Safety Study of FluMist With and Without Ampligen

NCT01591473 | Terminated Phase 1 DMC

• 1 other identifier: AMP-600
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate FluMist with and without Ampligen in healthy volunteers.

Conditions

Influenza, Human

Keywords

Influenza; Ampligen; Poly I:Poly C12U; Rintatolimod; FluMist

Outcome Measures

Primary Outcomes (1)

• Evaluate safety and tolerability

  Reactogenicity; other adverse events, serious adverse events, new onset of chronic illnesses, and adverse events of special interest

  Every 28 days

Secondary Outcomes (2)

• Evaluation of immune response

  Every 28 days

• Immunogenicity Assessments

  Every 28 days

Study Arms (6)

FluMist + Ampligen, Group 1

EXPERIMENTAL

Nasal administration; dose group 1; FluMist + Poly I:Poly C12U 50 ug; 3 doses separated by 28 days

Drug: Poly I:Poly C12U 50 ug; Drug: FluMist

FluMist + Ampligen, Group 2

EXPERIMENTAL

Nasal administration; dose group 2; FluMist + Poly I:Poly C12U 200 ug; 3 doses separated by 28 days

Drug: Poly I:Poly C12U 200 ug; Drug: FluMist

FluMist + Ampligen, Group 3

EXPERIMENTAL

Nasal administration; dose group 3; FluMist + Poly I:Poly C12U 500 ug; 3 doses separated by 28 days

Drug: Poly I:Poly C12U 500 ug; Drug: FluMist

FluMist + Ampligen, Group 4

EXPERIMENTAL

Nasal administration; dose group 4; FluMist + Poly I:Poly C12U 50 ug; 3 doses separated by 28 days

Drug: Poly I:Poly C12U 50 ug; Drug: FluMist

FluMist + Ampligen, Group 5

EXPERIMENTAL

Nasal administration; dose group 5; FluMist + Poly I:Poly C12U 1250 ug; 3 doses separated by 28 days

Drug: Poly I:Poly C12U 1250 ug; Drug: FluMist

FluMist + Placebo, Group 6

EXPERIMENTAL

Nasal administration; dose group 6; FluMist + placebo; 3 doses separated by 28 days

Drug: Placebo; Drug: FluMist

Interventions

Poly I:Poly C12U 50 ug DRUG

Poly I:Poly C12U 50 ug; 3 doses; nasal administration every 28 days

Also known as: Ampligen, Rintatolimod

FluMist + Ampligen, Group 1; FluMist + Ampligen, Group 4

Poly I:Poly C12U 200 ug DRUG

Poly I:Poly C12U 200 ug; 3 doses; nasal administration every 28 days

Also known as: Ampligen, Rintatolimod

FluMist + Ampligen, Group 2

Poly I:Poly C12U 500 ug DRUG

Poly I:Poly C12U 500 ug; 3 doses; nasal administration every 28 days

Also known as: Ampligen, Rintatolimod

FluMist + Ampligen, Group 3

Poly I:Poly C12U 1250 ug DRUG

Poly I:Poly C12U 1250 ug; 3 doses; nasal administration every 28 days

Also known as: Ampligen, Rintatolimod

FluMist + Ampligen, Group 5

Placebo DRUG

Placebo; 3 doses; nasal administration every 28 days

FluMist + Placebo, Group 6

FluMist DRUG

FluMist 0.2 ml; 3 doses; nasal administration every 28 days

FluMist + Ampligen, Group 1; FluMist + Ampligen, Group 2; FluMist + Ampligen, Group 3; FluMist + Ampligen, Group 4; FluMist + Ampligen, Group 5; FluMist + Placebo, Group 6

Eligibility Criteria

• Age: 19 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males and females in good general health, 19 to 49 years of age.
• Subjects must provide written informed consent.
• Subjects must be willing to participate through study completion.
• Have not been vaccinated for influenza virus in the current season or had a known influenza virus infection in the current season
• Subjects must be willing to undergo nasal washes and provide parotid saliva, urine and blood samples per protocol for safety and immunogenicity analyses.
• Females of childbearing potential must have a negative urine pregnancy test.
• A female volunteer must:
• Agree to consistently use effective contraception from at least 21 days prior to enrollment through the Day 84 clinic visit for sexual activity that could lead to pregnancy;
• Effective contraception is defined as using any of the following methods:
• condoms (male or female) with or without spermicide,
• diaphragm or cervical cap with spermicide,
• intrauterine device (IUD),
• hormonal contraception, or
• successful vasectomy in the male partner (considered successful if a volunteer reports that a male partner has \[1\] documentation of azoospermia by microscopy or \[2\] a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity post-vasectomy);
• Or not be of reproductive potential, such as having reached menopause (no menses for 1 year) or having undergone hysterectomy, bilateral oophorectomy, or tubal ligation;

You may not qualify if:

• Pregnant or lactating women.
• Any flu/cold, or respiratory tract symptoms and/or fever greater than 101 ºF in the 3 days prior to study enrollment and/or initial vaccination.
• Any intranasal medication administered in the 10 days prior to study enrollment and/or initial vaccination.
• History of Bell's palsy, significant cardiac history including history of arrhythmias, coagulopathy, history of cardiovascular accident, bone marrow diseases, known or suspected, autoimmune diseases (such as but not limited to psoriasis, rheumatoid arthritis, hyperthyroidism, hypothyroidism, vasculitis, Raynaud's phenomenon, rhabdomyolysis and myositis, nephritis, systemic lupus erythematosus and sarcoidosis, hemolytic anemia) and any history of malignancy.
• History of chronic rhinitis or presence of pre-existing nasal septal defect, nasal polyps or other gross abnormalities that might impact vaccine administration, or any previous nasal cautery or significant surgery for nasal septal defects.
• Any regular past or current use of intranasal illicit drugs, or a history of intravenous illicit drug use.
• Asthma, or other chronic respiratory disorders, of any severity, even if mild.
• Reactive HBVsAg or reactive HCV Ab.
• HIV positive by history or by screening test.
• History of alcohol or other substance abuse, or history of depression or suicidal ideation, or a suicide attempt within two (2) years of screening. A score of 5 or greater on the PHQ-9 at Baseline indicates symptoms of depression and will exclude subject. A score of greater than zero on question nine (9) of the PHQ-9 at Baseline indicates suicidal ideation and will exclude subject.
• Immunosuppressed, altered or compromised immune status as a consequence of disease (i.e. asplenia, recurrent severe infections) or chronic treatment (more than 14 days) with systemic corticosteroids (including inhaled or intranasally-administered drugs), alkylating drugs, anti-metabolites, radiation, or other immunosuppressive therapies within the preceding 6 months.
• Administration of immunoglobulins and/or any blood products within 3 months prior to enrollment.
• Receipt of an influenza vaccine within the past 6 months.
• Receipt of any vaccine in the past 30 days.
• Receipt of any investigational drug in the past 30 days.

Sponsors & Collaborators

• AIM ImmunoTech Inc.: lead

Study Sites (1)

The University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (3)

• Ichinohe T, Tamura S, Kawaguchi A, Ninomiya A, Imai M, Itamura S, Odagiri T, Tashiro M, Takahashi H, Sawa H, Mitchell WM, Strayer DR, Carter WA, Chiba J, Kurata T, Sata T, Hasegawa H. Cross-protection against H5N1 influenza virus infection is afforded by intranasal inoculation with seasonal trivalent inactivated influenza vaccine. J Infect Dis. 2007 Nov 1;196(9):1313-20. doi: 10.1086/521304. Epub 2007 Oct 5.

  PMID: 17922395 BACKGROUND

• Ichinohe T, Ainai A, Ami Y, Nagata N, Iwata N, Kawaguchi A, Suzaki Y, Odagiri T, Tashiro M, Takahashi H, Strayer DR, Carter WA, Chiba J, Tamura S, Sata T, Kurata T, Hasegawa H. Intranasal administration of adjuvant-combined vaccine protects monkeys from challenge with the highly pathogenic influenza A H5N1 virus. J Med Virol. 2010 Oct;82(10):1754-61. doi: 10.1002/jmv.21824.

  PMID: 20827774 BACKGROUND

• Overton ET, Goepfert PA, Cunningham P, Carter WA, Horvath J, Young D, Strayer DR. Intranasal seasonal influenza vaccine and a TLR-3 agonist, rintatolimod, induced cross-reactive IgA antibody formation against avian H5N1 and H7N9 influenza HA in humans. Vaccine. 2014 Sep 22;32(42):5490-5. doi: 10.1016/j.vaccine.2014.07.078. Epub 2014 Aug 13.

  PMID: 25128802 RESULT

MeSH Terms

Conditions

Influenza, Human

Interventions

poly(I).poly(c12,U); FluMist

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• David R Strayer, MD

  AIM ImmunoTech Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2012
• First Posted: May 4, 2012
• Study Start: April 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: August 1, 2015
• Last Updated: July 26, 2018

Record last verified: 2018-07

Locations

US (1)