A Randomized Observer-blinded Controlled Non-inferiority Trial to Evaluate the Immunogenicity of Locally Manufactured Meningococcal ACWY Vaccine 'Ingovax ACWY' in Bangladeshi Healthy Adults.

This study will be a randomized observer -blinded controlled non-inferiority study to evaluate and compare the immunogenicity of locally produced Ingovax ACWY with Quadri Meningo on a total of 88 healthy adult participants (18-45 years of age). 44 participants will receive locally produced Ingovax ACWY and 44 participants of comparator groups will receive Quadri Meningo which is produced by BiO-MeD Private Limited. Vaccination will be done in Day 0 following the screening and pre-immunization blood sample collection and post-immunization blood will be collected at Study Day 30. Follow- up by home visit will be carried out from Study day 1-6 and clinic follow-up is scheduled upto Study day 90. The hypothesis of this study is: locally produced subcutaneous Meningococcal vaccine Ingovax ACWY is non inferior and immunogenic among adults in Bangladesh as compared to Quadri Meningo.

开始日期2017-08-21

申办/合作机构

International Centre for Diarrhoeal Disease Research, Bangladesh

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2024-10-01·Vaccine

A phase 3 non-inferiority trial of locally manufactured Meningococcal ACWY vaccine ‘Ingovax ACWY’ among Bangladeshi adults

Article

作者: Ahmed, Raziuddin ; Islam, Shaumik ; Islam, Samnun ; Sarower Bhuyan, Golam ; Hoque, Shahinur ; Tauheed, Imam ; Mainul Ahasan, Mohammad ; Qadri, Firdausi ; Islam Chowdhury, Mohiul ; Panday, Alex S ; Kundu Tanu, Tanni ; Shariful Bari, Shaikh ; Chowdhury, Fahima ; Rahad Hossain, Md ; Ahmmed, Faisal ; Masudur Rahman Mia, Md ; Amir Hossain, Mohammad ; Biswas, Rajib ; Karim, Mahbubul ; Muktadir Rahman Ashik, Md ; Muktadir, Abdul ; Khan, Imran ; Ahmed, Faez ; Rahman Bhuiyan, Taufiqur ; Tarikul Islam, Md ; Ahmed, Tasnuva ; Muktadir, Hasneen

Meningococcal disease is caused by Neisseria meningitidis or meningococcus. Every year globally around 1.2 million people are affected and approximately 120,000 deaths occur due to meningitis. The disease can be prevented by a single dose of meningococcal vaccine. We carried out a randomized observer-blinded non-inferiority trial to evaluate and compare the immunogenicity and safety of a local meningococcal polysaccharide vaccine 'Ingovax ACWY' (test) with Quadri Meningo^TM (comparator), an approved meningococcal polysaccharide vaccine in India. A total of 88 healthy adults (18-45 years old) were randomized at a 1:1 ratio in two vaccine groups receiving a single dose vaccine subcutaneously. All participants were followed until three months post-vaccination. Blood for clinical parameters (hematology and biochemistry) and serum bactericidal assay (SBA) was collected prior to vaccination and one-month post-vaccination. Solicited adverse events (AEs) were assessed up to 6 days following vaccination and unsolicited AEs were monitored throughout the follow-up period. There was no significant difference in rates of AE between the two groups. The commonest solicited AE was injection site pain. No serious AEs were reported. There was no significant difference (p<0.05) in seroconversion rate as well as pre and post-vaccination SBA geometric mean titers (GMT)between test and comparator vaccine. The post-vaccination GMT ratio (GMR) of the test and comparator vaccine was found to be 0.9, 1, 1.29, and 0.85 for serogroup A, C, W135, and Y respectively. For all the serogroups, lower limit of 95% CI of the GMR was found to be greater than the pre-defined 0.5 non-inferiority margin suggesting that Ingovax ACWY is similar to Quadri Meningo^TM vaccine. We observed the immunogenicity and safety of Ingovax ACWY is non-inferior to comparator vaccine. The development of facilities for manufacturing polysaccharide ACWY vaccines locally will further lead to capacity building in the field of vaccines for Bangladesh.

2022-12-19·Avicenna Journal of Medical Biochemistry

Angiotensinogen Gene M235T and T174M Polymorphisms in Diabetic Nephropathy in a Bangladeshi Population

作者: Khan, Imran ; Hassan, Zahid ; Salim, Shahidul Islam ; Hossain, Khondoker Moazzem ; Ali, Liaquat ; Rahman, Md. Mizanur

Background: Marker gene polymorphisms linked with the renin-angiotensin-aldosterone system (RAAS) have been broadly studied in diabetic nephropathy (DN) patients considering that RAAS is a potential drug target to slow down kidney disease progression. Objectives: The aim of the present study was to determine the link between M235T and T174M variants of angiotensinogen (AGT) gene and DN. Methods: A total of 93 patients with DN, mean age of 56±8 years, systolic blood pressure (SBP) of 141±14, and diastolic blood pressure (DBP) of 84±7 mm Hg (mean±SD) were investigated, among whom 59 patients had a family history of type 2 diabetes mellitus. A total of 96 healthy subjects served as the control group with no family history of diabetic nephropathy (FHDN) and type 2 diabetes mellitus, a mean age of 47±10 years, SBP of 126±11, and DBP of 76±6 mm Hg. PCR–restriction fragment length polymorphism was employed for genotyping M235T and T174M molecular variants. Results: Genotype frequencies of the variants M235T (χ2=2.038, P=0.361) and T174M (χ2=2.952, P=0.229) did not show any statistically significant association with type 2 diabetic nephropathy (T2DN) compared to the control. Based on FHDN and family history of diabetes mellitus (FHDM), the frequency of genotypes of M235T marker (P=0.360) in FHDN, and (P=0.886) FHDM; T174M marker (P=0.641) in FHDN, and (P=0.425) FHDM also did not show any statistically significant association with T2DN compared to the controls. Conclusion: M235T and T174M variants were not associated with DN in a Bangladeshi population.

2022-01-01·Vaccine3区 · 医学

A non-inferiority trial comparing two killed, whole cell, oral cholera vaccines (Cholvax vs. Shanchol) in Dhaka, Bangladesh

3区 · 医学

Article

作者: Ross, Allen G ; Ahasan, Mohammad Mainul ; Sil, Arijit ; Clemens, John D ; Qadri, Firdausi ; Billah, Masum ; Bhuiyan, Taufiqur Rahman ; Excler, Jean-Louis ; Lynch, Julia ; Park, Ju Yeon ; Ashik, Md Muktadir Rahman ; Ferdous, Jannatul ; Khan, Imran ; Karim, Mahbubul ; Chon, Yun ; Teshome, Samuel ; Nahar, Zebun ; Ahmed, Faez ; Masud, Mir Mohammad Ibna ; Basher, Salima Raiyan ; Akter, Afroza ; Khan, Abdul Wahab ; Digilio, Laura ; Chowdhury, Fahima ; Kim, Deok Ryun ; Mia, Masudur Rahman ; Tauheed, Imam

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.

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