Phase I open label, clinical trial to evaluate the safety, tolerability and immunogenicity ofChikungunya vaccine in healthy adults of 18 to 50 years age
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To assess the safety
研究概览
简要总结
The study is a phase I, randomized, open label trial. This study will assess the safety and tolerance of 2
different doses of the test vaccine –40 μg.The study design has a treatment group – test group and a placebo group with 15 subjects in test group and
5 in placebo group. in ratio of 3:1. Randomization will be done in a way that allots 15 subjects to test group
and 5 subjects of placebo group.All subjects will be screened (via medical history, physical examination and laboratory investigations) to
establish the eligibility criteria as detailed below. This includes negative antibodies, CHIKV IgG, by ELISA
method.The test vaccine and placebo will be administered as 2 doses at 28 days interval on day 0±2 and 28±2 days.Subjects will be recruited on outâ€patient basis. Following vaccination, participants will remain at the study
site for at least 2 hours observation to detect any adverse event. If no untoward adverse event occurs, the
participant is allowed to leave the site.
Following vaccination, all participants will be monitored throughout the study period for adverse events
with daily telephone contacts (for 7 days after each vaccine dose,), interim study visits, subject diary cards,
and hematological& biochemical laboratory tests till Day 56.
Follow up will be done 28 days after dose 2 for endpoint analysis and interim clinical study report will be
prepared and submitted to DCG(I) at the completion of 56â€day time point when data for the endpoints
becomes available. However, subjects will be followed for 6 months after dose 2 vaccination for any chronic
adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.≥18 and ≤50 yrs inclusive on the day of screening 2.Able and willing to complete informed consent process with understanding of the purpose and procedures of the study 3.Medical history and physical examination without clinically significant findings at the time of screening.
- •4.Hematological and biochemical values either within institutional normal range and accompanied by physician approval.
- •5.Agree to keep a daily record of symptoms for the duration of the study 6.Available for clinical followâ€up throughout the study period via telephone contact as well as clinic visits 7.Female specific criteria: a.If female of child bearing potential – have a negative urine pregnancy test result within 24 hrs of the scheduled first vaccination; (a woman who has not undergone permanent sterilization procedure, and has had 4 menstrual periods in last 12 months is considered as ‘female of child bearing potential).
排除标准
- •Female specific criteria: Woman who is breast feeding or planning to become pregnant during the study period.
- •General Criteria: 1.History of suspected or confirmed Chikungunya fever.
- •(Case definition for Suspected Chikungunya: A subject meeting both the clinical and epidemiological criteria.
- •2.Clinical criteria: acute onset of fever >38.5°C and severe arthralgia/arthritis not explained by other medical conditions.
- •3.Epidemiological criteria: residing or having visited epidemic areas, having reported transmission within 15 days prior to the onset of symptoms.
- •Case definition for Confirmed Chikungunya: 4.A subject meeting the laboratory criteria of positive ELISA test for CHIKV IgG.) 5.Clinically significant abnormal clinical laboratory values including blood pressure(≥140 mmHg systolic and ≥90 mmHg diastolic) when 3 measurements are taken 30 min apart, in sitting position and atrest 6.Body mass index (BMI) ≥ 25 [BMI will be calculated as weight in Kilograms/(height in metres)2] 7.Test positive for HIV or Hepatitis B inf8.ection History of cardiovascular disease 8.History of immune deficiency or autoimmune disease 9.Have active or history of arthritis (joint swelling, pain, tenderness, warmth or erythema) within the last 6 months from date ofscreening 10.Have an active or history of malignant conditions including haematological malignancy.
- •11.Have a history of degenerative neurological disease (e.g. GuillainBarre Syndrome, multiple sclerosis) 12.Have received any vaccination within 4 weeks prior to the vaccination in this study 13.Have received blood transfusion or immunoglobulin within 30 days prior to vaccination in this study
- •Have a history of serious reactions to any vaccines that preclude receipt of study vaccinations as determined by the investigator 15.Have asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that is expected to require the use of oral or intravenous corticosteroids 16.Have diabetes mellitus (type I or II), with the exception of history of gestational diabetes 17.Have received any investigational drug in 6 weeks prior to screening 18.Is currently participating in any form of clinical trial that involves intervention.
- •19.Is likely to participate in any other clinical trial during the study period.
结局指标
主要结局
To assess the safety
时间窗: Occurrence of immediate adverse events and adverse events within 7 days post each dose | (reactogenicity). | Occurrence of AEs (including SAEs) till follow up post 2nd dose of vaccination.
and tolerability of CHIKV vaccine
时间窗: Occurrence of immediate adverse events and adverse events within 7 days post each dose | (reactogenicity). | Occurrence of AEs (including SAEs) till follow up post 2nd dose of vaccination.
次要结局
- To assess the immune response elicited by the CHIKV vaccine in(terms of CHIKV neutralizing antibodies by PRNT50)