This study will explore the responses of the immune system to infection with HIV and other
pathogens and the changes in these responses over time.
Healthy normal volunteers and HIV-infected patients 18 years of age or older may be eligible
for this study.
Prior to enrollment and yearly thereafter, vital signs, height and weight will be recorded.
A medical history will be obtained if relevant to the laboratory research for which the
sample will be used. A more extensive history and physical exam is not required but may be
performed if deemed necessary by the VRC clinician. A complete blood count will be performed
on the day of enrollment and yearly thereafter. Samples will be collected in the following
Blood will be drawn from a needle in an arm vein one or more times during the course of the
study. From 20 to 150 cc (4 to 30 teaspoonfuls) of blood will be collected at a time. No
more than 450 cc (less than 1 pint) of blood will be drawn during any 6-week period.
Urine and saliva samples will be collected by the volunteer in private.
Swab samples will be collected by a nurse or doctor, using a cotton swab to brush inside the
Samples may be used for the following tests:
- Hepatitis and other viral screening-This may include screening for different types of
viral liver infections, such as hepatitis A, B, C, D, E, or G; for cytomegalovirus
(related to the herpes virus); and for varicella zoster virus (responsible for chicken
pox in children and shingles in adults).
- Genetic testing-DNA in blood cells may be examined for genetic mutations (physical or
chemical changes) or deletions (missing pieces) that affect substances involved in the
body's ability to mount an inflammatory immune response. Alterations in the genes for
some of these substances have been shown to influence HIV infection.
- HLA testing-HLA type is a genetic marker of the immune system. Determining HLA type is
necessary in order to do certain research studies. Some HLA types have been associated
with an increased risk of diseases like arthritis and other rheumatologic problems. HLA
testing may be used to try to identify factors associated with the rate of progression
of HIV disease or related conditions.
- Other laboratory tests as clinically indicated or required for research needs.
Some samples collected in this study may be stored for future research.They will be labeled
without identifying information.
Those with interesting or strongly positive immune responses may be asked to return to the
VRC Clinic to provide samples of urine or oral secretions.
The Vaccine Research Center (VRC) is studying specific immune responses to HIV infection and
other pathogens in order to characterize protective responses that can prevent new infection
in uninfected individuals, as well as define those responses that lead to successful control
of viral replication in persons already infected with the pathogen. We wish to define the
specific human immune responses to HIV infection, other pathogens and vaccines using human
peripheral blood mononuclear cells, plasma, serum, urine, or oral secretions as a model.
- INCLUSION CRITERIA:
1. Willing to be tested for HIV.
Note: Subjects known to be HIV-infected will routinely have results of plasma
HIV RNA obtained at or within 90 days of the enrollment visit recorded;
volunteers believed to be HIV uninfected will usually have HIV ELISA (Western
blot if needed) and/or HIV RNA within 28 days of the enrollment visit recorded.
Test results do not have to be available before proceeding with enrollment.
Consent to be tested is required, but the testing itself does not have to be
completed if not needed by the research lab as subjects are eligible regardless
of HIV status.
2. Age: 18 years of age or older.
3. Ability to provide informed consent
1. Refusal to consent to follow study site policy on partner notification (if newly
diagnosed as HIV-positive while participating in this study).
2. Refusal to permit research specimens to be stored (frozen) for potential future
3. Any medical condition that, in the opinion of the Principal Investigator, would make
the subject inappropriate for protocol participation (such as coagulopathy or
inadequate venous access).
4. Women known to be pregnant