Evaluating HIV-1 Neutralization Antibody Breadth in Response to HIV gp120 Protein Vaccine in HIV-uninfected Adults With Quiescent Systemic Lupus Erythematosus

Completed · Phase 1

Conditions studied: HIV Infections, Systemic Lupus Erythematosus

In brief

The purpose of this study is to evaluate the breadth and potency of HIV-1 neutralizing antibody (nAb) responses and examine the safety and tolerability of an HIV gp120 protein vaccine (AIDSVAX® B/E) in HIV-uninfected adults diagnosed with Systemic Lupus Erythematosus (SLE) who have stable disease.

Key facts

Study ID

NCT03618056

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

1

Starts

2018-12-19

Expected to finish

2020-07-17

Last updated by the study team

2022-02-07

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• General and Demographic Criteria
• Age of 18 to 50 years
• Weight greater than 110 pounds
• Meets American College of Rheumatology (ACR) criteria for the classification of SLE with serologic evidence of disease including a positive test for antinuclear antibodies at a titer of 1:640 or greater, or the presence of a positive test for antibodies to double-strand DNA (dsDNA), or the presence of anti-Sm, anti-RNP, or anti-Ro antibodies, as documented by medical records and as assessed by a rheumatologist or designee.
• Currently taking hydroxychloroquine for SLE and for at least 6 months prior to enrollment
• Access to a participating HIV Vaccine Trials Network (HVTN) clinical research site (CRS) and willingness to be followed for the planned duration of the study
• Ability and willingness to provide informed consent
• Allows ongoing access to medical records pertaining to their rheumatologic disease
• 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
• Agrees not to enroll in another study of an investigational research agent before the last required protocol clinic visit
• HIV-Related Criteria:
• Willingness to receive HIV test results
• Willingness to discuss HIV infection risks and amenable to HIV risk reduction counseling.
• 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 (see protocol for more information)
• Laboratory Inclusion Values
• Hemogram/Complete blood count (CBC)
• Hemoglobin greater than or equal to 11.0 g/dL for volunteers who were assigned female sex at birth, greater than or equal to 12.0 g/dL for volunteers who were assigned male sex at birth.
• White blood cell count equal to 2,500 to 12,000 cells/mm\^3
• Total lymphocyte count greater than or equal to 800 cells/mm\^3
• Remaining differential either within institutional normal range or with site physician approval
• Platelets equal to 100,000 to 550,000/mm\^3
• Chemistry
• Chemistry panel: alanine amino transferase (ALT) and aspartate aminotransferase (AST) less than 1.25 times the institutional upper limit of normal; creatinine less than or equal to institutional upper limit of normal.
• Virology
• Negative HIV-1 and -2 blood test: volunteers must have a negative US Food and Drug Administration (FDA)-approved enzyme immunoassay (EIA) within 56 days prior to enrollment.

You may not qualify if…

• General
• Blood products received within 120 days before first vaccination
• Investigational research agents not used to treat SLE received within 30 days before first vaccination (additional exclusions may apply, see criteria below)
• Intent to participate in another study of an investigational research agent or any other study that requires non-HVTN HIV antibody testing during the planned duration of the HVTN 121 study
• Pregnant or breastfeeding
• Active duty and reserve US military personnel
• SLE status. The following criteria must be verified by a rheumatologist or designee
• Currently with active lupus as defined by a Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) greater than 4 (see protocol for more information).
• Documented SLEDAI score of greater than 20 in medical record at any time indicating severe activity, or evidence of moderate disease activity (SELENA-SLEDAI greater than 6) within the last six months, (see protocol for more information).
• Has had a condition listed on the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SLICC/ACR DI) or has had an increase in the SLICC/ACR D1 score within the last 12 months other than cataracts, premature ovarian failure or diabetes mellitus with approval of the PSRT http://www.clinexprheumatol.org/article.asp?a=2697
• A history of central nervous system (CNS) disease
• Thrombotic event within the past 12 months in association with confirmed antiphospholipid antibody
• A history of renal disease (SLE-related renal injury) confirmed by prior biopsy, active urine sediment, or proteinuria
• Prednisone dose greater than 10 mg/day for more than 6 months within the past year
• Administration of anti-B-cell therapy (rituximab or belimumab) or any investigational research agents used to treat SLE within the preceding 2 years
• Administration of cyclophosphamide within the preceding year; or administration of mycophenolate mofetil within the last 6 months; or administration of methotrexate, leflunomide, or azathioprine within the last 3 months
• Administration of any investigational immunosuppressant medication within the last year
• Administration of other immunosuppressive medications not listed above, with the exception of topical steroids, topical immunosuppressives (eg, cyclosporine, FK506), or ophthalmic immunosuppressives (eg, steroids, cyclosporine), within 6 months before first vaccination, unless approved by the HVTN 121 PSRT
• Vaccines and other Injections
• HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received control/placebo in an HIV vaccine trial, the HVTN 121 PSRT will determine eligibility on a case-by-case basis.
• Non-HIV experimental vaccine(s) received within the last 5 years in a prior vaccine trial. Exceptions may be made by the HVTN 121 PSRT for vaccines that have subsequently undergone licensure by the FDA. For volunteers who have received control/placebo in an experimental vaccine trial, the HVTN 121 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 121 PSRT on a case-by-case basis.
• Vaccines received within 30 days before first study vaccination or scheduled within 30 days after injection (eg, influenza, tetanus, pneumococcal, Hepatitis A or B, measles, mumps, and rubella [MMR]; oral polio vaccine [OPV]; varicella; yellow fever)
• Allergy treatment with antigen injections within 30 days before first vaccination or that are scheduled within 14 days after first vaccination
• Immune System
• Serious adverse reactions to vaccines or to vaccine components (such as yeast protein, amorphous aluminum hydroxyphosphate sulfate, L-histidine, polysorbate 80, sodium borate), 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.)

Where it is running

• Duke Human Vaccine Institute CRS — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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