What is Rotavirus?

Rotavirus is an 11
segmented dsRNA, triple
layered, non enveloped
virus belonging to
Reoviridae family
Group A-G. A is mostly
seen in humans
Typed based on the VP7
(G) and VP4 (P) domains
(27 G and 37 P types)
Important cause of acute
dehydrating gastroenteritis
in <5 years age group

Burden of Disease
Rotavirus is responsible for at least 36% of
all diarrhea admissions and for an
estimated 37% of diarrhea deaths
Developing countries bear the major
burden of mortality and morbidity due to
rotavirus
In India, 11.37 million episodes of diarrhea
with an estimated 78,583 deaths in the <5
yrs of age group in India
Tate JE et al Lancet ID 2012, John J et al
Vaccine 2014

Vaccines available and their efficacy

Two rotavirus vaccines are licensed and widely available
RotarixTM (Human strainG1P[8]) and Rotateq (Pentavalent
Human-Bovine reassortant- G1,G2,G3,G4 and P[8])
One indigenous vaccine developed and licensed in IndiaROTAVAC (G9P[11]). Lanzhou lamb vaccine in China
Efficacy of Rotarix and Rotateq in developed world is >8595%
Rotavirus
Vaccine
Asia
Bangladesh
Vietnam
Taiwan
Singapore
Hong Kong
Africa
South Africa
Malawi
Ghana
Kenya
Mali

Vaccine

Rotateq

Rotarix

Rotarix
Rotateq

Percent Efficacy (CI)

42.7 (10.4-63.9)
63.9 (7.6-90.9)
96.1 (85.1-99.5)
96.1 (85.1-99.5)
96.1 (85.1-99.5)
76.9 (56.0-88.4)
49.4 (19.2-68.3)
55.5 (28.0-73.1)
63.9 (-5.9-89.8)
17.6 (-22.9-45.0)

Reasons postulated

Vaccine related
cold chain failure
timing of vaccination
type of vaccine
concurrent immunization with
other oral vaccines
Host related
Concurrent enteric infections
Gut inflammation and
enteropathy
Micronutrient deficiency
Malnourishment
Gut micro flora
Maternal factors- maternal
antibodies, breast feeding
Qadri et al Vaccine 2013, Okayasu et al
Vaccine 2011, Serazin Nature Immunology
2010

Effect of Zinc and Probiotics

supplementation on rotavirus vaccine
immunogenicity
Randomized, double
blind placebo controlled
trial to assesses the
independent effect of
zinc (5mg), probiotics
(1010Lactobacillus
rhamnosus GG) or
placebo given daily for
six weeks starting one
week prior to the first of
two doses of Rotarix
Study conducted
between July 2012 and
April 2013

Results
Antibody

Time of
samplin
g

Probiotics
and Zinc
(N=137)

Zinc alone
(N=143)

Probiotic
alone
(N=136)

No
supplemen
t
(N=135)
46 (34.1%)

AntiPre
35 (25.6%)
42 (29.4%)
44 (32.4%)
Rotavirus IgA vaccinati
>=20 U/mL
on
AntiPost
71 (51.8%)
71 (49.7%)
75 (55.2%)
69 (51.1%)
Rotavirus IgA vaccinati
>=20 U/mL
on
AntiPre
9.3 (7.5,
10.8 (8.4,
11.3 (9.0,
12.2 (9.5,
Rotavirus IgA Vaccinati
11.6)
13.9)
14.2)
15.7)
GMT (95% CI)
on
AntiPost
23.4
23.9
25.4
26.0
Rotavirus
IgA Vaccinati
(17.5,seroconverting
31.3) (17.8, 32.1) (19.2,
33.6) (19.3, 34.9)
Proportion
of children
to vaccine
GMT (95% CI)
on
was significantly
higher
in those
received
Rotavirus
IgA
54 (39.4%)
40 (28.0who
%) 42
(30.9%)
37 (27.4%)
serocombined
Zinc and Probiotics supplementation as
conversion

compared to those who received Zinc or

Probiotics only

Effect of a 3 dose vs 5 dose rotavirus

vaccine administration on
immunogenicity
Phase IV
randomized,
parallel group
comparison
study at
Christian
Medical
College(CMC)
Study conducted
between March
and December
2012

R.Z. Kompithra
Vaccine2014

Results
Overall (n=88)
Baseline sero positives
(n=51)
Baseline sero negatives
(n=37)
3 dose arm (n=44)
5 dose arm (n=44)

GMC (95%CI)
Pre vaccination
Post vaccination
24.0 (16.3-35.2)
58.0 (39.4-85.1)
81.2 (60.1-109.7)
150.3 (105.1-215.7)
3.9 (2.5-5.8)

15.1 (8.5-26.3)

25.5 (14.5-44.5)
22.6 (13.0-39.0)

53.7 (29.7-96.6)
62.5 (37.1-104.8)

No significant difference between 3 dose and 5

dose administration on rotavirus IgA levels
Infants who were sero positive at baseline showed
a higher boost in IgA levels as compared to sero
negative infants

Effect of withholding of breast feeding

on rotavirus vaccine immunogenicity
Four hundred infants were
randomly assigned into 2
groups; mothers in the
breast feeding withholding
arm were requested not to
breast feed for 30 minutes
prior and 30 minutes post
vaccination. The other
group were encouraged to
breast feed
At enrollment and 4
weeks post 2nd dose of
Rotarix administration
blood was collected from
all infants. Blood at
enrollment &Breast milk
was collected at
enrollment and at time of
2nd dose administration
from mothers
T. Rongsen-Chandola et al.

Results
26% in the breast feeding withheld group and 27% in the
normal breast fed group sero converted

Serum IgA baseline

Breastfeeding
withheld
Median (IQR)
1.95 (0.33, 5.48)

Breastfeeding
encouraged
Median (IQR)
2.04 (0.59, 4.37)

Serum IgA post dose 2

6.77 (1.95, 35.38)

6.06 (1.72,
29.02)

Infant

Crude estimates
Co-efficient (95% CI)
p value
Infant serum IgA
baseline

0.50 (0.30, 0.70)

0.000

Maternal
Baseline mother
serum IgG

-0.22
(-0.37, -0.06)

0.006

Baseline breast milk

IgA
Baseline breast milk
IgG
Breast milk IgA at
dose 2
Breast milk IgG at
dose 2

-0.23
(-0.38, -0.07)
-0.14
(-0.22, -0.06)
-0.26
(-0.42, -0.11)
-0.15
(-0.23, -0.07)

0.004
0.001
0.001
0.000