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
Intervention: Influenza A (H1N1) monovalent vaccine
Intervention description: Two 15-microgram intramuscular vaccine injections given together form one dose; two doses (four total injections) are given 21 days apart
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 130.0
Sex: Female
Minimum age: 18 Years
Maximum age: 39 Years
Healthy volunteers: No
Keywords: Vaccine; Pregnant; Perinatal

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.
    

Eligibility criteria:

        Inclusion Criteria for Step I:

          -  Confirmed diagnosis of HIV-1 infection

          -  Pregnant

          -  Between 14 and 35 weeks of gestation

          -  Documented platelet count of greater than 50,000 mm3 and an absolute neutrophil count
             (ANC) of greater than 500 mm3 within 28 days prior to study entry

          -  Able to understand and comply with planned study procedures

          -  On antiretroviral therapy (ART) as outlined in the treatment guidelines for pregnant
             HIV-1 infected women. Women must be currently taking ART or should initiate ART either
             prior to or concomitantly with the first dose of the vaccine.

        Inclusion Criteria for Step II:

          -  Received the first dose of influenza A (H1N1) 2009 monovalent vaccine

          -  Has a documented platelet count of greater than 50,000 mm3 and an ANC of greater than
             500 mm3 within the 28 days prior to Step II entry

        Exclusion Criteria for Step I:

          -  Has a known allergy to eggs, egg products, neomycin, or polymyxin

          -  Has a history, in the opinion of the site investigator, of severe reactions following
             previous immunization with seasonal TIV

          -  Participation in a novel H1N1 influenza vaccine study in the past 2 years

          -  Proven history, by reverse transcription polymerase chain reaction (RT-PCR), of novel
             influenza H1N1 infection or positive influenza diagnostic test since June 2009
             (specificity to H1N1 not required) prior to study entry

          -  Received any other live licensed vaccine within 4 weeks or inactivated licensed
             vaccine within 2 weeks prior to study entry

          -  Received a nonlicensed agent (vaccine, drug, biologic, device, blood product, or
             medication) within 4 weeks prior to vaccination in this study or expects to receive
             another nonlicensed agent before delivery

          -  Acute illness and/or an oral temperature greater than or equal to 100.0 degrees F
             within 24 hours prior to study entry

          -  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)

          -  Active neoplastic disease (excluding nonmelanoma skin cancer, human papillomavirus
             [HPV]-related cervical dysplasia, and cervical intraepithelial neoplasia [CIN] Grades
             1, 2, or 3)

          -  Long-term use of glucocorticoids, including oral or parenteral prednisone or
             equivalent (at least 2.0 mg/kg per day or at least 20 mg total dose) for more than 2
             consecutive weeks (or 2 weeks total) in the past 3 months or high-dose inhaled
             steroids (more than 800 mcg/day of beclomethasone dipropionate or equivalent) within
             the past 3 months. Nasal and topical steroids are allowed.

          -  Received immunoglobulin or other blood products (with exception of Rho D immune
             globulin) within the 3 months prior to enrollment in this study

          -  Current diagnosis of uncontrolled major psychiatric disorder

          -  History of Guillain-Barre syndrome in the subject or subject's family (including
             parents, siblings, half-siblings, or children)

          -  Onset of a neurological disorder including (but not limited to) absent ankle and
             patellar deep tendon reflexes (DTRs) 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 (not thought to be related to pregnancy) within the past 6 months

          -  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. Pregnancy complications such as preterm labor,
             hypertension and pre-eclampsia are not exclusion criteria for this study.

        Exclusion Criteria for Step II:

          -  Received a nonlicensed agent (vaccine, drug, biologic, device, blood product, or
             medication), other than from participation in this study, since the study vaccine dose
             #1 or expects to receive another nonlicensed agent before delivery

          -  Use of anti-cancer chemotherapy or radiation therapy since study vaccine dose #1, new
             diagnosis of an active malignancy, or is immunosuppressed as a result of an underlying
             illness (other than HIV-1 infection) or treatment

          -  Use of glucocorticoids, including oral or parenteral prednisone or equivalent (at
             least 2.0 mg/kg per day or at least 20 mg total dose) or high-dose inhaled steroids
             (more than 800 mcg/day of beclomethasone dipropionate or equivalent) for more than 2
             consecutive weeks (or 2 weeks total) since study vaccine dose #1. Nasal and topical
             steroids are allowed.

          -  Received immunoglobulin or other blood products (with exception of Rho D immune
             globulin) since study vaccine dose #1

          -  A new diagnosis of uncontrolled major psychiatric disorder since study vaccine dose #1

          -  New occurrence or new awareness of Guillain-Barre syndrome in the subject or subject's
             family (including parents, siblings, half-siblings, or children) since study vaccine
             dose #1

          -  A new onset of a neurological disorder including (but not limited to) absent ankle and
             patellar DTRs in both legs (all four absent) since study vaccine dose #1

          -  Disproportionate loss of strength in lower extremity or extremities compared to the
             upper extremities (not thought to be related to pregnancy) since study vaccine dose #1

          -  Any Grade 3 toxicity or AE experienced by a participant unless the investigator has
             received protocol team approval

          -  Any Grade 4 toxicity or AE (other than injection site reaction or fever) that is
             definitely, probably, or possibly related to the study vaccine dose #1

          -  Any Grade 4 injection site reactions or fever experienced by a subject, unless the
             investigator has received protocol team approval

          -  Any Grade 4 AEs that are definitely not or probably not related to study vaccine,
             unless the investigator has received protocol team approval

          -  Any new clinical findings since the study vaccine dose #1, that, in the investigator's
             opinion, would compromise the safety of the participant

          -  Participant refuses further vaccination. The subject will still be asked to complete
             safety visits and be followed in the study.

          -  Participant withdraws consent. Participants may withdraw their consent for study
             participation at any time and for any reason, without penalty.