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

• Published in: Vaccine 2024-10, Vol.42 (23), p.126063-126063, Article 126063
• Main Authors: Ahmed, Tasnuva, Tauheed, Imam, Hoque, Shahinur, Sarower Bhuyan, Golam, Biswas, Rajib, Tarikul Islam, Md, Islam, Shaumik, Amir Hossain, Mohammad, Ahmmed, Faisal, Muktadir, Abdul, Muktadir, Hasneen, Ahmed, Faez, Karim, Mahbubul, Panday, Alex S, Kundu Tanu, Tanni, Muktadir Rahman Ashik, Md, Rahad Hossain, Md, Shariful Bari, Shaikh, Ahmed, Raziuddin, Masudur Rahman Mia, Md, Islam, Samnun, Khan, Imran, Mainul Ahasan, Mohammad, Chowdhury, Fahima, Rahman Bhuiyan, Taufiqur, Islam Chowdhury, Mohiul, Qadri, Firdausi
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Adults; Allergy and Immunology; Antibodies, Bacterial - blood; Antibodies, Bacterial - immunology; Bangladesh; Biochemistry; blood serum; Capacity development; Comparators; Disease; Epidemics; Fatalities; Female; Hematology; Humans; Immune response; Immunization; Immunogenicity; Immunogenicity, Vaccine; India; Infections; Ingovax ACWY; injection site; Male; Meningitis; Meningitis, Meningococcal - immunology; Meningitis, Meningococcal - prevention & control; Meningococcal disease; Meningococcal Infections - immunology; Meningococcal Infections - prevention & control; Meningococcal polysaccharide vaccine; Meningococcal Vaccines - administration & dosage; Meningococcal Vaccines - adverse effects; Meningococcal Vaccines - immunology; Middle Aged; Neisseria meningitidis; Neisseria meningitidis - immunology; Non-inferiority; pain; Pathogens; people; Pilgrimages; Pilgrims; Polysaccharides; Seroconversion; serotypes; vaccination; Vaccination - methods; Vaccines; Young Adult
• ISSN: 0264-410X; 1873-2518; 1873-2518
• DOI: 10.1016/j.vaccine.2024.06.030

AbstractMeningococcal 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