Assess the Safety & Immunogenicity of Stored Inactivated Influenza H5N1 Virus Vaccine Given With & Without Stored MF59 Adjuvant

Biomedical Advanced Research and Development Authority422 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

422

Conditions

A/Vietnam/H5N1 Influenza Virus

Interventions

7.5 mcg H5N1 (stored as monobulk)BIOLOGICAL

15 mcg H5N1 (stored as monobulk)BIOLOGICAL

90 mcg H5N1 (stored as monobulk)BIOLOGICAL

90 mcg H5N1 (stored in vials)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 49 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (6)

Radiant Research, Inc.

Atlanta, Georgia, United States

Clinical Research Advantage, Inc./Ridge Family Practice

Council Bluffs, Iowa, United States

Johnson County Clin-Trials, Inc.

Lenexa, Kansas, United States

Central Kentucky Researcch Associates, Inc.

Lexington, Kentucky, United States

Outcomes

Primary Outcomes

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

Time frame: Days 0 to 7

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

Time frame: Days 21 to 28

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

Time frame: Days 0 to 7

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

Time frame: Days 21 to 28

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

Time frame: Days 0 to 7

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

Data from ClinicalTrials.gov

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Secondary Outcomes

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

Time frame: First vaccination through 13 months

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.

Time frame: First vaccination through approximately 13 months after first vaccination

Number of Participants With Unsolicited Adverse Events (AE)

Number of participants with unsolicited adverse events (AE) through Visit 8 (Day 201)

Time frame: Day 0 (Visit 1) through Day 201 (Visit 8)

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)

Time frame: 21 days following each vaccination (Days 0-21, >21 Days)

Occurrence of Clinical Safety Laboratory AEs

Occurrence of clinical safety laboratory AEs at 7 and 21 days after each vaccination

Time frame: 7 and 21 days after each vaccination (Days 0, 7, 21, 28, and 42)

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

Time frame: Day 0 (Visit 1), Day 21 (Visit 4), Day 28 (Visit 6), Day 201 (Visit 8)

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

Time frame: Day 0 (Visit 1), Day 21 (Visit 4), Day 28 (Visit 6), Day 42 (Visit 7), Day 201 (Visit 8)

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

Time frame: 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)

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.

Time frame: Days 21, 28, 42, and 201

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.

Time frame: Days 21, 28, 42, and 201