Reactogenicity, Safety and Immunogenicity of a LAIV А/17/Hong Kong/2017/75108 H7N9 Influenza Vaccine

NCT03739229 | Unknown Phase 1 DMC

• 1 other identifier: LAIV-H7N9-02
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a single center phase I, double-blind placebo-controlled study to assess reactogenicity, safety and immunogenicity of a live monovalent A/17/Hong Kong/2017/75108 (H7N9) influenza vaccine in healthy male and female adults, 18 through 49 years of age.

Conditions

Vaccine Adverse Reaction

Keywords

pandemic; influenza; vaccine; H7N9

Outcome Measures

Primary Outcomes (4)

• Number of Participants with Immediate reactions

  Proportion of subjects experiencing immediate reactions (related or not related to the study) occuring within two hours of administration of any dose, measured as observed by study staff or reported by the subject to study staff

  2 hours

• Number of Participants with Solicited adverse events

  Proportion of subjects experiencing adverse events (related or not related to the study) commonly associated with intranasal vaccination (solicited local and systemic reactions) occurring greater than two hours after administration of any dose of study vaccine or placebo through 6 days following any dose, 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

• Number of Participants with Changes from baseline in laboratory findings and instrumental tests (ECG, echocardiogram, and spirometry)

  Proportion of subjects experiencing all other adverse events (including unsolicited events) occurring during the 6 days following any dose, measured as observed by study staff or reported by the subject to study staff. This includes abnormal laboratory findings from blood specimens and urinalysis collected on Days 3, 6, 31 and 34; IgE level data for Days 0, 3, 28, and 56, as well as instrumental test data (ECG, echocardiogram, and spirometry) on the third day after each vaccination.

  Days 3, 6, 31 and 34

• Number of Participants with Serious adverse events (SAEs)

  Proportion of subjects experiencing all serious adverse events (SAEs) occurring within 4 weeks of receipt of any dose, as observed by study staff, reported by the subject to study staff, or noted by the subject on a diary card. This includes abnormal laboratory findings from blood specimens collected on Days 28 (pre-vaccination) and 56.

  4 weeks of receipt of any dose

Secondary Outcomes (3)

• Number of Participants with Immune responses

  Days 0, 3, 28, and 56

• Number of Participants with Virus shedding at Days 0-6 after each dose

  Days 0-6 after each dose

• Number and name of mutations leading to any loss of attenuation phenotype of the vaccine virus (genetic stability)

  Days 0-6 after each dose

Other Outcomes (1)

• Cellular immune responses (cytokines and T-cells)

  Days 0, 28, and 56

Study Arms (2)

H7N9 LAIV

ACTIVE COMPARATOR

H7N9 live influenza vaccine at study entry (dose 1) and four weeks post-dose one (dose 2), subjects will receive two, 0.25 ml intranasal doses of study vaccine (total dose 0.50 ml at each study vaccine administration).

Biological: Placebo; Biological: H7N9 LAIV

Placebo

PLACEBO COMPARATOR

Lyophilized purified allantoic fluid of chicken embryos with stabilizers at study entry (dose 1) and four weeks post-dose one (dose 2), subjects will receive two, 0.25 ml intranasal doses of placebo (total dose 0.50 ml at each placebo administration).

Biological: Placebo; Biological: H7N9 LAIV

Interventions

Placebo BIOLOGICAL

2 intranasal administrations of lyophilized purified allantoic fluid of chicken embryos with stabilizers

H7N9 LAIV; Placebo

H7N9 LAIV BIOLOGICAL

2 intranasal administrations of H7N9 live influenza vaccine

H7N9 LAIV; 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
• Joint Stock Company Microgen, Russia: collaborator

Related Publications (1)

• Kiseleva I, Isakova-Sivak I, Stukova M, Erofeeva M, Donina S, Larionova N, Krutikova E, Bazhenova E, Stepanova E, Vasilyev K, Matyushenko V, Krylova M, Galatonova J, Ershov A, Lioznov D, Sparrow EG, Torelli G, Rudenko L. A Phase 1 Randomized Placebo-Controlled Study to Assess the Safety, Immunogenicity and Genetic Stability of a New Potential Pandemic H7N9 Live Attenuated Influenza Vaccine in Healthy Adults. Vaccines (Basel). 2020 Jun 10;8(2):296. doi: 10.3390/vaccines8020296.

  PMID: 32532097 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

Central Study Contacts

Marina A Stukova, MD, PhD

CONTACT

+7(812)499-15-21; marina.stukova@influenza.spb.ru

Maria M Pisareva, PhD

CONTACT

+7(812)499-15-20; maria.pisareva@influenza.spb.ru

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: November 1, 2018
• First Posted: November 13, 2018
• Study Start: December 3, 2018
• Primary Completion: June 3, 2019
• Study Completion: July 3, 2019
• Last Updated: November 13, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share