CTRI/2024/03/064910招募中3 期
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Immunogenicity and Safety of Single dose of Dengue Tetravalent Vaccine, Live Attenuated (Recombinant, Lyophilized) – “DengiAll†of Panacea Biotec Limited in Healthy Indian Adults.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 10,335
- 试验地点
- 19
- 主要终点
- To evaluate the efficacy of “DengiAll†among adults in preventing symptomatic laboratory confirmed dengue infection over a period of 2 years after vaccination
研究概览
简要总结
This will be a double-blind, multi-centric, placebo-controlled, randomized, single dose, two arm study. This study aims to evaluate the efficacy, immunogenicity, and safety of a single dose of Panacea’s ‘Dengue Tetravalent Vaccine, Live Attenuated (Recombinant, Lyophilized).
In this study, 10335healthy adults will be enrolled. Participants will be screened, and eligibleparticipants will be enrolled in the study. The participant allocation ratiofor investigational vaccine and placebo is 2:1.
The enrolled participantswill be randomly selected into the following subsets:
1. Vaccine efficacy (VE) and Safety
2. Immunogenicity and Reactogenicity subset
3. Viremia subset
4. T cell immune response subset
The study duration per participantwill be for 2 years post vaccination.
All 10335 participantswill have 8 scheduled or planned visits per protocol
(Screening visit, Randomization/vaccinationvisit and follow-up visits till 2 years post vaccination)
Participantswho belong to the viremia cohort will, in addition, have 2 more scheduledvisits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy adults between 18 to 60 years of age, in good health, based on medical history, clinical laboratory tests (protocol specified) and physical examination. 2.Participants willing to participate throughout the study period of 2 years (after signing written informed consent) Inclusion Criteria for Women:  Female with non-child bearing potential (Females having documented history of surgical sterilization or are postmenopausal.
- •12 months of amenorrhea after the last menstrual period)  Female with child bearing potential is eligible if she: has used an effective method of contraception or abstinence from at least 4 weeks prior to vaccination AND is willing to avoid pregnancies up to 90 days post vaccination by use of an effective method of contraception or abstinence AND has negative serum pregnancy test on the screening day and negative urine pregnancy test on the day of vaccination.
排除标准
- •Women who are pregnant or breastfeeding.
- •Acute or chronic, clinically significant pulmonary, cardiovascular, endocrine, metabolic, gastrointestinal, neurological, hepatic, renal functional abnormality or any other systemic disorder, that are assessed by the investigator (based on medical history or physical examination) as being clinically unstable within the prior 4 weeks as evidenced by: â–ª Hospitalization for the condition, including surgical interventions.
- •â–ª New significant organ function deterioration.
- •â–ª Needing addition of new treatments or major dose adjustments of current treatments (mild or moderate well-controlled comorbidities are allowed)
- •Any confirmed or suspected condition with impaired/altered function of immune system (e.g., immunodeficient or autoimmune conditions)
- •Known case of HIV, Hepatitis B, and Hepatitis C reported by the participant
- •History of any bleeding disorder
- •History of severe allergic reactions or anaphylaxis.
- •History of allergy to any of the component of Investigational Medicinal product
- •Any evidence of clinically significant acute illness or infection or fever within the past 3 days of study screening for study participation
- •Any evidence of clinically significant acute illness or infection or fever within the past 3 days of vaccination
- •Oral Temperature should not be ≥ 37.8°C (100°F) on the day of vaccination (temporary exclusion).
- •Any major surgery within the past 90 days prior to vaccination
- •Any abnormal laboratory value which is considered clinically significant by the Investigator or is grade III or higher.
- •History of intake of anti-cancer chemotherapy or radiation therapy at any time in the past
- •Chronic (> 14 days continuously) systemic corticosteroid therapy / within the past 90 days prior to vaccination or planned use through the study period (prednisone, or equivalent, ≥ 0.5 mg/kg per day).
- •Received any other immunosuppressive therapy prior to study entry within the past 90 days prior to vaccination or planned treatment during the trial duration.
- •(Inhaled, intranasal, and topical steroids are allowed)
- •Have received blood products in the past 90 days prior to vaccination, including transfusions or immunoglobulin
- •Receipt of any vaccine in the past 4 weeks prior to study vaccination (vaccination can be planned 4 weeks after trial vaccination has been given)
- •Previous receipt of any Dengue vaccine (licensed or Experimental)
- •Current alcohol use or drug addiction that may interfere with the participants’ ability to comply with the trial procedures.
- •Concurrent/planned participation in any other clinical trial
- •Individuals who are part of study team or close family members of individuals conducting this study
- •Inability of participants to remain in follow-up for 2 years.
结局指标
主要结局
To evaluate the efficacy of “DengiAll†among adults in preventing symptomatic laboratory confirmed dengue infection over a period of 2 years after vaccination
时间窗: Febrile illness with laboratory confirmation of dengue determined by NS1-ELISA and/or rRT-PCR, occurring one month to 2 years post vaccination (vaccine or placebo).
次要结局
- 4.To evaluate the efficacy of DengiAll among adults in preventing symptomatic laboratory confirmed dengue infection by dengue virus serotypes over a period of 2 years after vaccination(4. Febrile illness with laboratory confirmed dengue occurring one month to 2 years post vaccination.)
- 7. To assess the cell mediated immune responses post vaccination.(7a. The number of CD4, CD8 T cells and NK cells in whole blood of pre vaccination and post vaccination samples at Day 28, 180, 1 year and 2 years.)
- 2. To assess the immunogenicity of “DengiAll†in comparison to the placebo using serum plaque reduction neutralization titer 50% (PRNT50) against dengue virus serotypes.(2a.The Geometric Mean Antibody serum plaque reduction neutralization titer 50 percent (PRNT50) to dengue virus serotypes in vaccinated and placebo arms on Days 0, 28, 56, 84 ,180, 1 year and 2 years post vaccination.)
- 1.To determine the safety of “DengiAll†in adults as assessed by the frequency of adverse events, graded by seriousness, causality and severity.(1a. All solicited AEs and Unsolicited AEs occurring within 28 days post vaccination, with respect to causality, seriousness, severity and frequency in)
- 6. To evaluate the efficacy of DengiAll in preventing symptomatic laboratory confirmed dengue infection by baseline serostatus.
- 8. Estimation of the ratio of Neutralizing Antibodies to Non Neutralizing Antibodies by NNT.(8. Ratio of the Neutralizing Antibodies to Non Neutralizing Antibodies by Net Neutralization Assay will be carried out on Day 28 and 84 in a subset of the immunogenicity cohort.)
- 3. To determine viremia in a subset of dengue naïve and exposed trial participants on Days 9 and Day 12 post vaccination.(3. Presence of Viremia for each serotype in a sub set of Dengue trial participants on Day 9 and Day 12 post vaccination.)
- 5. To compare the incidence of laboratory confirmed severe dengue and dengue related deaths between DengiAll and placebo groups(5a. Incidence of Severe Dengue cases.)
研究者
研究点 (19)
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