Evaluating the Safety and Immune Response of an Adenovirus-Based HIV Vaccine in HIV-Uninfected Adults

Completed · Phase 1 · Has a placebo group

Conditions studied: HIV Infections

In brief

The purpose of this study is to evaluate the safety and immune response of an adenovirus-based HIV vaccine in HIV-uninfected adults.

Key facts

Study ID: NCT01103687
Run by: National Institute of Allergy and Infectious Diseases (NIAID)
People needed: 24
Starts: 2010-07-01
Expected to finish: 2016-05-01
Last updated by the study team: 2017-09-08

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Willing to be followed for the planned duration of the study
Able and willing to provide informed consent
Assessment of understanding, including the completion of a questionnaire prior to vaccination; verbally demonstrated understanding of all questionnaire items answered incorrectly
Willing to receive HIV test results
In good general health as shown by medical history, physical exam, and screening laboratory tests
Hemoglobin levels greater than or equal to 11.0 g/dL for women and greater than or equal to 12.5 g/dL for men
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 accompanied by site physician approval
Platelet levels between 125,000 and 550,000/mm3
Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, and total bilirubin less than 1.25 times the institutional upper limit of normal; and creatinine less than or equal to the institutional upper limit of normal
Negative HIV-1 and 2 blood test
Negative hepatitis B surface antigen (HBsAg)
Negative anti-hepatitis C virus antibodies (anti-HCV), or negative HCV polymerase chain reaction (PCR) if the anti-HCV is positive
Normal urine test; more information about this criterion can be found in the protocol
Female participants must have a negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test performed on the day of vaccination prior to vaccination
Female participants must agree to consistently use contraception from at least 21 days prior to study entry through the last study visit. More information on this criterion can be found in the protocol.

You may not qualify if…

Received HIV vaccine(s) in a prior HIV vaccine trial. Participants who received a control/placebo in an HIV vaccine trial are not excluded but documentation of the identity of the study control/placebo must be obtained.
Immunosuppressive medications received within 168 days before vaccination (e.g., oral/parenteral corticosteroids, and/or cytotoxic medications). People taking corticosteroid nasal spray for allergic rhinitis and topical corticosteroids for mild, uncomplicated dermatitis are not excluded.
Blood products received within 120 days before vaccination
Immunoglobulin received within 60 days before vaccination
Live attenuated vaccines received within 30 days before vaccination (e.g., measles, mumps, and rubella [MMR]; oral polio vaccine [OPV]; varicella; yellow fever; Flumist® influenza)
Investigational research agents received within 30 days before vaccination
Any vaccines that are not live attenuated vaccines and were received within 14 days prior to vaccination (e.g., influenza, tetanus, pneumococcal, Hepatitis A or B)
Clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health. More information on this criterion can be found in the protocol.
Any medical, psychiatric, or social condition, or occupational or other responsibility 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
Serious adverse reactions to vaccines including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain. People who had a nonanaphylactic adverse reaction to the pertussis vaccine as a child are not excluded.
Known autoimmune disease
Known immunodeficiency
Active syphilis infection. People who had syphilis that was fully treated more than 6 months before study entry are not excluded.
Asthma other than mild, well-controlled asthma. More information on this criterion can be found in the protocol.
Diabetes mellitus type 1 or type 2, including cases controlled with diet alone. People with a history of isolated gestational diabetes are not excluded.
Thyroidectomy, or thyroid disease requiring medication in the 12 months before study entry
Angioedema in the 3 years before study entry if episodes are considered serious or have required medication in the 2 years before study entry
If a person has been diagnosed with high blood pressure during screening or previously, they will be excluded for high blood pressure that is not well controlled. If a person has NOT been diagnosed with high blood pressure during screening or previously, they will be excluded for systolic blood pressure greater than or equal to 150 mm Hg at study entry or diastolic blood pressure greater than or equal to 100 mm Hg at study entry.
Body mass index (BMI) greater than or equal to 40, or BMI greater than or equal to 35 and two or more of the following conditions: age greater than 45, systolic blood pressure greater than 140 mm Hg, diastolic blood pressure greater than 90 mm Hg, current smoker, or known hyperlipidemia
Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, platelet disorder requiring special precautions)
Cancer. People with a surgical excision and subsequent observation period that in the investigator's estimation has a reasonable assurance of sustained cure or is unlikely to recur during the study period are not excluded.
Seizure disorder or experienced a seizure in the 3 years before study entry. People with a history of seizures who have not required medications or had a seizure in the 3 years before study entry are not excluded.
Absence of a functional spleen
Psychiatric condition that makes study compliance difficult (e.g., people with psychoses in the 3 years before study entry, ongoing risk for suicide, history of suicide attempt or gesture in the 3 years before study entry)
Pregnant or breastfeeding

Where it is running

Brigham and Women's Hosp. Novel Adenoviral Vector Prophylactic HIV Vaccine Non-Network CRS — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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