."— Presentation transcript:

1 Rotavirus & Rotavirus Vaccine By Dr. Asad Ramlawi DGPHC & PH Beithlehem / Palestine

2 Rotavirus First identified as cause of diarrhea in 1973 Most common cause of severe diarrhea in infants and children Nearly universal infection by 5 years of age Responsible for up to 500,000 diarrheal deaths each year worldwide

3 Lengthy (~5 days on average) and severe purging causes electrolyte depletion/ dehydration/ complications Rotavirus often spreads beyond the intestines into the blood stream Rotavirus can replicate in most organs Rotavirus – Diarrhea/Vomiting/Fever plus viremia in 90% of infected children Blutt et al. Rotavirus antigenemia in children is associated with viremia. PLoS Med 2007;4:e121.

4  Acute gastroenteritis Virtually all children infected by age 3-5 years “Democratic” virus Highest rates of disease between 6-24 months First infections are most severe  Natural infection confers immunity against subsequent severe re-infections Vaccines mimic the protective first infection without causing the severe illness  Worldwide distribution accounts for ~5% of all deaths among children <5 years old Epidemiology of rotavirus

5 Electron micrograph of rotavirus

6 Reovirus (RNA) VP7 and VP4 antigens define virus serotype and induce neutralizing antibody 5 predominant strains in U.S. (G1-G4, G9) and account for 90% of isolates G1 strain accounts for 75% of infections Very stable and may remain viable for weeks or months if not disinfected Rotavirus

7 Rotavirus Pathogenesis Entry through mouth Replication in epithelium of small intestine Replication outside intestine and viremia uncommon Infection leads to isotonic diarrhea

8 Rotavirus seasonality (onset and peak) was very consistent during the pre-licensure period “Winter gastroenteritis”

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10 Total AGE and Rotavirus AGE cases in NVSN, Jan-April, 2006-2008 51 % EIA+ 54 % EIA+ 6 % EIA+ Centers for Disease Control and Prevention. Delayed onset and diminished magnitude of rotavirus activity – United States, November 2007-May 2008. MMWR 2008; 57:697–700.

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12 6 Independent US Hospital-based Studies Reported 85-95% Reduction in Rotavirus Cases 2008 vs Previous Years 1. Clark F et al. 2. Daskalaki I et al. 3. Patel JA et al. 4. Harrison CJ et al. 5. Hatch S et al. 48th ICAAC / 46th IDSA Washington DC October 25-28, 2008; 6. Chang H et al. ACIP Atlanta October 22-23, 2008 Philadelphia, PA 1 87% reduction in Community acquired cases (Children's Hospital of Philadelphia) Kansas City, MO 4 88% reduction Hospitalization Galveston, TX 3 94% reduction Hospitalization or ED Philadelphia, PA 2 94% reduction Hospitalization (St Chris) New York State 6 85% reduction Hospitalization/ED Worcester, MA 5 95% reduction Hospitalization, ED, Outpatient

13 Epidemiological Implications Monitoring for age redistribution: Will severe rotavirus infections be deferred to older ages? Varicella

14 Rotavirus Epidemiology ReservoirHuman-GI tract TransmissionFecal-oral, fomites TemporalFall and winter pattern(temperate areas) Communicability2 days before to 10 days after onset

15 Rotavirus Disease in the United States Annually* responsible for: –More than 400,000 physician visits –More than 200,000 emergency dept visits –55,000-70,000 hospitalizations –20-60 deaths Annual direct and indirect costs are estimated at approximately $1 billion *prevaccine era

16 =1 dose 56% coverage with >=1 dose 31% coverage with >=1 dose

17 Estimates of annual rotavirus infection burden for U.S. children <3 years old, 2006 Payne DC, et al. Active, population-based surveillance for severe rotavirus gastroenteritis in children in the United States. Pediatrics 2008; 122:1235-43.

18 Risk Groups for Rotavirus Diarrhea Groups with increased exposure to virus –Children in child care centers –Children in hospital wards (nosocomial rotavirus) –Caretakers, parents of these children –Children, adults with immuno- deficiency related diseases (e.g. SCID, HIV, bone marrow transplant)

19 Rotavirus Clinical Features Short incubation period (usually less than 48 hours) First infection after age 3 months generally most severe May be asymptomatic or result in severe dehydrating diarrhea with fever and vomiting Gastrointestinal symptoms generally resolve in 3 to 7 days

20 Rotavirus Complications Severe diarrhea Dehydration Electrolyte imbalance Metabolic acidosis Immunodeficient children may have more severe or persistent disease

21 Rotavirus Immunity Antibody against VP7 and VP4 probably important for protection First infection usually does not lead to permanent immunity Reinfection can occur at any age Subsequent infections generally less severe

22 Rotavirus Vaccines RV5 (RotaTeq ® ) –Contains five reassortant rotaviruses developed from human and bovine parent rotavirus strains –Vaccine viruses suspended in a buffer solution –Contains no preservatives or thimerosal

23 Rotavirus Vaccines RV1 (Rotarix ® ) –Contains one strain of live attenuated human rotavirus (type G1P[8]) –provided as a lyophilized powder that is reconstituted before administration –Contains no preservatives or thimerosal

24 Rotavirus Vaccine Effectiveness Condition Any rotavirus diarrhea Severe diarrhea Effectiveness 74%-87% 95%-98% Both vaccines significantly reduced physician visits for diarrhea, and reduced rotavirus-related hospitalization

25 Rotavirus Vaccine Recommendations Routine immunization of all infants without a contraindication 2 (RV1) or 3 (RV5) oral doses beginning at 2 months of age Subsequent doses in the series should be separated from the previous dose by 1 to 2 months MMWR 2009;58:(RR-2)

26 For both rotavirus vaccines –maximum age for first dose is 14 weeks 6 days –minimum interval between doses is 4 weeks –maximum age for any dose is 8 months 0 days Rotavirus Vaccine Recommendations MMWR 2009;58:(RR-2)

27 Rotavirus Vaccine Recommendations Routine immunization of all infants without a contraindication 2 (RV1) or 3 (RV5) oral doses beginning at 2 months of age Subsequent doses in the series should be separated from the previous dose by 1 to 2 months MMWR 2009;58:(RR-2)

28 For both rotavirus vaccines –maximum age for first dose is 14 weeks 6 days –minimum interval between doses is 4 weeks –maximum age for any dose is 8 months 0 days Rotavirus Vaccine Recommendations MMWR 2009;58:(RR-2)

29 ACIP did not define a maximum interval between doses If the interval between doses is prolonged, the child can still receive the vaccine as long as it can be given on or before the child’s 8 month birthday It is not necessary to restart the series or add doses because of a prolonged interval between doses Rotavirus Vaccine Recommendations MMWR 2009;58:(RR-2)

30 Completed the series with the same product whenever possible If the product used for a prior dose or doses is not available or is not known continue or complete the series with the product that is available If any dose in the series was RV5 (RotaTeq) or the vaccine brand used for any prior dose in the series is not known, a total of three doses of rotavirus vaccine should be administered Rotavirus Vaccine Recommendations MMWR 2009;58:(RR-2)

31 Rotavirus Vaccine Contraindications Severe allergic reaction to a vaccine component or following a prior dose of vaccine

32 Rotavirus Vaccine Precautions* Altered immunocompetence Acute, moderate or severe gastroenteritis or other acute illness History of intussusception *the decision to vaccinate if a precaution is present should be made on a case-by-case risk and benefit basis

33 Vaccine Effectiveness RotaTeq® & Rotarix® Clinical Trials  Very large, multi-national clinical trials  90-100% effective in preventing severe rotavirus gastroenteritis  74-85% effective against rotavirus of any severity Post-licensure (RotaTeq®) case/control studies in US  Texas Children’s Hospital (Houston) *  New York *  New Vaccine Surveillance Network (NVSN) * presented to ACIP, Oct. 2008

34 Immunosuppressed Household Contacts of Rotavirus Vaccine Recipients Infants living in households with persons who have or are suspected of having an immunodeficiency disorder or impaired immune status can be vaccinated Protection provided by vaccinating the infant outweighs the small risk for transmitting vaccine virus

35 Pregnant Household Contacts of Rotavirus Vaccine Recipients Infants living in households with pregnant women should be vaccinated –majority of women of childbearing age have pre-existing immunity to rotavirus –risk for infection by vaccine virus is considered to be very low

36 Rotavirus Vaccine Adverse Reactions Vomiting 15%-18% Diarrhea 9%-24% Irritability 13%-62% Fever 40%-43% Serious adverse None reactions

37 Rotavirus Vaccine Storage and Handling Store at 36-46 o F (2-8 o C) and protect from light RV1 diluent may be stored at room temperature Do not freeze vaccines or diluent Administer RV5 as soon as possible after being removed from refrigeration RV1 should be administered within 24 hours of reconstitution

38 THANK YOU !


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