Reactogenicity, Safety, and Immunogenicity of a Live Monovalent H5N2 Influenza Vaccine

NCT01719783 | Completed Phase 1 Results DMC

• 1 other identifier: LAIV-H5N2-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety profile of two intranasal doses of LAIV A/17/turkey/Turkey/05/133 (H5N2) in healthy adults.

Conditions

Influenza

Keywords

influenza; vaccine; pandemic

Outcome Measures

Primary Outcomes (1)

• Adverse Events by Severity

  Occurrence of participants with adverse events associated with intranasal administration, by worst grade of severity

  6 days

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 Secretory IgA

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

Other Outcomes (6)

• Number/Percentage of Subjects Exhibiting CD8+ IFNγ+ Responses

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

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

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

• Number/Percentage of Subjects Exhibiting CD8+ IFNγ+ Effector Memory T Cell Responses

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

Study Arms (2)

LAIV H5N2

EXPERIMENTAL

Two doses of live monovalent influenza vaccine A/17/turkey/Turkey/05/133 ( live monovalent (LAIV H5N2) given intranasally

Biological: LAIV H5N2

Placebo

PLACEBO COMPARATOR

two doses of placebo solution intranasal

Other: Placebo

Interventions

LAIV H5N2 BIOLOGICAL

2 doses provided intranasally

Also known as: A/17/turkey/Turkey/05/133(H5N2)live influenza vaccine

LAIV H5N2

Placebo OTHER

2 doses of placebo provided intranasally

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 adverse event (AE) following immunization, at least possibly related to previous receipt of any influenza vaccine.

Sponsors & Collaborators

• PATH: lead
• Microgen: 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, Stukova M, Erofeeva M, Naykhin A, Donina S, Larionova N, Pisareva M, Krivitskaya V, Flores J; Russian LAIV Trial Study Group. Clinical testing of pre-pandemic live attenuated A/H5N2 influenza candidate vaccine in adult volunteers: results from a placebo-controlled, randomized double-blind phase I study. Vaccine. 2015 Sep 22;33(39):5110-7. doi: 10.1016/j.vaccine.2015.08.019. Epub 2015 Aug 19.

  PMID: 26296497 DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Study was completed as expected.

Results Point of Contact

• Title: Jorge Flores
• Organization: PATH

jeflores@path.org

(202) 822-0033

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 26, 2012
• First Posted: November 1, 2012
• Study Start: September 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: November 28, 2018
• Results First Posted: November 28, 2018

Record last verified: 2018-11

Locations

RU (1)