NCT02680002

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
422

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 11, 2016

Completed
19 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2017

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

August 31, 2020

Completed
Last Updated

August 31, 2020

Status Verified

April 1, 2019

Enrollment Period

2 months

First QC Date

January 26, 2016

Results QC Date

April 17, 2019

Last Update Submit

August 14, 2020

Conditions

A/Vietnam/H5N1 Influenza Virus

Outcome Measures

Primary Outcomes (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 0 to 7) following Dose 1

    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

    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

    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

    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

    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

    Days 21 to 28

  • 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 Outcomes (10)

  • Number of Participants With Vaccine-associated Serious Adverse Events (SAE) or Adverse Event of Special Interests (AESI)

    First vaccination through 13 months

  • 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

  • Number of Participants With Unsolicited Adverse Events (AE)

    Day 0 (Visit 1) through Day 201 (Visit 8)

  • Frequency of Unsolicited Adverse Events (AE)

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

  • Occurrence of Clinical Safety Laboratory AEs

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

  • +5 more secondary outcomes

Study Arms (6)

7.5 mcg H5N1 (monobulk) Plus MF59 (monobulk)

EXPERIMENTAL

Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg hemagglutinin (HA) antigen stored long-term as monobulk inactivated

Biological: 7.5 mcg H5N1 (stored as monobulk)Other: MF59 (stored as monobulk)

15 mcg H5N1 (monobulk) Plus MF59 (monobulk)

EXPERIMENTAL

Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long-term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long-term as monobulk MF59 adjuvant

Biological: 15 mcg H5N1 (stored as monobulk)Other: MF59 (stored as monobulk)

7.5 mcg H5N1 (monobulk) Plus MF59 (vials)

EXPERIMENTAL

Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg HA antigen stored long-term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short-term in vials as MF59 adjuvant

Biological: 7.5 mcg H5N1 (stored as monobulk)Other: MF59

15 mcg H5N1 (monobulk) Plus MF59 (vials)

EXPERIMENTAL

Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long-term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short-term in vials as MF59 adjuvant

Biological: 15 mcg H5N1 (stored as monobulk)Other: MF59

90 mcg H5N1 (monobulk) without MF59

EXPERIMENTAL

Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long-term as monobulk inactivated A/Vietnam/H5N1 antigen formulated and filled in 2015, administered without MF59

Biological: 90 mcg H5N1 (stored as monobulk)

90 mcg H5N1 (vials) without MF59

EXPERIMENTAL

Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long-term in vials as inactivated A/Vietnam/H5N1 vaccine, administered without MF59

Biological: 90 mcg H5N1 (stored in vials)

Interventions

7.5 mcg H5N1 (stored as monobulk)BIOLOGICAL
7.5 mcg H5N1 (monobulk) Plus MF59 (monobulk)7.5 mcg H5N1 (monobulk) Plus MF59 (vials)
15 mcg H5N1 (stored as monobulk)BIOLOGICAL
15 mcg H5N1 (monobulk) Plus MF59 (monobulk)15 mcg H5N1 (monobulk) Plus MF59 (vials)
90 mcg H5N1 (stored as monobulk)BIOLOGICAL
90 mcg H5N1 (monobulk) without MF59
90 mcg H5N1 (stored in vials)BIOLOGICAL
90 mcg H5N1 (vials) without MF59
MF59OTHER
15 mcg H5N1 (monobulk) Plus MF59 (vials)7.5 mcg H5N1 (monobulk) Plus MF59 (vials)
MF59 (stored as monobulk)OTHER
15 mcg H5N1 (monobulk) Plus MF59 (monobulk)7.5 mcg H5N1 (monobulk) Plus MF59 (monobulk)

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Radiant Research, Inc.

Atlanta, Georgia, 30328, United States

Location

Clinical Research Advantage, Inc./Ridge Family Practice

Council Bluffs, Iowa, 51503, United States

Location

Johnson County Clin-Trials, Inc.

Lenexa, Kansas, 66219, United States

Location

Central Kentucky Researcch Associates, Inc.

Lexington, Kentucky, 40509, United States

Location

Radiant Research, Inc.

Edina, Minnesota, 55435, United States

Location

Rochester Clinical Research, Inc.

Rochester, New York, 14609, United States

Location

Related Publications (1)

  • 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.

    PMID: 30553570BACKGROUND

Related Links

MeSH Terms

Interventions

MF59 oil emulsion

Limitations and Caveats

Protocol implied Clinical Study Report (CSR) would include Day 386 (end-of-study) data. Following start of study it was decided CSR would include data up to and including Day 201. CSR addendum will include data from Day 201-Day 386.

Results Point of Contact

Title
Silvija Tresnjak-Smith
Organization
BARDA
Silvija.Tresnjak-Smith@hhs.gov
202-557-1993

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2016

First Posted

February 11, 2016

Study Start

March 1, 2016

Primary Completion

May 13, 2016

Study Completion

March 31, 2017

Last Updated

August 31, 2020

Results First Posted

August 31, 2020

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will share

The study results will be posted on publicly available clinical trial registers.

Locations

US(6)