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

NCT03263403 | Completed Phase 2 DMC

• 1 other identifier: PR-17068
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Meningococcal Vaccine

Keywords

Meningococcal Vaccine; Ingovax ACWY; adults; Bangladeshi; immunogenicity

Outcome Measures

Primary Outcomes (1)

• Assessment of proportion of participants showing seroconversion (defined as a ≥4-fold rise in SBA titers) vaccinated with either Ingovax ACWY Vaccine (Incepta) or Menomune ® -A/C/Y/W-135 vaccine (Sanofi Pasteur Inc.). The non-inferiority margin will be

  The test vaccine will induce similar seroconversion rates in compare to reference vaccine (defined as a ≥4-fold rise in SBA titers). This will be done by calculating the responder rate through comparing the pre and 30(±2) days post-vaccination serum bactericidal titres among Ingovax ACWY' or Menomune® - A/C/Y/W-135 vaccinated participants. The non-inferiority margin will be 10%. Serum bactericidal assay(SBA) titres and fold-rises will be logarithmically transformed prior to statistical analyses in order to better approximate normality.

  30 days after administration of vaccine

Secondary Outcomes (5)

• To compare the GMTs between vaccines, and GMT ratios.

  30 days after administration of vaccine

• Number of immediate reactions reported within 30 minutes after vaccination

  30 minutes post vaccination

• Number of solicited adverse events (prelisted in the participant's memory aid) occurring up to 6 days following vaccination.

  Post vaccination Day 1 to Day 6

• Number of unsolicited AEs up to 28days after vaccination.

  28 days following vaccination

• Occurrence of serious adverse events (SAEs) throughout the trial

  upto 90 days post vaccination

Study Arms (2)

Test Group

EXPERIMENTAL

44 participants will be randomly assigned to the test group for receiving the locally produced meningococcal vaccine "Ingovax ACWY" (Incepta).

Biological: Ingovax ACWY

Comparator Group

ACTIVE COMPARATOR

44 participants will be randomly assigned to the comparator group for receiving 'Quadri Meningo' (BiO-MeD Private Limited).

Biological: Quadri Meningo

Interventions

Ingovax ACWY BIOLOGICAL

The pharmaceutical company in Bangladesh is now currently marketing meningococcal vaccine of Yuxi Walvax Biotechnology Co. Ltd which is filled finish by Incepta Vaccines Ltd. This fill finish meningococcal vaccine is already registered and licensed in Bangladesh. However, at present, no locally produced meningococcal vaccine is available in Bangladesh. Once this clinical trial is completed, it will then proceed for registration and licensure in Bangladesh. Ingovax ACWY is a freeze-dried preparation of the group-specific polysaccharide antigens from Neisseria meningitidis Group A, Group C, Group Y and Group W135. When reconstituted, the vaccine is a clear, colorless sterile solution for subcutaneous use.

Test Group

Quadri Meningo BIOLOGICAL

Meningococcal polysaccharide vaccine Quadri Meningo vaccine manufactured by BiO-MeD Private Limited. Quadri Meningo \[Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined\] is a freeze-dried preparation of the Group-specific polysaccharide antigens from Neisseria meningitidis, Group A, Group C, Group Y, and Group W-135. After reconstitution with diluent, the vaccine is a clear colourless liquid.

Comparator Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Apparently healthy adult of 18 to 45 years of age.
• Sex: Male, Female and Transgender
• Apparently healthy based on a medical history taken prior to vaccination. Any underlying chronic illness must be documented to be in stable condition.
• Women with child bearing potential must be non pregnant which will be confirmed by negative urine pregnancy test during screening and prior to vaccination on day 0 as well. Moreover, medical history will be taken thoroughly by study physician from the woman of childbearing age to completely exclude the probability of pregnancy.Women who are married and living with a partner must agree to use a reliable contraceptive method to prevent pregnancy until final follow-up following vaccination. However abstinence is also acceptable.

You may not qualify if:

• Prior history of Meningitis infection or vaccination with any Meningococcal vaccine.
• Prior history of taking any other polysaccharide vaccine (Pneumococcal Vaccine, Typhoid Vaccine) in last 6 months.
• Receipt of investigational drugs or other investigational vaccines within 3 months prior to first injection with the study vaccine.
• Recent febrile illness (within last two weeks).
• Clinically significant abnormalities in screening hematology or serum chemistry, as determined by the Study Physician.
• Known or suspected hypersensitivity to any component of Meningococcal ACWY polysaccharide vaccine.
• Known or suspected impairment of immunologic function or recent use of immunomodulatory medications (e.g, systemic corticosteroids). Does not include topical and inhaled steroids.
• Pregnant women, nursing mothers, and women planning to become pregnant within the study period.
• Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• Incepta Vaccine Limited: collaborator

Study Sites (1)

Mohiul Islam Chowdhury

Dhaka, 1212, Bangladesh

Location

Related Publications (8)

• 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.

  PMID: 17008668 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.

  PMID: 19346387 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.

  PMID: 21492496 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.

  PMID: 27086142 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.

  PMID: 17604802 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.

  PMID: 11731951 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.

  PMID: 9048846 BACKGROUND

• 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.

  PMID: 38897895 DERIVED

Study Officials

• Firdausi Qadri, PhD

  International Centre for Diarrhoeal Disease Research, Bangladesh

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Since the test and comparator drugs used in this clinical study have different package of vial, a double blind design is not appropriate. Study investigators along with study staffs involved in safety evaluation and laboratory analysis will be blinded regarding the assigned treatment of the participant. The vaccine administration team will be unblinded to the treatment assignment list. The vaccine administrator team members will not be involved in the evaluation of vaccine safety and laboratory analysis.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible participants will be assigned to receive the Ingovax ACWY Vaccine and Quadri Meningo Vaccine, in a 1:1 ratio across the target population according to the randomization schedule. 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.

Study Record Dates

• First Submitted: August 20, 2017
• First Posted: August 28, 2017
• Study Start: August 21, 2017
• Primary Completion: March 19, 2018
• Study Completion: March 19, 2018
• Last Updated: March 22, 2018

Record last verified: 2018-03

Locations

BA (1)