Safety Trial of Live Attenuated Influenza (H7N3) Vaccine

NCT01511419 | Completed Phase 1 Results DMC

• 1 other identifier: LAIV-H7N3-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The study hypothesis is that two doses of cold-adapted, live monovalent A/17/mallard/Netherlands/00/95 (H7N3) influenza vaccine will be safe and immunogenic in healthy adults.

Conditions

Influenza; Avian Influenza

Keywords

Influenza; Vaccine; Pandemic; H7N3

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Immediate Reactions

  From administration of any dose, immediate reaction measured as observed by study staff or reported by the subject to study staff in case of an anaphylactic reaction.

  2 hours post-administration on Days 0 and 28

• Adverse Events Associated With Intranasal Vaccination

  From solicited local and systemic reactions

  Greater than 2 hours through 7 days following any dose

• All Other Adverse Events

  Including unsolicited events and abnormal laboratory findings

  7 days following any dose

• Participants With Serious Adverse Events (SAEs)

  Including abnormal laboratory findings

  Within 4 weeks of receipt of any dose

Secondary Outcomes (10)

• Number/Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI)

  28 days (Dose 1) and 56 days (Dose 2)

• Number/Percentage of Subjects With Serum Neutralizing Antibodies

  28 days (Dose 1) and 56 days (Dose 2)

• Number/Percentage of Subjects With Seroconversion for Serum Immunoglobulin A (IgA)

  28 days (Dose 1) and 56 days (Dose 2)

• Number/Percentage of Subjects With Seroconversion for Serum Immunoglobulin G (IgG)

  28 days (Dose 1) and 56 days (Dose 2)

• Number/Percentage of Subjects With Seroconversion for Mucosal IgA

  28 days (Dose 1) and 56 days (Dose 2)

Other Outcomes (6)

• Number/Percentage of Subjects Exhibiting CD4+ IFNγ+ Responses

  Days 0, 28 & 56

• Number/Percentage of Subjects Exhibiting CD4+ IFNγ+ Central Memory T Cell Responses

  Days 0, 28 & 56

• Number/Percentage of Subjects Exhibiting CD4+ IFNγ+ Effector Memory T Cell Responses

  Days 0, 28 & 56

Study Arms (2)

LAIV H7N3

EXPERIMENTAL

Test drug/agent: Live-attenuated A/17/mallard/Netherlands/00/95 influenza vaccine (LAIV H7N3) grown in embryonated chicken eggs. Name of active ingredient(s): Live-attenuated A/17/mallard/Netherlands/00/95 influenza vaccine. Dose: ≥7.5 log egg infectious dose (EID) 50/0.5 ml dose; 0.25 ml/nare. Route of administration: Intranasal aerosol. Duration of treatment: Two doses were delivered, one on Day 0 and one on Day 28.

Biological: LAIV H7N3

Placebo

PLACEBO COMPARATOR

Reference drug: Placebo; saline inoculated in embryonated chicken eggs and subsequently prepared in the same way as test vaccine. Dose: 0.5 ml; 0.25 ml/nare Route of administration: Intranasal aerosol Duration of treatment: Two doses were delivered, one on Day 0 and one on Day 28

Biological: placebo

Interventions

LAIV H7N3 BIOLOGICAL

2 doses of vaccine

Also known as: A/17/mallard/Netherlands/00/95 (H7N3)

LAIV H7N3

placebo BIOLOGICAL

2 doses of placebo

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.
• 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 throughout the entire period of participation in the study.

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 (\>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 H5 or H7 containing influenza vaccine.
• History of asthma.
• Hypersensitivity after previous administration of any influenza vaccine.
• History of wheezing after past receipt of any live influenza vaccine.
• Other AE following immunization, at least possibly related to previous receipt of any influenza vaccine.

Sponsors & Collaborators

• PATH: lead
• Ministry of Health, Russian Federation: collaborator
• Research Institute of Influenza, Russia: collaborator
• Institute of Experimental Medicine, Russia: collaborator

Study Sites (1)

Research Institute of Influenza

Saint Petersburg, 197376, Russia

Location

Related Publications (2)

• Kiseleva I, Dubrovina I, Fedorova E, Larionova N, Isakova-Sivak I, Bazhenova E, Pisareva M, Kuznetsova V, Flores J, Rudenko L. Genetic stability of live attenuated vaccines against potentially pandemic influenza viruses. Vaccine. 2015 Dec 8;33(49):7008-14. doi: 10.1016/j.vaccine.2015.09.050. Epub 2015 Oct 2.

  PMID: 26432909 DERIVED

• Rudenko L, Kiseleva I, Naykhin AN, Erofeeva M, Stukova M, Donina S, Petukhova G, Pisareva M, Krivitskaya V, Grudinin M, Buzitskaya Z, Isakova-Sivak I, Kuznetsova S, Larionova N, Desheva J, Dubrovina I, Nikiforova A, Victor JC, Neuzil K, Flores J, Tsvetnitsky V, Kiselev O. Assessment of human immune responses to H7 avian influenza virus of pandemic potential: results from a placebo-controlled, randomized double-blind phase I study of live attenuated H7N3 influenza vaccine. PLoS One. 2014 Feb 12;9(2):e87962. doi: 10.1371/journal.pone.0087962. eCollection 2014.

  PMID: 24533064 DERIVED

MeSH Terms

Conditions

Influenza, Human; Influenza in Birds

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Study was completed as expected.

Results Point of Contact

• Title: Jorge Flores
• Organization: PATH

jeflores@path.org

(202) 822-0033

Study Officials

• Oleg I Kiselev, MD, PhD, DSc

  Research Institute of Influenza

  PRINCIPAL INVESTIGATOR

• Larisa G Rudenko, MD, PhD, DSc

  Institute of Experimental Medicine

  STUDY DIRECTOR

• Kathleen M Neuzil, MD, MPH

  PATH Vaccine Solutions

  STUDY DIRECTOR

• Igor Victorevich

  Microgen

  STUDY DIRECTOR

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: January 5, 2012
• First Posted: January 18, 2012
• Study Start: April 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: July 1, 2012
• Last Updated: April 22, 2019
• Results First Posted: April 22, 2019

Record last verified: 2019-01

Locations

RU (1)