Shanchol (oral cholera vaccine) / Sanofi - LARVOL DELTA

A double-blind, randomised phase III clinical trial to evaluate safety, immunogenicity, non-inferiority & lot to lot consistency of single component oral cholera vaccine BBV131 (Hillchol®) in comparison to Shanchol™. (PubMed, Vaccine) - "The findings indicate that BBV131 demonstrates non-inferior immunogenicity and comparable safety to Shanchol™ in healthy Indian adults and children, supporting its potential as an effective OCV."

Head-to-Head • Journal • P3 data • Cholera • Pain • Xerostomia

The 30-year evolution of oral cholera vaccines: A case study of a collaborative network alternative innovation model. (PubMed, PLOS Glob Public Health) - "The evolution of OCVs demonstrates how a collaborative network innovation model can successfully develop new pharmaceutical products that are affordable and well-suited for use in context. This model could be applied to other areas of pharmaceutical innovation, such as pandemic preparedness, for more equitable outcomes for global public health."

Journal • Cholera

Vibrio cholerae-specific Serological Profiling Among Children, Adolescent, and Adults After Oral Cholera Vaccination. (ASTMH 2024) - "Immune responses are currently being characterized across a wide range of immunoreactive biomarkers including V. cholerae Inaba and Ogawa O-specific polysaccharide (OSP), lipopolysaccharide (LPS), cholera toxin B subunit (CtxB), Toxin co-regulated pilus A (TcpA), hemolysin A, sialidase-specific IgA, IgA1, IgA2, IgM, IgG, IgG1, IgG2, IgG3, IgG4, vibriocidal titers, antibody-dependent complement deposition, OSP-specific FcαR and FcγR2A binding activities. These serological biomarkers would be helpful to understand distinct immune responses among children, adolescents, and adults after vaccination with Shanchol TM or Euvichol-S."

Clinical • Late-breaking abstract • Cholera • Infectious Disease

Seroconversion and kinetics of vibriocidal antibodies during the first 90 days of re-vaccination with oral cholera vaccine in an endemic population (ASTMH 2024) - "We therefore conclude that vibriocidal antibody titers generated in response to re-vaccination still wane quickly irrespective of previous vaccination status. However, despite the observed decline, the levels of vibriocidal antibodies remained elevated over baseline values across all groups, an important aspect for Zambia where there is no empirical evidence as to the ideal time for re-vaccination."

Clinical • Cholera

Cholera resurgence in Africa: assessing progress, challenges, and public health response towards the 2030 global elimination target. (PubMed, Infez Med) - "Despite ongoing challenges, global targets are achievable provided strong institutional infrastructure and additional evidence-based public health initiatives are promulgated and enacted. The Global Roadmap to Ending Cholera Outbreaks by 2030 is a resourceful tool for advancing this fight and eradicating cholera."

Journal • Review • Cholera

Seroconversion and Kinetics of Vibriocidal Antibodies during the First 90 Days of Re-Vaccination with Oral Cholera Vaccine in an Endemic Population. (PubMed, Vaccines (Basel)) - "We therefore conclude that vibriocidal antibody titers generated in response to re-vaccination still wane quickly, irrespective of previous vaccination status. However, despite the observed decline, the levels of vibriocidal antibodies remained elevated over baseline values across all groups, an important aspect for Zambia where there is no empirical evidence as to the ideal time for re-vaccination."

Journal • Cholera • Human Immunodeficiency Virus • Infectious Disease

Safety and immunogenicity of the Euvichol-S oral cholera vaccine for prevention of Vibrio cholerae O1 infection in Nepal: an observer-blind, active-controlled, randomised, non-inferiority, phase 3 trial. (PubMed, Lancet Glob Health) - P3 | "A two-dose regimen of Euvichol-S vaccine was non-inferior to the active control vaccine, Shanchol, in terms of seroconversion rates 2 weeks after the second dose. The simplified formulation and production requirements of the Euvichol-S vaccine have the potential to increase the supply of oral cholera vaccine and reduce the gap between the current oral cholera vaccine supply and demand."

Head-to-Head • Journal • P3 data • Cholera • Immunology • Infectious Disease

Do Oral Cholera Vaccine and Water, Sanitation, and Hygiene Combine to Provide Greater Protection Against Cholera? Results From a Cluster-Randomized Trial of Oral Cholera Vaccine in Kolkata, India. (PubMed, Open Forum Infect Dis) - "These findings suggest that the combination of a vaccine policy and improved WASH reduces cholera risk more than either would alone, although the magnitude of either intervention was not affected by the other. Future randomized trials investigating OCV and WASH interventions separately and together are recommended to further understand the interaction between OCV and WASH."

Journal • Cholera

Oral killed cholera vaccines for preventing cholera. (PubMed, Cochrane Database Syst Rev) - "Two doses of Dukoral reduces cases of cholera at two-year follow-up. Two doses of Shanchol reduces cases of cholera at five-year follow-up, and a single dose of Shanchol reduces cases of cholera at two-year follow-up. Overall, the vaccines were safe and well-tolerated. We found no trials on other BivWC vaccines (Euvichol/Euvichol-Plus). However, BivWC products (Shanchol, Euvichol/Euvichol-Plus) are considered to produce comparable vibriocidal responses. Therefore, it is reasonable to apply the results from Shanchol trials to the other BivWC products (Euvichol/Euvichol-Plus)."

Journal • Review • Cholera • Infectious Disease

Prospective observational studies to provide confidence in the protection conferred by newer generation, inactivated oral cholera vaccines: a proposal. (PubMed, EClinicalMedicine) - "However, their clinical development is made complex because placebo-controlled randomised trials of OCV efficacy are no longer ethically permissible and because the serum vibriocidal antibodies used to measure OCV responses are not correlates of OCV protection against cholera. Here, we propose an observational study design with features to enhance methodological rigor to provide credible evidence of protection against cholera by these newer vaccines."

Journal • Observational data • Review • Cholera

Comparison of the immunogenicity and safety of Euvichol-Plus with Shanchol in healthy Indian adults and children: an open-label, randomised, multicentre, non-inferiority, parallel-group, phase 3 trial. (PubMed, Lancet Reg Health Southeast Asia) - "Euvichol-Plus appears to be non-inferior to Shanchol in terms of immunogenicity and safety in healthy Indian adults and children. Techinvention Lifecare Private Limited, Mumbai, India."

Head-to-Head • Journal • P3 data • Cholera • Cough • Pain • Respiratory Diseases

Effectiveness of the Euvichol® oral cholera vaccine at 2 years: a case-control and bias-indicator study in Haiti. (PubMed, Int J Infect Dis) - "Between 10 - 27 months after vaccination, Euvichol® was effective and similar to Shanchol,™ suggesting that it can serve as one component of multi-sectoral comprehensive cholera control."

Journal • Cholera

Gut microbiota-derived metabolites alter human-derived macrophage stimulation and may increase immune responses to oral cholera vaccine (ASTMH 2023) - "Macrophages preconditioned with microbe-derived SL had greater IL-6 production (P=0.0003, t test) after stimulation with LPS compared to cell preconditioned with bacterial lipids lacking SL, indicating that the innate immune response to LPS was greater in the presence of microbe-derived SL. Here, we have identified SL-producing microbes isolated from vaccine recipients that correlate with OSP MBC responses in OCV recipients and found that lipids from these microbes impact innate immune responses to vaccine antigens in vitro."

Gut Microbiota • Cholera • IL6

Effectiveness of the Euvichol® oral cholera vaccine at 2 years: a case-control and bias-indicator study in Haiti (ASTMH 2023) - "VE estimates and bias-indicator estimates for Euvichol ® in Haiti are comparable to prior estimates of Shanchol ® in Haiti, which demonstrated robust evidence of VE up to 2 years post-vaccination. Further research to evaluate the effectiveness of OCV in children and over longer periods are needed."

Clinical • Cholera

Effectiveness of the Euvichol® oral cholera vaccine at 2 years: a case-control and bias-indicator study in Haiti (ASTMH 2023) - "VE estimates and bias-indicator estimates for Euvichol ® in Haiti are comparable to prior estimates of Shanchol ® in Haiti, which demonstrated robust evidence of VE up to 2 years post-vaccination. Further research to evaluate the effectiveness of OCV in children and over longer periods are needed."

Clinical • Cholera

Oral cholera vaccine coverage evaluation survey: Forcibly Displaced Myanmar Nationals and host community in Cox's Bazar, Bangladesh. (PubMed, Front Public Health) - "Our findings demonstrate that the OCV campaign in the FDMN camps was successful, reaching over 90% coverage, while coverage in the host community was much lower. In order to make sure that OCV vaccination efforts are reaching the target population and having the desired impact, our study emphasizes the need to inform the target population of when and where to get vaccinated."

Journal • Cholera

Immune Non-Inferiority, Safety and Lot-to-Lot Consistency of Oral Cholera Vaccine-Simplified Compared to Shanchol™ (clinicaltrials.gov) - P3 | N=2530 | Completed | Sponsor: International Vaccine Institute | Recruiting ➔ Completed

Head-to-Head • Trial completion • Cholera

A thermostable, dry formulation inactivated Hikojima whole cell/cholera toxin B subunit oral cholera vaccine. (PubMed, Vaccine) - "The new vaccine, which is easy and inexpensive to manufacture, could be stored for at least 26 months at 25 °C and for at least 8 months at 40 °C with preservation of cell morphology and with no loss of protective Ogawa and Inaba lipopolysaccharides or CTB. It also proved to be well tolerated and to have equivalent oral immunogenicity in mice as Shanchol and Dukoral® OCVs with regard to both serum and intestinal-mucosal antibody responses."

Journal • Cholera

Hillchol131: To Evaluate Safety of Oral Cholera Vaccine Hillchol® (BBV131) (clinicaltrials.gov) - P3 | N=1800 | Recruiting | Sponsor: Bharat Biotech International Limited

Head-to-Head • New P3 trial • Cholera

Assessment of the influence of ABO blood groups on oral cholera vaccine immunogenicity in a cholera endemic area in Zambia. (PubMed, BMC Public Health) - "Our results do not support the idea that ABO blood grouping influence vaccine uptake and responses against cholera."

Journal • Cholera • Infectious Disease

Cost of oral cholera vaccine delivery in a mass immunization program for children in urban Bangladesh. (PubMed, Vaccine X) - "This analysis provides useful benchmarks for the possible costs related to delivery of OCV to children and future OCV cost-effectiveness models should factor in these possible cost disparities. Attempts to reduce the cost per dose are likely to have a greater impact on the cost of similar vaccination campaigns in many resource-poor settings."

Journal • Cholera

Extended Dose Intervals With Oral Cholera Vaccine in Cameroon (clinicaltrials.gov) - P2 | N=181 | Completed | Sponsor: Johns Hopkins Bloomberg School of Public Health | Active, not recruiting ➔ Completed

Trial completion • Cholera

Co-administration of Oral Cholera Vaccine with Oral Polio Vaccine among Bangladeshi Young Children: A Randomized Controlled Open Label Trial to Assess Interference. (PubMed, Clin Infect Dis) - "Co-administration of bOPV and OCV is safe and effective in children aged 1-3 years and can be cost-beneficial."

Journal • Cholera

A Phase III Randomized, Modified Double-blind, Multi-centric, Comparative Study, to Evaluate the Non-inferiority of Immunogenicity and Safety of Hillchol® (BBV131)to Shanchol™ Along With Lot-to-lot Consistency of Hillchol®(BBV131). (clinicaltrials.gov) - P3 | N=1800 | Active, not recruiting | Sponsor: Bharat Biotech International Limited

Head-to-Head • New P3 trial • Cholera

Immunogenicity and waning immunity from the oral cholera vaccine (Shanchol™) in adults residing in Lukanga Swamps of Zambia. (PubMed, PLoS One) - "We found that Shanchol™ was immunogenic in our study population and that vibriocidal antibodies may not be a good marker for long-term immunity. The observed rise in titres after 36 months suggests natural exposure, and this may be a critical time window opening for natural transmission in an endemic areas. We recommend re-vaccination at this time point in high risk areas."

Clinical • Journal • Cholera