Safety of and Immune Response to an H1N1 Influenza Vaccine in HIV Infected Pregnant Women

On June 11, 2009, the World Health Organization declared a pandemic of the new H1N1
influenza virus, after the virus had caused significant fevers and respiratory illnesses in
Mexico and the United States. Pregnant women are particularly susceptible to influenza
viruses and appear to be at increased risk of the H1N1 virus. People infected with HIV are
at an increased risk of complications from influenza. Both these populations—pregnant women
and HIV infected people—tend to have lower than normal antibody responses to seasonal
influenza vaccines. Data suggest that larger than average doses of a vaccine counteract a
weak antibody response. Preliminary results from ongoing studies of influenza A (H1N1) 2009
monovalent vaccines indicate that the vaccine increases immune activation. This study will
test the safety and antibody response of high doses of the influenza A (H1N1) 2009
monovalent vaccine in pregnant women infected with HIV.

Participation in this study will last until 6 months after participants have delivered their
babies or up to 52 weeks. Participants will receive two doses of the H1N1 vaccine during
pregnancy, delivered at study entry and after 21 days. Each dose will consist of two
intramuscular injections (four total injections). On the days of the injections,
participants will have their babies' heart rates checked before and after vaccination. At
these visits, and at follow-up visits on Days 21, 31, and 42, participants will complete a
review of symptoms, physical and neurological exams, and a blood draw. For 10 days after
receiving each dose of the vaccine, participants will be asked to keep track of their
temperatures and symptoms or reactions in a journal. Participants will be contacted on Day 2
and Day 10 after the first dose of vaccine is given and on Day 2 after the second dose of
vaccine is given. Some participants will also receive a phone call after 6 months.

At delivery of each participant's baby, blood will be drawn from both the mother and
umbilical cord. At 3 and 6 months after delivery, participants may come in for follow-up
visits involving, for both mother and child, a review of symptoms, brief physical exams, and
blood draws.