A/Vietnam/H5N1 Influenza Virus Clinical Trial
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
| Verified date | April 2019 |
| Source | Biomedical Advanced Research and Development Authority |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 422 |
| Est. completion date | March 31, 2017 |
| Est. primary completion date | May 13, 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 49 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Radiant Research, Inc. | Atlanta | Georgia |
| United States | Clinical Research Advantage, Inc./Ridge Family Practice | Council Bluffs | Iowa |
| United States | Radiant Research, Inc. | Edina | Minnesota |
| United States | Johnson County Clin-Trials, Inc. | Lenexa | Kansas |
| United States | Central Kentucky Researcch Associates, Inc. | Lexington | Kentucky |
| United States | Rochester Clinical Research, Inc. | Rochester | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Biomedical Advanced Research and Development Authority | PPD |
United States,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Occurence of mild, moderate, or severe solicited local symptoms during the 7 days (Days 0 to 7) following Dose 1 | Days 0 to 7 | |
| Primary | Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Occurence of mild, moderate, or severe solicited local symptoms during the 7 days (Days 21 to 28) following Dose 2 | Days 21 to 28 | |
| Primary | 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. | Number of participants with >=1 mild, moderate, or severe solicited local symptoms during the 7 days (Days 0 to 7) following Dose 1 | Days 0 to 7 | |
| Primary | 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. | Number of participants with >=1 mild, moderate, or severe solicited local symptoms during the 7 days (Days 21 to 29) following Dose 2 | Days 21 to 28 | |
| Primary | Number of Participants With Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Number of participants with mild, moderate, or severe solicited systemic reactogenicity adverse events during the 7 days (Days 0 to 7) following Dose 1 | Days 0 to 7 | |
| Primary | Number of Participants With of Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Number of participants with of mild, moderate, or severe solicited systemic reactogenicity adverse events during the 7 days (Days 21 to 28) following Dose 2 | Days 21 to 28 | |
| Primary | Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibody | Geometric Mean Titer (GMT) of hemagglutination inhibition (HAI) antibody against A/Vietnam/H5N1 antigen in each study group | 21 days after receipt of second dose of vaccine (Day 42) (plus or minus 3 days) | |
| Secondary | Number of Participants With Vaccine-associated Serious Adverse Events (SAE) or Adverse Event of Special Interests (AESI) | Number of participants with vaccine-associated serious adverse events (SAE) or adverse event of special interests (AESI) and occurence of AESIs or AEs leading to study withdrawal | First vaccination through 13 months | |
| Secondary | Number of Participants With Adverse Events of Special Interest (AESI) or Adverse Events (AE) Leading to Study Withdrawal. | Number of participants with adverse events of special interest (AESI) or adverse events (AE) leading to study withdrawal. | First vaccination through approximately 13 months after first vaccination | |
| Secondary | Number of Participants With Unsolicited Adverse Events (AE) | Number of participants with unsolicited adverse events (AE) through Visit 8 (Day 201) | Day 0 (Visit 1) through Day 201 (Visit 8) | |
| Secondary | Frequency of Unsolicited Adverse Events (AE) | Frequency of unsolicited adverse events (AE) for 21 days following Dose 1 (Days 0-21) and after Dose 2 (>21 Days) | 21 days following each vaccination (Days 0-21, >21 Days) | |
| Secondary | Occurrence of Clinical Safety Laboratory AEs | Occurrence of clinical safety laboratory AEs at 7 and 21 days after each vaccination | 7 and 21 days after each vaccination (Days 0, 7, 21, 28, and 42) | |
| Secondary | GMT (Geometric Mean Titers) of Serum HAI (Hemagglutination Inhibition) Antibodies | Overall GMTs of HAI antibodies at baseline (Day 0) and Days 21, 28 and 201 | Day 0 (Visit 1), Day 21 (Visit 4), Day 28 (Visit 6), Day 201 (Visit 8) | |
| Secondary | GMT (Geometric Mean Titers) of Serum Microneutralization (MN) Antibodies | GMT of serum MN antibodies at baseline (Day 0) and Days 21, 28, 42 and 201 | Day 0 (Visit 1), Day 21 (Visit 4), Day 28 (Visit 6), Day 42 (Visit 7), Day 201 (Visit 8) | |
| Secondary | Serum HAI (Hemagglutination Inhibition) Titer of at Least 1:40 | Proportion of participants achieving a serum HAI titer of at least 1:40 against the A/Vietnam/H5N1 antigen | 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) | |
| Secondary | Seroconversion Rate (SCR) for Hemagglutination Inhibition (HAI) Antibodies | Defined as proportion of subjects achieving either a prevaccination HAI titer of <1:10 and postvaccination titer of at least 1:40 or a prevaccination HAI titer of at least 1:10 and a 4-fold or greater increase of HAI postvaccination antibody titers against the A/Vietnam/H5N1 antigen; if baseline HAI titer is undetectable, it will be assigned a vaue of half the lower limit of detection. | Days 21, 28, 42, and 201 | |
| Secondary | Seroconversion Rate (SCR) for Microneutralization (MN) Antibodies | Defined as proportion of subjects achieving either a prevaccination MN titer of <1:10 and postvaccination titer of at least 1:40 or a prevaccination MN titer of at least 1:10 and a 4-fold or greater increase of MN postvaccination antibody titers against the A/Vietnam/H5N1 antigen; if baseline MN titer is undetectable, it will be assigned a vaue of half the lower limit of detection. | Days 21, 28, 42, and 201 |