Evaluating the Safety and Immune Response of a Prime-Boost HIV Vaccine Regimen in Healthy, HIV-Uninfected, Vaccinia-Naive Adults

Completed · Phase 1 · Has a placebo group

Conditions studied: HIV Infections

In brief

This study will test the safety and immune responses of a prime-boost regimen of two HIV vaccines- a DNA vaccine followed by a modified vaccinia Ankara (MVA) vaccine- in healthy, HIV-uninfected, vaccinia-naive adults.

Key facts

Study ID

NCT01571960

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

48

Starts

2012-04-01

Expected to finish

2016-01-01

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 willingness 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 and 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 3 years following initial study injection
• Agrees not to enroll in another study of an investigational research agent prior to completion of last required protocol clinic visit (excludes annual contacts for safety surveillance)
• Good general health as shown by medical history, physical exam, and screening laboratory tests
• Assessed by the clinic staff as being at low risk of HIV infection
• Hemoglobin greater than or equal to 11.0 g/dL for participants who were born female, or greater than or equal to 13.0 g/dL for participants who were born male
• White blood cell (WBC) count of 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
• Platelet level of 125,000 to 550,000/mm\^3
• Chemistry panel: ALT, AST, alkaline phosphatase, and creatinine values less than or equal to institutional upper limits of normal
• Negative HIV-1 and HIV-2 blood test: U.S. participants must have a negative Food and Drug Administration (FDA)-approved immunoassay
• Negative hepatitis B surface antigen (HBsAg)
• Negative anti-hepatitis C virus (HCV) antibodies or negative HCV polymerase chain reaction (PCR) if the anti-HCV is positive
• Normal urine: negative urine glucose, negative or trace urine protein, and negative or trace urine hemoglobin (if trace hemoglobin is present on dipstick, a microscopic urinalysis for red blood cells [RBCs] within institutional normal range)
• Participants who were born female: negative serum or urine beta human chorionic gonadotropin (HCG) pregnancy test performed prior to vaccination on the day of initial vaccination
• Reproductive status: A participant who was born female must either: (1) 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. Effective contraception is defined as using any of the following methods: condoms (male or female) with or without a spermicide, diaphragm or cervical cap with spermicide, intrauterine device (IUD), hormonal contraception, or successful vasectomy in the male partner (considered successful if a participant reports that a male partner has either documentation of azoospermia by microscopy or a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity postvasectomy); or (2) Not be of reproductive potential, such as having reached menopause (no menses for 1 year) or having undergone hysterectomy, bilateral oophorectomy, or tubal ligation; or (3) Be sexually abstinent.
• 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…

• Vaccinia (smallpox) vaccine determined by (1) clinical evidence of vaccinia scarification; (2) self-reported history of vaccinia vaccination; (3) date of birth; or (4) U.S. military service prior to 1989 or after December 2002 (not excluded: a participant born before 1975, or with past U.S. military service, who self-reports he/she did not receive vaccinia vaccine and has no evidence of scarification)
• Untreated or incompletely treated syphilis infection
• HIV vaccine(s) received in a prior HIV vaccine trial. For potential participants who have received control/placebo in an HIV vaccine trial, the HVTN 094 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 potential participants who have received control/placebo in an experimental vaccine trial, the HVTN 094 PSRT will determine eligibility on a case-by-case basis. For potential participants who have received an experimental vaccine(s) greater than 5 years ago, eligibility for enrollment will be determined by the HVTN 094 PSRT on a case-by-case basis.
• Immunosuppressive medications received within 168 days before first vaccination. Not excluded: (1) corticosteroid nasal spray for allergic rhinitis; (2) topical corticosteroids for mild, uncomplicated dermatitis; or (3) oral/parenteral corticosteroids given for non-chronic conditions not expected to recur (length of therapy 10 days or less 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 during the planned duration of the HVTN 094 study
• 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 (TB) 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. 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
• A condition that requires active medical intervention or monitoring to avert grave danger to the participant's health or well-being during the study period
• A condition or process for which signs or symptoms could be confused with reactions to vaccine; or
• Any condition specifically listed among the exclusion criteria below
• 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: a participant 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)
• ECG with clinically significant findings or features that would interfere with the assessment of myocarditis/pericarditis as determined by a contract ECG lab or cardiologist, including any of the following:

Where it is running

• Alabama CRS — Birmingham, Alabama, United States
• Bridge HIV CRS — San Francisco, California, United States
• Brigham and Women's Hospital Vaccine CRS (BWH VCRS) — Boston, Massachusetts, United States
• University of Rochester Vaccines to Prevent HIV Infection CRS — Rochester, New York, United States

Full record on ClinicalTrials.gov

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