NCT00981695Unknown1 期
An Open Randomized Phase I/II Study Evaluating Safety and Immunogenicity of a Candidate HIV-1 Vaccine, MVA.HIVA, Administered to Healthy Infants Born to HIV-1-infected Mothers
适应症
干预措施
试验速览
- 阶段
- 1 期
- 入组人数
- 72
- 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:
Primary: Safety and immunogenicity of MVA.HIVA vaccine in 20-week-old healthy Kenyan infants born to HIV-1-infected mothers.
Secondary:
- HIV-1 immunogenicity comparison between MVA.HIVA and age-matched unvaccinated control arms in each cohort (breastfeeding or formula feeding)
- HIV-1 immunogenicity comparison between breastfeeding and formula feeding infants receiving MVA.HIVA
- HIV-1 immunogenicity comparison between breastfeeding and formula feeding infants in the age-matched unvaccinated control group
- Comparison of responses to certain Kenyan Extended Programme on Immunization (KEPI) vaccines (OPV, DTP, HBV, and HiB) between MVA.HIVA versus age-matched unvaccinated controls in each cohort, between breast versus formula feeding infants in the age-matched unvaccinated control group, and between breast versus formula infants receiving MVA.HIVA
- Comparison of immune activation and phenotypic profile of lymphocytes between breast and formula feeding infants in each cohort (MVA.HIVA and age-matched unvaccinated control)
- Build capacity for Infant HIV-1 Vaccine Clinical Trials Centre in Nairobi, Kenya.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •Infant Inclusion Criteria
- •Healthy infants
- •< 3 days of age (day of birth = Day 0) at enrolment
- •Birth weight > 2500 grams
- •Born to an eligible woman
- •Written informed consent by parent
排除标准
- •HIV infection, as determined by a filter paper and/or RNA test prior to vaccination.
- •Participation in any other HIV-1 vaccine or drug trial.
- •Failure to receive all standard KEPI immunizations according to national immunization programme.
- •Weight for age z-scores outside of 2 standard deviations of normal at the time of vaccination.
- •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., 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 by the time of vaccination.
- •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.
- •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.
研究组 & 干预措施
Vaccinees
Experimental
18 breast-fed and 18 formula-fed infants at the age of 20 weeks
干预措施: MVA.HIVA (Biological)
Controls
No Intervention
18 breast-fed and 18 formula-fed infants at the age of 20 weeks
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 28 weeks after vaccination
次要结局
- For immunogenicity to KEPI vaccines: Antibody levels to specific vaccines as measured by ELISA.(1 week before and 1 week after vaccination)
- For immunogenicity to MVA.HIVA: Frequency of IFN-γ-producing cells determined in an ELISPOT assay after overnight stimulation with a pool of HIVA-derived peptides.(Up to 24 weeks after vaccination)
研究者
研究点 (1)
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