NCT00982579已完成1 期
An Open Randomized Phase I Study Evaluating Safety and Immunogenicity of a Candidate HIV-1 Vaccine, MVA.HIVA, Administered to Healthy Infants Born to HIV-1/2-uninfected Mothers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- For safety and reactogenicity: Actively and passively collected data on adverse events
研究概览
简要总结
Objectives:
Safety and immunogenicity of MVA.HIVA vaccine in 20-week-old healthy Gambian infants born to HIV-1/2-uninfected mothers.
Gross impact of MVA.HIVA on the immunogenicity of EPI vaccines (DTwPHib, HepB, PCV-7 and OPV) when administered at 20 weeks (4 weeks after the last EPI vaccines), who have had BCG vaccine within the first 4 weeks of life.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infants, 19 weeks of age, with weight for age z-scores within 2 standard deviations of normal.
- •Have received all standard EPI immunizations according to national immunization programme.
- •Written informed consent by parent.
- •Mother HIV-1/2-uninfected.
排除标准
- •Acute disease at the time of vaccination (acute disease is defined as the presence of a moderate or severe illness with or without fever). All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory tract infection with or without low-grade febrile illness, i.e. axillary temperature of <37.5 °C ).
- •Axillary temperature of ≥ 37.5 °C at the time of vaccination.
- •Any clinically significant abnormal finding on screening from biochemistry or haematology at 19 weeks.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products.
- •Presence of any underlying disease that compromises the diagnosis and evaluation of response to the vaccine.
- •Invasive bacterial infections (pneumonia, meningitis).
- •Any other on-going chronic illness requiring hospital specialist supervision.
- •Administration of immunoglobulins and/or any blood products within one month preceding the planned administration of the vaccine candidate.
- •Any history of anaphylaxis in reaction to vaccination.
- •Research physician's assessment of lack of willingness by parents to participate and comply with all requirements of the protocol, or identification of any factor felt to significantly increase the infant's risk of suffering an adverse outcome.
- •Likelihood of travel away from the study area.
- •Untreated malaria infection.
- •Any other clinical evidence of infection.
结局指标
主要结局
For safety and reactogenicity: Actively and passively collected data on adverse events
时间窗: Up to 16 weeks after vaccination
次要结局
- For immunity to EPI vaccines: Antibody levels to specific vaccines.(1 week before and 1 week after vaccination)
- For immunogenicity: Frequency of IFN-γ producing cells determined in ex-vivo (effector) and 10-day cultured (memory) ELISPOT assays after overnight stimulation with pools of HIVA-derived peptides(Up to 16 weeks after vaccination)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
1 期
Safety and Immunogenicity Study of Candidate HIV-1 Vaccine Given to Healthy Infants Born to HIV-1-infected MothersHIV InfectionsHIV-1NCT00981695Medical Research Council72
已完成
1 期
A Phase I Study to Evaluate the Safety and Immunogenicity of Heterologous Boost Immunizations With MVA-CMDRHIVNCT01889719Rockefeller University14
已完成
1 期
A Phase I Study of the Safety and Immunogenicity of MVA85A in Healthy Gambian VolunteersTuberculosisNCT00423839University of Oxford12
已完成
1 期
Evaluating the Safety and Immune Response to an HIV Vaccine in Healthy, HIV-Uninfected Adults Who Have Participated in Previous HIV Vaccine Clinical Trials and in Adults Who Have Not Participated in Previous HIV Vaccine Clinical TrialsHIV InfectionsNCT01376726National Institute of Allergy and Infectious Diseases (NIAID)36
终止
1 期
A Phase I Safety and Immunogenicity Preventive Vaccine Trial Based on the HIV-1 Tat and V2-deleted Env Proteins (ISS P-002)HIV InfectionNCT01441193Barbara Ensoli, MD11