NCT01623232

Brief Summary

This is a Phase 1,2 randomized, double-blind, multi-center, clinical trial, in participants aged 65 years and older, evaluating the immunogenicity and safety of a water-in-oil emulsion adjuvant (MAS-1 adjuvant, Mercia Pharma, Inc, Scarsdale, NY) combined with each of the three reduced HA antigen dose levels of trivalent influenza virus vaccine compared with licensed, unadjuvanted, standard dose trivalent virus (TIV). Immunogenicity for each of the three viral strains (A/H1N1, A/H3N2, and B virus) in the concurrent influenza seasonal vaccine will be assessed.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

4 active sites

Status
withdrawn

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

June 15, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 19, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

September 26, 2012

Status Verified

September 1, 2012

Enrollment Period

1.1 years

First QC Date

June 15, 2012

Last Update Submit

September 25, 2012

Conditions

Influenza VaccinesAged

Keywords

vaccineinfluenzavirus Ainfluenzavirus Badjuvant

Outcome Measures

Primary Outcomes (1)

  • safety

    Participants with at least one vaccine-related adverse event (AE) from the following four categories: solicited AEs, unsolicited AEs, serious AEs, and abnormal safety labs for severity grade 2 or higher, grade 3 only, and grade 4 or 5.

    12 months

Secondary Outcomes (8)

  • immunogenicity

    6 months

  • immunogenicity

    1 month

  • immunogenicity

    1 month

  • immunogenicity

    6 months

  • immunogenicity

    6 months

  • +3 more secondary outcomes

Study Arms (4)

adjuvant plus 1 �g of HA antigen

EXPERIMENTAL

MAS-1-adjuvant-formulated influenza vaccine, at three HA antigen dose levels containing 1 �g of HA antigen

Biological: MAS-1 adjuvant and influenza HA antigen

adjuvant plus 3 �g of HA antigen

EXPERIMENTAL

MAS-1-adjuvant-formulated influenza vaccine, at three HA antigen dose levels containing 3 �g of HA antigen

Biological: MAS-1 adjuvant and influenza HA antigen

adjuvant plus 5 �g of HA antigen

EXPERIMENTAL

MAS-1-adjuvant-formulated influenza vaccine, at three HA antigen dose levels containing 5 �g of HA antigen

Biological: MAS-1 adjuvant and influenza HA antigen

licensed influenza vaccine

ACTIVE COMPARATOR

licensed, inactivated, standard dose influenza vaccine without adjuvant

Biological: standard dose, inactivated trivalent influenza vaccine (TIV)

Interventions

MAS-1 adjuvant and influenza HA antigenBIOLOGICAL

Vaccines will be administered IM in the deltoid muscle. HA antigen of each of three viral strains at doses of 1 micrograms, 3 micrograms, or 5 micrograms per viral strain adjuvanted with MAS-1 adjuvant and as nonadjuvanted standard dose TIV will be tested. 1. Treatment Group 1:each 0.3 mL dose will be administered as an emulsion containing 0.186 grams of MAS-1 oil vehicle and 1 micrograms HA of each of three viral strains in 0.08 mL sterile phosphate buffered saline (PBS). 2. Treatment Group 2:each 0.3 mL dose will be administered as an emulsion containing 0.186 grams of MAS-1 oil vehicle and 3 micrograms HA of each of three viral strains in 0.08 mL sterile PBS. 3. Treatment Group 3:each 0.3 mL dose will be administered as an emulsion containing 0.186 grams of MAS-1 oil vehicle and 5 micrograms HA of each of three viral strains in 0.08 mL sterile PBS.

Also known as: MER4101
adjuvant plus 1 �g of HA antigenadjuvant plus 3 �g of HA antigenadjuvant plus 5 �g of HA antigen
standard dose, inactivated trivalent influenza vaccine (TIV)BIOLOGICAL

Vaccine will be administered IM in the deltoid muscle. HA antigen of each of three viral strains as nonadjuvanted standard dose TIV will be tested. 4\. Treatment Group 4:0.5 mL dose of licensed, unadjuvanted, standard dose influenza virus vaccine with 15 micrograms HA of each of 3 viral strains.

licensed influenza vaccine

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Ambulatory persons aged at least 65 years or older on the day of enrollment. Participants will be considered ambulatory if they are not institutionalized, bedridden, or homebound.
  • Written informed consent form and Authorization to Obtain and Release Protected Health Information (HIPAA) form signed.
  • Medically stable. Participants may have clinically stable underlying chronic conditions such as, but not limited to hypertension, diabetes, congestive heart failure, ischemic heart disease, or chronic lung disease, but their symptoms/signs must be controlled, as judged by the investigator, based on physical examination and medical history. Participants with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease 4 weeks before receipt of the test article, are eligible.
  • Body Mass Index (BMI)\<40
  • Normal ranges for safety labs including:
  • WBC count 3,600 - 11,200 cells/mm3
  • Platelets: 150,000-450,000/mm3
  • Hemoglobin \>sex-specific institutional lower limit of normal (Female 11 g/dL and Male 12.5 g/dL).
  • Chemistry Panel: ALT, AST, total bilirubin \<1.1 times and CPK \<1.25 times the upper limit of normal for the study; glucose 65 to 100 mg/dL; creatinine 0.40 to 1.40 mg/dL
  • Absolute neutrophil, lymphocyte and eosinophil counts are within the study normal range.
  • Normal urine dipstick: negative or trace urine protein, negative or trace urine blood.
  • Able to attend all scheduled visits and to comply with all trial procedures.

You may not qualify if:

  • Systemic hypersensitivity to eggs, chicken proteins, or any of the other vaccine components, or a history of a life-threatening reaction to TIV or a vaccine containing any of the same substances.
  • History of congenital or acquired immunodeficiency, Human Immunodeficiency Virus infection, hepatitis C or B virus infection, or autoimmune disease, or immunosuppressive therapy or radiation therapy in the preceding six months.
  • Systemic corticosteroid therapy, as follows:
  • Continuous use with a dosage equivalent to \>15 mg per day of oral prednisone for 90 days preceding vaccination.
  • Sporadic use with a dosage equivalent to \>40 mg per day of oral prednisone for \>14 consecutive days in the 90 days preceding vaccination.
  • Neoplastic disease or any hematologic malignancy (except localized skin or prostate cancer that is stable at the time of vaccination in the absence of therapy, and history of neoplastic disease but disease-free for 5 years).
  • Current alcohol abuse or drug addiction that may interfere with trial procedures.
  • Receipt of blood or blood-derived products in the past three months.
  • Receipt of influenza vaccine in the past six months.
  • Receipt of any other vaccine in the past four weeks.
  • Planned receipt of another vaccine in the four weeks following the trial vaccination.
  • Planned participation in another clinical trial during the present trial period. Concomitant participation in an observational trial (not involving drugs, vaccines, or medical devices) is acceptable.
  • History of Guillain-Barr syndrome.
  • An acute febrile illness within 24 hours prior to vaccination. Vaccination will be deferred until the participant has been afebrile for at least 24 hours.
  • Signs and symptoms of an acute infectious respiratory ill

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1290, United States

Location

Iowa City VA Health Care System, Iowa City, IA

Iowa City, Iowa, 52246-2208, United States

Location

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417, United States

Location

St. Louis VA Medical Center John Cochran Division, St. Louis, MO

St Louis, Missouri, 63106, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Geoffrey J. Gorse, MD

    St. Louis VA Medical Center John Cochran Division, St. Louis, MO

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2012

First Posted

June 19, 2012

Study Start

October 1, 2012

Primary Completion

November 1, 2013

Study Completion

June 1, 2014

Last Updated

September 26, 2012

Record last verified: 2012-09

Locations

US(4)