clinical Trials - HIV / AIDS

Smallpox Vaccine:

This clinical trial is designed to evaluate the safety and immunogenicity of MVA-BN® (IMVAMUNE™) smallpox vaccine in 18-55 year old naïve and previously vaccinated HIV-infected subjects with CD4 counts ≥ 200-500/μl. After reading the criteria if you are interested in this trial and/or you have additional questions, please call us at (702) 384-9101.

The following criteria are necessary for inclusion into this trial:

Groups 1 and 2 a/b (all subjects):

Read, signed and dated informed consent form after being advised of the risks and benefits of the study in language understood by the subject, and prior to performance of any study specific procedure.
Subjects between 18 and 55 years of age.
Women must have a negative serum pregnancy test at screening and negative urine pregnancy test within 24 hours prior to vaccination.
Women of childbearing potential must have used an acceptable method of contraception for 30 days prior to the first vaccination, must agree to use an acceptable method of contraception during the study and must not become pregnant for at least 28 days after the last vaccination. A woman is considered of childbearing potential unless post-menopausal or surgically sterilized. (Acceptable contraception methods are restricted to abstinence, barrier contraceptive, intrauterine devices or licensed hormonal products).
Cardiac enzymes within normal institutional limits.
White blood cells > 2500/mm3 and <11,000/mm3.
Absolute neutrophil count (ANC) >1000/mm3
Negative urine glucose by dipstick or urinalysis.
12-lead Electrocardiogram (ECG) without clinically significant findings.
Availability for follow-up for the planned duration of the study (26 weeks after the last vaccination).
If previously vaccinated against small pox, time since most current smallpox vaccination > 10 years.

Group 2 a/b (HIV Infected subjects)

HIV-1 infection documented by ELISA and confirmed by Western blot at any time prior to study entry. HIV-1 DNA PCR, HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test other than ELISA is acceptable as an alternative test at any time prior to study entry.
Either on stable antiretroviral therapy (combination of three of more antiretroviral drugs as defined by DHHS “Guideline for the use of antiretroviral agents for the treatment of HIV-1 in adolescents and adults” for greater than 6 months prior to enrollment, maintaining and undetectable VL with a cut-off of <400 copies/ml. Substitutions of one drug for another in the same class due to reasons other than virologic failure and allowed)

OR
Not on antiretroviral therapy for at least 8 weeks prior to study entry. For Patients not on antiretroviral therapy the following Plasma HIV-1 level (determined by CLIA certified laboratory) are allowed at screening:

< 50,000 copies/ml for subjects with CD4 counts > 350/µl.
< 10,000 copies/ml for subjects with CD4 counts < 350/µl.
CD4 cells > 350-500/µl (Group 2a) or > 200 – 500/µl (Group 2b)
Hemoglobin > 9.0 g/dL.
Platelets > 100,000/mm3
Adequate renal function defined as:

Calculated Creatinine Clearance (CrCl) > 50 ml/min as estimated by the Cockcroft-Gault equation.
Urine protein < +1 proteinuria.
Adequate hepatic function defined as:

Total bilirubin < 2 x ULN unless elevation is explained by antiviral therapy and in the absence of other evidence of significant liver disease.

AST (SGOT), ALT (SGPT) and alkaline phosphatase < 2.5 x ULN.

Group 1 (Healthy subjects):

Negative ELISA for HIV
Hemoglobin within normal limits.
Platelets within normal limits.
Adequate renal function defined as:
Serum creatinine without clinically significant findings.
Urine protein < 30 mg/dL or non or trace protein.
Adequate hepatic function defined as:
Total bilirubin < 1.5 x ULN in the absence of other evidence of significant liver disease.
AST (SGOT), ALT (SGPT) and alkaline phosphatase without clinically significant findings.

The following criteria would exclude a patient from this trial:

Groups 1 and 2 (all subjects):

Pregnant or breast-feeding women.
Uncontrolled serious infection i.e. not responding to antimicrobial therapy.
History of any serious medical condition (other than HIV infection in Group 2), which in the opinion of the investigator would compromise the safety of the subject.
History of or active autoimmune disease. Persons with vitiligo or thyroid disease taking thyroid replacement are not excluded.
Known or suspected impairment of immunologic function.
History of malignancy, other than squamous cell or basal cell skin cancer.
History or clinical manifestation of clinically significant and severe hematological, renal, hepatic, pulmonary, central nervous, cardiovascular or gastrointestinal disorders.
Clinically significant mental disorder not adequately controlled by medical treatment.
Any condition which might interfere with study objectives or would limit the subject’s ability to complete the study in the opinion of the investigator.
History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure.
History of an immediate family member who has had onset of ischemic heart disease before the age of 50 years.
Ten percent or greater risk of developing a myocardial infarction or coronary death within the next 10 years using the National Cholesterol Education Program’s Risk Assessment Tool.
History of intravenous drug abuse (within the last 12 months).
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Known allergy to egg or aminoglycoside (gentamicin).
History of anaphylaxis or severe allergic reaction.
Acute disease at the time of enrollment.
Temperature > 100.4 F at the time of enrollment.
Subjects undergoing treatment for tuberculosis infection or disease.
Having received any vaccinations or planned vaccinations with a live vaccine within 30 days prior to or after study vaccination.
Having received any vaccinations with a killed vaccine within 14 days prior or after study vaccination.
Chronic administration of systemic immunosuppressants during a period starting from six months prior to administration of the vaccine and ending at study conclusion.
Post organ transplant subjects whether or not receiving chronic immunosuppressive therapy.
Administration or planned administration of immunoglobulins and/or any blood products during a period starting from 3 months prior to administration of the vaccine and ending at study conclusion.
Use of any investigational or non-registered drug or vaccine other that the study vaccine within 30 days preceding the first dose of the study vaccine, or planned administration of such a drug during the study period.
Study personnel.