Clinical trial NCT02680002: Assess the Safety & Immunogenicity of Stored Inactivated Influenza H5N1 Virus Vaccine Given With & Without Stored MF59 Adjuvant
Official title: Randomized, Double-Blinded, Phase 2 Study to Assess Safety & Immunogenicity of Stored Inactivated Monovalent Influenza A/Vietnam/H5N1 Virus Vaccine Administered Intramuscularly at Different Dose Levels Given With & Without Stored MF59® Adjuvant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: A/Vietnam/H5N1 Influenza Virus
Lead sponsor: Biomedical Advanced Research and Development Authority
Sponsor class: FED
Collaborators: name: PPD Development, LP
First posted: 2016-02-11
Enrollment: 422
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The main purpose of this study is to assess the usability of long-term stored H5N1 antigen and adjuvant. The study is designed to assist in stockpile management by assessing the safety, reactogenicity, and immunogenicity long-term stored influenza A/Vietnam/H5N1 vaccine when administered with or without MF59® adjuvant.

Detailed description: This study is a randomized, double-blinded, Phase 2 study to assess the safety and immunogenicity of 2 doses of long-term stored inactivated monovalent influenza A/Vietnam/H5N1 virus vaccine administered intramuscularly with or without MF59 adjuvant in healthy males and nonpregnant females, aged 18 to 49 years, inclusive. This study is designed to assist in stockpile management and will assess the usability of long-term stored H5N1 antigen (ie, stored \>10 years) and adjuvant (ie, stored \>5 years).

Eligibility criteria: Inclusion Criteria:

* Male or nonpregnant female
* Provide written informed consent prior to study-related procedures
* Stable health status
* Access to consistent and reliable means of telephone contact
* Able to understand and comply with planned study procedures
* Agree to stay in contact with site, and no plans to move from study area for study duration

Exclusion Criteria:

* Allergic to eggs, other vaccine components, or squalene-based adjuvants
* Women with positive pregnancy test within 24 hours of vaccination, or are breastfeeding
* Females of childbearing potential who refuse acceptable birth control, if sexually active, have not used birth control for 2 months prior to study entry
* Have immunosuppression or use anticancer chemotherapy or radiation therapy within preceding 36 months
* Have an active neoplastic disease or history of hematologic malignancy
* Have long term use (≥14 consecutive days) of glucocorticoids (\>20 mg/day) or high-dose inhaled steroids (\>800 mcg/day) within preceding 6 months
* Diagnosis of schizophrenia, bipolar disease, or major psychiatric diagnosis
* Have been hospitalized for psychiatric illness, attempted suicide or deemed danger to self or others within past 10 years

Primary outcomes:
measure: Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.
timeFrame: Days 0 to 7
measure: Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.
timeFrame: Days 21 to 28
measure: Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.
timeFrame: Days 0 to 7
measure: Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.
timeFrame: Days 21 to 28
measure: Number of Participants With Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination.
timeFrame: Days 0 to 7
measure: Number of Participants With of Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination.
timeFrame: Days 21 to 28
measure: Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibody
timeFrame: 21 days after receipt of second dose of vaccine (Day 42) (plus or minus 3 days)
Secondary outcomes:
measure: Number of Participants With Vaccine-associated Serious Adverse Events (SAE) or Adverse Event of Special Interests (AESI)
timeFrame: First vaccination through 13 months
measure: Number of Participants With Adverse Events of Special Interest (AESI) or Adverse Events (AE) Leading to Study Withdrawal.
timeFrame: First vaccination through approximately 13 months after first vaccination
measure: Number of Participants With Unsolicited Adverse Events (AE)
timeFrame: Day 0 (Visit 1) through Day 201 (Visit 8)
measure: Frequency of Unsolicited Adverse Events (AE)
timeFrame: 21 days following each vaccination (Days 0-21, >21 Days)
measure: Occurrence of Clinical Safety Laboratory AEs
timeFrame: 7 and 21 days after each vaccination (Days 0, 7, 21, 28, and 42)
measure: GMT (Geometric Mean Titers) of Serum HAI (Hemagglutination Inhibition) Antibodies
timeFrame: Day 0 (Visit 1), Day 21 (Visit 4), Day 28 (Visit 6), Day 201 (Visit 8)
measure: GMT (Geometric Mean Titers) of Serum Microneutralization (MN) Antibodies
timeFrame: Day 0 (Visit 1), Day 21 (Visit 4), Day 28 (Visit 6), Day 42 (Visit 7), Day 201 (Visit 8)
measure: Serum HAI (Hemagglutination Inhibition) Titer of at Least 1:40
timeFrame: Days 0 (Visit 1), 21 (Visit 4, +1day), 28 (Visit 6, +1 day), 42 (Visit 7, plus or minus 3 days), and 201 (Visit 8, plus or minus 7 days)
measure: Seroconversion Rate (SCR) for Hemagglutination Inhibition (HAI) Antibodies
timeFrame: Days 21, 28, 42, and 201
measure: Seroconversion Rate (SCR) for Microneutralization (MN) Antibodies
timeFrame: Days 21, 28, 42, and 201
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Radiant Research, Inc.
state: Georgia
city: Council Bluffs
country: United States
facility: Clinical Research Advantage, Inc./Ridge Family Practice
state: Iowa
city: Lenexa
country: United States
facility: Johnson County Clin-Trials, Inc.
state: Kansas
city: Lexington
country: United States
facility: Central Kentucky Researcch Associates, Inc.
state: Kentucky
city: Edina
country: United States
facility: Radiant Research, Inc.
state: Minnesota
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc.
state: New York
Study officials:
References:
citation: Oshansky CM, Zhou J, Gao Y, Schweinle JE, Biscardi K, DeBeauchamp J, Pavetto C, Wollish A; BRITE Study Coordination Team; Webby RJ, Cioce V, Donis RO, Bright RA. Safety and immunogenicity of influenza A(H5N1) vaccine stored up to twelve years in the National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS). Vaccine. 2019 Jan 14;37(3):435-443. doi: 10.1016/j.vaccine.2018.11.069. Epub 2018 Dec 12.