A Phase III, open label, multicenter, parallel group, randomized Clinical Study to compare the Immunogenicity and Safety of Euvichol-Plus vaccine with Oral Cholera Vaccine Shanchol in healthy adults and children above age of one year

Start Date09 Aug 2021

Sponsor / Collaborator

Techinvention Lifecare Pvt Ltd.

NCT03373669 / CompletedPhase 4IIT

Effect of Extended Dose Intervals on the Immune Response to Oral Cholera Vaccine

Cholera is a life-threatening disease if prompt actions are not taken. The most recent estimates of the global burden of cholera estimate that there are more than 1.3 billion people at risk. Of which, 2.86 million (range: 1.3-4.0 million) will contract cholera and 95,000 (21,000-143,000) will die each year. A safe, effective, and affordable killed whole-cell oral cholera vaccine (OCV) is now being used widely to prevent cholera in areas at risk. This regimen demonstrated 65% efficacy retained for at least 3 years and even up to 5 years in an endemic setting.
The primary aim of this project is to determine changes in the vibriocidal geometric mean titers (GMT) in subjects who receive the second dose of oral cholera vaccine (OCV) at different intervals: 2 weeks, or 6 months following the first dose of vaccine. Secondary aims include a) vibriocidal antibody response rates in subjects who receive OCV at 2 weeks or 6 months following the first dose of vaccine, b) age specific serum vibriocidal GMTs following the second dose among participants given the second dose of OCV at intervals of 2 weeks or 6 months following the first dose of vaccine, c) GMT and antibody response rates of Immunoglobulin A (IgA) and Immunoglobulin G (IgG) anti-lipopolysaccharide (anti-LPS) as measured by ELISA following the second dose among participants given the second dose of OCV at intervals of 2 weeks or 6 months following the first dose of vaccine. Our hypothesis is that the vibriocidal GMT following the second dose, when given after 6 months will not be inferior to the response when the second dose is given according to the standard interval of two weeks.

Start Date16 Nov 2017

Sponsor / Collaborator

Johns Hopkins Bloomberg School of Public Health

NCT02742558 / CompletedPhase 2IIT

A Randomized Observer Blinded Controlled Non Inferiority Trial to Evaluate the Safety and Immunogenicity of Locally Manufactured Inactivated Bivalent Whole Cell-oral Cholera Vaccine (WC-OCV) 'Cholvax' in Bangladeshi Healthy Adults and Children

To evaluate and compare the safety and immunogenicity of the Cholvax with ShancholTM, Investigators will conduct a clinical trial study Bangladeshi healthy adults and children. Cholvax is locally produced orally administered whole cell inactivated bivalent cholera vaccine. Incepta vaccine Limited, a leading pharmaceutical company in Bangladesh is now producing the oral cholera vaccine, Cholvax with technological support from International Vaccine Institute (IVI). Cholvax meets international Good Manufacturing Practice (GMP) standards and WHO production guidelines. Cholvax has the same formulation as ShancholTM in terms of strains and formulation. By this transfer of technology, it expected that the vaccine will become available for use in public health programs in Bangladesh and in the future in other cholera-affected countries in Asia and Africa to control endemic cholera, as well as to help control large-scale epidemics and outbreaks.
Investigators will also evaluate and compare the safety and immunogenicity of 3 Cholvax lots (lot-to-lot consistency).

Start Date01 Apr 2016

Sponsor / Collaborator

International Centre for Diarrhoeal Disease Research, Bangladesh

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100 Clinical Results associated with Cholera vaccine inactivated oral(Institute For International Vaccine Development Inc)

100 Translational Medicine associated with Cholera vaccine inactivated oral(Institute For International Vaccine Development Inc)

100 Patents (Medical) associated with Cholera vaccine inactivated oral(Institute For International Vaccine Development Inc)

Literatures (Medical) associated with Cholera vaccine inactivated oral(Institute For International Vaccine Development Inc)

01 Jun 2024·Public health in practice (Oxford, England)

The reactive cholera vaccination campaign in urban Dhaka in 2022: experience, lessons learned and future directions

Review

Author: Islam, Md Nazmul ; Chowdhury, Fahima ; Amin, Mohammad Ashraful ; Rahman, Aninda ; Khan, Ashraful Islam ; Islam, Md Taufiqul ; Islam A Bari, Tajul ; Bhuiyan, Taufiqur Rahman ; Khan, Zahid Hasan ; Tanvir, Nabid Anjum ; Khanam, Farhana ; Qadri, Firdausi

Introduction:

An upsurge of diarrheal cases occurred in Dhaka, Bangladesh, with approximately 30% of the cases being identified as cholera in 2022. To combat this situation, a reactive Oral Cholera Vaccination campaign was organized in five highly cholera-affected areas of Dhaka city. The paper is a descriptive tale of experience gathering, organization and implementation of reactive oral cholera vaccination campaign.

Study design:

This is a descriptive report of a reactive oral cholera vaccination campaign.

Methods:

Population density maps were generated using GIS technology before launching the campaign. The target population comprised individuals aged over one year, excluding pregnant women, totaling 2,374,976 people residing in above mentioned areas. The campaign utilized Euvichol-Plus, an OCV with adherence to the necessary cold chain requirements. Total 700 teams, each consisting of six members, were deployed across the five zones. The campaign was conducted in two rounds, where first round took place in June-July 2022, followed by second round in August 2022. During the campaign, data on adverse events following immunization (AEFI) was collected. Expert teams from various government and non-government organizations monitored regularly and ensured the campaign's success.

Results:

The first round achieved a coverage rate of 99%, whereas in the second round, 86.3% of individuals among the first dose recipients. During the campaigns, a total of 57 AEFIs were reported.

Conclusions:

This campaign serves as a model for a multispectral approach in combating cholera epidemics, highlighting the collaborative efforts of policymakers, health authorities, local communities, and health partners.

01 May 2024·The Lancet. Global health

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

Article

Author: Ganapathy, Ravi ; Saluja, Tarun ; Kim, Bo Mi ; Park, Eun Lyeong ; Park, Youngran ; Baik, Yeong Ok ; Tamrakar, Dipesh ; Park, Youngshin ; Pansuriya, Ruchir Kumar ; Chaudhary, Shipra ; Kanodia, Piush ; Lee, Young Jin ; Cho, Haeun ; Lee, Jinae ; Jeon, Suhi ; Wartel, T Anh ; Kim, Deok Ryun ; Yang, Jae Seung ; Vemula, Sridhar ; Lynch, Julia A ; Thaisrivichai, Patchara ; Song, Katerina Rok ; Chapagain, Ram Hari ; Shrestha, Rajeev ; Gupta, Birendra ; Her, Howard L ; Lee, Jiyoung

BACKGROUND:

In October, 2017, WHO launched a strategy to eliminate cholera by 2030. A primary challenge in meeting this goal is the limited global supply capacity of oral cholera vaccine and the worsening of cholera outbreaks since 2021. To help address the current shortage of oral cholera vaccine, a WHO prequalified oral cholera vaccine, Euvichol-Plus was reformulated by reducing the number of components and inactivation methods. We aimed to evaluate the immunogenicity and safety of Euvichol-S (EuBiologics, Seoul, South Korea) compared with an active control vaccine, Shanchol (Sanofi Healthcare India, Telangana, India) in participants of various ages in Nepal.

METHODS:

We did an observer-blind, active-controlled, randomised, non-inferiority, phase 3 trial at four hospitals in Nepal. Eligible participants were healthy individuals aged 1-40 years without a history of cholera vaccination. Individuals with a history of hypersensitivity reactions to other preventive vaccines, severe chronic disease, previous cholera vaccination, receipt of blood or blood-derived products in the past 3 months or other vaccine within 4 weeks before enrolment, and pregnant or lactating women were excluded. Participants were randomly assigned (1:1:1:1) by block randomisation (block sizes of two, four, six, or eight) to one of four groups (groups A-D); groups C and D were stratified by age (1-5, 6-17, and 18-40 years). Participants in groups A-C were assigned to receive two 1·5 mL doses of Euvichol-S (three different lots) and participants in group D were assigned to receive the active control vaccine, Shanchol. All participants and site staff (with the exception of those who prepared and administered the study vaccines) were masked to group assignment. The primary immunogenicity endpoint was non-inferiority of immunogenicity of Euvichol-S (group C) versus Shanchol (group D) at 2 weeks after the second vaccine dose, measured by the seroconversion rate, defined as the proportion of participants who had achieved seroconversion (defined as ≥four-fold increase in V cholerae O1 Inaba and Ogawa titres compared with baseline). The primary immunogenicity endpoint was assessed in the per-protocol analysis set, which included all participants who received all their planned vaccine administrations, had no important protocol deviations, and who provided blood samples for all immunogenicity assessments. The primary safety endpoint was the number of solicited adverse events, unsolicited adverse events, and serious adverse events after each vaccine dose in all ages and each age stratum, assessed in all participants who received at least one dose of the Euvichol-S or Shanchol. Non-inferiority of Euvichol-S compared with Shanchol was shown if the lower limit of the 95% CI for the difference between the seroconversion rates in Euvichol-S group C versus Shanchol group D was above the predefined non-inferiority margin of -10%. The trial was registered at ClinicalTrials.gov, NCT04760236.

FINDINGS:

Between Oct 6, 2021, and Jan 19, 2022, 2529 healthy participants (1261 [49·9%] males; 1268 [50·1%] females), were randomly assigned to group A (n=330; Euvichol-S lot number ES-2002), group B (n=331; Euvichol-S ES-2003), group C (n=934; Euvichol-S ES-2004]), or group D (n=934; Shanchol). Non-inferiority of Euvichol-S versus Shanchol in seroconversion rate for both serotypes at 2 weeks after the second dose was confirmed in all ages (difference in seroconversion rate for V cholerae O1 Inaba -0·00 [95% CI -1·86 to 1·86]; for V cholerae O1 Ogawa -1·62 [-4·80 to 1·56]). Treatment-emergent adverse events were reported in 244 (9·7%) of 2529 participants in the safety analysis set, with a total of 403 events; 247 events were reported among 151 (9·5%) of 1595 Euvichol-S recipients and 156 events among 93 (10·0%) of 934 Shanchol recipients. Pyrexia was the most common adverse event in both groups (57 events among 56 [3·5%] of 1595 Euvichol-S recipients and 37 events among 35 [3·7%] of 934 Shanchol recipients). No serious adverse events were deemed to be vaccine-related.

INTERPRETATION:

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.

FUNDING:

The Bill & Melinda Gates Foundation.

TRANSLATION:

For the Nepali translation of the abstract see Supplementary Materials section.

01 May 2024·The Lancet. Infectious diseases

Effectiveness of one dose of killed oral cholera vaccine in an endemic community in the Democratic Republic of the Congo: a matched case-control study

Article

Author: Leung, Daniel T ; Xu, Hanmeng ; Kulondwa, Jean-Claude ; Cumming, Oliver ; Itongwa, Moïse ; Malembaka, Espoir Bwenge ; Kavunga-Membo, Hugo ; Mukadi-Bamuleka, Daniel ; Lessler, Justin ; Gallandat, Karin ; Okitayemba, Placide Welo ; Lunguya, Octavie ; Lee, Elizabeth C ; Bodisa-Matamu, Tavia ; Taty, Nagède ; Azman, Andrew S ; Knee, Jackie ; Tshiwedi-Tsilabia, Esperance ; Saidi, Jaime Mufitini ; Bengehya, Justin ; Demby, Maya N ; Debes, Amanda K ; Kitoga, Faida ; Hutchins, Chloe ; Hulse, Juan Dent ; Bugeme, Patrick Musole ; Rumedeka, Baron Bashige

BACKGROUND:

A global shortage of cholera vaccines has increased the use of single-dose regimens, rather than the standard two-dose regimen. There is sparse evidence on single-dose protection, particularly in children. In 2020, a mass vaccination campaign was conducted in Uvira, an endemic urban setting in eastern Democratic Republic of the Congo, resulting in largely single-dose coverage. We examined the effectiveness of a single-dose of the oral cholera vaccine Euvichol-Plus in this high-burden setting.

METHODS:

In this matched case-control study, we recruited individuals with medically attended confirmed cholera in the two cholera treatment facilities in the city of Uvira. The control group consisted of age-matched, sex-matched, and neighbourhood-matched community individuals. We recruited across two distinct periods: Oct 14, 2021, to March 10, 2022 (12-17 months after vaccination), and Nov 21, 2022, to Oct 18, 2023 (24-36 months after vaccination). Study staff administered structured questionnaires to all participants to capture demographics, household conditions, potential confounding variables, and vaccination status. The odds of vaccination for the case and control groups were contrasted in conditional logistic regression models to estimate unadjusted and adjusted vaccine effectiveness.

FINDINGS:

We enrolled 658 individuals with confirmed cholera and 2274 matched individuals for the control group. 99 (15·1%) individuals in the case group were younger than 5 years at the time of vaccination. The adjusted single-dose vaccine effectiveness was 52·7% (95% CI 31·4 to 67·4) 12-17 months after vaccination and 44·7% (24·8 to 59·4) 24-36 months after vaccination. Although protection in the first 12-17 months after vaccination was similar for children aged 1-4 years and older individuals, the estimate of protection in children aged 1-4 years appeared to wane during the third year after vaccination (adjusted vaccine effectiveness 32·9%, 95% CI -30·7 to 65·5), with CIs spanning the null.

INTERPRETATION:

A single dose of Euvichol-Plus provided substantial protection against medically attended cholera for at least 36 months after vaccination in this cholera-endemic setting. Although the evidence provides support for similar levels of protection in young children and others in the short term, protection among children younger than 5 years might wane significantly during the third year after vaccination.

FUNDING:

Wellcome Trust and Gavi, the Vaccine Alliance.

News (Medical) associated with Cholera vaccine inactivated oral(Institute For International Vaccine Development Inc)

28 Aug 2023

·www.pharmaceutical-technology.com

GC Biopharma and Eubiologics enter deal to produce cholera vaccine

The companies will jointly manufacture the cholera vaccine from the first half of 2024. Credit: Andrey_Popov / Shutterstock.com. South Korean biopharmaceutical firm GC Biopharma has signed a memorandum of understanding (MOU) with Eubiologics to jointly manufacture oral cholera vaccine, Euvichol. Under the deal, both companies will collaborate for the vaccine supply. Eubiologics will oversee the bulk manufacturing of the vaccine while GC Biopharma will be responsible for conducting the packaging process including the bottling of vials. The parties will jointly manufacture Euvichol from the first half of 2024 for supply to the United Nations International Children’s Emergency Fund (UNICEF). UNICEF had sought further supply of vaccines apart from those of a plastic-tubed Euvichol-Plus to address the recent spread of cholera infection in various areas such as Africa. Eubiologics and the International Vaccine Institute (IVI) co-developed Euvichol for the prevention of cholera. The vaccine received World Health Organization Prequalification in 2015 and the supply of doses to UNICEF started in 2016. As of 2022, a total of 100 million vaccine doses were supplied to the UN agency. Eubiologics vice-president Kyeong-Ho Min said: “With the more frequent floods and droughts due to climate change and global warming, the world is currently experiencing rapid spread of cholera, leading to a shortage of vaccine supply. “The MOU will be a big boost to the increase of vaccine supply, and it will bring us not only more revenue, but also a way to further contribute to controlling the spread of cholera.”

Vaccine

25 Aug 2023

·www.prnewswire.com

GC Biopharma to Produce Cholera Vaccines Jointly with Eubiologics

YONGIN, South Korea, Aug. 25, 2023 /PRNewswire/ -- GC Biopharma (006280.KS), a South Korean biopharmaceutical company, announced today that it has signed a MOU at its headquarters in Yongin, South Korea with Eubiologics for a co-production of Euvichol, an oral cholera vaccine. Under the MOU, both parties agreed to cooperate for a successful supply of the vaccine. While Eubiologics, a developer and producer of Euvichol, takes charge of the bulk vaccine production, GC Biopharma will be in charge of the packaging process including vial bottling. The two companies will produce the vaccine together from the first half of 2024 in order to supply to UNICEF. UNICEF has requested for an additional supply of the vaccine on top of the normal supply of a plastic-tubed Euvichol-Plus to cope with a recent spread of cholera infection in many regions including Africa. Euvichol is an oral vaccine jointly developed by Eubiologics and International Vaccine Institute (IVI) for the prevention of cholera, a disease that is prevalent mainly in the developing countries. The vaccine has obtained WHO Prequalification in 2015, and since starting to supply to UNICEF in 2016, the total cumulative supply of the vaccine as of 2022 has exceeded 100 million doses. Eubiologics in currently supplying 100% of cholera vaccines administered by UNICEF. Kyeong-Ho Min, Vice President of Eubiologics commented, "With the more frequent floods and droughts due to climate change and global warming, the world is currently experiencing rapid spread of cholera, leading to a shortage of vaccine supply." And He added that "the MOU will be a big boost to the increase of vaccine supply, and it will bring us not only more revenue, but also a way to further contribute to controlling the spread of cholera". Woo Jin Lee, Head of Global Business Division of GC Biopharma, stated, "Both companies will extend their utmost efforts for the increase of cholera vaccine supply based on their unique strengths" and added that "we will continue to explore more collaboration with other parties to contribute to the better public health of the world". About GC Biopharma GC Biopharma (formerly known as Green Cross Corporation) is a biopharmaceutical company that delivers life-saving and life-sustaining protein therapeutics and vaccines. Headquartered in Yongin, South Korea, GC Biopharma is one of the leading plasma protein and vaccine product manufacturers globally and has been dedicated to quality healthcare solutions for more than half a century. This press release may contain biopharmaceuticals in forward-looking statements, which express the current beliefs and expectations of GC Biopharma's management. Such statements do not represent any guarantee by GC Biopharma or its management of future performance and involve known and unknown risks, uncertainties and other factors. GC Biopharma undertakes no obligation to update or revise any forward-looking statement contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. GC Biopharma Contacts (Media) Sohee Kim [email protected] Yelin Jun [email protected] SOURCE GC Biopharma

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100 Deals associated with Cholera vaccine inactivated oral(Institute For International Vaccine Development Inc)

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Indication	Country/Location	Organization	Date
Cholera	IN	-	01 Jan 2009

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02027207 (Pubmed \| Br Dent J) Manual	Phase 3	Cholera	204,700	Cholera Vaccine	xggepablju(jeyknrtcxr) = griqtygwnh btilwngesf (lyuxaxrmgf )	Positive	05 May 2016
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