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Trial record 30 of 157 for:    Recruiting, Not yet recruiting, Available Studies | "Influenza, Human"

Two Doses of Multimeric-001 (M-001) Followed by Influenza Vaccine

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ClinicalTrials.gov Identifier: NCT03058692
Recruitment Status : Not yet recruiting
First Posted : February 23, 2017
Last Update Posted : November 27, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is a Phase II randomized, double-blind, placebo-controlled trial in 120 males and non-pregnant females, 18 to 49 years old, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity of two priming doses of M-001 followed by IIV. Primary objectives: To assess the safety and reactogenicity of M-001 vaccine following receipt of two doses; To assess the safety and reactogenicity of an influenza vaccine following immunization with two doses of M-001 vaccine or placebo, and to assess the serum hemagglutination inhibition (HAI) antibody responses to the IIV viruses after receipt of the IIV when administered to adults following receipt of placebo or two doses of M-001 vaccine.

Condition or disease Intervention/treatment Phase
Influenza Biological: Influenza Multimeric-001 Vaccine Biological: Influenza Virus Vaccine Inactivated Other: Placebo Phase 2

Detailed Description:
This is a Phase II randomized, double-blind, placebo-controlled trial in 120 males and non-pregnant females, 18 to 49 years old, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity of two priming doses of M-001 followed by inactivated influenza vaccine (IIV). The duration of this trial for each subject will be approximately 15 months. Primary objectives: To assess the safety and reactogenicity of M-001 vaccine following receipt of two doses; To assess the safety and reactogenicity of an influenza vaccine following immunization with two doses of M-001 vaccine or placebo, and to assess the serum hemagglutination inhibition (HAI) antibody responses to the IIV viruses after receipt of the IIV when administered to adults following receipt of placebo or two doses of M-001 vaccine. Secondary Objectives: To assess unsolicited AEs following receipt of two doses of M-001 or placebo followed by receipt of IIV; To assess medically-attended adverse events (MAAEs) including new-onset chronic medical conditions (NOCMCs) and potentially immune-mediated medical conditions (PIMMCs) following receipt of two doses of M-001 or placebo followed by receipt of IIV, and to assess the serum neutralizing (Neut) antibody responses to the influenza vaccine viruses when administered to adults following receipt of placebo or two doses of M-001 vaccine.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial to Assess the Safety, Reactogenicity and Immunogenicity of Two Doses of Multimeric-001 (M-001) Followed by Seasonal Trivalent Influenza Vaccine
Anticipated Study Start Date : March 12, 2018
Estimated Primary Completion Date : January 30, 2019
Estimated Study Completion Date : January 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: M-001 + IIV
Two 1 mg doses of M-001 each on Days 1 and 22, followed by IIV
Biological: Influenza Multimeric-001 Vaccine
The M-001 vaccine consists of 3 repetitions of 9 conserved linear epitopes that are prepared as a single recombinant protein. The M-001 vaccine is expected to protect against existing as well as future seasonal and pandemic virus strains.
Biological: Influenza Virus Vaccine Inactivated
Seasonal trivalent vaccine consisting of three inactivated influenza viruses
Placebo Comparator: Placebo+ IIV
Placebo on both Days 1 and 22, followed by IIV
Biological: Influenza Virus Vaccine Inactivated
Seasonal trivalent vaccine consisting of three inactivated influenza viruses
Other: Placebo
Placebo is saline injection


Outcome Measures

Primary Outcome Measures :
  1. Geometric mean titers (GMTs) of HAI antibody vs. influenza vaccine virus [ Time Frame: 21 days after each vaccination ]
  2. Occurrence of clinical safety laboratory abnormalities [ Time Frame: Days 1-8 ]
  3. Occurrence of clinical safety laboratory abnormalities [ Time Frame: Days 22-29 ]
  4. Occurrence of solicited injection site and systemic reactogenicity [ Time Frame: Days 1-8 ]
  5. Occurrence of solicited injection site and systemic reactogenicity [ Time Frame: Days 22-29 ]
  6. Occurrence of solicited injection site and systemic reactogenicity [ Time Frame: Days 43-50 ]
  7. Occurrence of solicited injection site and systemic reactogenicity [ Time Frame: Days 64-72 ]
  8. Occurrence of study vaccine-related MAAEs including NOCMCs and PIMMCs [ Time Frame: Vaccination Day 1-429 ]
  9. Occurrence of study vaccine-related SAEs [ Time Frame: vaccination Day 1-429 ]
  10. Percentage of subjects achieving an HAI titer of 40 or greater vs. influenza vaccine virus [ Time Frame: 21 days after each vaccination ]
  11. Percentage of subjects achieving HAI seroconversion (pre-vaccination HAI titer <10 and post-vaccination HAI titer > /=40, or pre-vaccination HAI titer > /=10 and min 4-fold rise in post-vaccination HAI antibody titer) to influenza vaccine virus [ Time Frame: 21 days after each vaccination ]

Secondary Outcome Measures :
  1. GMTs of Neut Antibody vs. influenza vaccine virus [ Time Frame: 21 days after each vaccination ]
  2. Occurrence of MAAEs including NOCMCs and PIMMCs [ Time Frame: Day 1 - 429 ]
  3. Occurrence of unsolicited AEs [ Time Frame: Day 1 - 86 ]
  4. Percent of subjects achieving Neut seroconversion (prevaccination Neut titer <10 and post-vaccination Neut titer > /=40, or prevaccination Neut titer > /=10 and a min 4-fold rise in postvaccination Neut Ab titer) to influenza vaccine virus [ Time Frame: 21 days after each vaccination ]
  5. Percentage of subjects achieving a Neut titer of 40 or greater vs. influenza vaccine virus [ Time Frame: 21 days after each vaccination ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Provide written informed consent prior to initiation of any study procedures.
  2. Are able to understand and comply with planned study procedures and be available for all study visits.
  3. Are males or non-pregnant females, 18 to 49 years old, inclusive.
  4. Are in good health, as determined by vital signs%, medical history, and targeted physical examination to ensure any existing medical diagnoses or conditions (except those exclusionary) are stable.

    • Vital signs include oral temperature, pulse, and blood pressure.

      --Stable chronic medical condition - no change in prescription medication, dose, or frequency of medication in the last 3 months (defined as 90 days) and health outcomes of the specific disease are considered to be within acceptable limits in the last 6 months (defined as 180 days). Any change that is due to change of health care provider, insurance company etc., or that is done for financial reasons, as long as in the same class of medication, will not be considered a violation of this inclusion criterion. Any change in prescription medication due to improvement of a disease outcome, as determined by the site principal investigator or appropriate sub-investigator, will not be considered a violation of this inclusion criterion.

    • Subjects may be on chronic or as needed (prn) medications if, in the opinion of the site principal investigator or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity. Note: Topical, nasal, and inhaled medications (with the exception of steroids as outlined in the Subject Exclusion Criteria (see Section 5.2)), vitamins, and contraceptives are permitted.
  5. Oral temperature is less than 100.0°F.
  6. Pulse is 50 to 115 bpm, inclusive.
  7. Systolic blood pressure is 85 to 150 mm Hg, inclusive.
  8. Diastolic blood pressure is 55 to 95 mmHg, inclusive.
  9. Women of childbearing potential‡ must use an acceptable method of contraception§ from 30 days prior to vaccination until 60 days after the last study vaccination.

    • Not sterilized via tubal ligation, bilateral oophorectomy, hysterectomy, or successful Essure® placement (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or < 1 year of the last menses if menopausal).
    • Includes, but is not limited to, non-male sexual relationships, abstinence from sexual intercourse with a male partner, monogamous relationship with a vasectomized partner, male condoms with the use of applied spermicide, intrauterine devices, NuvaRing®, and licensed hormonal methods such as implants, injectables, contraceptive patches or oral contraceptives ("the pill"). Method of contraception will be captured on the appropriate data collection form.
  10. Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to study vaccination.

Exclusion Criteria:

  1. Have an acute illness1, as determined by the site PI or appropriate sub-investigator, within 72 hours prior to study vaccination.

    -An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site PI or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol.

  2. Have any medical disease or condition that, in the opinion of the site PI or appropriate sub-investigator, is a contraindication to study participation2.

    -Including acute or chronic medical disease or condition, defined as persisting for at least 90 days, that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this study.

  3. Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior to study vaccination.
  4. Have known active neoplastic disease or a history of any hematologic malignancy. Non-melanoma skin cancers that are not active are permitted.
  5. Have known HIV, hepatitis B, or hepatitis C infection.
  6. Have known hypersensitivity or allergy to eggs, egg or chicken protein, or other components of the study vaccine.
  7. Have a history of severe reactions following previous immunization with licensed or unlicensed influenza vaccines.
  8. Have a history of Guillain-Barré Syndrome.
  9. Have a history of alcohol or drug abuse within 5 years prior to study vaccination.
  10. Have any diagnosis, current or past, of schizophrenia, bipolar disease, or other psychiatric diagnosis that may interfere with subject compliance or safety evaluations.
  11. Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others within 10 years prior to study vaccination.
  12. Have taken oral or parenteral (including intraarticular) corticosteroids of any dose within 30 days prior to study vaccination.
  13. Have taken high-dose3 dose inhaled corticosteroids within 30 days prior to study vaccination.

    • High-dose defined as >840 mcg/day of beclomethasone dipropionate CFC or equivalent.
    • Topical and nasal steroids are permissible.
  14. Received any licensed live vaccine within 30 days prior to the first study vaccination.
  15. Received a licensed inactivated vaccine within 14 days prior to the first study vaccination.
  16. Received any influenza vaccine (inactivated or live) within 30 days prior to the first study vaccination.
  17. Plans to receive any licensed vaccine from the time of the first study vaccination through the follow-up visit at approximately 21 days after the last study vaccination.
  18. Received immunoglobulin or other blood products (with exception of Rho D immunoglobulin) within 90 days prior to study vaccination.
  19. Received an experimental agent5 within 30 days prior to the first study vaccination, or expects to receive an experimental agent6 during the 15-month trial-reporting period.

    • Including vaccine, drug, biologic, device, blood product, or medication.
    • Other than from participation in this study.
  20. Are participating or plan to participate in another clinical trial with an interventional agent7 that will be received during the 15-month trial-reporting period.

    -including agent (licensed or unlicensed vaccine, drug, biologic, device, blood product, or medication) during the 9-month study period.

  21. Plan to travel outside the U.S. (continental U.S., Hawaii and Alaska) in the time between the first study vaccination and 21 days after the last study vaccination.
  22. Female subjects who are breastfeeding or plan to breastfeed at any given time from the first study vaccination until 30 days after the last study vaccination.
  23. Blood donation or planned blood donation within 30 days prior to the study vaccination through 30 days after the last blood drawn for this study.
  24. Have signs or symptoms that could confound or confuse assessment of study vaccine reactogenicity.

    -The study vaccination should be postponed/deferred until signs or symptoms have resolved and if within the acceptable protocol-specified window for that visit.

  25. Have a history of convulsions or encephalomyelitis within 90 days prior to study vaccination.
  26. Have a history of a potentially immune-mediated medical condition.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03058692


Contacts
Contact: Robert Atmar 17137986849 ratmar@bcm.tmc.edu

Locations
United States, Iowa
University of Iowa - Vaccine Research and Education Unit Not yet recruiting
Iowa City, Iowa, United States, 52242-2600
United States, Ohio
Cincinnati Children's Hospital Medical Center - Infectious Diseases Not yet recruiting
Cincinnati, Ohio, United States, 45229-3039
United States, Texas
Baylor College of Medicine - Molecular Virology and Microbiology Not yet recruiting
Houston, Texas, United States, 77030-3411
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
More Information

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT03058692     History of Changes
Other Study ID Numbers: 14-0112
HHSN272201300015I
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 21, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Immunogenicity
Influenza Vaccine
M-001 vaccine
Reactogenicity
Safety

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs