Immunogenicity and Safety of Three Tetravalent Formulations of Dengue Vaccine Candidates in Healthy Adults Aged 18 to 45 Years in the US
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 260
- 试验地点
- 10
- 主要终点
- Percentage of Participants With Antibody Titers of >= 10 1/Dilution (1/Dil) Against Each Dengue Virus Serotype Strain: CYD Vaccine 5555 and 5553 Formulation
研究概览
简要总结
This study used 3 different formulations of tetravalent CYD dengue vaccine.
The primary objective of the study was to evaluate the neutralizing antibody response after 2 doses of two different formulations of tetravalent dengue vaccine administered at Month 0 and Month 6.
The secondary objectives were:
- To evaluate the safety of the 3 formulations of tetravalent CYD dengue vaccine.
- To describe the neutralizing antibody responses to each of the 3 vaccine formulations.
- To describe vaccine viremia after the first and second dose of each of the 3 vaccine formulations in a subset of participants.
详细描述
All participants provided blood samples for immunogenicity assessments, while vaccine viremia was assessed in a subset of participants in each group.
Safety was assessed in all participants as follows: solicited adverse event (AE) prelisted in the diary card were collected for 7 days after vaccination for solicited injection site reactions and 14 days for solicited systemic reactions , unsolicited AEs were collected for 28 days after vaccination, and serious adverse event (SAE) information collected throughout the study up to 6 months after vaccination.
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 (Participant, Investigator)
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
- •Healthy, as determined by medical history, clinical examination, and biological safety parameters.
- •Aged 18 to 45 years on the day of inclusion.
- •Provision of informed consent signed by the participant or another legally acceptable representative.
- •For a woman of child-bearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to the first vaccination, and until at least 4 weeks after the last study vaccination.
- •Able to attend all scheduled visits and to comply with all trial procedures.
排除标准
- •Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.
- •For a woman of child-bearing potential, known or suspected pregnancy or positive serum/urine pregnancy test.
- •Breast-feeding woman.
- •Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination.
- •Planned participation in another clinical trial during the present trial period.
- •Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term (at least 2 weeks within the previous 3 months) systemic corticosteroids therapy (at a dose of at least 10 mg). Topical steroids were allowed.
- •Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances.
- •Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the investigator.
- •Current or past alcohol abuse or drug addiction that may interfere with the participant's ability to comply with trial procedures.
- •Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response.
- •Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
- •Planned receipt of any vaccine in the 4 weeks following each of the trial vaccinations.
- •Human Immunodeficiency Virus (HIV), hepatitis B surface antigen, or hepatitis C virus seropositivity in blood sample taken at Screening.
- •Participant deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
- •Clinically significant laboratory test abnormalities (as determined by the investigator) in blood sample taken at Screening.
- •Previous residence in, travel or planned travel of more than 2 weeks during the study period to areas with high dengue infection endemicity.
- •Reported history of flavivirus infection as reported by the participant.
- •Previous vaccination against flavivirus diseases (including Japanese encephalitis, tick-borne encephalitis, and yellow fever).
- •Flavivirus vaccination planned during the trial period.
研究组 & 干预措施
CYD Dengue Vaccine 5555 Formulation
Participants received 3 doses of CYD dengue vaccine (5555 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
干预措施: Tetravalent CYD Dengue Vaccine , 5555 formulation (Biological)
CYD Dengue Vaccine 4444 Formulation
Participants received 3 doses of CYD dengue vaccine (4444 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
干预措施: Tetravalent CYD Dengue Vaccine, 4444 formulation (Biological)
CYD Dengue Vaccine 5553 Formulation
Participants received 3 doses of CYD dengue vaccine (5553 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
干预措施: Tetravalent CYD Dengue Vaccine , 5553 formulation (Biological)
结局指标
主要结局
Percentage of Participants With Antibody Titers of >= 10 1/Dilution (1/Dil) Against Each Dengue Virus Serotype Strain: CYD Vaccine 5555 and 5553 Formulation
时间窗: Pre-injection 1 (Day 0), 30 days post-injection 2 (Month 7)
Percentage of participants with antibody titers \>= 10 (1/dil) against each serotypes (1, 2, 3 and 4) of the dengue virus strains was assessed by dengue plaque reduction neutralization test (PRNT).
次要结局
- Number of Participants With Solicited Injection Site Reactions After Any Vaccination(7 days after any injection 1, 2 or 3)
- Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain(Pre-injection 1 (Day 0), 30 days post-injection 1(Month 1), injection 2 (Month 7) and injection 3 (Month 13))
- Number of Participants With Solicited Systemic Reactions After Any Vaccination(14 days after any injection 1, 2 or 3)
- Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain(Pre-injection 1 (Day 0), 30 days post-injection 1(Month 1), injection 2 (Month 7) and injection 3 (Month 13))
- Number of Participants With Vaccine Viremia(7 days post-injection 1 and 2, 14 days post-injection 1 and 2)
- Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes(Pre-injection 1 (Day 0), 30 days post-injection 1(Month 1), injection 2 (Month 7) and injection 3 (Month 13))