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Article ; Online: A snap-shot of a diarrheal epidemic in Dhaka due to enterotoxigenic

Tauheed, Imam / Ahmed, Tasnuva / Akter, Afroza / Firoj, Md Golam / Ahmmed, Faisal / Rahman, Sadia Isfat Ara / Afrad, Mokibul Hassan / Islam, Md Nazmul / Rahman, Aninda / Khan, Ashraful Islam / Alam, Baharul / Bhuiyan, Taufiqur Rahman / Chowdhury, Fahima / Qadri, Firdausi

Frontiers in public health

2023 Volume 11, Page(s) 1132927

Abstract: Background: Enterotoxigenic : Methodology: Under the 2% systematic surveillance system, stool samples collected from diarrheal patients of icddr,b hospital were cultured and diagnostic testing was done for ETEC and : Results: A total of 2,937 ... ...

Abstract	Background: Enterotoxigenic Methodology: Under the 2% systematic surveillance system, stool samples collected from diarrheal patients of icddr,b hospital were cultured and diagnostic testing was done for ETEC and Results: A total of 2,937 stool specimens were tested of which 12% were ETEC and 20% were Conclusion: Changing patterns of enterotoxin and CFs observed in ETEC pathogens should be taken into consideration for ETEC vaccine development. Considering cholera and ETEC biannual trends in causing diarrheal epidemics and outbreaks, emphasizes the need for thoughts on combination vaccine strategies for preventing acute watery diarrhea due to the two major bacterial pathogens.
MeSH term(s)	Humans ; Vibrio cholerae O1 ; Enterotoxigenic Escherichia coli ; Escherichia coli Infections/epidemiology ; Escherichia coli Infections/microbiology ; Bangladesh/epidemiology ; Diarrhea/epidemiology ; Epidemics ; Enterotoxins
Chemical Substances	Enterotoxins
Language	English
Publishing date	2023-04-14
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2711781-9
ISSN	2296-2565 ; 2296-2565
ISSN (online)	2296-2565
ISSN	2296-2565
DOI	10.3389/fpubh.2023.1132927
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Article: Determining clinical biomarkers to predict long-term SARS-CoV-2 antibody response among COVID-19 patients in Bangladesh.

Ahmed, Tasnuva / Hasan, S M Tafsir / Akter, Afroza / Tauheed, Imam / Akhtar, Marjahan / Rahman, Sadia Isfat Ara / Bhuiyan, Taufiqur Rahman / Ahmed, Tahmeed / Qadri, Firdausi / Chowdhury, Fahima

Frontiers in medicine

2023 Volume 10, Page(s) 1111037

Abstract: Background: Information on antibody responses following SARS-CoV-2 infection, including the magnitude and duration of responses, is limited. In this analysis, we aimed to identify clinical biomarkers that can predict long-term antibody responses ... ...

Abstract	Background: Information on antibody responses following SARS-CoV-2 infection, including the magnitude and duration of responses, is limited. In this analysis, we aimed to identify clinical biomarkers that can predict long-term antibody responses following natural SARS-CoV-2 infection. Methodology: In this prospective study, we enrolled 100 COVID-19 patients between November 2020 and February 2021 and followed them for 6 months. The association of clinical laboratory parameters on enrollment, including lactate dehydrogenase (LDH), neutrophil-lymphocyte ratio (NLR), C-reactive protein (CRP), ferritin, procalcitonin (PCT), and D-dimer, with predicting the geometric mean (GM) concentration of SARS-CoV-2 receptor-binding domain (RBD)-specific IgG antibody at 3 and 6 months post-infection was assessed in multivariable linear regression models. Result: The mean ± SD age of patients in the cohort was 46.8 ± 14 years, and 58.8% were male. Data from 68 patients at 3 months follow-up and 55 patients at 6 months follow-up were analyzed. Over 90% of patients were seropositive against RBD-specific IgG till 6 months post-infection. At 3 months, for any 10% increase in absolute lymphocyte count and NLR, there was a 6.28% (95% CI: 9.68, -2.77) decrease and 4.93% (95% CI: 2.43, 7.50) increase, respectively, in GM of IgG concentration, while any 10% increase for LDH, CRP, ferritin, and procalcitonin was associated with a 10.63, 2.87, 2.54, and 3.11% increase in the GM of IgG concentration, respectively. Any 10% increase in LDH, CRP, and ferritin was similarly associated with an 11.28, 2.48, and 3.0% increase in GM of IgG concentration at 6 months post-infection. Conclusion: Several clinical biomarkers in the acute phase of SARS-CoV-2 infection are associated with enhanced IgG antibody response detected after 6 months of disease onset. The measurement of SARS-CoV-2 specific antibody responses requires improved techniques and is not feasible in all settings. Baseline clinical biomarkers can be a useful alternative as they can predict antibody response during the convalescence period. Individuals with an increased level of NLR, CRP, LDH, ferritin, and procalcitonin may benefit from the boosting effect of vaccines. Further analyses will determine whether biochemical parameters can predict RBD-specific IgG antibody responses at later time points and the association of neutralizing antibody responses.
Language	English
Publishing date	2023-05-24
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2775999-4
ISSN	2296-858X
ISSN	2296-858X
DOI	10.3389/fmed.2023.1111037
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Article ; Online: Cholera toxin and O-specific polysaccharide immune responses after oral cholera vaccination with Dukoral in different age groups of Bangladeshi participants.

mSphere

2024 Volume 9, Issue 3, Page(s) e0056523

Abstract: Vaccination is important to prevent cholera. There are limited data comparing anti-O-specific polysaccharide (OSP) and anti-cholera toxin-specific immune responses following oral whole-cell with cholera toxin B-subunit (WC-rBS) vaccine (Dukoral, Valneva) ...

Abstract	Vaccination is important to prevent cholera. There are limited data comparing anti-O-specific polysaccharide (OSP) and anti-cholera toxin-specific immune responses following oral whole-cell with cholera toxin B-subunit (WC-rBS) vaccine (Dukoral, Valneva) administration in different age groups. An understanding of the differences is relevant because young children are less well protected by oral cholera vaccines than older children and adults. We compared responses in 50 adults and 49 children (ages 2 to <18) who were administered two doses of WC-rBS at a standard 14-day interval. All age groups had significant IgA and IgG plasma-blast responses to the OSP and cholera toxin B-subunit (CtxB) antigens that peaked 7 days after vaccination. However, in adults and older children (ages 5 to <18), antibody responses directed at the OSP antigen were largely IgA and IgG, with a minimal IgM response, while younger children (ages 2 to <5) mounted significant increases in IgM with minimal increases in IgA and IgG antibody responses 30 days after vaccination. In adults, anti-OSP and CtxB memory B-cell responses were detected after completion of the vaccination series, while children only mounted CtxB-specific IgG memory B-cell responses and no OSP-memory B-cell responses. In summary, children and adults living in a cholera endemic area mounted different responses to the WC-rBS vaccine, which may be a result of more prior exposure to
MeSH term(s)	Adult ; Child ; Humans ; Adolescent ; Child, Preschool ; Aged ; Infant, Newborn ; Cholera Vaccines ; Cholera/prevention & control ; Cholera Toxin ; O Antigens ; Vibrio cholerae O1 ; Immunoglobulin M ; Antibodies, Bacterial ; Immunoglobulin A ; Vaccination ; Antibody Formation ; Immunoglobulin G
Chemical Substances	Dukoral ; Cholera Vaccines ; Cholera Toxin (9012-63-9) ; O Antigens ; Immunoglobulin M ; Antibodies, Bacterial ; Immunoglobulin A ; Immunoglobulin G
Language	English
Publishing date	2024-02-23
Publishing country	United States
Document type	Journal Article
ISSN	2379-5042
ISSN (online)	2379-5042
DOI	10.1128/msphere.00565-23
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Article ; Online: The Fatal Clinical Outcome of Severe COVID-19 in Hospitalized Patients: Findings from a Prospective Cohort Study in Dhaka, Bangladesh.

Medicina (Kaunas, Lithuania)

2023 Volume 59, Issue 7

Abstract: Background and ... ...

Abstract	Background and Objectives
MeSH term(s)	Adult ; Humans ; Male ; COVID-19 ; SARS-CoV-2 ; Prospective Studies ; Bangladesh/epidemiology ; Antiviral Agents ; Anticoagulants ; Immunoglobulin G ; Immunoglobulin M
Chemical Substances	Antiviral Agents ; Anticoagulants ; Immunoglobulin G ; Immunoglobulin M
Language	English
Publishing date	2023-07-10
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2188113-3
ISSN	1648-9144 ; 1010-660X
ISSN (online)	1648-9144
ISSN	1010-660X
DOI	10.3390/medicina59071280
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Article ; Online: Long-term sialidase-specific immune responses after natural infection with cholera: Findings from a longitudinal cohort study in Bangladesh.

Chowdhury, Fahima / Akter, Afroza / Bhuiyan, Taufiqur Rahman / Biswas, Rajib / Firoj, Md Golam / Tauheed, Imam / Harris, Jason B / Larocque, Regina C / Ross, Allen G / McMillan, Nigel A J / Charles, Richelle C / Ryan, Edward T / Calderwood, Stephen B / Qadri, Firdausi

Frontiers in immunology

2022 Volume 13, Page(s) 1067737

Abstract: Background: Immune responses that target sialidase occur following natural cholera and have been associated with protection against cholera. Sialidase is a neuraminidase that facilitates the binding of cholera toxin (CT) to intestinal epithelial cells. ... ...

Abstract	Background: Immune responses that target sialidase occur following natural cholera and have been associated with protection against cholera. Sialidase is a neuraminidase that facilitates the binding of cholera toxin (CT) to intestinal epithelial cells. Despite this, little is known about age-related sialidase-specific immune responses and the impact of nutritional status and co-infection on sialidase-specific immunity. Methods: We enrolled 50 culture-confirmed Results: This longitudinal cohort study showed age-dependent differences in anti-sialidase immune response after natural cholera infection. Adult patients developed plasma anti-sialidase IgA and IgG responses after acute infection (P<0.05), which gradually decreased from day 30 on. In children, no significant anti-sialidase IgA, IgM, and IgG response was seen with the exception of a late IgG response at study day 540 (p=0.05 compared to adults). There was a correlation between anti-sialidase IgA with vibriocidal titers, as well as anti-sialidase IgA and IgG with anti-LPS and anti-CtxB antibody responses in adult patients, whereas in children, a significant positive correlation was seen only between anti-sialidase IgA and CtxB IgA responses. Stunted children showed significantly lower anti-sialidase IgA, IgG, and IgM antibody responses and higher LPS IgG and IgM antibody responses than healthy children. The anti-sialidase IgA and IgG responses were significantly higher in cases with concomitant parasitic infection. Conclusion: Our data suggest that cholera patients develop age-distinct systemic and mucosal immune responses against sialidase. The stunted children have a lower anti-sialidase antibody response which may be associated with gut enteropathy and the neuraminidase plays an important role in augmented immune response in cholera patients infected with parasites.
MeSH term(s)	Adult ; Child ; Humans ; Cholera ; Neuraminidase ; Longitudinal Studies ; Bangladesh ; Coinfection ; B-Lymphocytes ; Immunologic Memory ; Immunoglobulin G ; Antibodies, Bacterial ; Lipopolysaccharides ; Cohort Studies ; Cholera Toxin ; Immunoglobulin M ; Immunoglobulin A
Chemical Substances	Neuraminidase (EC 3.2.1.18) ; Immunoglobulin G ; Antibodies, Bacterial ; Lipopolysaccharides ; Cholera Toxin (9012-63-9) ; Immunoglobulin M ; Immunoglobulin A
Language	English
Publishing date	2022-12-22
Publishing country	Switzerland
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	2606827-8
ISSN	1664-3224 ; 1664-3224
ISSN (online)	1664-3224
ISSN	1664-3224
DOI	10.3389/fimmu.2022.1067737
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Article ; Online: Correlation of antigen-specific immune response with disease severity among COVID-19 patients in Bangladesh.

Frontiers in immunology

2022 Volume 13, Page(s) 929849

Abstract: Coronavirus disease 2019 (COVID-19) is a protean disease causing different degrees of clinical severity including fatality. In addition to humoral immunity, antigen-specific T cells may play a critical role in defining the protective immune response ... ...

Abstract	Coronavirus disease 2019 (COVID-19) is a protean disease causing different degrees of clinical severity including fatality. In addition to humoral immunity, antigen-specific T cells may play a critical role in defining the protective immune response against SARS-CoV-2, the virus that causes this disease. As a part of a longitudinal cohort study in Bangladesh to investigate B and T cell-specific immune responses, we sought to evaluate the activation-induced marker (AIM) and the status of different immune cell subsets during a COVID-19 infection. We analyzed a total of 115 participants, which included participants with asymptomatic, mild, moderate, and severe clinical symptoms. We observed decreased mucosal-associated invariant T (MAIT) cell frequency on the initial days of the COVID-19 infection in symptomatic patients compared to asymptomatic patients. However, natural killer (NK) cells were found to be elevated in symptomatic patients just after the onset of the disease compared to both asymptomatic patients and healthy individuals. Moreover, we found a significant increase of AIM
MeSH term(s)	Bangladesh/epidemiology ; CD40 Ligand ; CD8-Positive T-Lymphocytes ; COVID-19 ; Humans ; Immunity, Humoral ; Longitudinal Studies ; SARS-CoV-2 ; Severity of Illness Index
Chemical Substances	CD40 Ligand (147205-72-9)
Language	English
Publishing date	2022-09-28
Publishing country	Switzerland
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, N.I.H., Extramural
ZDB-ID	2606827-8
ISSN	1664-3224 ; 1664-3224
ISSN (online)	1664-3224
ISSN	1664-3224
DOI	10.3389/fimmu.2022.929849
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Article ; Online: Appearance of tolerance-induction and non-inflammatory SARS-CoV-2 spike-specific IgG4 antibodies after COVID-19 booster vaccinations.

Akhtar, Marjahan / Islam, Md Rashedul / Khaton, Fatema / Soltana, Umma Hany / Jafrin, Syeda Anoushka / Rahman, Sadia Isfat Ara / Tauheed, Imam / Ahmed, Tasnuva / Khan, Ishtiakul Islam / Akter, Afroza / Khan, Zahid Hasan / Islam, Md Taufiqul / Khanam, Farhana / Biswas, Prasanta Kumar / Ahmmed, Faisal / Ahmed, Shakeel / Rashid, Md Mamunur / Hossain, Md Zakir / Alam, Ahmed Nawsher /

Alamgir, A S M / Rahman, Mahbubur / Ryan, Edward T / Harris, Jason B / LaRocque, Regina C / Flora, Meerjady Sabrina / Chowdhury, Fahima / Khan, Ashraful Islam / Banu, Sayera / Shirin, Tahmina / Bhuiyan, Taufiqur Rahman / Qadri, Firdausi

Frontiers in immunology

2023 Volume 14, Page(s) 1309997

Abstract: Background: Understanding the characteristics of the humoral immune responses following COVID-19 vaccinations is crucial for refining vaccination strategies and predicting immune responses to emerging SARS-CoV-2 variants.: Methods: A longitudinal ... ...

Abstract	Background: Understanding the characteristics of the humoral immune responses following COVID-19 vaccinations is crucial for refining vaccination strategies and predicting immune responses to emerging SARS-CoV-2 variants. Methods: A longitudinal analysis of SARS-CoV-2 spike receptor binding domain (RBD) specific IgG antibody responses, encompassing IgG subclasses IgG1, IgG2, IgG3, and IgG4 was performed. Participants received four mRNA vaccine doses (group 1; n=10) or two ChAdOx1 nCoV-19 and two mRNA booster doses (group 2; n=19) in Bangladesh over two years. Results: Findings demonstrate robust IgG responses after primary Covishield or mRNA doses; declining to baseline within six months. First mRNA booster restored and surpassed primary IgG responses but waned after six months. Surprisingly, a second mRNA booster did not increase IgG levels further. Comprehensive IgG subclass analysis showed primary Covishield/mRNA vaccination generated predominantly IgG1 responses with limited IgG2/IgG3, Remarkably, IgG4 responses exhibited a distinct pattern. IgG4 remained undetectable initially but increased extensively six months after the second mRNA dose, eventually replacing IgG1 after the 3rd/4th mRNA doses. Conversely, initial Covishield recipients lack IgG4, surged post-second mRNA booster. Notably, mRNA-vaccinated individuals displayed earlier, robust IgG4 levels post first mRNA booster versus Covishield counterparts. IgG1 to IgG4 ratios decreased with increasing doses, most pronounced with four mRNA doses. This study highlights IgG response kinetics, influenced by vaccine type and doses, impacting immunological tolerance and IgG4 induction, shaping future vaccination strategies. Conclusions: This study highlights the dynamics of IgG responses dependent on vaccine type and number of doses, leading to immunological tolerance and IgG4 induction, and shaping future vaccination strategies.
MeSH term(s)	Humans ; Immunoglobulin G ; ChAdOx1 nCoV-19 ; SARS-CoV-2 ; COVID-19/prevention & control ; Vaccination ; Antibodies, Viral ; RNA, Messenger
Chemical Substances	Immunoglobulin G ; ChAdOx1 nCoV-19 (B5S3K2V0G8) ; Antibodies, Viral ; RNA, Messenger
Language	English
Publishing date	2023-12-20
Publishing country	Switzerland
Document type	Journal Article ; Research Support, U.S. Gov't, Non-P.H.S. ; Research Support, Non-U.S. Gov't
ZDB-ID	2606827-8
ISSN	1664-3224 ; 1664-3224
ISSN (online)	1664-3224
ISSN	1664-3224
DOI	10.3389/fimmu.2023.1309997
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Article: A non-inferiority trial comparing two killed, whole cell, oral cholera vaccines (Cholvax vs. Shanchol) in Dhaka, Bangladesh

Chowdhury, Fahima / Akter, Afroza / Bhuiyan, Taufiqur Rahman / Tauheed, Imam / Teshome, Samuel / Sil, Arijit / Park, Ju Yeon / Chon, Yun / Ferdous, Jannatul / Basher, Salima Raiyan / Ahmed, Faez / Karim, Mahbubul / Ahasan, Mohammad Mainul / Mia, Masudur Rahman / Masud, Mir Mohammad Ibna / Khan, Abdul Wahab / Billah, Masum / Nahar, Zebun / Khan, Imran /

Ross, Allen G. / Kim, Deok Ryun / Ashik, Md. Muktadir Rahman / Digilio, Laura / Lynch, Julia / Excler, Jean-Louis / Clemens, John D. / Qadri, Firdausi

Vaccine. 2022 Jan. 28, v. 40, no. 4

2022

Abstract: Bangladesh remains cholera endemic with biannual seasonal peaks causing epidemics. At least 300,000 severe cases and over 4,500 deaths occur each year. The available oral cholera vaccineshave not yet been adopted for cholera control in Bangladesh due to ... ...

Abstract	Bangladesh remains cholera endemic with biannual seasonal peaks causing epidemics. At least 300,000 severe cases and over 4,500 deaths occur each year. The available oral cholera vaccineshave not yet been adopted for cholera control in Bangladesh due to insufficient number of doses available for endemic control. With a public private partnership, icddr,b initiated a collaboration between vaccine manufacturers in Bangladesh and abroad. A locally manufactured Oral Cholera Vaccine (OCV) named Cholvax became available for testing in Bangladesh. We evaluated the safety and immunogenicity of this locally produced Cholvax (Incepta Vaccine Ltd) inexpensive OCV comparatively to Shanchol (Shantha Biotechnics-Sanofi Pasteur) which is licensed in several countries. We conducted a randomized non-inferiority clinical trial of bivalent, killed oral whole-cell cholera vaccine Cholvax vs. Shanchol in the cholera-endemic area of Mirpur, Dhaka, among three different age cohorts (1–5, 6–17 and 18–45 years) between April 2016 and April 2017. Two vaccine doses were given at 14 days apart to 2,052 healthy participants. No vaccine-related serious adverse events were reported. There were no significant differences in the frequency of solicited (7.31% vs. 6.73%) and unsolicited (1.46% vs. 1.07%) adverse events reported between the Cholvax and Shanchol groups. Vibriocidal antibody responses among the overall population for O1 Ogawa (81% vs. 77%) and O1 Inaba (83% vs. 84%) serotypes showed that Cholvax was non-inferior to Shanchol, with the non-inferiority margin of −10%. For O1 Inaba, GMT was 462.60 (Test group), 450.84 (Comparator group) with GMR 1.02(95% CI: 0.92, 1.13). For O1 Ogawa, GMT was 419.64 (Test group), 387.22 (Comparator group) with GMR 1.12 (95% CI: 1.02, 1.23). Cholvax was safe and non-inferior to Shanchol in terms of immunogenicity in the different age groups. These results support public use of Cholvax to contribute for reduction of the cholera burden in Bangladesh. ClinicalTrials.gov number: NCT027425581.
Keywords	antibodies ; cholera ; clinical trials ; immunogenicity ; public-private partnerships ; serotypes ; vaccines ; Bangladesh
Language	English
Dates of publication	2022-0128
Size	p. 640-649.
Publishing place	Elsevier Ltd
Document type	Article
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2021.12.015
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Article: A non-inferiority trial comparing two recombinant vaccines (Hepa-B vs. Engerix-B) for hepatitis B among adults in Dhaka, Bangladesh

Vaccine. 2021 Oct. 15, v. 39, no. 43

2021

Abstract: Worldwide Hepatitis B is known as one of the imperative causes of mortality and morbidity as well as occupational health hazard among health workers. Bangladesh is intermediate endemic country for Hepatitis B infection for which the government has ... ...

Abstract	Worldwide Hepatitis B is known as one of the imperative causes of mortality and morbidity as well as occupational health hazard among health workers. Bangladesh is intermediate endemic country for Hepatitis B infection for which the government has introduced hepatitis B vaccination into the Expanded Programme on Immunization (EPI) nationwide since 2009 for new born children. However, the people who were born before 2009, was dependent on imported hepatitis B vaccine as there was no locally manufactured hepatitis B vaccine in Bangladesh. Hence, we conducted a randomized observer blinded non-inferiority clinical trial to assess the immunogenicity and safety of the locally manufactured Hepa-B vaccine in comparison with World Health Organization prequalified Engerix-B vaccine.Total 158 eligible adult participants were enrolled in this study with mean age of 30 and 29 years old in Hepa-B and Engerix-B groups, respectively. Both the vaccines were administered intramuscularly at 0, 1 and 6 months schedule. Baseline and post vaccination anti-HBs titers were measure at different time points. Seroconversion rate post three doses of Hepa-B vaccine was 98.67% similar to the comparator Engerix-B vaccine which was 100%. The geometric mean test ratios of both vaccines at all analysis time points were found > 0.5 predefined non-inferiority margin. Soreness at the injection site was the most common symptom for both the vaccines which resolved without any complication. No serious adverse event was reported throughout the study period.These results suggest that locally manufactured hepatitis B vaccine ‘Hepa-B’ vaccine is non-inferior to the well-known licensed ‘Engerix-B’ vaccine. ClinicalTrials.gov NCT03627507.
Keywords	World Health Organization ; adults ; clinical trials ; health hazards ; hepatitis B ; immunogenicity ; injection site ; morbidity ; mortality ; occupational health and safety ; seroconversion ; vaccination ; Bangladesh
Language	English
Dates of publication	2021-1015
Size	p. 6385-6390.
Publishing place	Elsevier Ltd
Document type	Article
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2021.09.031
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Article: A phase I/II study to evaluate safety, tolerability and immunogenicity of Hillchol®, an inactivated single Hikojima strain based oral cholera vaccine, in a sequentially age descending population in Bangladesh

Vaccine. 2021 July 22, v. 39, no. 32

2021

Abstract: The World Health Organization (WHO) recommends the use of oral cholera vaccines (OCVs) as part of an integrated control program, both in highly endemic settings and during cholera epidemics. The available and internationally recommended WHO-prequalified ... ...

Abstract	The World Health Organization (WHO) recommends the use of oral cholera vaccines (OCVs) as part of an integrated control program, both in highly endemic settings and during cholera epidemics. The available and internationally recommended WHO-prequalified OCVs (Dukoral, Shanchol, Euvichol) contain multiple heat and formalin-killed V. cholerae strains of Inaba and Ogawa serotypes. MSD Wellcome Trust Hilleman Laboratories Pvt. Ltd. in technical collaboration with University of Gothenburg, Sweden has developed a new single strain OCV, Hillchol. This vaccine consists of formaldehyde-inactivated whole cell El Tor V. cholerae O1 bacteria engineered into the Hikojima serotype for stable expression of both the Ogawa (AB) and Inaba (AC) LPS antigens on the bacterial surface. We evaluated the safety and immunogenicity of this novel and potentially much less expensive OCV in comparison with Shanchol. We conducted a randomized, non-inferiority, age-descending clinical trial of OCV (Hillchol vs. Shanchol) in the Mirpur area of Dhaka city from July 2016 to May 2017. This study was carried out in three different age cohorts (1–<5, 5–17 and ≥18 years old). Two doses of vaccine were given at 14 days intervals to 560 healthy participants. No serious adverse events were reported. There were no significant differences in the rates of adverse events between the test vaccine (Hillchol) and the comparator (Shanchol) group. Serum vibriocidal antibody responses in all age groups combined were comparable for all the O1 Ogawa (59% vs. 67%; 90% CI of difference: −14.55, −0.84) and Inaba (70% vs. 71%; 90% CI of difference: −7.24, 5.77) serotypes, showing that the Hillchol vaccine was non-inferior to Shanchol. This new vaccine was also non-inferior to Shanchol in the different age strata. The safety and immunogenicity profile of the new OCV Hillchol is comparable to Shanchol in persons residing in a cholera-endemic setting. ClinicalTrials.gov number: NCT02823899.
Keywords	World Health Organization ; antibodies ; blood serum ; cholera ; clinical trials ; heat ; immunogenicity ; serotypes ; vaccines ; Bangladesh ; Sweden
Language	English
Dates of publication	2021-0722
Size	p. 4450-4457.
Publishing place	Elsevier Ltd
Document type	Article
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2021.06.069
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