A Study of a Seasonal Trivalent Split, Inactivated Influenza Vaccine

NCT02585700 | Completed Phase 1 Results

• 1 other identifier: TORLAK-100
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase I, double-blind, randomized, placebo-controlled trial with two groups of participants to receive seasonal trivalent split, inactivated influenza vaccine (A/H1N1; A/H3N2 and B) or placebo (phosphate buffered saline). A total of 60 healthy male and female adults 18 through 45 years of age will be randomized to receive vaccine (30) or placebo (30).

Conditions

Influenza, Human

Keywords

Grippe; Human Flu; Human influenza

Outcome Measures

Primary Outcomes (5)

• Number of Subjects With Immediate Adverse Events

  Number of subjects with observed immediate adverse events, including allergic reaction or anaphylaxis, following administration of the study product.

  30-minute post-vaccination period.

• Number and Percentage of Subjects With Solicited Local Reactogenicity

  Number of subjects reporting solicited local reactions (redness, swelling, induration, pain and tenderness) at the injection site post-vaccination with study vaccine or placebo

  7-day period (Days 0-6) post-vaccination.

• Number and Percentage of Subjects With Solicited Systemic Reactogenicity

  Number of subjects reporting solicited systemic reactions (fever, fatigue/malaise, muscle aches, joint aches, chills, nausea, vomiting, and headache) post-vaccination with study vaccine or Placebo

  7-day period (Days 0-6) post-vaccination.

• Number and Percentage of Subjects With Occurrence of Unsolicited Adverse Events

  These data are presented broadly as number per group for the study. Please see AE reporting section for more specific details on AEs.

  Within 21 days post vaccination

• Number and Percentage of Subjects With Occurrence of Serious Adverse Events (SAE)

  Over the entire study period (Day 90).

Secondary Outcomes (6)

• Number and Percentage of Seroconverted Subjects Against 3 Strains of Influenza Vaccine.

  Day 21

• Number and Percentage of Seroprotected Subjects Against 3 Strains of Influenza Vaccine

  Day 0 and Day 21 post vaccination

• Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies Pre- (Day 0) and Post-vaccination (Day 21) for Each of the 3 Antigens

  Pre- (Day 0) and post-vaccination (Day 21)

• Geometric Mean Fold Rises (GMFRs) of Serum (HAI) Antibodies (Post-vaccination / Pre-vaccination) for Each of the 3 Antigens.

  Pre- (Day 0) and post-vaccination (Day 21)

• Geometric Mean Neutralization Titers of Neutralizing Antibodies (MNT) Pre- (Day 0) and Post-vaccination (Day 21) for Each of the 3 Antigens.

  Pre- (Day 0) and post-vaccination (Day 21)

Study Arms (2)

Vaccine

EXPERIMENTAL

0.5 mL of influenza vaccine, split, inactivated with 15 mcg of haemagglutination (HA) of each of 3 strains: * NYMC BX-51B reassortant of B/Massachusetts/2/2012 * X-181 reassortant of H1/A/California/7/2009 * X-223A reassortant of H3/A/Texas/50/2012.

Biological: Influenza vaccine, split inactivated

Placebo

PLACEBO COMPARATOR

0.5 mL of phosphate buffered saline

Other: Placebo

Interventions

Influenza vaccine, split inactivated BIOLOGICAL

Seasonal trivalent inactivated influenza vaccine (TIV), inactivated split virion, purified by sucrose gradient ultracentrifugation. The vaccine is produced in hen's eggs, and inactivated with beta-propiolactone.

Vaccine

Placebo OTHER

0.5 mL of phosphate buffered saline

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female adult 18 through 45 years of age at the enrollment visit.
• Literate (by self-report) and willing to provide written informed consent.
• Healthy, as established by the medical history, physical examination, and screening laboratory evaluations.
• Capable and willing to complete Memory Aids and willing to return for all follow-up visits.
• For females, willing to utilize reliable birth control measures (e.g., intrauterine device, hormonal contraception, condoms) from Day 0 through the Day 21 visit.

You may not qualify if:

• Participation in another clinical trial involving any therapy within the previous three months or planned enrollment in such a trial during the period of this study.
• Receipt of any non-study vaccine within 4 weeks prior to enrollment or refusal to postpone receipt of such vaccines until after the Day 21 visit.
• Current or recent (within 2 weeks of vaccination) acute illness with or without fever.
• Receipt of immune globulin or other blood products within 3 months prior to study enrollment or planned receipt of such products prior to the Day 21 visit.
• Chronic administration (defined as more than 14 consecutively-prescribed days) of immunosuppressants or other immune-modulating therapy within six months prior to study vaccination. (For corticosteroids, this means prednisone or equivalent, equal or more than 0.5 mg per kg per day; topical steroids are allowed.)
• History of asthma.
• Hypersensitivity after previous administration of any vaccine.
• Suspected or known hypersensitivity to any of the study vaccine components, including chicken or egg protein.
• Acute or chronic clinically significant pulmonary, cardiovascular, hepatobiliary, metabolic, neurologic, psychiatric or renal functional abnormality, as determined by medical history, physical examination or clinical laboratory screening tests, which in the opinion of the investigator, might interfere with the study objectives.
• History of any blood or solid organ cancer.
• History of thrombocytopenic purpura or known bleeding disorder.
• History of seizures.
• Known or suspected immunosuppressed or immunodeficient condition of any kind.
• Confirmed hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
• Known HIV infection (self-report).

Sponsors & Collaborators

• Institute of Virology, Vaccines and Sera, Torlak: lead
• Department of Health and Human Services: collaborator
• World Health Organization: collaborator
• PATH: collaborator
• Comac Medical: collaborator

Study Sites (1)

Clinical Center of Serbia

Belgrade, Serbia

Location

Related Publications (1)

• Stevanovic G, Lavadinovic L, Filipovic Vignjevic S, Holt R, Ilic K, Berlanda Scorza F, Sparrow E, Stoiljkovic V, Torelli G, Madenwald T, Socquet M, Barac A, Ilieva-Borisova Y, Pelemis M, Flores J. Safety and immunogenicity of a seasonal trivalent inactivated split influenza vaccine: a phase I randomized clinical trial in healthy Serbian adults. Hum Vaccin Immunother. 2018 Mar 4;14(3):579-586. doi: 10.1080/21645515.2017.1415683. Epub 2018 Feb 23.

  PMID: 29239682 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Limitations and Caveats

No limitations

Results Point of Contact

• Title: Dr. Goran Stevanovic
• Organization: Clinical Center of Serbia-Clinic for Infectious and Tropical Diseases

goran_ste@yahoo.com

+381 64 1703059

Study Officials

• Goran Stevanovic, PhD

  Clinic for Infectious and Tropical Diseases

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2015
• First Posted: October 23, 2015
• Study Start: November 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: January 15, 2019
• Results First Posted: January 15, 2019

Record last verified: 2015-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)