Reactogenicity, Safety and Immunogenicity of a LAIV H7N9 Influenza Vaccine

NCT02480101 | Completed Phase 1 DMC

• 1 other identifier: LAIV-H7N9-01
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a single centre phase I, double-blind placebo-controlled study to assess reactogenicity, safety and immunogenicity of a live monovalent A/17/Anhui/2013/61 (H7N9) influenza vaccine in healthy male and female adults, 18 through 49 years of age .

Conditions

Influenza

Keywords

influenza vaccine pandemic

Outcome Measures

Primary Outcomes (4)

• Immediate reactions

  Immediate reactions occurring within two hours of administration of any dose, measured as observed by study staff or reported by the subject to study staff

  2 hours

• Solicited adverse events

  Adverse events commonly associated with intranasal vaccination (solicited local and systemic reactions), measured as observed by study staff or reported by the subject to study staff

  Greater than two hours after administration of any dose of study vaccine or placebo through 6 days following any dose

• Changes from baseline in laboratory findings

  Abnormal laboratory findings from blood and urine specimens

  Days 3, 6 and 34

• Serious adverse events (SAEs)

  All SAEs during 56 days, as observed by study staff, reported by the subject to study staff, or noted by the subject on a diary card, including abnormal laboratory findings from blood specimens collected on Days 28 (pre-vaccination) and 56

  4 weeks of receipt of any dose

Secondary Outcomes (3)

• Immune responses

  Days 0, 28 and 56

• Virus shedding

  Days 0-6 after each dose

• Virus stability

  Days 0-6 after each dose

Other Outcomes (1)

• Cellular immune responses (cytokine and T-cell)

  Days 0, 28 and 56

Study Arms (2)

H7N9 LAIV

ACTIVE COMPARATOR

H7N9 live influenza vaccine

Biological: H7N9 live influenza vaccine

Placebo

PLACEBO COMPARATOR

Lyophilized purified allantoic fluid of chicken embryos with stabilizers

Biological: Placebo

Interventions

H7N9 live influenza vaccine BIOLOGICAL

H7N9 live influenza vaccine

Also known as: LAIV H7N9

H7N9 LAIV

Placebo BIOLOGICAL

Lyophilized purified allantoic fluid of chicken embryos with stabilizers

Placebo

Eligibility Criteria

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

You may qualify if:

• Legal male or female adult 18 through 49 years of age at the enrollment visit.
• Literate and willing to provide written informed consent.
• A signed informed consent.
• Free of obvious health problems, as established by the medical history and screening evaluations, including physical examination.
• Capable and willing to complete diary cards and willing to return for all follow-up visits
• Willing to comply with the rules of the isolation unit (including willing and able to take oseltamivir influenza antiviral medication, should that be recommended by a study physician).
• For females, willing to take reliable birth control measures through day 56.

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 four weeks prior to enrollment or refusal to postpone receipt of such vaccines until four weeks after study completion.
• Practice of nasal irrigation on a regular basis within the past six months or has engaged in nasal irrigation within two weeks prior to enrollment.
• Recent history of frequent nose bleeds (more than 5 within the past year).
• Clinically relevant abnormal paranasal anatomy.
• Recent history (within the past month) of rhino or sinus surgery, or surgery for any traumatic injury of the nose.
• Current or recent (within two weeks of enrollment) acute respiratory illness with or without fever.
• Other acute illness at the time of study enrollment.
• Receipt of immune globulin or other blood products within three months prior to study enrollment or planned receipt of such products during the period of subject participation in the study.
• Chronic administration (defined as more than 14 consecutively-prescribed days) of immunosuppressants or other immune-modulating therapy within six months prior to study enrollment (for corticosteroids, this means prednisone or equivalent, 0.5 mg per kg per day; topical steroids are allowed, exclusive of nasal.)
• Participation in any previous trial of any H7 or H5 containing influenza vaccine.
• History of bronchial asthma.
• Hypersensitivity and allergy reactions after previous administration of any vaccine.
• History of wheezing after past receipt of any live influenza vaccine.
• Other AE following immunization (body temperature more than 40°C, collapse, non-febrile seizures, anaphylaxis), at least possibly related to previous receipt of any vaccine (not only influenza).

Sponsors & Collaborators

• Research Institute of Influenza, Russia: lead
• World Health Organization: collaborator
• Institute of Experimental Medicine, Russia: collaborator

Related Publications (1)

• Rudenko L, Isakova-Sivak I, Naykhin A, Kiseleva I, Stukova M, Erofeeva M, Korenkov D, Matyushenko V, Sparrow E, Kieny MP. H7N9 live attenuated influenza vaccine in healthy adults: a randomised, double-blind, placebo-controlled, phase 1 trial. Lancet Infect Dis. 2016 Mar;16(3):303-10. doi: 10.1016/S1473-3099(15)00378-3. Epub 2015 Dec 8.

  PMID: 26673391 DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

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

Study Officials

• Larisa G Rudenko, MD PhD DSc

  Institute of Experimental Medicine

  STUDY CHAIR

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: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 16, 2015
• First Posted: June 24, 2015
• Study Start: October 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: April 1, 2015
• Last Updated: June 24, 2015

Record last verified: 2015-06