Non Inferiority Trial of Locally Manufactured Meningococcal ACWY Vaccine 'Ingovax ACWY' in Bangladesh.

Summary

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.

Timeline

Start

2017-08-21

Primary completion

2018-03-19

Completion

2018-03-19

Outcome

Met primary endpoint

paper lower limit of 95% CI of the GMR was found to be greater than the pre-defined 0.5 non-inferiority margin PMID 38897895 ↗

paper We observed the immunogenicity and safety of Ingovax ACWY is non-inferior to comparator vaccine. PMID 38897895 ↗

Publications

• Background Hart CA, Thomson AP. Meningococcal disease and its management in children. BMJ. 2006 Sep 30;333(7570):685-90. doi: 10.1136/bmj.38968.683958.AE. No abstract available.
• Background Hossain MA, Ahmed D, Ahmed T, Islam N, Breiman RF. Increasing isolations of Neisseria meningitides serogroup A from blood and cerebrospinal fluid in Dhaka, Bangladesh, 1999-2006. Am J Trop Med Hyg. 2009 Apr;80(4):615-8.
• Background Vyse A, Wolter JM, Chen J, Ng T, Soriano-Gabarro M. Meningococcal disease in Asia: an under-recognized public health burden. Epidemiol Infect. 2011 Jul;139(7):967-85. doi: 10.1017/S0950268811000574. Epub 2011 Apr 15.
• Background Crum-Cianflone N, Sullivan E. Meningococcal Vaccinations. Infect Dis Ther. 2016 Jun;5(2):89-112. doi: 10.1007/s40121-016-0107-0. Epub 2016 Apr 16.
• Background Stephens DS, Greenwood B, Brandtzaeg P. Epidemic meningitis, meningococcaemia, and Neisseria meningitidis. Lancet. 2007 Jun 30;369(9580):2196-2210. doi: 10.1016/S0140-6736(07)61016-2.
• Background Memish ZA. Meningococcal disease and travel. Clin Infect Dis. 2002 Jan 1;34(1):84-90. doi: 10.1086/323403. Epub 2001 Nov 20.
• Background Control and prevention of meningococcal disease: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 1997 Feb 14;46(RR-5):1-10.
• Ahmed T, Tauheed I, Hoque S, Sarower Bhuyan G, Biswas R, Tarikul Islam M, Islam S, Amir Hossain M, Ahmmed F, Muktadir A, Muktadir H, Ahmed F, Karim M, Panday AS, Kundu Tanu T, Muktadir Rahman Ashik M, Rahad Hossain M, Shariful Bari S, Ahmed R, Masudur Rahman Mia M, Islam S, Khan I, Mainul Ahasan M, Chowdhury F, Rahman Bhuiyan T, Islam Chowdhury M, Qadri F. A phase 3 non-inferiority trial of locally manufactured Meningococcal ACWY vaccine 'Ingovax ACWY' among Bangladeshi adults. Vaccine. 2024 Oct 3;42(23):126063. doi: 10.1016/j.vaccine.2024.06.030. Epub 2024 Jun 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ingovax ACWY	Unknown	0.5 ml	Subcutaneous
Comparator	Quadri Meningo	Vaccine	0.5 ml	Subcutaneous

Indications