Table 1.
Licensed vaccines and vaccine candidates designed to prevent gastroenteritis caused by rotavirus, norovirus and Vibrio cholerae.
| Pathogen | Vaccine (s) | Status* | Comment | Selected references |
|---|---|---|---|---|
| Rotavirus | RotaTeq ®/Rotarix ® | Worldwide License | Eight years post-licensure; worldwide distribution; demonstrated effectiveness. Both prequalified by WHO. | Giaquinto et al., 201110; O'Ryan et al., 201113 |
| Rotashield® | First licensed rotavirus vaccine in 1998 (USA); was withdrawn due to association with intestinal intussusception. | Currently in clinical trials using a 2-dose regimen beginning within the first 30 d of life demonstrating 64% efficacy for the first 12 months of life. | Armah et al., 201342 | |
| LLR®/Rotavin-M1®/Rotavac® | Restricted license | Used only in China/Vietnam/India respectively; lack of robust effectiveness data. | Fu et al., 2012;61 Dang et al., 2012;62 Bhandari et al., 201465 | |
| RV3BB/UK reassortant | Early clinical development | Phase I or early phase II studies. | Danchin et al., 2013;63 Luna et al., 201366 | |
| Subunit vaccines/Inactivated rotavirus vaccine | Early clinical development | Immunogenic in the BALB/c mice model. | Lappalainen et al., 2013;67 Jiang et al., 200870 | |
| Norovirus | Intramuscular vaccine candidate containing GI.1 and GII.4 VLPs | Advanced clinical development | Phase I adult challenge study completed, moving into phase IIb/III studies. | Treanor et al., 2014118 |
| P particle-based vaccines | Preclinical development | Considered as a norovirus vaccine as well as a delivery system for other antigens, such as rotavirus, influenza and hepatitis E; immunogenic in the mouse model. | Tan and Jiang, 201417 | |
| Trivalent vaccine including norovirus GII.4 and GI.3 VLPs and rotavirus rVP6 | Preclinical development | Immunogenic in the BALB/c mouse model. | Tamminen et al., 2013115 | |
| Multivalent alphavirus replicon particles (VRPs) | Preclinical development | Considered as a delivery system or adjuvant; immunogenic in a BALB/c mouse model. | LoBue et al., 2009113 | |
| V. cholerae | Dukoral® | Worldwide License | Licensed in 65 countries. Short-term protection and potential herd effect. Prequalified by WHO. | Taylor et al., 2000;132 Ali et al., 2005139 |
| Shanchol® | Worldwide License | Prequalified by WHO. Demonstrated effectiveness. | Sur et al., 2011134 | |
| mORCVAX® | Restricted License | Identical to Shanchol®. Distributed in Vietnam only. | Anh et al., 2007;136 2011137 | |
| CVD-103HgR | Restricted License | Production as Orochol®/Mutacol® stopped in 2004. New clinical studies are ongoing. | Chen et al., 2014128 | |
| Peru-15 (CholeraGarde®) | Early clinical development | Safe and immunogenic. Efficacy evidenced in volunteers in the USA. A phase II trial in an endemic region is ongoing. | Cohen et al., 2002141; Qadri et al., 2007143 | |
| V.cholerae 638 | Early clinical development | Safe and immunogenic. Efficacy evidenced in volunteers in Cuba. Phase I/II trials in endemic regions are required. | García et al., 2005;146 Diaz Jidy et al., 2010147 | |
| CVD 112 | Early clinical development | Safety, immunogenicity and efficacy evidenced in phase II trials. No information about further trials. | Tacket et al., 1995148 | |
| VA1.3 / 1.4 | Early clinical development | Safe and immunogenic after phase I trial. Phase II trials suggested. | Mahalanabis et al., 2009;149 Kanungo et al., 2014150 | |
| IEM 108 | Preclinical development | Prevent fluid accumulation in rabbit ligated loops | Liang et al., 2003151 | |
| VCUSM2 | Preclinical development | Prevent fluid accumulation in rabbit ligated loops and RITARD model | Ravichandran et al. 2006152 | |
| TLP01 | Preclinical development | Safe and immunogenic in rabbits and rats | Ledon et al., 2012153 |
*Status: Worldwide Licensed in an important number of countries in several continents; restricted license in one or few countries; Advanced clinical development (phase IIb/III); Early clinical development (phase I/II); Preclinical development in animal models