Immune Response to Pneumococcal Vaccination in HIV Infected Individuals

All potential study candidates will be asked to fill out a questionnaire concerning their
medical history and medications. This survey will determine eligibility. If eligible, as
part of the experimental protocol the HIV positive participants will agree to be randomized
to immediate vs. delayed pneumococcal immunization and 3 blood draws around the time of
immunization. The HIV negative control population will agree to immunization with
pneumococcal polysaccharide vaccine (PPV), not standard of care for this population, and 3
blood draws around the time of immunization. The investigators will study the effect of
pneumococcal vaccination in HIV positive adults. At the present time it is recommended that
all HIV positive individuals receive the pneumococcal vaccine at the time of diagnosis with
those with cluster of differentiation (CD4) count <200 to be vaccinated either immediately
or alternatively, treated with highly active antiretroviral therapy (HAART) for 6 months
followed by PPV. All patients are recommended to be re-vaccinated at 5 years. This is the
standard of care. It is however unclear how the HIV positive patients respond to PPV. In the
1st part of the study, Part I, newly diagnosed HIV positive individuals will be recruited.
As standard of care, these individuals will receive the pneumococcal vaccine regardless of
their participation in this study. Those that agree to participate in the study will be
grouped according to their CD4 count: >500, 200-500 or <200. Those with a CD4 count <200
will be randomly assigned to receive the vaccine immediately or to receive HAART for 6
months prior to vaccination, this is in accordance with the present recommendations, either
immediate vaccination or giving HAART for 6 months prior to vaccination is considered
acceptable.. Thus ALL HIV positive individuals will receive the vaccine as presently
recommended. The HIV positive volunteers agree to (experimental part of the protocol):

1. Be randomized to either immediate vaccination vs. 6 months after start of HAART if the
CD4 count is <200

2. Donate blood specimens at 3 different times: day 0, day of vaccination: 2 mL, at day 7,
40 mL and at day 28-42 a one time sample of 2 mL.

3. Have their blood samples subjected to antibody analysis (concentration and functional
activity) and antibody gene usage analysis There will be 4 HIV positive groups in this
part of the study: CD4>500, CD4 200-500, CD4 < 200 immediate vaccination and CD4 <200,
delayed vaccination.

There will be 19 individuals per group. The HIV negative controls in Part I of the study
(n=19) who agree to participate will also be vaccinated with the pneumococcal vaccine. This
is NOT a vaccine recommended for healthy adults but is NOT contra-indicated.

Thus as part of the experimental procedure for these individuals they will:

1. Receive the FDA approved pneumococcal vaccine

2. Blood samples will be obtained at day 0: 2 mL, day 7 40 mL and day 28-42, one time
sample of 2 mL.

3. Blood samples will be analyzed for antibody concentration, functional activity and gene
family usage.

In summary, we will study a total of 5 groups in Part I:

Group 1: HIV positive CD4>500 Group 2: HIV positive CD4 200-500 Group 3: HIV positive CD4 <
200 immediate vaccination Group 4: HIV positive CD4<200 delayed (6 months) vaccination Group
5: HIV negative In part II of the study the investigators will evaluate the effect of a
second pneumococcal vaccination, which is presently recommended, in HIV positive
individuals, to be received 5 years after the first vaccination. Again, only those HIV
positive individuals who are due for their second pneumovax will be asked to participate.
They will be grouped according to their CD4 counts as CD4 >500 or CD4 200-500. Thus ALL HIV
positive individuals will receive the vaccine as recommended.

The HIV positive volunteers solely agree to;

1. Donate blood specimens at 3 different occasions: day 0, day of vaccination: 2 mL, at
day 7, 40 mL and at day 28-42 a one time sample of 2 mL.

2. Have their blood samples subjected to antibody analysis (concentration and functional
activity) and antibody gene usage analysis There will be 2 HIV positive groups: CD4>500
and CD4 count 200-500. There will be 19 individuals per group.

The HIV negative controls in Part II of the study who agree to participate will be recruited
from the population of individuals previously vaccinated with pneumovax. They will also be
vaccinated for the second time with the pneumococcal vaccine, 5 years after the first
vaccination. This is NOT a vaccine recommended for healthy adults but is NOT
contra-indicated. Thus as part of the experimental procedure for these individuals they
will:

1. Receive the FDA approved pneumococcal vaccine

2. Blood samples will be obtained at day 0: 2 mL, day 7 40 mL and day 28-42 one time
sample of 2 mL.

3. Blood samples will be analyzed for antibody concentration, functional activity and gene
family usage.

In summary, we will study 3 groups in Part II of the study Group 6: HIV positive CD4>500,
2nd PPV Group 7: HIV positive CD4 200-500, 2nd PPV Group 8: HIV negative, 2nd PPV.

Inclusion Criteria:

- HIV negative:

- never immunized with PPV23

- HIV positive:

- need for PPV23 per standard of care

Exclusion Criteria:

- steroid use

- other immunosuppressive agents;

- pregnancy

- incapable of completing consent form