Skip to main content
OpenTrials
Completed

NCT Number: NCT02680002

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

A/Vietnam/H5N1 Influenza Virus

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Radiant Research, Inc., Atlanta, Georgia, United States

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Biological

MF59

Other

MF59 (stored as monobulk)

Other

Primary outcomes

  1. Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.

    Time frame: Days 0 to 7

    Occurence of mild, moderate, or severe solicited local symptoms during the 7 days (Days 0 to 7) following Dose 1

  2. Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.

    Time frame: Days 21 to 28

    Occurence of mild, moderate, or severe solicited local symptoms during the 7 days (Days 21 to 28) following Dose 2

  3. 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.

    Time frame: Days 0 to 7

    Number of participants with >=1 mild, moderate, or severe solicited local symptoms during the 7 days (Days 0 to 7) following Dose 1

  4. 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.

    Time frame: Days 21 to 28

    Number of participants with >=1 mild, moderate, or severe solicited local symptoms during the 7 days (Days 21 to 29) following Dose 2

  5. Number of Participants With Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination.

    Time frame: Days 0 to 7

    Number of participants with mild, moderate, or severe solicited systemic reactogenicity adverse events during the 7 days (Days 0 to 7) following Dose 1

  6. Number of Participants With of Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination.

    Time frame: Days 21 to 28

    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

  7. Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibody

    Time frame: 21 days after receipt of second dose of vaccine (Day 42) (plus or minus 3 days)

    Geometric Mean Titer (GMT) of hemagglutination inhibition (HAI) antibody against A/Vietnam/H5N1 antigen in each study group

Secondary outcomes

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

    Time frame: First vaccination through 13 months

    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

  2. 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 adverse events of special interest (AESI) or adverse events (AE) leading to study withdrawal.

  3. Number of Participants With Unsolicited Adverse Events (AE)

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

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

  4. Frequency of Unsolicited Adverse Events (AE)

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

    Frequency of unsolicited adverse events (AE) for 21 days following Dose 1 (Days 0-21) and after Dose 2 (>21 Days)

  5. Occurrence of Clinical Safety Laboratory AEs

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

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

  6. GMT (Geometric Mean Titers) of Serum HAI (Hemagglutination Inhibition) Antibodies

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

    Overall GMTs of HAI antibodies at baseline (Day 0) and Days 21, 28 and 201

  7. GMT (Geometric Mean Titers) of Serum Microneutralization (MN) Antibodies

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

    GMT of serum MN antibodies at baseline (Day 0) and Days 21, 28, 42 and 201

  8. Serum HAI (Hemagglutination Inhibition) Titer of at Least 1:40

    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)

    Proportion of participants achieving a serum HAI titer of at least 1:40 against the A/Vietnam/H5N1 antigen

  9. Seroconversion Rate (SCR) for Hemagglutination Inhibition (HAI) Antibodies

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

    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.

  10. Seroconversion Rate (SCR) for Microneutralization (MN) Antibodies

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

    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.

Sponsors and collaborators

Lead sponsor

Biomedical Advanced Research and Development Authority

Fed

Collaborators

  • PPD Development, LP

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Feb 11, 2016
Registry last updated
Aug 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.