This document summarizes several candidate rotavirus vaccines including their serotype, producer, and efficacy. It discusses both Jennerian and non-Jennerian approach derived vaccines. For currently licensed vaccines, it provides details on Rotarix (monovalent G1P[8] human strain vaccine produced by GSK), RotaTeq (pentavalent bovine-human reassortant vaccine produced by Merck), and recently WHO prequalified Rotavac (G10P[12] lamb strain vaccine produced in India).

1. Rotavirus vaccines
Aditya S Kulkarni, Eshna Laha, Akshay Patil

2. Candidate Vaccines Derived by
Jennerain Approach
Vaccine Concept of
formulation
Serotype
(Genotype)
Company or
producer
RIT 4237 Monovalent live oral
bovine NCDV strain
P[1]G6 Smith Kline
Beecham
WC3 Monovalent live oral
bovine WC3 strain
P[5]G6 Merck (USA)
RRV Monovalent live oral
rhesus MMU 18006
strain
P[3]G3 DynCorp
(USA)
LLR Monovalent live oral
lamb LLR strain
P[12]G10 Lanzhou Institute of
Biological Products
(China)

3. Bovine strains
RIT4237 (G6P[1]) : 0% to 76% against any rotavirus diarrhea
WC3 (G6P[5]) : 0% to 100% against severe disease
Rhesus Rotavirus strain :
MMU18006 (G3P[3]) 0% to 60% against any rotavirus diarrhea
0% to 85% against severe rotavirus diarrhea
Lamb Rotavirus Strain :
LLR (G10P[12]) : 44.3% in children 9-11 month old
52.8% in children 12-17 month old
51.8% in children 18-35month old
• No Jennerian vaccine has provided complete protection against rotavirus diarrhea,
a result, several non-Jennerian candidate vaccines were developed.
Efficacy

4. - Involved use of Bovine-Human, rhesus-human reassortant rotaviruses of
Monovalent / Quadrivalent / Pentavalent / Hexavalent type
4
Vaccine strains
(Trade name)
Concept of formulation Serotype
(Genotype)
Company or
producer
Wa x UK Monovalent live oral human (Wa) bovine
(UK) reassortant
P[8[G6 DynCorp
(USA)
Wa x DS-1 x UK Monovalent live oral human (Wa and DS-
1) bovine (UK) reassortant
P[8[G2] DynCorp
(USA)
RRV X HRV-D X
DS-1 X ST-3
(RotaShield)
Quadrivalent live oral human rhesus (RRV)
reassortants
P[3]G1, G2, G3 and
G4
Wyeth Ayerst
(USA)
WC3 X WI79 X
SC2 X WO78 X
BrB (RotaTeq)
Pentavalent live oral human bovine (WC3)
reassortants
P[5]G1, G2, G3, G4
and P[8[G6]
Merck (USA)
UK based
reassortant
Quadrivalent live oral human bovine (UK)
reassortants
P[5]G1, G2, G3, G4 NIH (USA)
UK based
reassortant
Pentavalent live oral human bovine (UK)
reassortants
P[5]G1, G2, G3, G4 ,
G9
S I I (India)
UK based
reassortant
Hexavalent live oral human bovine (UK)
reassortants
P[5]G1, G2, G3, G4 ,
G8, G9
NIAID (USA)
Candidate Vaccines Derived By Modified
Jennerian Approach

5. - Live human or naturally attenuated human neonatal rotaviruses or
inactivated human rotaviruses of monovalent type and virus like
particles (VLPs) are used
Candidate Vaccines Derived by Non-Jennerian
Approach
Vaccine Concept of formulation Serotype
(Genotype)
Company or
producer
Rotarix Monovalent live oral human 89-12
strain
P[8]G1 GlaxoSmithKline
(Belgium)
RV3 Monovalent live oral human
neonatal RV3 strain
P[6]G3 DynCorp (USA)
116E Monovalent live oral human
neonatal 116E strain
P[11]G9 Bharat Biotech (India)
I321 Monovalent live oral human
neonatal 1321 strain
P[11]G10 Bharat Biotech (India)
BIRV Monovalent inactivated human
AU64 strain
P[4]G1 Biken (Japan)
VLPs Simian (SA11) virus like particles VP2/6 Lederle / Green Cross
(Korea)

6. 6
Rotarix
• A monovalent vaccine (G1P[8])
• A virulent wild type 89-12 strain of G1P[8] specificity
attenuated by multiple passages in Vero cell culture
• Launched by Glaxo Smith Kline Biologicals, Belgium in 2004
Doses – Two at 2 and 4 month of age
• Efficacy – 86% against severe rotavirus disease
•Efficacy data not yet available from India, However, preliminary
data indicates good immunogenicity i.e Seroconversion to anti-
rotavirus IgA (58.3%) and higher GMC (49.2U/ml) of anti rotavirus
IgA and safety of Rotarix vaccine
(Narang et al., 2009; Human Vaccines)
Rotavirus Vaccines of Current Choice

7. 7
RotaTeq
• A pentavalent vaccine (G1,G2,G3,G4, P[8])
- bovine human reassortant
• Vero cell cultures - Coinfected with WC3 (bovine) rotavirus and
G1P[8] human rotavirus strain (WI79)
• Genetic reassortment occurred. Guinea pig antiserum to WC3 was used to select a
reassortant with G1 protein. Preparation evaluated clinically
• Reassortants with other G serotypes (G2, G3, G4) developed in a similar manner
• Launched by MERCK Inc. USA in 2006 Doses – Three at 2, 4 and 6
month of age
• Efficacy - 74% and 98% protection against all and severe disease
respectively
•Projected efficacy of RotaTeq vaccine as estimated by a
Mathematical Model – 70% – 82%
(Khoury et al., 2011; Human Vaccines)
Rotavirus Vaccines of Current Choice

8. • Efficacy in the first year of life was 56.3% (36.7-69.9)(similar to
that of two other licensed rotavirus vaccines in developing
country settings).
• Efficacy in the second year of life – 48.9% (17.4-64.4)
• Overall vaccine efficacy against severe rotavirus gastroenteritis
upto two years of life is 55.1% (95% CI 39.9-66.4)
Rotavac

9.  G10P(12) lamb strain developed at Lanzhou Institute of China was
administered to ca. 20,000 children with no evidence of side effects. The
inoculation with this strain stimulated NA against multiple human G types in
>50% of vaccines.
 G3P2A(6) strain from Australia is reported to be safe and moderately
immunogenic after administration to children (35-58% seroconverted)