PER-046-16招募中未知
A PHASE 1 CLINICAL TRIAL TO EVALUATE THE IMMUNOGENICITY OF AIDSVAX B/E BIVALENT GP120 VACCINE AND MVA/HIV62B IN HEALTHY, HIV-1–UNINFECTED ADULT PARTICIPANTS WHO PREVIOUSLY RECEIVED MVA/HIV62B IN DNA/MVA OR MVA/MVA REGIMENS IN HVTN 205
Instituto Nacional de Alergias y Enfermedades Infecciosas (NIAID). EEUU,0 个研究点目标入组 10 人开始时间: 2017年2月8日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 10
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
- 性别
- All
入选标准
- •26.Age of 18 to 55 years
- •27.Prior participation in HVTN 205 with assignment to treatment (not placebo) arm:
- •a.Assigned to HVTN 205 Group 1 or Group 3, and received all 4 scheduled vaccinations (2 injections of pGA2/JS7 DNA (months 0, 2) and 2 injections of MVA/HIV62 (months 4, 6); OR
- •b.Assigned to HVTN 205 Group 4, and received at least vaccinations 1, 2 and 4 (3 injections of MVA/HIV62 at months 0, 2 and 6).
- •28.Access to a participating HVTN CRS and willingness to be followed for the planned duration of the study
- •29.Ability and willingness to provide informed consent
- •30.Assessment of understanding: volunteer demonstrates understanding of this study; completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly
- •31.Willing to be contacted 2 years following initial study injection.
- •32.Agrees not to enroll in another study of an investigational research agent
- •33.Good general health as shown by medical history, physical exam, and screening laboratory tests
- •HIV-Related Criteria:
- •34.Willingness to receive HIV test results
- •35.Willingness to discuss HIV infection risks and amenable to HIV risk reduction counseling.
- •36.Assessed by the clinic staff as being at low risk” for HIV infection and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit.
- •Laboratory Inclusion Values
- •Hemogram/CBC
- •37.Hemoglobin ≥ 11.0 g/dL for volunteers who were born female, ≥ 13.0 g/dL for volunteers who were born male
- •38.White blood cell count = 3,300 to 12,000 cells/mm3
- •39.Total lymphocyte count ≥ 800 cells/mm3
- •40.Remaining differential either within institutional normal range or with site physician approval
- •41.Platelets = 125,000 to 550,000/mm3
- •42.Chemistry panel: ALT, AST, and alkaline phosphatase < 1.25 times the institutional upper limit of normal; creatinine ≤ institutional upper limit of normal.
- •43.Cardiac Troponin T or I (cTnT or cTnI) does not exceed the institutional upper limit of normal
- •44.Negative HIV-1 and -2 blood test: Participants must have a negative test result for HIV infection following the HVTN Lab Program’s in-study HIV testing algorithm, prior to initial enrollment.
- •45.Negative Hepatitis B surface antigen (HBsAg)
- •46.Negative anti-Hepatitis C virus Ab (anti-HCV), or negative HCV polymerase chain reaction (PCR) if the anti-HCV is positive
- •47.Normal urine:
- •Negative urine glucose, and
- •Negative or trace urine protein, and
- •Negative or trace urine hemoglobin (if trace hemoglobin is present on dipstick, a microscopic urinalysis with red blood cells levels within institutional normal range).
- •Reproductive Status
- •48.Volunteers who were born female: negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test performed prior to vaccination on the day of initial vaccination. Persons who are NOT of reproductive potential due to having undergone total hysterectomy or bilateral oophorectomy (verified by medical records), are not required to undergo pregnancy testing.
- •49.Reproductive status: A volunteer who was born female must:
- •Agree to consistently use effective contraception (Appendix A) for sexual activity that could lead to pregnancy from at least 21 days pri
排除标准
- •36.Blood products received within 120 days before first vaccination
- •37.Investigational research agents received within 30 days before first vaccination
- •38.Body mass index (BMI) ≥ 40
- •39.Volunteer has 2 or more of the following cardiac risk factors:
- •Participant report of history of elevated blood cholesterol defined as fasting LDL >160 mg/dL;
- •First degree relative (eg, mother, father, brother, or sister) who had coronary artery disease before the age of 50 years;
- •Current smoker; or
- •40.Pregnant or breastfeeding
- •41. Active duty and reserve US military personnel
- •Vaccines and other Injections
- •42.Any clinically significant AE related to vaccination in HVTN 205, for which revaccination would be a safety concern such as any grade 3 or 4 related AE
- •43.Smallpox vaccine received within the last 5 years
- •44.HIV vaccine(s) received in a prior HIV vaccine trial other than HVTN 205. For HVTN 205 participants who have subsequently received control/placebo in another HIV vaccine trial, the HVTN 114 PSRT will determine eligibility on a case-by-case basis.
- •45.Non-HIV experimental vaccine(s) received within the last 5 years in a prior vaccine trial. Exceptions may be made for vaccines that have subsequently undergone licensure by the FDA. For volunteers who have received control/placebo in an experimental vaccine trial, the HVTN 114 PSRT will determine eligibility on a case-by-case basis. For volunteers who have received an experimental vaccine(s) greater than 5 years ago, eligibility for enrollment will be determined by the HVTN 114 PSRT on a case-by-case basis.
- •46.Live attenuated vaccines other than influenza vaccine received within 30 days before first vaccination or scheduled within 14 days after injection (eg, measles, mumps, and rubella [MMR]; oral polio vaccine [OPV]; varicella; yellow fever)
- •47.Influenza vaccine or any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination (eg, tetanus, pneumococcal, Hepatitis A or B)
- •48.Allergy treatment with antigen injections within 30 days before first vaccination or that are scheduled within 14 days after first vaccination
- •Immune System
- •49.Immunosuppressive medications received within 168 days before first vaccination. (Not exclusionary: [1] corticosteroid nasal spray; [2] inhaled corticosteroids; [3] topical corticosteroids for mild, uncomplicated dermatitis; or [4] a single course of oral/parenteral corticosteroids at doses < 2 mg/kg/day and length of therapy < 11 days with completion at least 30 days prior to enrollment.)
- •50.Serious adverse reactions to vaccines or to vaccine components, including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain. (Not excluded from participation: a volunteer who had a nonanaphylactic adverse reaction to pertussis vaccine as a child.)
- •51.Hypersensitivity to eggs or egg products
- •52.Immunoglobulin received within 60 days before first vaccination
- •53.Autoimmune disease (eg, myositis)
- •54.Immunodeficiency
- •55.History of myocarditis, pericarditis, cardiomyopathy, congestive heart failure with permanent sequelae, clinically significant arrhythmia (including any arrhythmia requiring medication, treatment, or clinical follow-up)
- •56.ECG with clinically significant findings, or features that would interf
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