Phase I Study of Vaccination Schedule of Experimental HIV Vaccines

Completed · Phase 1

Conditions studied: HIV Infections

In brief

This study will test whether a vaccination schedule of experimental HIV vaccines is safe and whether it causes side effects in healthy adult volunteers. It will also compare the effects of vaccine injected into the muscle (intramuscular), just under the skin (subcutaneous), or into the skin (intradermal) and will monitor the social impact of being in an HIV vaccine study. Healthy volunteers 18-50 years old may be eligible for this 42-week study. Participants are screened for antibodies to adenovirus, a common virus that causes upper respiratory infections, such as the common cold. Half of the participants selected will be positive and half will be negative for antibodies to the virus. The vaccines used in this study are known as VRC-HIVDNA016-00-VP (called the "DNA vaccine") and VRC-HIVADV014-00-VP (called the "rAd5 vaccine"). The DNA vaccine codes for four HIV proteins. The rAd5 vaccine is made using an adenovirus that has been modified to contain DNA that codes for three HIV proteins. These vaccines cannot cause HIV or adenoviral infections. Participants are randomly assigned to one of six possible vaccination schedules that include "prime" and "booster" vaccines. The first vaccinations prime the immune system and the immune response is then boosted later. The groups differ in the type of vaccines given (DNA vaccine prime with rAd5 booster or rAd5 prime with rAd5 booster), in how the vaccine is administered (intramuscularly, subcutaneously or intradermally) and in the schedule of administration. All shots are given in the upper arm. Subjects fill out a diary card at home for 5 days after each vaccination, recording their temperature and any symptoms. The cards are turned in to the clinic at the first visit after all 5 days are completed. Subjects return for clinic visits about 3 days after each prime vaccination and either come in or call the clinic about 7 days after the injection. They call a study nurse 1 or 2 days after the booster vaccination. Participants have 15-20 clinic visits during the course of the study, depending on their vaccination schedule. At each visit, they are checked for health changes or problems, asked how they are feeling and if they have taken any medications or other treatments, including over-the-counter medicines, herbal supplements, etc. Blood and urine samples are collected at some visits. Subjects are tested for HIV several times and asked questions about their sexual behavior and drug use. Throughout the stu...

Key facts

Study ID: NCT00321061
Run by: National Institute of Allergy and Infectious Diseases (NIAID)
People needed: 60
Starts: 2006-04-25
Expected to finish: 2009-12-02
Last updated by the study team: 2017-07-02

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

A volunteer will be excluded if one or more of the following conditions apply:
Women:
Woman who is breast-feeding or planning to become pregnant during the 42 weeks of study participation.
Volunteer has received any of the following substances:
HIV vaccine in a prior clinical trial.
Immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past 3 months (with the exception of corticosteroid nasal spray for allergic rhinitis; topical corticosteroids for an acute uncomplicated dermatitis, short-acting beta-agonists in controlled asthmatics; or a course of corticosteroids that was 10 days or fewer in duration that was completed at least 2 weeks prior to study enrollment for a non-chronic condition).
Blood products within 120 days prior to HIV screening.
Immunoglobulin within 60 days prior to HIV screening.
Investigational research agents within 30 days prior to initial study vaccine administration.
Live attenuated vaccines within 30 days prior to initial 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-tuberculosis 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, functional asplenia or any condition resulting in the absence or removal of the spleen.

Where it is running

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

Full record on ClinicalTrials.gov

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