Improving Immunogenicity of Influenza Vaccine in HIV Infected Individuals

Inclusion Criteria:

1. A confirmed diagnosis of HIV-1 infection as documented by any licensed ELISA test kit
and confirmed by Western blot at any time prior to study entry or any measurable HIV
RNA viral load in the chart. Serum HIV-1 antigen, plasma HIV-1 RNA, or a second
antibody test by a method other than ELISA is acceptable as an alternative
confirmatory test.

2. > 18 years

3. Able to understand and comply with planned study procedures.

4. Provides written informed consent prior to initiation of any study procedures.

5. Subject should be 1) on stable antiretroviral therapy as outlined in the DHHS
treatment guidelines for HIV-1 infected individuals OR 2) not on antiretroviral
therapy and not intending to start treatment within the next 30 days.

Exclusion Criteria:

1. Has a known allergy to eggs or other components in the vaccines (these may include,
but are not limited to: gelatin, formaldehyde, octoxinol and chicken protein).

2. Has a history, in the opinion of the site investigator, of severe reactions following
previous immunization with seasonal TIV.

3. Participation in a novel H1N1 influenza vaccine study in the past two years.

4. Proven history, by RT-PCR, of novel influenza H1N1 infection, or, has a positive
influenza diagnostic testing since June 2009 (specificity to H1N1 not required) prior
to study entry.

5. Received any other live licensed vaccine within 4 weeks or inactivated licensed
vaccine within 1 week prior to study entry.

6. Scheduled administration of any live virus vaccine or inactivated vaccine at or
between entry and the Day 21 visit. NOTE: Live or inactivated vaccines expected to
be administered between study entry and the Day 21 visit should be excluded to
prevent potential interference with immunogenicity responses and confounding safety
results.

7. Received a non-licensed agent (vaccine, drug, biologic, device, blood product, or
medication) within 4 weeks prior to vaccination in this study with the exception of
new antiretroviral medications as part of a phase 3 trial.

8. An acute illness and/or an oral temperature greater than or equal to 100.0 degrees F
within 24 hours prior to study entry.

9. Use of anti-cancer chemotherapy or radiation therapy within the preceding 36 months
of study enrollment, or has immunosuppression as a result of an underlying illness or
treatment (other than HIV-1 infection).

10. Active neoplastic disease (excluding non-melanoma skin cancer, and HPV-related
cervical dysplasia, CIN grades 1, 2 or 3).

11. Use of immunomodulators (e.g., interleukins, interferons, cyclosporine), HIV vaccine,
systemic cytotoxic chemotherapy, or investigational therapy within 30 days prior to
study entry. NOTE: Subjects receiving stable physiologic glucocorticoid doses,
defined as prednisone ≤10 mg/day, will not be excluded. Subjects receiving
corticosteroids for acute therapy for an opportunistic infection such as Pneumocystis
jiroveci pneumonia (PCP), or receiving a short course (defined as ≤2 weeks) of
pharmacologic glucocorticoid therapy will not be excluded.

12. Received immunoglobulin or other blood products

13. Current diagnosis of uncontrolled major psychiatric disorder.

14. History of Guillain-Barré Syndrome in the subject or subject's family (parents,
siblings, half siblings, or children).

15. Any condition that would, in the opinion of the site investigator, place the subject
at an unacceptable risk of injury or render the subject unable to meet the
requirements of the protocol.