Safety of and Immune Response to an H1N1 Influenza Vaccine in HIV Infected Pregnant Women
Condition: HIV Infections; H1N1 Influenza Virus
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      Both pregnant women and people infected with HIV are at increased risk of viral infection,
      including influenza infection. Pregnant women infected with HIV may be at particular risk of
      infection from the new H1N1 influenza virus. This study tested the safety and immunogenicity
      of an H1N1 influenza vaccine in pregnant women infected with HIV.
    

Detailed description: 
      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 at an increased risk of complications from influenza.
      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 may increase immune activation. This study tested 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 lasted until 6 months after participants had delivered their
      babies or up to 52 weeks. Participants received two doses of the H1N1 vaccine at study entry
      and after 21 days. Each dose consisted of two intramuscular injections (four total
      injections). On the days of the injections, participants had their babies' heart rates
      checked before and after vaccination. At these visits, and at follow-up visits on Days 21,
      31, and 42, participants completed a review of symptoms, physical and neurological exams, and
      a blood draw. For 10 days after receiving each dose of the vaccine, participants were asked
      to keep track of their temperatures and symptoms or reactions in a journal. Participants were
      contacted on Day 2 and Day 10 after the first dose of vaccine was given and on Day 2 after
      the second dose of vaccine was given. Some participants also received a phone call after 6
      months.

      At delivery of each participant's baby, blood was drawn from both the mother and umbilical
      cord (or from the baby if the cord blood could not be obtained). At 3 and 6 months after
      delivery, participants came in for follow-up visits involving, for both mother and child, a
      review of symptoms, brief physical exams, and blood draws (at 6 months only some women had a
      clinic visit, the rest received a phone call).
    

Intervention name(s): Influenza A (H1N1) monovalent vaccine
Intervention type(s): Biological
Intervention description(s): Two 15-microgram intramuscular vaccine injections given together form one dose; two doses (four total injections) are given 21 days apart
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Vaccine; Pregnant; Perinatal