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

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 greater than or equal to 40
• •Bleeding disorder diagnosed by a doctor
• •Malignancy. Participants with surgical excisions and subsequent observation periods, that in the investigator's estimation have a reasonable assurance of sustained cure or are unlikely to recur during the period of study, are not excluded.
• •Seizure disorder, unless the participant has not required medication or had a seizure within the last 3 years.
• •Asplenia
• •Pregnant or breastfeeding