PACTR201304000534302Other未知
A Phase I Study of Prime-Boost HIV Vaccine Combinations Using Modified Vaccinia Ankara and Adenovirus Type 26 Vectors with Mosaic and Natural Sequence Inserts in Healthy, HIV-Uninfected Adults
适应症
试验速览
- 阶段
- 未知
- 状态
- Other
- 发起方
- Janssen
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Year(s) 至 50 Year(s)（—）
- 性别
- All
入选标准
- •1. Able to read and willing to complete the informed consent process.
- •2. ¿ 18 to 50 years old at the time of study enrollment (enrollment is defined as the time of first vaccination, but a participant must be 18 at time of consent).
- •3. Healthy adults (determined by medical history, physical examination, and clinical
- •judgement).
- •4. Laboratory criteria within 56 days prior to enrollment:
- •o Hemoglobin: Women: ¿11 g/dL; ¿Men 12.5 g/dL
- •o White cell count: 2,500 to 11,000 cells/mm3
- •o Platelets: 125,000 to 450,000 per mm3
- •o Urinalysis: protein and blood <1+, glucose negative
- •o ALT/AST¿1.25x institutional upper limits of normal, and creatinine ¿1.25x
- •institutional upper limits of normal.
- •5. Negative for HIV infection (negative U.S. FDA-approved HIV diagnostic blood test).
- •6. All female subjects must:
- •o Have a negative pregnancy test at the screening visit;
- •o Have a negative pregnancy test immediately prior to each vaccine/placebo
- •vaccination;
- •o Provide verbal assurance that adequate birth control measures have been
- •followed for 56 days prior to the first vaccine/placebo vaccination and will
- •continue to be followed for at least 3 months after the final vaccine/placebo
- •vaccination. Adequate birth control is defined as follows:
- •¿ Contraceptive medications delivered orally, intramuscularly, vaginally, or
- •implanted underneath the skin;
- •¿ Surgical methods (hysterectomy or bilateral tubal ligation);
- •¿ Condoms, diaphragms;
- •¿ Intrauterine device (IUD) or
- •¿ Abstinence.
- •7. Available and willing to participate for the duration of the study visits and follow up.
- •8. Amenable to HIV risk reduction counseling and committed to maintaining behavior
- •consistent with low risk of HIV exposure through the last required protocol clinic visit.
- •9. Pass the Test of Understanding.
- •10. Must be willing to provide verifiable identification.
- •11. Must have a means to be contacted.
- •12. Assessed by the clinic staff as being at low risk for HIV infection.
排除标准
- •1. Confirmed HIV-1/-2 infection.
- •2. Chronic active hepatitis B or active hepatitis C or active syphilis infection.
- •3. A woman who is breastfeeding.
- •4. Any clinically significant acute or chronic medical condition that in the opinion of the investigator would preclude participation.
- •5. Major surgery within the 4 weeks prior to study entry or planned major surgery through the course of the study.
- •6. History of myocarditis, pericarditis, cardiomyopathy, congestive heart failure with
- •permanent sequelae, clinically significant arrhythmia.
- •7. ECG with clinically significant findings, or features that would interfere with the assessment of myo/pericarditis.
- •8. History of diabetes mellitus type 1 or type 2, including cases controlled with diet alone. (Not excluded: history of isolated gestational diabetes.)
- •9. Thyroidectomy, or thyroid disease requiring medication during the last 12 months.
- •10. Hypertension.
- •11. Major psychiatric illness and/or substance abuse problems during the past 12 months that
- •in the opinion of the investigator would preclude participation.
- •12. Receipt of live attenuated vaccine within 30 days or plans to receive within 30 days postvaccination.
- •13. Use of experimental therapeutic agents within 30 days of study entry.
- •14. Current or planned participation in another clinical study during the study period.
- •15. Receipt of blood products or immunoglobulin in the past 3 months
- •16. History of anaphylaxis or other serious adverse reactions to vaccines or egg products or neomycin or streptomycin
- •17. History of chronic urticaria
- •18. Chronic or recurrent use of medications which modify host immune response, e.g. cancer chemotherapeutic agents, parenteral corticosteroids
- •19. Recipient of an HIV vaccine candidate at any time, receipt of a pox-virus vaccine in the last 10 years, and receipt of other experimental vaccine(s) within the last 5 years.
- •20. Subjects who cannot communicate reliably with the investigator.
研究者
相似试验
已完成
不适用
Safety & Immunogenicity of HIV Vaccines in Healthy Kenyan Adults (HIV-CORE 004)HIV/AIDSPACTR201403000794397niversity of Oxford72
进行中（未招募）
1 期
ot applicableHuman Immunodeficiency Virus (HIV) infectionMedDRA version: 20.1 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestationsEUCTR2017-003081-27-FRInserm-ANRS192
进行中（未招募）
1 期
A Phase I/II randomised therapeutic HIV vaccine trial in individualswho started antiretrovirals during primary or chronic infectioHIV InfectionMedDRA version: 20.0Level: LLTClassification code 10020441Term: Human immunodeficiency virus infection, unspecifiedSystem Organ Class: 100000004862EUCTR2017-003081-27-ITINSERM-ANRS1
进行中（未招募）
1 期
A comparative clinical trial, with randomization, of a therapeutic vaccine against HIV in people on antiretroviral treatment who initiated such treatment during primary or chronic infection.Human Immunodeficiency Virus (HIV) infectionMedDRA version: 20.1 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestationsEUCTR2017-003081-27-ESInserm-ANRS192
已完成
1 期
Evaluating the Safety and Immune Response of a Prime-Boost HIV Vaccine Regimen in Healthy, HIV-Uninfected, Vaccinia-Naive AdultsHIV InfectionsNCT01571960National Institute of Allergy and Infectious Diseases (NIAID)48