Higher Dose Intradermal H5 Vaccine
Summary
This study will compare the influenza A/H5N1 virus vaccine given by injection in the muscle versus injection in the skin in healthy adults. The study will look at the safety of the injections, how the body reacts, and what the body's immune response does when the vaccine is given in the muscle versus in the skin. The study will look at 226 healthy volunteers, ages 18-49 years old. Study procedures will include getting 2 doses of vaccine 28 days apart, physical exams, follow-up clinic visits to check the places on the body where each vaccine was given, and blood sample collections. Volunteers will complete a memory aid by writing down temperatures and health changes for 7 days after each vaccination. Volunteers will be involved in the study for up to 241 days.
Description
Influenza A viruses have the potential to cause worldwide epidemics and/or pandemics resulting in significant morbidity and mortality. Two-hundred twenty-six healthy male and female subjects aged 18 to 49 years, inclusive, in the United States (US) will be enrolled into this single-center, randomized, double-blinded, placebo-controlled trial of intradermal (ID) and intramuscular (IM) injection with subvirion (SV) inactivated influenza A/H5N1 vaccine. The study will have two vaccine groups. Vaccine group 1: the subject will receive 0.1 mL of H5 Hemagglutination (HA) by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm. Vaccine group 2: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm. All eligible subjects will be enrolled and randomized 1:1 (113 subjects per vaccine group) to either vaccine group 1 or vaccine group 2. All subjects will receive two doses of approximately 30micrograms of H5 HA by their assigned route, either IM or ID, separated by approximately 28 days. At each vaccination visit, all subjects will also receive a saline placebo in the opposite arm by the different route as their vaccine route (i.e. if vaccine is administered by the ID route in one arm, then a saline placebo will be administered by the IM route in the opposite arm). The second vaccine dose will be administered by the same route as per vaccine group assigned at original randomization. Subjects will be observed in the clinic for approximately 15 minutes after each vaccination. Subjects will return on Day 2 for arm check and assessment of adverse events. All subjects will maintain a memory aid recording oral temperature, and systemic and local adverse events for 7 days after each vaccination. They will return to clinic on Day 8 for adverse event (AE) assessment, concomitant medication assessment, a targeted physical exam (if indicated), and review of memory aid. AE data will be captured Day 0 through Day 56. Serious AE data will be captured from Day 0 through the end of each subject's participation in the study (approximately 7 months). The subjects, staff assessing subjects, and lab personnel will be blinded. Serum for immunogenicity evaluations will be obtained prior to the first vaccination, at Day 0; prior to the second vaccination, at Day 28; on Day 56 and approximately Day 208 (7months after dose 1). The primary objectives are to compare the immunogenicity of a similar dosage level of a subvirion inactivated influenza A/H5N1 vaccine given by ID or IM injection one month after receipt of the second dose of vaccine and to compare the safety and reactogenicity of ID and IM immunization at a similar dosage level of a subvirion inactivated influenza A/H5N1 vaccine among healthy young adults. The secondary objective is to evaluate serum antibody responses approximately 1 and 7 months after the first vaccination. This study is linked to Division of Microbiology and Infectious Diseases protocol 07-0022.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Conditions
Influenza
Intervention
Inactivated Influenza A Vaccine A/H5N1, Placebo (ID), Inactivated Influenza A Vaccine A/H5N1, Placebo (IM)
Location
Baylor College of Medicine
Houston
Texas
United States
77030
Status
Completed
Source
National Institute of Allergy and Infectious Diseases (NIAID)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00439335
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:39:58-0400
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Medical and Biotech [MESH] Definitions
Poliovirus Vaccines
Vaccines used to prevent POLIOMYELITIS. They include inactivated (POLIOVIRUS VACCINE, INACTIVATED) and oral vaccines (POLIOVIRUS VACCINE, ORAL).
Poliovirus Vaccine, Inactivated
A suspension of formalin-inactivated poliovirus grown in monkey kidney cell tissue culture and used to prevent POLIOMYELITIS.
Influenza A Virus, H5n1 Subtype
A subtype of INFLUENZA A VIRUS comprised of the surface proteins hemagglutinin 5 and neuraminidase 1. The H5N1 subtype, frequently referred to as the bird flu virus, is endemic in wild birds and very contagious among both domestic (POULTRY) and wild birds. It does not usually infect humans, but some cases have been reported.
Influenza Vaccines
Vaccines used to prevent infection by viruses in the family ORTHOMYXOVIRIDAE. It includes both killed or attenuated vaccines. The composition of the vaccines is changed each year in response to antigenic shifts and changes in prevalence of influenza virus strains. The vaccine is usually bivalent or trivalent, containing one or two INFLUENZAVIRUS A strains and one INFLUENZAVIRUS B strain.
Diphtheria-tetanus Vaccine
A combined vaccine used to prevent infection with diphtheria and tetanus toxoid. This is used in place of DTP vaccine (DIPHTHERIA-TETANUS-PERTUSSIS VACCINE) when PERTUSSIS VACCINE is contraindicated.
