A Randomized Observer-blinded Controlled Non-inferiority Trial to Evaluate the Immunogenicity of Locally Manufactured Meningococcal ACWY Vaccine 'Ingovax ACWY' in Bangladeshi Healthy Adults.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
Protocol Title: A randomized observer-blinded controlled non-inferiority trial to evaluate the immunogenicity of locally manufactured Meningococcal ACWY vaccine 'Ingovax ACWY' in Bangladeshi healthy adults.
Background:
- Burden:
Meningococcal disease is an infectious disease caused by Neisseria meningitidis or meningococcus, which may present clinically as meningococcemia or meningitis, or presence of both features. Meningococcal meningitis causes inflammation of the membranes covering the brain and spinal cord. Meningococcal meningitis or meningococcemia is a life-threatening disease. It affects adults, adolescents and children as well. Every year more than 1.2 million people are affected by meningitis. It causes approximately 120,000 deaths globally each year. It can cause severe brain damage and is fatal in 50% of cases if untreated. According to a review article on meningococcal disease in Asia, results from four retrospective hospital-based studies conducted in Bangladesh showed that N. meningitidis present up to 35% of positive cultures in all ages, and up to 18% in children aged <2 years with bacterial meningitis. At the International Centre for Diarrhoeal Disease Research in Bangladesh, of 628 blood and CSF samples, N. meningitidis was detected in 24•8% (n=156), of which 97•7% were serogroup A and the rest 2.3% were serogroup B between 1999 and 2006. Of the 156 N. meningitidis isolates, 89 (57%) were from blood and 67 (43%) from CSF. Meningococcemia occurs without meningitis in 5% to 20% among the meningococcal infections. Globally the case-fatality ratio of meningococcemia is up to 40%.
Despite of prompt diagnosis and the availability of appropriate treatments, the diseases is still a threat to the people. In spite of getting antibiotic in time, one in ten infected people die within 2 days of their first symptoms, one in four survivors is left with long-term disabilities such as loss of limb (s), deafness, nervous system problems, or brain damage. The disease can be transmitted as long as the symptoms persist or until 24 hours of effective treatment have been started. Carriers without symptoms can transmit the disease for about 6 months. Moreover, the disease can easily spread from person to person by respiratory droplets of sneezing or coughing or by sharing utensils. 2. Knowledge gap:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Test Group
44 participants will be randomly assigned to the test group for receiving the locally produced meningococcal vaccine "Ingovax ACWY" (Incepta).
干预措施: Ingovax ACWY (Biological)
Comparator Group
44 participants will be randomly assigned to the comparator group for receiving 'Quadri Meningo' (BiO-MeD Private Limited).
干预措施: Quadri Meningo (Biological)
结局指标
主要结局
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
时间窗: 30 days after administration of vaccine
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.
次要结局
- 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)