PER-061-20尚未招募未知
B-ENHANCEMENT OF HBV VACCINATION IN PERSONS LIVING WITH HIV (BEe-HIVe): Evaluation of HEPLISAV-B
El Instituto Nacional de Alergia y Enfermedades Infecciosas (NIAID) de los Estados Unidos,0 个研究点目标入组 0 人开始时间: 2020年12月23日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
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
入选标准
- •Group A and B:
- •HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load.
- •On current HIV-1 antiretroviral therapy (ART) for >56 days prior to study entry.
- •CD4+ T-cell count >100 cells/mm3 obtained within 180 days prior to study entry.
- •HIV-1 RNA <1000 copies/mL obtained within 180 days prior to study entry.
- •The following laboratory values obtained within 45 days prior to study entry by laboratory that operates in accordance with GCLP and participates in appropriate external quality assurance programs.
- •Hemoglobin >9 g/dL for men and >8 g/dL for women.
- •International normalized ratio (INR) ≤1.5 x ULN,
- •Albumin ≥3 g/dL.
- •Aspartate aminotransferase (AST) (SGOT) >2.5 × ULN.
- •Alanine aminotransferase (ALT) (SGPT) >2.5 × ULN.
- •Hemoglobin A1c <9.0%.
- •For individuals of reproductive potential who can become pregnant, a negative serum or urine pregnancy test (urine test must have a sensitivity of <25 mIU/mL) within 2 days prior to study entry.
- •If participating in sexual activity that could lead to pregnancy, individuals of reproductive potential who can become pregnant must agree to use contraception throughout the study. At least one of the following must be used throughout the study:
- •Condom (male or female) with or without spermicide
- •Diaphragm or cervical cap with spermicide.
- •Intrauterine device (IUD)
- •Hormone-based contraceptive.
- •Adequate venous access for the purpose of phlebotomy. Age >18 and <70 years.
- •Ability and willingness of participant or, if the participant lacks decision-making capacity, their legal guardian/representative to provide informed consent.
- •Willingness to be contacted by telephone, text message, or e-mail by study staff throughout the study.
- •Inclusion Criteria, Group A only:
- •Serum Hepatitis B antibody <10 mlU/mL, non-reactive (negative), or indeterminate as determined by certified laboratory within 45 days prior to study entry.
- •Documentation of HBV vaccination >168 days prior to study entry. Inclusion Criterion,
- •Group B only:
- •Serum Hepatitis B antibody non-reactive (negative) as determined by a certified laboratory within 45 days prior to study entry.
排除标准
- •Group A and B:
- •Infection or prior exposure to HBV defined as HBsAg positive or HBV core antibody (HBcAb) positive any time prior to or at screening.
- •Serum HBsAb level >10 mlU/mL or positive at screening or any other time prior to screening.
- •Presence of any active or acute AIDS-defining opportunistic infections within 45 days prior to study entry.
- •History of solid organ transplantation.
- •Current or prior history of clinical hepatic decompensation (e.g., ascites, encephalopathy, or variceal hemorrhage).
- •Diagnosis of chronic kidney disease (CKD) stage G4 (eGFR of 15-29 mL/min/1.73m2) or CKD stage G5 also referred to as End-Stage Renal Disease (eGFR of <15 mL/min/1.73m2).
- •Cancer diagnosis within 5 years prior to study entry, other than squamous or basal cell carcinoma of the skin.
- •Currently receiving chemotherapy.
- •Chronic use and/or receipt of the following within 45 days prior to study entry: systemically administered immunosuppressive agents (e.g., prednisone equivalent >10 mg/day, systemic corticosteroids [more than 3 consecutive days]) or other immunomodulators, with the exception of inhaled steroids.
- •Currently breastfeeding. Individuals who plan to become pregnant during the study.
- •Plan to discontinue ART during the study.
- •Known allergy/sensitivity or any hypersensitivity to any HBV vaccine or yeast.
- •Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- •Active, serious infection (other than HIV-1 or hepatitis C virus [HCV]) requiring parenteral antibiotics, antivirals, or antifungals within 45 days prior to study entry.
- •Receipt of any inactivated virus vaccine within 14 days prior to study entry.
- •Receipt of any of the following within 45 days prior to study entry:
- •Live virus vaccine
- •Granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony- stimulating factor (GM-CSF)
- •Any other investigational medicinal agent.
- •Receipt of immunoglobulin or blood products within 90 days prior to study entry.
- •Receipt of an injection of DNA plasmids or oligonucleotides within 60 days prior to study entry.
- •Exclusion Criteria, Group A only:
- •Hepatitis B virus vaccination < 168 days prior to study entry.
- •Exclusion Criteria, Group B only:
- •Known HBV vaccination prior to study entry.
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