NCT04566484终止2 期
A Phase II/III Adaptive Seamless Design, Randomized, Controlled Trial To Evaluate Safety And Immunogenicity of 2 Dose-Regimen of BBV87 Chikungunya Vaccine In Healthy Subjects Aged 12 to 65 Years in Latin America and Asia.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3,210
- 试验地点
- 7
- 主要终点
- Geometric mean titers (GMT) of neutralization antibody
研究概览
简要总结
This study has a Phase II with part A and part B and a Phase III with part C. This Adaptive seamless design will prospectively include planned modifications and incorporate both dose selection (parts A and B) and confirmation of the selected dose (part C) based on the accumulation of subjects' data within the entire study period as shown below. Part C will be randomized for immunogenicity subset and will be open label for safety cohort. The participants assigned to the control group from all parts (i.e, Part A, B and C) will be continuously followed up from the enrollment until the end of the study.
详细描述
Protocol Number: IVI-CHIK-001
Study Sites: Study participants will be enrolled from the following sites:
- Centro de Vacunacion Internacional S.A. CEVAXIN, Panama
- Centro de Estudios en Infectologia Pediatrica (CEIP), Colombia
- Centro de Atencion y Diagnostico de Enfermedades Infecciosas (CDI), Colombia
- Centro de Atención e Investigación Médica S.A.S.(CAIMED) Colombia
- Clinica de la Costa,Colombia.
- Centro de Estudios Clínicos Salud Avanzada. (CECLISA), Guatemala.
- Clinica Clínica San Agustín,Costa Rica.
- Tropical Medicine, Mahidol University, Thailand
Site Principal Investigators:
- Dr Xavier Saez-Llorens, MD Centro de Vacunacion Internacional S.A. CEVAXIN,Ciudad de Panama, Panama
- Dr Alexandra Sierra ,MD Centro de Estudios en Infectologia Pediatrica (CEIP), Cali, Colombia
- Dr Luis Angel Villar, MD Centro de Atencion y Diagnostico de Enfermedades Infecciosas (CDI), Colombia
- Myriam Tatiana Medina Bernal, MD. Centro de Atención e Investigación Médica S.A.S.(CAIMED) Colombia
- Dr Andrés Angelo Cadena Bonfanti Clinica de la Costa,Colombia.
- Dr Mario Melgar,MD. Centro de Estudios Clínicos Salud Avanzada. (CECLISA),Guatemala.
- Dr Javier Cespedes, MD Clinica Clínica San Agustín,Costa Rica.
- Prof Punnee Pitisuttithum,MD Tropical Medicine, Mahidol University, Bangkok,Thailand
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
Observer-blind in Phase 2 (parts A and B) and phase 3 in the immuno subcohort of Part C. It will be Open label in the safety cohort
入排标准
- 年龄范围
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In order to be eligible to participate in this study, any individual must meet the following criteria:
- •Part A first component : Healthy participants 18 to 65 years of age at enrollment. Good health is based on medical history and physical examination Part A second component, Part B and Part C: Healthy participants 12 to 65 years of age at enrollment. Good health is based on medical history and physical examination
- •Participants/Parent(s)/LAR who have voluntarily signed and dated informed consent/assent based on local regulation. In case of a public health emergency in which site visits is not permitted, the informed consent can be obtained in accordance with the local IRB/EC or local regulatory agency guidelines.
- •Participants/Parent(s)/LAR who are able to attend all scheduled visits and to comply with all trial procedures Criteria applicable to women and adolescents of childbearing potential
- •Negative result on a pregnancy test (urine/serum) on day of enrollment before receiving study products.
- •Agree to use effective birth control^ methods (or abstinence) during the duration of the study.
- •Adequate birth control is defined as follows, but not limited to: contraceptive medications delivered orally, intramuscularly, vaginally, or implanted underneath the skin, surgical methods (hysterectomy or bilateral tubal ligation), condoms, diaphragms, intrauterine device (IUD), and abstinence.
- •Note: If the subject during the pregnancy counseling process, answers yes to menopausal statuts with amenorrhea for at least 2 years, hysterectomy, or tubal ligation,therefore is not of childbearing potential.
- •Exclusion Criteria
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Any current or pre-existing health conditions (e.g., any major congenital defects, etc) which in the opinion of the investigator may affect the safety of the subject or the study endpoints.
- •Participants concomitantly enrolled or scheduled to be enrolled in another trial
- •Any female participant who is lactating, pregnant* or planning for pregnancy** during the course of study period
- •History of rheumatoid arthritis and moderate or severe arthritis or arthralgia within past 90 days prior to Screening visit
- •Documented thrombocytopenia
- •Medical history of uncontrolled coagulopathy or blood disorders.
- •Medical history of seropositivity for Human Immunodeficiency Virus (HIV) infection.
- •Medical history or suspected congenital or acquired immune function disorders.
- •Chronic use of systemic steroids (>2 mg/kg/day or >20 mg/day prednisone or equivalent for periods exceeding 10 days within the past 3 months ), cytotoxic or other immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months.
- •Receipt of blood or blood-derived products in the past 3 months
- •Individuals who received any other vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study or who are planning to receive any vaccine within 4 weeks of the study vaccine administration, except emergency vaccination after any dose.
- •Known history or allergy to vaccine components and excipients.
- •Any abnormality or chronic disease which in the opinion of the investigator might be detrimental for the safety of the participant and interfere with the assessment of the study objectives
- •Participants/Parent(s)/LAR planning to move from the study area before the end of study period
- •Deprived of freedom by administrative or court order, or in an emergency setting, or hospitalized involuntarily (part of a vulnerable population).
- •Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures
- •As per Investigator's medical judgment individual could be excluded from the study in spite of meeting all inclusion/exclusion criteria mentioned above
- •Employee of the study center directly involved with the proposed study or with study investigators
- •Temporary Contraindication Should a subject experience one of the conditions/situations listed below, the Investigator will postpone/delay further vaccination until the condition/situation is resolved.
- •Febrile illness (temperature ≥ 38.0°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator's judgment.
- •Receipt of any vaccine in the 4 weeks preceding the trial vaccination.
- •Lactation:This Investigational Product (IP) has not been specifically studied in pregnant and lactating women. No data on lactating women are available. There is no information about harm to an unborn child or a child who is breastfeeding. Breastfeeding women will not be enrolled. Should a female participant decide to breastfeed during the vaccination period, she will be excluded from further vaccination, but will be followed for safety until the end of the study
- •Pregnancy Test ( serum/urine) is necessary for all female participants of childbearing age from menarche.
- •For pre-menarche females, the young female subjects will declare by themselves if they have not yet started menstruation. If a young female patient reaches menarche during the study, then she is to be considered as a woman of childbearing potential from that time forward.
排除标准
- 未提供
研究组 & 干预措施
BBV87vaccine(BBV87 20 µg/ BBV87 40 µg)
Experimental
The test article, inactivated Chikungunya virus vaccine 'BBV87', is available in a 2 mL clear glass USP Type 1 vial that contains a single dose of 0.5 mL of the vaccine as singlehuman dose (SHD). Vials are stoppered and sealed with tear-down aluminum seals.
• Route: BBV87 vaccine will be given to participants intramuscularly in the deltoid region of the upper arm. 0.5 mL of the investigational vaccine (BBV87 20 µg/ BBV87 40 µg) will be administered.
干预措施: BBV87 Chikungunya vaccine (Drug)
Normal Saline
Placebo Comparator
Each 0.5 ml vial of placebo will contain normal saline.The placebo will be given to participants intramuscularly in the deltoid region of the upper arm.0.5 mL of placebo will be administered.
干预措施: Normal Saline (Drug)
结局指标
主要结局
Geometric mean titers (GMT) of neutralization antibody
时间窗: 28 days post second dose
Geometric mean titers (GMT) of neutralization antibody measured by plaque reduction neutralization test (PRNT50 and/or micro-PRNT) at 28 days post second dose of BBV87/ Placebo
Proportion of participants with treatment emergent adverse events (TEAEs)
时间窗: On or after vaccination.
Proportion of participants with treatment emergent adverse events (TEAEs) TEAEs are defined for this trial as any AEs/AESIs/SAEs that occur on or after vaccination.
次要结局
- Seroconversion rates(At 28 days post second dose of BBV87/ Placebo compared to baseline)
- GMT of neutralization antibody(at 6 months (168 days) post second dose of BBV87/ Placebo (Part B and C only))
- GMT of Chikungunya-binding IgG titers(At 6 months (168 days) post second dose of BBV87/ Placebo)
- Seroconversion rates of Chikungunya-binding IgG titers(At 28 days post first dose of BBV87/ Placebo compared to baseline)
- Seroconversion rates Chikungunya-binding IgG titers(At 6 months (168 days)post second dose of BBV87/ Placebo vaccine compared to baseline (Part B and C only))
- Proportion of participants with solicited local and systemic adverse events within 7 days post vaccination(Within 7 days post vaccination)
- Proportion of participants with unsolicited adverse events within 28 days post vaccination(Within 28 days post vaccination)
- Proportion of participants with Serious Adverse Events(During entire study period)
- Proportion of participants Adverse Events of Special Interest(During entire study period)
研究者
研究点 (7)
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