Safety of and Immune Response to a Prime-Boost Vaccine Regimen in HIV-Uninfected Vaccine-Naive Adults

Not Applicable

• Conditions: -B24 Unspecified human immunodeficiency virus [HIV] disease; Unspecified human immunodeficiency virus [HIV] disease; B24

• Registration Number: PER-001-09
• Lead Sponsor: INSTITUTO NACIONAL DE ALERGIAS Y ENFERMEDADES INFECCIOSAS DE LOS ESTADOS UNIDOS,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-05-15
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Age of 18-50 years
• Access to a participating HVTN CRS and willingness to receive follow-up for the planned duration of the study
• Ability and willingness to provide informed consent
• Assessment of understanding: complete a questionnaire before receiving the first vaccination; Show that you understand all the items in the questionnaire that you answered incorrectly.
• Good willingness to receive HIV test results
• Good health, documented by medical history, physical examination and laboratory tests for selection
• Hemoglobin> 11.0 g / dl for volunteers who were born with female sex and> 13.0 g / dl for volunteers who were born with male sex
• Ieucocyte count = 3000 to 12000 cells / mm ^ 3
• Total number of lymphocytes> 800 cells / mm ^ 3
• Rest of the leukocytic formula: within the normal institutional limits or accompanied by the approval of the center doctor
• Thrombocytes = from 125,000 to 550,000 / mm3
• Biochemical analysis: ALT <1.25 times the upper limit of normal institutional values; creatinine level less than or equal to the upper limit of normal institutional values.
• Cardiac troponin 1 or T (cTn1 or cTnT): does not exceed the upper limit of normal institutional values
• Negative blood test result of HIV-1 and VlH-2: US participants they must have obtained a negative result in an enzyme immunoassay (EIA) approved by the US Food and Drug Administration (FDA). Centers located outside the US They will perform the analyzes available and approved at the local level.
• Negative result in hepatitis B surface antigen analysis (MBsAg)
• Negative result in the analysis of antibodies against hepatitis C virus (against HCV). or in the polymerase chain reaction (PCR) for HCV if the result of the previous analysis is positive
• Normal urine: negative for glycosuria, and negative or traces of proteinuria, and negative or traces of hemoglobin in urine (if there are traces of hemoglobin in the test strip, a microscopic analysis of urine with a result that is within the normal range institutional).
• Volunteers born with female sex: negative result in a pregnancy test for human chorionic gonadotropin beta ((3-HCG) in serum or urine performed before vaccination on the same day of the first vaccination
• Volunteers born with female sex should agree not to seek to get pregnant by alternative methods, such as artificial insemination or in vitro fertilization until after the last scheduled visit of the protocol.

Exclusion Criteria

• HIV vaccine(s) or other experimental vaccines, received in a prior HIV vaccine trial. More information on this criterion can be found in the study protocol.
• Receipt of smallpox vaccination
• Excessive alcohol use, frequent binge drinking, chronic marijuana abuse, or use of any other illicit drugs, such as cocaine or methamphetamine, within the past 12 months
• History of newly acquired or newly diagnosed syphilis; history of newly acquired gonorrhea, nongonococcal urethritis, herpes simplex virus type 2 (HSV2), chlamydia, pelvic inflammatory disease (PID), trichomonas, mucopurulent cervicitis,epididymitis, proctitis, lymphogranuloma venereum, chancroid, or hepatitis B within the past 12 months
• Immunosuppressive medication received within 168 days before first vaccination. Certain medications are excluded from this criterion; more information can be found in the study protocol.
• 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
• Influenza vaccine or any vaccines that are not live attenuated and were received within 14 days prior to first vaccination or that are scheduled within 14 days after injection
• Allergy treatment with antigen injections within 30 days before first vaccination or scheduled within 14 days after injection
• Intent to participate in another study of an investigational research agent during the planned duration of this study
• Current anti-tuberculosis (TB) prophylaxis or therapy
• Clinically significant medical condition. More information on this criterion can be found in the study protocol.
• Any medical, psychiatric, or social condition or occupational or other responsibility that in the opinion of the investigator might interfere with the study protocol
• Serious adverse reactions to vaccines. More information on this criterion can be found in the study protocol.
• Allergy to eggs and/or egg products
• History of or known active cardiac disease. More information on this criterion can be found in the study protocol.
• 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, sister, or brother) who had coronary artery disease before the age of 50 years; (3) current smoker; or (4) body mass index greater than or equal to 35.
• Electrocardiogram (ECG) with clinically significant findings. More information on this criterion can be found in the study protocol.
• Autoimmune disease
• Immunodeficiency
• Asthma other than mild, well-controlled asthma. More information on this criterion can be found in the study protocol.
• Diabetes mellitus, type 1 or type 2, including cases controlled with diet alone. Those with a history of isolated gestational diabetes are not excluded.
• Thyroidectomy or thyroid disease requiring medication during the last 12 months
• Angioedema within the last 3 years if episodes are considered serious or have required medication within the last 2 years
• Hypertension. More information on this criterion can be found in the study protocol.
• Body mass index greate

Study & Design

• Study Type: Interventional
• Study Design: Not specified