A Study in Healthy Adults to Assess Priming With Antigenically Mismatched Live Attenuated A/H7N3 Influenza Virus Vaccine Followed by Inactivated A/H7N9 Influenza Virus Vaccine

NCT03581903 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 16-003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess priming with antigenically mismatched live attenuated A/H7N3 influenza virus vaccine followed by inactivated A/H7N9 influenza virus vaccine in healthy adults.

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

• Hemagglutination-inhibition (HAI) antibody response to H7N9 virus following administration of pIIV

  Defined as 4-fold or greater response to a titer of 1:40 or above with 95% confidence intervals for both antigens

  Measured through Day 28

Secondary Outcomes (7)

• Frequency of reactogenicity events following each dose of vaccine

  Measured through Day 180

• Severity of reactogenicity events following each dose of vaccine

  Measured through Day 180

• Frequency of adverse events following each dose of vaccine

  Measured through Day 180

• Severity of adverse events following each dose of vaccine

  Measured through Day 180

• Frequency of vaccine viral shedding after each dose

  Measured through Day 180

Study Arms (1)

H7N3 pLAIV + H7N9 pIIV

EXPERIMENTAL

Participants will receive H7N3 pLAIV on Days 0 and 28, followed by H7N9 pIIV on Day 84.

Biological: H7N3 pLAIV; Biological: H7N9 pIIV

Interventions

H7N3 pLAIV BIOLOGICAL

Approximately 10\^7.0 fluorescent focus units (FFUs) administered intranasally by an Accuspray device

Also known as: Live attenuated A/H7N3 influenza virus vaccine

H7N3 pLAIV + H7N9 pIIV

H7N9 pIIV BIOLOGICAL

30 micrograms administered by intramuscular (IM) injection

Also known as: Inactivated A/H7N9 influenza virus vaccine

H7N3 pLAIV + H7N9 pIIV

Eligibility Criteria

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

You may qualify if:

• Adult males and non-pregnant, non-breastfeeding females between 18 years and 49 years of age, inclusive. Children will not be recruited or enrolled in this study because they are not in the apparent risk group, for safety considerations, and because of the need for isolation.
• Agree to storage of blood specimens for future research.
• Available for the duration of the trial. Subjects must be willing and able to remain within the Isolation Unit for the specified duration of confinement.
• Provide written informed consent prior to initiation of any study procedures, including future use of specimens.
• Female subjects of child-bearing potential must agree to use effective birth control methods for the duration of the study (for example, pharmacologic contraceptives including oral, parenteral, and transcutaneous delivery; condoms with spermicide; diaphragm with spermicide; intrauterine device; abstinence from heterosexual intercourse, surgical sterilization). All female subjects will be considered being of child bearing potential except those who have undergone hysterectomy or tubal ligation and those in whom menopause occurred at least 1 year prior to the study.
• Agrees not to participate in another clinical trial with an investigational product for the entire duration of the study.
• Female subjects of childbearing potential must have a negative urine and serum pregnancy test within 24 hours (urine) to 48 hours (serum) prior to study vaccination.

You may not qualify if:

• Pregnancy as determined by a positive human choriogonadotropin (beta-HCG) test.
• Currently breastfeeding or planning to breastfeed or become pregnant at some point during the duration of the study.
• Any current illness requiring daily medication other than the following: vitamins, birth control, anti-hypertensive medication, antihistamines, anti-depressant medication, cholesterol-lowering medication, treatment for gastroesophageal reflux disease, and thyroid medication unless approved by the principal investigator (PI).
• Behavioral or cognitive impairment or psychiatric disease that in the opinion of the investigator affects the ability of the subject to understand and cooperate with the study protocol.
• Previous enrollment in an H7 vaccine trial or in any study of an avian influenza vaccine.
• Seropositive to the H7N3 or H7N9 influenza A virus (serum HAI titer greater than 1:8).
• Positive urine drug toxicology test indicating narcotic use/dependency.
• Have medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months.
• Other condition that in the opinion of the investigator would jeopardize the safety or rights of a subject participating in the trial or would render the subject unable to comply with the protocol.
• Have a history of severe reactions following previous immunization with licensed or unlicensed influenza virus vaccines.
• Have known hypersensitivity or allergy to eggs, egg or chicken protein, or other components of the study vaccine.
• Allergy to oseltamivir as determined by subject report.
• Current diagnosis of asthma or reactive airway disease (within the past 2 years).
• History of Guillain-Barré Syndrome.
• Positive enzyme-linked immunosorbent assay (ELISA) and confirmatory Western blot tests for human immunodeficiency virus-1 (HIV-1).

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

University of Rochester Medical Center Vaccine Research Unit (Outpatient)

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

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

Study Officials

• Angela Branche, M.D.

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2018
• First Posted: July 10, 2018
• Study Start: September 19, 2017
• Primary Completion: September 14, 2018
• Study Completion: February 6, 2019
• Last Updated: March 25, 2019

Record last verified: 2019-03

Locations

US (1)