Reactogenicity, Safety and Immunogenicity of a Live Monovalent A/17/CALIFORNIA/66/395 (H2N2) Influenza Vaccine

NCT01982331 | Completed Phase 1 Results DMC

• 1 other identifier: LAIV-H2N2-01
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase I study to evaluate the safety of a vaccine to protect against influenza viruses of the H2N2 subtype. A total of 40 adults will be enrolled and receive two doses of vaccine or placebo one month apart.

Conditions

Influenza

Keywords

H2N2; vaccine

Outcome Measures

Primary Outcomes (5)

• Percentage of Participants With Immediate Reactions

  Measured as observed by study staff or reported by the subject to study staff whether related or not related.

  2 hours

• Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 1

  Adverse events commonly associated with intranasal vaccination 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. Solicited local reactions included: dryness of the nose, nose bleeds, ticklish nose, nasal congestion, runny nose, ticklish throat, catarrhal nasopharynx. Solicited systemic reactions included: body temperature, feverishness/subjective fever, chills, cough, difficulty breathing, sore throat, headache, confusion, convulsions/seizures, fatigue/malaise, joint aches, muscle aches, pink or red eyes, draining eyes, swollen eyelids, ear pain or discharge, rash, abdominal pain, diarrhea, vomiting.

  7 days

• Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 2

  Adverse events commonly associated with intranasal vaccination 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. Solicited local reactions included: dryness of the nose, nose bleeds, ticklish nose, nasal congestion, runny nose, ticklish throat, catarrhal nasopharynx. Solicited systemic reactions included: body temperature, feverishness/subjective fever, chills, cough, difficulty breathing, sore throat, headache, confusion, convulsions/seizures, fatigue/malaise, joint aches, muscle aches, pink or red eyes, draining eyes, swollen eyelids, ear pain or discharge, rash, abdominal pain, diarrhea, vomiting.

  7 days

• Percentage of Subjects With Unsolicited Adverse Events After Vaccination 1

  All other adverse events (including unsolicited events and abnormal laboratory parameters) occurring during the 6 days following any dose, measured as observed by study staff or reported by the subject to study staff.

  7 days following each vaccination

• Percentage of Subjects With Unsolicited Adverse Events After Vaccination 2

  All other adverse events (including unsolicited events and abnormal laboratory parameters) occurring during the 6 days following any dose, measured as observed by study staff or reported by the subject to study staff.

  7 days following each vaccination

Secondary Outcomes (10)

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

  Day 28, Day 56 and Day 112

• Percentage of Subjects With Seroconversion for Serum Neutralizing Antibodies

  Day 28, Day 56 and Day 112

• Percentage of Subjects With Seroconversion for Serum Immunoglobulin A Antibodies

  Day 28, Day 56 and Day 112

• Percentage of Subjects With Seroconversion for Serum Immunoglobulin G Antibodies

  Day 28, Day 56 and Day 112

• Percentage of Subjects With Seroconversion for Secretory Immunoglobulin A Antibodies From Nasal Mucosa

  Day 28 and Day 56

Study Arms (2)

LAIV H2N2 vaccine

EXPERIMENTAL

LAIV H2N2 vaccine A/17/California/66/395 (H2N2) live monovalent influenza vaccine delivered intranasally 2 doses 1 month apart

Biological: LAIV H2N2

Placebo

PLACEBO COMPARATOR

Placebo is composed of a lyophilizate containing the same concentrations of stabilizers as LAIV vaccine. It is prepared onsite in an identical fashion to the vaccine and delivered intranasally.

Other: Placebo

Interventions

LAIV H2N2 BIOLOGICAL

vaccine is delivered intranasally, .25 cc to each nostril at day 0 and day 28

Also known as: Monovalent A/17/California/66/395 (LAIV H2N2) vaccine

LAIV H2N2 vaccine

Placebo OTHER

placebo delivered intranasally. .25cc to each nostril at day 0 and day 28

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Legal male or female adult aged 18 through 40 years
• Literate and willing to provide written informed consent.
• A signed informed consent.
• Free of obvious health problems, as established by 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 isolation unit (including willing and able to take oseltamivir influenza antiviral medication, should that be recommended by 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 trial period.
• 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 during period of subject participation in the study.
• Chronic administration (defined as more than 14 consecutively-prescribed days) of immunosuppressants and/or other immune-modulating therapy within six months prior to study enrollment.
• Participation in any previous trial of any H2N2 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 (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

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

Study Sites (1)

Research Institute of Influenza

Saint Petersburg, Russia

Location

Related Publications (2)

• Rak A, Donina S, Zabrodskaya Y, Rudenko L, Isakova-Sivak I. Cross-Reactivity of SARS-CoV-2 Nucleocapsid-Binding Antibodies and Its Implication for COVID-19 Serology Tests. Viruses. 2022 Sep 14;14(9):2041. doi: 10.3390/v14092041.

  PMID: 36146847 DERIVED

• 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

MeSH Terms

Conditions

Influenza, Human

Interventions

Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Results Point of Contact

• Title: Jorge Flores
• Organization: PATH

jeflores@path.org

(202) 822-0033

Study Officials

• Oleg I Kiselev, Ph.D.

  Research Institute of Influenza

  PRINCIPAL INVESTIGATOR

• Jorge E Flores, MD, Ph.D.

  PATH

  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: October 30, 2013
• First Posted: November 13, 2013
• Study Start: October 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: March 1, 2014
• Last Updated: February 26, 2019
• Results First Posted: February 6, 2019

Record last verified: 2019-02

Locations

RU (1)