Evaluating the Safety and Immunogenicity of ALVAC-HIV and MF59®- or AS01B-adjuvanted Bivalent Subtype C gp120 in Healthy, HIV-uninfected Adult Participants

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: HIV Infections

In brief

A phase 1/2a clinical trial to evaluate the safety and immunogenicity of ALVAC-HIV (vCP2438) and of MF59®- or AS01B-adjuvanted clade C Env protein, in healthy, HIV-uninfected adult participants

Key facts

Study ID

NCT03122223

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

160

Starts

2018-01-16

Expected to finish

2020-07-30

Last updated by the study team

2023-03-14

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• General and Demographic Criteria:
• Age of 18 to 40 years
• Access to a participating HVTN clinical research site (CRS) and willingness to be followed for the planned duration of the study
• Ability and willingness to provide informed consent
• Assessment of understanding: volunteer demonstrates understanding of this study; provides answers to 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 clinic visit
• Good general health as shown by medical history, physical exam, and screening laboratory tests
• 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 the study protocol for more information about low risk guidelines).
• 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 13.0 g/dL for volunteers who were assigned male sex at birth. For transgender participants who have been on hormone therapy for more than 6 consecutive months, determine hemoglobin eligibility based on the gender with which they identify (ie, a transgender female who has been on hormone therapy for more than 6 consecutive months should be assessed for eligibility using the hemoglobin parameters for persons assigned female sex at birth).
• White blood cell count equal to 3,300 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 125,000 to 550,000/mm\^3
• Chemistry:
• Chemistry panel: ALT, AST, and ALP 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: US volunteers must have a negative FDA-approved enzyme immunoassay (EIA). Non-US sites may use locally available assays that have been approved by HVTN Laboratory Operations.
• Negative Hepatitis B surface antigen (HBsAg)
• Negative anti-Hepatitis C virus antibodies (anti-HCV), or negative HCV polymerase chain reaction (PCR) if the anti-HCV is positive
• Urine:

You may not qualify if…

• General:
• Blood products received within 120 days before first vaccination
• Investigational research agents received within 30 days before first vaccination
• Body mass index (BMI) greater than or equal to 40; or BMI greater than or equal to 35 with 2 or more of the following: systolic blood pressure greater than 140 mm Hg, diastolic blood pressure greater than 90 mm Hg, current smoker, known hyperlipidemia
• 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 120 study
• Pregnant or breastfeeding
• Active duty and reserve U.S. military personnel
• 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 120 PSRT will determine eligibility on a case-by-case basis.
• Previous receipt of monoclonal antibodies (mAbs), whether licensed or investigational; the HVTN 120 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 for vaccines that have subsequently undergone licensure. For volunteers who have received control/placebo in an experimental vaccine trial, the HVTN 120 PSRT will determine eligibility on a case-by-case basis. For volunteers who have received an experimental vaccine(s) more than 5 years ago, eligibility for enrollment will be determined by the HVTN 120 PSRT on a case-by-case basis.
• Live attenuated vaccines received within 30 days before first study vaccination or scheduled within 14 days after first study vaccination (eg, measles, mumps, and rubella [MMR]; oral polio vaccine [OPV]; varicella; yellow fever; live attenuated influenza vaccine)
• Any vaccines that are not live attenuated vaccines and were received within 14 days prior to first study vaccination (eg, tetanus, pneumococcal, Hepatitis A or B)
• Allergy treatment with antigen injections within 30 days before first study vaccination or that are scheduled within 14 days after first study vaccination
• Immune System:
• Immunosuppressive medications received within 168 days before first study 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 prednisone or equivalent at doses less than or equal to 60 mg/day and length of therapy less than 11 days with completion at least 30 days prior to enrollment.
• Serious adverse reactions to vaccines or to vaccine components such as eggs, egg products, or neomycin, 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.)
• Immunoglobulin received within 60 days before first study vaccination (for mAb see criterion above)
• Autoimmune disease
• Immunodeficiency
• Clinically Significant Medical Conditions:
• Clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health. A clinically significant condition or process includes but is not limited to:
• A process that would affect the immune response,
• A process that would require medication that affects the immune response,
• Any contraindication to repeated injections or blood draws,

Where it is running

• Bridge HIV CRS — San Francisco, California, United States
• The Hope Clinic of the Emory Vaccine Center CRS — Decatur, Georgia, United States
• Brigham and Women's Hospital Vaccine CRS (BWH VCRS) — Boston, Massachusetts, United States
• Fenway Health (FH) CRS — Boston, Massachusetts, United States
• University of Rochester Vaccines to Prevent HIV Infection CRS — Rochester, New York, United States
• Case Clinical Research Site — Cleveland, Ohio, United States
• Penn Prevention CRS — Philadelphia, Pennsylvania, United States
• Vanderbilt Vaccine (VV) CRS — Nashville, Tennessee, United States
• Seattle Vaccine and Prevention CRS — Seattle, Washington, United States
• National Institute for Medical Research (NIMR) - Mbeya Medical Research Center (MMRC) Network CRS — Mbeya, Tanzania
• Matero Reference Clinic CRS — Lusaka, Zambia
• Seke South CRS — Chitungwiza, Zimbabwe

Full record on ClinicalTrials.gov

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