Safety of and Immune Response to the PENNVAX-B DNA Vaccine With and Without IL-12 in HIV-uninfected Adults

NCT00991354 | Completed Phase 1 DMC

• 2 other identifiers: HVTN 08010741
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 3

Brief Summary

An effective vaccine may be the only way to stop the HIV pandemic. The purpose of this study is to determine the safety of and immune response to the DNA vaccine, PENNVAX-B with or without an IL-12 adjuvant when given using electroporation.

Conditions

HIV Infections

Keywords

HIV Seronegativity; HIV Preventive Vaccine

Outcome Measures

Primary Outcomes (6)

• Frequency and severity of local injection/EP site reactogenicity signs and symptoms

  Throughout study

• Magnitude of local injection/EP site pain as measured by a VAS

  Throughout study

• Frequency of AEs categorized by MedDRA body system, MedDRA preferred term, severity and assessed relationship to study products; detailed description of all AEs meeting DAIDS criteria for expedited reporting

  Throughout study

• WBC, neutrophils, lymphocytes, hemoglobin, alkaline phosphatase, platelets, ALT, AST, creatinine, and creatine phosphokinase (CPK)

  At baseline and post-vaccinations

• Number of participants with early discontinuation of vaccinations and reason for discontinuation

  Throughout study

• Distribution of responses to questions regarding acceptability of study injections via EP

  Throughout study

Secondary Outcomes (5)

• Frequency of T-cell responses as measured by IFN-γ ELISpot

  Two Weeks after the second and third vaccinations

• Frequency of CD4+ T cell responses measured by intracellular cytokine staining (ICS) for IFN-γ and/or IL-2 to HIV potential T-cell epitope (PTE) peptide pools representing Gag, Pol, and Env

  After the second and third vaccinations

• Frequency of CD8+ T cell responses measured by ICS for IFN-γ and/or IL-2 to HIV PTE peptide pools representing Gag, Pol, and Env

  After the second and third vaccinations

• Frequency of humoral responses detected by HIV-1-specific neutralizing and binding antibody assays from serum samples

  Two weeks after last vaccination

• Frequency of vaccine-induced positive results with end-of-study HIV serological testing by commercial assays

  Throughout study

Study Arms (3)

Group 1

EXPERIMENTAL

Participants will receive 3 mg of PENNVAX-B vaccine or placebo at Months 0, 1, and 3.

Biological: PENNVAX-B

Group 2

EXPERIMENTAL

Participants will receive 3 mg of PENNVAX-B vaccine and 1 mg of IL-12 vaccine or placebo at Months 0, 1, and 3.

Biological: PENNVAX-B; Biological: IL-12 DNA plasmids

Group 3

EXPERIMENTAL

Participants will receive 3 mg of PENNVAX-B vaccine and 1 mg of IL-12 vaccine or placebo at Months 0, 1, and 3.

Biological: PENNVAX-B; Biological: IL-12 DNA plasmids

Interventions

PENNVAX-B BIOLOGICAL

DNA vaccine encoding the Gag, Pol, and Env proteins of HIV

Group 1; Group 2; Group 3

IL-12 DNA plasmids BIOLOGICAL

Adjuvant for HIV vaccines

Group 2; Group 3

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Access to a participating HVTN 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 and the Step Study results; completes a questionnaire prior to first vaccination, with verbal demonstration of understanding of all questionnaire items answered incorrectly
• Willing to receive HIV test results
• Willingness to discuss HIV infection risks, amenable to risk reduction counseling, committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit
• Assessed by the clinic staff as being at "low risk" for HIV infection on the basis of behaviors within the 12 months prior to enrollment
• Good general health as shown by medical history, physical exam, and screening laboratory tests
• Certain laboratory values. Details on this criterion can be found in the protocol.
• Negative HIV-1 and -2 blood test: US participants must have a negative FDA-approved enzyme immunoassay (EIA).
• 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
• Volunteers who were born female: negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test performed prior to vaccination on the day of initial vaccination
• Reproductive status: A volunteer who was born female must agree to consistently use effective contraception from at least 21 days prior to enrollment through the last required protocol clinic visit for sexual activity that could lead to pregnancy, or not be of reproductive potential, or be sexually abstinent
• Volunteers 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:

• Within the 12 months prior to enrollment: excessive daily alcohol use or frequent binge drinking or chronic marijuana abuse or any other illicit drug use
• Within the 12 months prior to enrollment: a history of newly acquired or diagnosed syphilis; newly acquired gonorrhea, non-gonococcal urethritis, herpes simplex virus type 2 (HSV2), chlamydia, pelvic inflammatory disease (PID), trichomonas, mucopurulent cervicitis, epididymitis, proctitis, lymphogranuloma venereum, or chancroid
• 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, documentation of the identity of the study control/placebo must be provided to the HVTN 080 PSRT, who 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 or for those who have received control/placebo in an experimental vaccine trial.
• 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
• 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 080 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, HPV)
• 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
• Allergy to amide-type local anesthetics

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (3)

Univ. of Rochester HVTN CRS

Rochester, New York, 14642-0001, United States

Location

3535 Market Street CRS

Philadelphia, Pennsylvania, 19104, United States

Location

Vanderbilt Vaccine CRS

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• Jin X, Morgan C, Yu X, DeRosa S, Tomaras GD, Montefiori DC, Kublin J, Corey L, Keefer MC; NIAID HIV Vaccine Trials Network. Multiple factors affect immunogenicity of DNA plasmid HIV vaccines in human clinical trials. Vaccine. 2015 May 11;33(20):2347-53. doi: 10.1016/j.vaccine.2015.03.036. Epub 2015 Mar 25.

  PMID: 25820067 DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2009
• First Posted: October 8, 2009
• Study Start: November 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: March 1, 2011
• Last Updated: October 14, 2021

Record last verified: 2021-10

Locations

US (3)