Safety of and Immune Response to an H1N1 Influenza Virus Vaccine in HIV Infected Children and Youth
Condition: HIV Infections; H1N1 Influenza Virus
MeSH terms: Influenza, Human; HIV Infections
Intervention: Influenza A (H1N1) 2009 monovalent vaccine
Intervention description: Two doses of vaccine, delivered 21 days apart, with each dose consisting of two 15-microgram intramuscular injections
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 155.0
Sex: All
Minimum age: 4 Years
Maximum age: 25 Years
Healthy volunteers: No
Keywords: Influenza A Virus, H1N1 Subtype; Vaccine; Children; Adolescents; HIV-Infected; Perinatal HIV Infection; Treatment experienced

Summary:

      Children and people infected with HIV are particularly susceptible to influenza infections.
      This study testED the safety and effectiveness of a vaccine for the new H1N1 influenza virus
      in children and youth infected with HIV.
    

Eligibility criteria:

        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
             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 steroids (at least 2 mg/kg per
             day or at least 20 mg total dose) for more than 2 weeks since vaccine Dose #1 or
             high-dose inhaled steroids (more than 800 mcg/day of beclomethasone dipropionate or
             equivalent) since Dose #1 (nasal and topical steroids are allowed)

          -  Has received immunoglobulin or other blood products since Dose #1

          -  Any Grade 3 toxicity or adverse event (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 study vaccine

          -  Any Grade 4 injection site reactions or fever experienced by a participant, 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

          -  New occurrence or new awareness of Guillain-Barre syndrome in the participant or
             participant's family (parents, siblings, half-siblings, or children) since Dose #1

          -  New onset of a neurological disorder including (but not limited to) absent ankle and
             patellar deep tendon reflexes in both legs (all four absent) since Dose #1

          -  Disproportionate loss of strength in lower extremity or extremities compared to the
             upper extremities (not thought to be related to pregnancy) since Dose #1

          -  Documented infection with 2009 Influenza A (H1N1) since Dose #1

          -  Refusal of further vaccination by participant, parent, or guardian

          -  Development of any new disease that the investigator judges to be clinically
             significant or clinically significant findings since Dose #1 that, in the
             investigator's opinion, would compromise the safety of the subject

          -  Withdrawal of consent. Consent may be withdrawn at any time and for any reason,
             without penalty.