A Randomized, Double Blind Phase 1b Trial to Examine the Influence of Antigenic Competition on the Immunogenicity of HIV-1 Gag/Pol: A Comparison of rAd5 Gag/Pol Env A/B/C to rAd5 Gag/Pol
- Conditions
- -B20 Human immunodeficiency virus [HIV] disease resulting in infectious and parasitic diseases-B24 Unspecified human immunodeficiency virus [HIV] diseaseHuman immunodeficiency virus [HIV] disease resulting in infectious and parasitic diseasesUnspecified human immunodeficiency virus [HIV] diseaseB20B24
- Registration Number
- PER-031-10
- Lead Sponsor
- Division de SIDA de los Institutos Nacionales de Salud (USA),
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 7
• 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
• Completes a questionnaire prior to vaccination that demonstrates an understanding of this study and that in a previous trial there was an association of increased HIV acquisition with receipt of that study vaccine
• 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
• Willingness to continue annual follow-up contact after the last required protocol clinic visit, for a total of 5 years following enrollment
• 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 on the basis of sexual behaviors within the 12 months prior to enrollment
• Adenovirus 5 (Ad5) neutralizing antibody (nAb) titer less than 1:18
• Hemoglobin greater than or equal to 11.0 g/dL for volunteers who were born female, or greater than or equal to 13.0 g/dL for volunteers who were born male
• White blood cell (WBC) count between 3,300 and 12,000 cells/mm3
• Total lymphocyte count greater than or equal to 800 cells/mm3
• Remaining differential either within institutional normal range or with site physician approval
• Platelet count between 125,000 and 550,000/mm3
• Alanine aminotransferase (ALT) less than or equal to 1.25 times institutional upper limits of normal
• Negative HIV-1 and HIV-2 blood test: U.S. participants must have negative FDA-approved enzyme immunoassay (EIA). Non-U.S. sites may use locally available assays that have been approved by HVTN laboratory operations.
• Negative for Hepatitis B surface antigen (HBsAg)
• Negative for anti-Hepatitis C virus antibodies (anti-HCV), or negative HCV polymerase chain reaction (PCR) test if the anti-HCV is positive
• Negative pregnancy test for female participants prior to vaccination on the day of vaccination
• Agreement to avoid pregnancy for female participants, either through abstinence or appropriate use of contraceptives
• If born male, must be fully circumcised (as documented at screening examination)
• Within the 12 months prior to enrollment: excessive daily alcohol use, frequent binge drinking, chronic marijuana abuse, or any other use of illicit drugs
• Within the 12 months prior to enrollment: a history of newly acquired syphilis, gonorrhea, non-gonococcal urethritis, herpes simplex virus type 2 (HSV2), Chlamydia, pelvic inflammatory disease (PID), trichomonas, mucopurulent cervicitis, epididymitis, proctitis, lymphogranuloma venereum, chancroid, or hepatitis B virus
• Received non-HIV experimental vaccine(s) 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 the control or placebo in an experimental vaccine trial, the HVTN 084 PSRT will determine eligibility on a case-by-case basis.
• For potential participants who received the control or placebo in an HIV vaccine trial, documentation of the identity of the study control or placebo must be provided to the HVTN 084 protocol safety review team (PSRT), who will determine eligibility on a case-by-case basis.
• Serious adverse reactions to vaccines including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, or abdominal pain. A participant who had a nonanaphylactic adverse reaction to pertussis vaccine as a child will not be excluded.
• Immunosuppressive medications received within 168 days before first vaccination, except (1) corticosteroid nasal spray for allergic rhinitis, (2) topical corticosteroids for mild, uncomplicated dermatitis, or (3) oral or 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 vaccination or scheduled within 14 days after injection (e.g., measles, mumps, and rubella [MMR]; oral polio vaccine [OPV]; varicella; yellow fever)
• Influenza vaccines or any vaccines that are not live attenuated vaccines (e.g., tetanus, pneumococcal, hepatitis A or B), or allergy treatment with antigen injections that were received within 14 days prior to the vaccination
• 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 study
• Current anti-tuberculosis (TB) prophylaxis or therapy
• Clinically significant medical condition, physical examination findings, abnormal laboratory results, or past medical history with implications for current health.
• 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
• Angioedema (hereditary, acquired, or idiopathic) or idiopathic urticaria within the last 3 years if episodes are considered serious or have required medication within the last 2 years
• Autoimmune disease
• Immunodeficiency
• Untreated or incompletely treated syphilis infection
• Asthma other than mild, well-controlled asthma
• Diabetes mellitus t
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:measured by Enzyme-Linked Immunospot (ELISpot)<br>Measure:Magnitude of Gag and/or Pol-specific T-cell responses, as<br>Timepoints:Measured 4 weeks after immunization<br>;<br>Outcome name:measured by ELISpot<br>Measure:Number of Gag and/or Pol epitopes targeted by CD4+ and CD8+ T-cells, as<br>Timepoints:During the study<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:assessed by ELISpot<br>Measure:Number of individuals mounting T-cell responses to Gag and/or Pol<br>Timepoints:Measured 4 weeks after immunization<br>;<br>Outcome name:By physical examination performed during the study.<br>Measure:Local and systemic reactogenicity signs and symptoms, laboratory measures of safety, adverse events (AEs), and AEs reported on an expedited basis to Division of AIDS (DAIDS)<br>Timepoints:Measured over 6 months after immunization<br>;<br>Outcome name:measured by intracellular cytokine staining (ICS)<br>Measure:Magnitude of Gag and/or Pol-specific CD4+ and CD8+ T-cell responses<br>Timepoints:Measured 4 weeks after immunization<br>