Evaluating the Safety and Immune Response to Three HIV Vaccine Schedules in Healthy, HIV-Uninfected Adults

Completed · Phase 1 · Has a placebo group

Conditions studied: HIV Infections

In brief

NOTE: This study has stopped enrolling new participants, and all study vaccinations for currently enrolled participants have been stopped. Currently, there are no vaccines approved for the prevention of HIV infection, but there are many clinical trials taking place that are studying experimental HIV vaccines. The purpose of this study is to evaluate the safety and tolerability of three different HIV vaccine schedules in healthy, HIV-uninfected adults.

Key facts

Study ID

NCT01783977

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

143

Starts

2013-04-01

Expected to finish

2018-10-24

Last updated by the study team

2021-10-15

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Access to a participating HIV Vaccine Trials Network (HVTN) clinical research site (CRS) and willing to be followed for the planned duration of the study
• Ability and willingness to provide informed consent
• Assessment of understanding: participant demonstrates understanding of this study; completes a questionnaire prior to first vaccination, with verbal demonstration of understanding of all questionnaire items answered incorrectly
• Willingness to receive HIV test results
• Willingness to discuss HIV infection risks, amenable to HIV risk reduction counseling, and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit
• Willing to be contacted annually after completion of scheduled clinic visits for a total of 5 years following initial study injection
• Agrees not to enroll in another study of an investigational research agent before the last required protocol clinic visit
• Good general health as shown by medical history, physical exam, and screening laboratory tests
• Assessed by the clinic staff as being at "low risk" for HIV infection
• Hemoglobin greater than or equal to 11.0 g/dL for participants who were born female and greater than or equal to 13.0 g/dL for participants who were born male
• 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 panel: alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase less than 1.25 times the institutional upper limit of normal (IULN); creatinine less than 1.1 times the IULN
• Negative HIV-1 and -2 blood test: Participants in the United States must have a negative Food and Drug Administration (FDA)-approved enzyme immunoassay. Non-U.S. 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
• 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 cell levels within institutional normal range)
• Participants who were born female: negative serum or urine beta human chorionic gonadotropin pregnancy test performed prior to vaccination on the day of initial vaccination
• Reproductive status: Participants who were born female must agree to consistently use effective contraception for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment through the last required protocol clinic visit. More information on this criterion can be found in the protocol.
• Participants who were born female must also agree not to seek pregnancy through alternative methods, such as artificial insemination or in vitro fertilization until after the last required protocol clinic visit

You may not qualify if…

• Untreated or incompletely treated syphilis infection
• HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received control/placebo in an HIV vaccine trial, the HVTN 092 Protocol Safety Review Team (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 by the FDA. For volunteers who have received control/placebo in an experimental vaccine trial, the HVTN 092 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 092 PSRT on a case-by-case basis.
• Immunosuppressive medications received within 168 days before first vaccination. (Not excluded: [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 less than 2 mg/kg/day and length of therapy less than 11 days with completion at least 30 days prior to enrollment.)
• Blood products received within 120 days before first vaccination
• Immunoglobulin received within 60 days before first vaccination
• Live attenuated vaccines other than influenza vaccine received within 30 days before first vaccination or scheduled within 14 days after injection (e.g., measles, mumps, and rubella [MMR]; oral polio vaccine [OPV]; varicella; yellow fever)
• Investigational research agents received within 30 days before first vaccination
• Intent to participate in another study of an investigational research agent before the last required protocol clinic visit
• Influenza vaccine or any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination (e.g., tetanus, pneumococcal, hepatitis A or B)
• Allergy treatment with antigen injections within 30 days before first vaccination or that are scheduled within 14 days after first vaccination
• Current anti-tuberculosis prophylaxis or therapy
• Clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health. More information on this criterion can be found in the protocol.
• Any medical, psychiatric, occupational, or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety or reactogenicity, or a participant's ability to give informed consent
• Serious adverse reactions to vaccines, including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain. (Not excluded: participants who had a nonanaphylactic adverse reaction to pertussis vaccine as a child.)
• Hypersensitivity to eggs or egg products
• History of myocarditis, pericarditis, cardiomyopathy, congestive heart failure with permanent sequelae, clinically significant arrhythmia (including any arrhythmia requiring medication, treatment, or clinical follow-up)
• Participants who have two or more of the following cardiac risk factors: (1) participant report of history of elevated blood cholesterol defined as fasting low-density lipoprotein (LDL) greater than 160 mg/dL; (2) first degree relative (e.g., mother, father, brother, or sister) who had coronary artery disease before the age of 50 years); (3) current smoker; or (4) body mass index (BMI) greater than or equal to 35
• Electrocardiogram (ECG) with clinically significant findings, or features that would interfere with the assessment of myo/pericarditis, as determined by the contract ECG lab, cardiologist, or study clinician. More information on this criterion can be found in the protocol.
• Autoimmune disease. (Not excluded: mild, well-controlled psoriasis.)
• Immunodeficiency
• Asthma other than mild, well-controlled asthma. More information on this criterion can be found in the protocol.
• Diabetes mellitus type 1 or type 2, including cases controlled with diet alone. (Not excluded: history of isolated gestational diabetes.)
• Thyroidectomy, or thyroid disease requiring medication during the last 12 months
• History of hereditary angioedema, acquired angioedema, or idiopathic angioedema

Where it is running

• Alabama CRS — Birmingham, Alabama, United States
• Bridge HIV CRS — San Francisco, California, United States
• The Hope Clinic of the Emory Vaccine Center CRS — Decatur, Georgia, United States
• UIC Project WISH CRS — Chicago, Illinois, United States
• Brigham and Women's Hospital Vaccine CRS (BWH VCRS) — Boston, Massachusetts, United States
• Penn Prevention Crs — Philadelphia, Pennsylvania, United States
• Seattle Vaccine and Prevention CRS — Seattle, Washington, United States
• Lausanne Vaccine and Immunotherapy Center CRS — Lausanne, Canton of Vaud, Switzerland

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.