HIV VACCINE BOOSTING STUDY FOR FORMER PARTICIPANTS OF HVTN 205 STUDY
- Conditions
- -Z206 Contact with and exposure to human immunodeficiency virus [HIV]Contact with and exposure to human immunodeficiency virus [HIV]Z206
- Registration Number
- PER-046-16
- Lead Sponsor
- Instituto Nacional de Alergias y Enfermedades Infecciosas (NIAID). EEUU,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
26.Age of 18 to 55 years
27.Prior participation in HVTN 205 with assignment to treatment (not placebo) arm:
a.Assigned to HVTN 205 Group 1 or Group 3, and received all 4 scheduled vaccinations (2 injections of pGA2/JS7 DNA (months 0, 2) and 2 injections of MVA/HIV62 (months 4, 6); OR
b.Assigned to HVTN 205 Group 4, and received at least vaccinations 1, 2 and 4 (3 injections of MVA/HIV62 at months 0, 2 and 6).
28.Access to a participating HVTN CRS and willingness to be followed for the planned duration of the study
29.Ability and willingness to provide informed consent
30.Assessment of understanding: volunteer demonstrates understanding of this study; completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly
31.Willing to be contacted 2 years following initial study injection.
32.Agrees not to enroll in another study of an investigational research agent
33.Good general health as shown by medical history, physical exam, and screening laboratory tests
HIV-Related Criteria:
34.Willingness to receive HIV test results
35.Willingness to discuss HIV infection risks and amenable to HIV risk reduction counseling.
36.Assessed by the clinic staff as being at low risk” for HIV infection and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit.
Laboratory Inclusion Values
Hemogram/CBC
37.Hemoglobin ≥ 11.0 g/dL for volunteers who were born female, ≥ 13.0 g/dL for volunteers who were born male
38.White blood cell count = 3,300 to 12,000 cells/mm3
39.Total lymphocyte count ≥ 800 cells/mm3
40.Remaining differential either within institutional normal range or with site physician approval
41.Platelets = 125,000 to 550,000/mm3
Chemistry
42.Chemistry panel: ALT, AST, and alkaline phosphatase < 1.25 times the institutional upper limit of normal; creatinine ≤ institutional upper limit of normal.
43.Cardiac Troponin T or I (cTnT or cTnI) does not exceed the institutional upper limit of normal
Virology
44.Negative HIV-1 and -2 blood test: Participants must have a negative test result for HIV infection following the HVTN Lab Program’s in-study HIV testing algorithm, prior to initial enrollment.
45.Negative Hepatitis B surface antigen (HBsAg)
46.Negative anti-Hepatitis C virus Ab (anti-HCV), or negative HCV polymerase chain reaction (PCR) if the anti-HCV is positive
Urine
47.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 cells levels within institutional normal range).
Reproductive Status
48.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. Persons who are NOT of reproductive potential due to having undergone total hysterectomy or bilateral oophorectomy (verified by medical records), are not required to undergo pregnancy testing.
49.Reproductive status: A volunteer who was born female must:
•Agree to consistently use effective contraception (Appendix A) for sexual activity that could lead to pregnancy from at least 21 days pri
36.Blood products received within 120 days before first vaccination
37.Investigational research agents received within 30 days before first vaccination
38.Body mass index (BMI) ≥ 40
39.Volunteer has 2 or more of the following cardiac risk factors:
•Participant report of history of elevated blood cholesterol defined as fasting LDL >160 mg/dL;
•First degree relative (eg, mother, father, brother, or sister) who had coronary artery disease before the age of 50 years;
•Current smoker; or
•BMI ≥ 35
40.Pregnant or breastfeeding
41. Active duty and reserve US military personnel
Vaccines and other Injections
42.Any clinically significant AE related to vaccination in HVTN 205, for which revaccination would be a safety concern such as any grade 3 or 4 related AE
43.Smallpox vaccine received within the last 5 years
44.HIV vaccine(s) received in a prior HIV vaccine trial other than HVTN 205. For HVTN 205 participants who have subsequently received control/placebo in another HIV vaccine trial, the HVTN 114 PSRT will determine eligibility on a case-by-case basis.
45.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 114 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 114 PSRT on a case-by-case basis.
46.Live attenuated vaccines other than influenza vaccine received within 30 days before first vaccination or scheduled within 14 days after injection (eg, measles, mumps, and rubella [MMR]; oral polio vaccine [OPV]; varicella; yellow fever)
47.Influenza vaccine or any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination (eg, tetanus, pneumococcal, Hepatitis A or B)
48.Allergy treatment with antigen injections within 30 days before first vaccination or that are scheduled within 14 days after first vaccination
Immune System
49.Immunosuppressive medications received within 168 days before first vaccination. (Not exclusionary: [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 < 2 mg/kg/day and length of therapy < 11 days with completion at least 30 days prior to enrollment.)
50.Serious adverse reactions to vaccines or to vaccine components, including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain. (Not excluded from participation: a volunteer who had a nonanaphylactic adverse reaction to pertussis vaccine as a child.)
51.Hypersensitivity to eggs or egg products
52.Immunoglobulin received within 60 days before first vaccination
53.Autoimmune disease (eg, myositis)
54.Immunodeficiency
Cardiac
55.History of myocarditis, pericarditis, cardiomyopathy, congestive heart failure with permanent sequelae, clinically significant arrhythmia (including any arrhythmia requiring medication, treatment, or clinical follow-up)
56.ECG with clinically significant findings, or features that would interf
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method