Rotavirus disease & prevention - the Indian context

ROTAVIRUS DISEASE & PREVENTION – AN INDIAN

CONTEXTFacilitator - Dr Gaurav Gupta

What’ s this talk going to be about ?

A bit about diarrhea & ORS Epidemiology & disease burden of

Rotavirus Efficacy of Rotavirus vaccine incl

differences between Rotarix v/s Rotateq Special issues with RV vaccines CME









Improvement in hygiene and sanitation does not significantly reduce Rotavirus

infection

Almost every child infected by 2 years irrespective of Socio Economic

Class

Rotavirus is:Highly Contagious: Person to person, feco-oral,

respiratory droplets

Resistant to inactivation: Most soaps and disinfectants not effective

Highly Stable: Retains infectivity for several weeks

Country wise Mortality due to rotavirus*

Number of deaths due to rotavirus disease (and

percentage of the global total) in 10 countries with

the greatest number of deaths due to rotavirus

disease.

23% of all deaths due to rotavirus disease occurred in India

Adapted from: Umesh Parashar, Global Mortality Associated with Rotavirus among Children • JID 2009:200 (Suppl 1) • S9-15

Global Distribution of Rotavirus Serotypes1

G1P[8]65%

G3P[8]3%

G4P[8]9%

G9P[6]1%G9P[8]

3%

Other7%

G2P[4]12%

Other=untypeable and rare G-P combinations.1. Santos N, Hoshino Y. Rev Med Virol. 2005;15:29–56. Reproduced by permission of John Wiley & Sons Limited.

Rotavirus Strains Diversity in India

G2 P[4], 25.7%

G12 P[4][6][8], 6.5%

G9 P[8], 8.5%

G1 P[8], 22.1%

Unique features: Diversity of rotavirus strains & mixed infections. Need for vaccines formulated against a broad range of strains.2

It is found that the predominant Rota Virus strain (type) in cities varied from year to year and from city to city. 3

1. The Journal of Infectious Diseases 2009; 200:S147–53. 2. Indian J. Med Res 118, Aug 2003, Pg 59-67 3. Journal of Clinical Microbiology. Oct 2001, Pg 3524-3529.

IRSN Data

Rotavirus Disease Burden In India

122,000-153,000

457,000-884,000

2 million

Estimated annual number and risk of death, hospitalization, and outpatientvisits due to rotavirus diarrhea in children <5 years of age in India.

Adapted from: J. E. Tate et al. Disease and economic burden of rotavirus diarrhea in India/Vaccine 27 S (2009) F18–F24

EVENTSRISK

1 in every 177-196 children

1 in every 31-59 children

1 in every 13 children

Deaths

Hospitalizations

Outpatient Visits





21

Rationale for Development of pentavalent vaccine

Predominance of individual serotypes can vary from year to year and by geographic region.1

Primary infections are usually associated with more severe disease than subsequent infections.2

Protection against disease is thought to increase with each subsequent infection.2

Immunity following primary infection is thought to be predominantly serotype specific.2

1. Santos N et al. Rev Med Virol. 2005;15:29–56. 2. Velázquez FR et al. N Engl J Med. 1996;335:1022–1028.

Vaccines should mimic the natural infection pattern

A multivalent vaccine is expected to give more diverse protection against multiple serotypes with the 1st dose

2 doses are expected to give good protection against moderate to severe diarrheas

3 doses are expected to give good protection against mild diarrheas as well

“CROSS-PROTECTIVE”(HETEROTYPIC)Im

mun

e Re

spon

se

SEROTYPE-SPECIFIC(HOMOTYPIC)

Number of Infections1 2 3

• After primary infection, antibody response appears to be predominantly serotype specific (homotypic).1,2

• After subsequent infections, a broadened, cross-reactive (heterotypic) antibody response can occur.1,2

1. Cortese MM et al. MMWR Morb Mort Wkly Rep. 2009;58(RR02):1–25. 2. Jiang B et al. Clin Infect Dis. 2002;34:1351–1361.

(Graph for illustrative purposes only)

Homotypic and Heterotypic Immunity Following Natural Infection1,2

First infection elicited a HOMOTYPIC protective response

Second & subsequent infections elicited a HETEROTYPIC protective response









In which one of these patients should you not recommend receiving

a first dose of rotavirus vaccine?

A 10-week-old boy born HIV positive A 16-week-old adopted girl from unknown

parentage A 12-week-old premature stable boy in

the neonatal intensive care unit A 13-week-old girl who is breastfeeding

In which one of these patients should you not recommend receiving

a first dose of rotavirus vaccine?

A 10-week-old boy born HIV positive A 16-week-old adopted girl from unknown

parentage A 12-week-old premature stable boy in

the neonatal intensive care unit A 13-week-old girl who is breastfeeding

For which of the following infants would you potentially consider using one

vaccine over the other?

An infant with short bowel syndrome An infant with HIV An infant with severe combined

immunodeficiency disease An infant with spina bifida

For which of the following infants would you potentially consider using one

vaccine over the other?

An infant with short bowel syndrome An infant with HIV An infant with severe combined

immunodeficiency disease An infant with spina bifida

The potential for decreasing the burden of rotavirus disease, including mortality, is greatest

in:

Mexico Africa Brazil India

The potential for decreasing the burden of rotavirus disease, including mortality, is greatest

in:

Mexico Africa Brazil India

Which of the following children should be given a first dose of rotavirus vaccine?

A full-term 5-week-old infant A full-term 33-week-old infant A full-term 16-week-old infant A preterm 8-week-old infant

Which of the following children should be given a first dose of rotavirus vaccine?

A full-term 5-week-old infant A full-term 33-week-old infant A full-term 16-week-old infant A preterm 8-week-old infant

Which of the following is a contraindication to rotavirus vaccination

in infants and small children?

Hirschspung disease HIV Malabsorption syndrome Severe combined immunodeficiency

syndrome

Which of the following is a contraindication to rotavirus vaccination

in infants and small children?

Hirschspung disease HIV Malabsorption syndrome Severe combined immunodeficiency

syndrome

The classic clinical triad of rotavirus gastroenteritis consists of:

Intermittent fever, diarrhea, and abdominal pain

Low-grade fever, vomiting, and copious, watery diarrhea

Projectile vomiting, abdominal pain, and watery diarrhea

Vomiting, fever greater than 102°F, and intermittent diarrhea

The classic clinical triad of rotavirus gastroenteritis consists of:

Intermittent fever, diarrhea, and abdominal pain

Low-grade fever, vomiting, and copious, watery diarrhea

Projectile vomiting, abdominal pain, and watery diarrhea

Vomiting, fever greater than 102°F, and intermittent diarrhea

According to recommendations from the IAP, at what age should the patient have

received her initial dose of rotavirus vaccine?

Between 8 weeks and 32 weeks Between 6 weeks and 14 weeks, 6 days Between 12 weeks and 24 weeks Between 4 weeks and 14 weeks, 6 days

According to recommendations from the IAP, at what age should the patient have

received her initial dose of rotavirus vaccine?

Between 8 weeks and 32 weeks Between 6 weeks and 14 weeks, 6 days Between 12 weeks and 24 weeks Between 4 weeks and 14 weeks, 6 days

Which of the following statements is true regarding the rotavirus vaccines?

The ACIP, AAP & IAP recommend Rotarix® because it can be administered in a 2-dose series

The ACIP, AAP & IAP recommend RotaTeq® because it is more effective in preventing severe rotavirus disease

The ACIP, AAP & IAP recommend Rotarix ® when initiation of the vaccine series is delayed

The ACIP, AAP & IAP do not recommend one vaccine over the other

Which of the following statements is true regarding the rotavirus vaccines?

The ACIP, AAP & IAP recommend Rotarix® because it can be administered in a 2-dose series

The ACIP, AAP & IAP recommend RotaTeq® because it is more effective in preventing severe rotavirus disease

The ACIP, AAP & IAP recommend Rotarix ® when initiation of the vaccine series is delayed

The ACIP, AAP & IAP do not recommend one vaccine over the other

A parent wants assurance that her son will not develop intussusception from a

rotavirus vaccine. What should you tell her?

The benefit of preventing severe rotavirus gastroenteritis outweighs the small potential risk for intussusception

There is no risk for intussusception from rotavirus vaccination

No association between RV vaccines and intussusception has been observed in either pre- or postlicensure studies

RotaShield® was taken off the market, but not because of an association with intussusception

A parent wants assurance that her son will not develop intussusception from a

rotavirus vaccine. What should you tell her?

The benefit of preventing severe rotavirus gastroenteritis outweighs the small potential risk for intussusception

There is no risk for intussusception from rotavirus vaccination

No association between RV vaccines and intussusception has been observed in either pre- or postlicensure studies

RotaShield® was taken off the market, but not because of an association with intussusception

Why are we not using more rotavirus vaccine?

Concerns regarding RV burden in India? Concerns regarding RV vaccine efficacy? Concerns regarding LM / admission with

AGE after RV vaccine? Cost of vaccine Side-effects of vaccine Short window period for vaccination Lack of patient awareness/ unable to

convinve parents ?

Health & Medicine

Rotavirus disease & prevention - the Indian context