Safety of and Immune Response to an H1N1 Influenza Virus Vaccine in HIV Infected Children and Youth

Inclusion Criteria for Step I:

• HIV infected
• HIV-1 was perinatally acquired, in the opinion of the investigator
• Participants receiving antiretrovirals (ARVs) must have been receiving a stable regimen for 90 days prior to entry with no intention to modify their regimen within 60 days following study entry
• Participants not receiving ARVs at entry must not have received ARVs within 90 days prior to entry and must NOT plan to initiate ARVs within 60 days following study entry
• Ability to complete all study immunizations and evaluations, in the opinion of the investigator
• Agrees to use contraception, if necessary
• Documented platelet count of more than 50,000 per mm3 and an absolute neutrophil count (ANC) of more than 500 per mm3 within the 30 days prior to study entry
• Youth of legal age (from 18 to 25 years of age), parent or legal guardian, or participants who are emancipated minors must provide informed consent

Inclusion Criteria for Step II:

• Received the first dose of Influenza A (H1N1) 2009 monovalent vaccine at least 21 days ago
• Documented platelet count of more than 50,000 per mm3 and an ANC of more than 500 per mm3 within the 30 days prior to Step II entry
• If a woman became pregnant after Dose #1, she must be at more than 14 weeks of gestation and have her obstetrician's permission to receive the vaccine

Exclusion Criteria for Step I:

• Pregnancy
• Known allergy to egg protein (egg or egg product) or other components in the vaccines (these may include, but are not limited to: neomycin and polymyxin)
• History, in the opinion of the site investigator, of severe reactions following previous immunization with seasonal influenza vaccines that would contraindicate receipt of any influenza vaccine.
• History of probable or proven pandemic 2009 Influenza A (H1N1) infection prior to study entry
• Has received any live licensed vaccine within 4 weeks or inactivated licensed vaccine within 2 weeks prior to study entry
• Has received a nonlicensed agent (vaccine, drug, biologic, device, blood product, or medication) within 4 weeks prior to study entry or expects to receive another nonlicensed agent during the course of the study
• Has an acute illness or a documented temperature greater than or equal to 100.0 degrees Fahrenheit within 24 hours prior to study entry
• Use of anti-cancer chemotherapy or radiation therapy within the 36 months preceding study entry or has immunosuppression as a result of an underlying illness or treatment (other than HIV-1 infection)
• Has an active neoplastic disease
• Long-term use of glucocorticoids, including oral or parenteral prednisone or equivalent (at least 2 mg/kg per day or at least 20 mg total dose) for more than 2 weeks in the past 6 months or high-dose inhaled steroids (more than 800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months. Nasal and topical steroids are allowed.
• Has received immunoglobulin or other blood products within the 3 months prior to study entry
• History of Guillain-Barre syndrome in the subject or subject's family, including parents, siblings, half-siblings, and children
• Onset of a neurological disorder including (but not limited to) absent ankle and patellar deep tendon reflexes in both legs (all four absent) within the past 6 months
• Disproportionate loss of strength in lower extremity or extremities compared to the upper extremities within the past 6 months
• Has any condition that would, in the opinion of the site investigator, place the participant at an unacceptable risk of injury or render the participant unable to meet the requirements of the protocol

Exclusion Criteria for Step II:

• Has received a nonlicensed agent (vaccine, drug, biologic, device, blood product, or medication), other than from participation in this study, since Dose #1 or expects to receive another nonlicensed agent before the end of the study
• Use of anti-cancer chemotherapy or radiation therapy since Dose #1, new diagnosis of a