Vaccine Treatment for HIV-Infection

Completed · Phase 1

Conditions studied: Healthy

In brief

This study will determine the safety and side effects of an experimental adenoviral vector vaccine given to patients who previously received a different HIV vaccine (VRC-HIVDNA016-00-VP) in a prior NIAID study. The study will also monitor participants for the social impact of being in an HIV vaccine study (e.g., problems with insurance, health care, friends, family, employment, housing, and so forth). The study vaccine is made using an adenovirus (a common virus that causes upper respiratory infections, such as the common cold, eye infection, urine infection or diarrhea) that has been modified to contain DNA that codes for three HIV proteins. The modified virus cannot reproduce in the body and cannot cause HIV disease or adenoviral infections. Healthy volunteers who previously received three injections of the VRC-HIVDNA016-00-VP under the NIAID study VRC 007 (protocol 04-I-0254) may be eligible for this study. Participants receive one injection of the adenoviral vector vaccine. It is given the day they enroll in the study, as a single injection in an upper arm muscle. Also on that day they have a brief physical examination, medical history, blood and urine tests, pregnancy test for women, and counseling, as needed, about HIV and pregnancy avoidance. Subjects are observed for side effects for at least 30 minutes after the vaccination and are required to telephone the clinic staff 1 to 2 days after the injection for follow-up. In addition, they are given a diary card to take home, on which they record their temperature and any symptoms daily for 5 days. Subjects return to the clinic for 5 follow-up visits at weeks 2, 4, 6, 12 and 24 after the injection. At each visit they are checked for health changes or problems since the last visit, asked how they are feeling and what medications they are taking. They have blood drawn at every visit and urine samples collected at most visits. They are tested for HIV three or more times and are questioned about their sexual behavior and drug use. They also complete a "social impact" questionnaire at the last visit. Subjects are asked to undergo apheresis at the week 4 visit. This procedure allows collection of a larger number of white blood cells than can be obtained by a simple blood draw. The white cells are studied to see how the immune system responds to the study vaccine. For apheresis, blood is collected through a needle in an arm vein and spun in a machine that separates the components. The white blood cells are extracted and the rest of the blood is returned to the body through the same needle. Subjects who do not undergo apheresis have about 1/3 cup of blood sample drawn using a needle.

Key facts

Study ID

NCT00108654

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

14

Starts

2005-04-13

Expected to finish

2008-01-15

Last updated by the study team

2017-07-02

Who can join

Age: 20 and older, up to 37. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• A volunteer will be excluded if one or more of the following conditions apply:
• Women:
• Breast-feeding or planning to become pregnant during the 24 weeks of study participation.
• Volunteer has received any of the following substances:
• Immunosuppressive or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis).
• Blood products within 120 days prior to HIV screening.
• Immunoglobulin within 60 days prior to HIV screening.
• Live attenuated vaccines within 30 days prior to initial study vaccine administration.
• Investigational research agents within 30 days prior to study vaccine administration.
• Medically indicated subunit or killed vaccines, e.g. influenza, pneumococcal, or allergy treatment with antigen injections, within 14 days of study vaccine administration.
• Current anti-TB prophylaxis or therapy.
• Volunteer has a history of any of the following clinically significant conditions:
• Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain.
• Autoimmune disease or immunodeficiency.
• Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that requires the use of oral or intravenous corticosteroids.
• Diabetes mellitus (type I or II), with the exception of gestational diabetes.
• History of thyroidectomy or thyroid disease that required medication within the past 12 months.
• Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years.
• Hypertension that is not well-controlled by medication or is more than 145/95 at enrollment.
• Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws.
• Syphilis infection that is active or a positive serology due to a syphilis infection treated less than six months ago.
• Malignancy that is active or treated malignancy for which there is not reasonable assurance of sustained cure or malignancy that is likely to recur during the period of the study.
• Seizure disorder other than: 1) febrile seizures under the age of two, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) a singular seizure not requiring treatment within the last 3 years.
• Asplenia or any condition resulting in the absence or removal of the spleen.
• Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder; disorder requiring lithium; or within five years prior to enrollment, history of a suicide plan or attempt.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.