BEe-HIVe
- Conditions
- -Z21 Asymptomatic human immunodeficiency virus [HIV] infection statusAsymptomatic human immunodeficiency virus [HIV] infection statusZ21
- Registration Number
- PER-061-20
- Lead Sponsor
- El Instituto Nacional de Alergia y Enfermedades Infecciosas (NIAID) de los Estados Unidos,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:for both groups:<br>HBsAb measure,<br>Adverse event reports<br>Measure:Group A: Seroprotection response defined as HBsAb > 10 mIU/mL at 8 weeks after the two-dose series (week 12) in Arm 1 and at 4 weeks after the three-dose series (week 28) in Arms 2 and 3. Reported AEs from study vaccination initiation to study discontinuation.<br><br>Group B: Seroprotective response defined as HBsAB > 10mIU/mL 4 weeks after the vaccination series (Week 28) Reported AEs from study vaccination initiation to study discontinuation.<br><br>Timepoints:Group A: in arm 1 at week 12, in arms 2 and 3 at week 28. AE will be collected and reported during 72 weeks.<br><br>Group B: 4 weeks after vaccination series HBsAb measure. 72 weeks to collect Adverse Event reports.<br>
- Secondary Outcome Measures
Name Time Method