Immune Responses to Two Experimental HIV Vaccines in Healthy Adults

Completed · Phase 1

Conditions studied: HIV Negative, Adaptive Immunity, Innate Immunity

In brief

Background: The primary focus of the Vaccine Research Center (VRC) at the NIH is to develop vaccines for HIV/AIDS. The main purpose of this study is to look in detail at the body s immune response to two experimental HIV vaccines currently in development at the VRC. One is known as the rAd5 vaccine and the other is known as the DNA vaccine. These vaccines are made with pieces of manufactured DNA. They do not contain live or killed HIV. It is impossible for study vaccines to give you HIV and they cannot cause you to give HIV to someone else. Both of these experimental vaccines have been given to people before in other research studies. They have not been approved for treating or preventing HIV infection. Purpose: The main purpose of this study is to look in detail at the body s immune responses after the experimental HIV vaccines are given and to assess safety of the study vaccines. Eligibility: Healthy volunteers between the ages of 18 and 50 who are not infected with HIV and who meet the eligibility requirements. Design: Participants will be screened with a medical history (including questions about sexual history and drug use), physical exam, and blood tests. The study will have two groups: \<TAB\>One group will receive one injection of the rAd5 vaccine, and have 8 clinic visits over 3 months. \<TAB\>The second group will have three injections of the DNA vaccine, one injection of the rAd5 vaccine, and have 12 clinic visits over 6 months. All participants will be asked to provide blood and body fluid samples for testing during the study. Payment for participation will be provided....

Key facts

Study ID

NCT01386489

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

36

Starts

2011-06-17

Expected to finish

2014-03-19

Last updated by the study team

2019-12-16

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:
• Woman who is breast-feeding or planning to become pregnant during study participation.
• Woman who is known to not have a cervix or who report having a clinically significant abnormal Pap smear without a subsequent normal result.
• Volunteer has received any of the following substances:
• Systemic immunosuppressive medications or cytotoxic medications within the 12 weeks prior to enrollment. [With the exception that a short course (duration of 10 days or less or a single injection) of corticosteroids for a self-limited condition at least 2 weeks prior to enrollment in the study will not exclude study participation.]
• Blood products or immunoglobulin within 56 days (8 weeks) prior to enrollment.
• Investigational research agents within 28 days (4 weeks) prior to enrollment.
• Live attenuated vaccines within 28 days (4 weeks) prior to enrollment.
• Medically indicated subunit or killed vaccines, e.g. influenza, pneumococcal, or allergy treatment with antigen injections, within 14 days (2 weeks) prior to enrollment.
• 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, urticaria (hives), respiratory difficulty, angioedema, or abdominal pain.
• Clinically significant 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.
• Thyroid disease that is not well controlled.
• A history of hereditary angioedema (HAE), acquired angioedema (AAE), or idiopathic forms of angioedema.
• Generalized idiopathic urticaria within the 1 year prior to enrollment.
• Hypertension that is not well controlled by medication.
• 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.
• 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, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) seizures that have not required treatment within the last 3 years.
• Asplenia, functional 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; disorder requiring lithium; or within five years prior to enrollment, history of a suicide plan or attempt.
• Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer s ability to give informed consent.

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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