Safety and Immunogenicity of Priming With Live Attenuated A/H7N9 Influenza Virus Vaccine Followed By Inactivated A/H7N9 Influenza Virus Vaccine With AS03 Adjuvant

NCT02957656 | Completed Phase 1 DMC

• 1 other identifier: 16-002
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and immunogenicity of one dose of H7N9 pandemic live attenuated influenza vaccine (H7N9 pLAIV) followed by AS03-adjuvanted H7N9 pandemic inactivated influenza vaccine (H7N9 pIIV).

Conditions

Influenza A Virus, H7N9 Subtype

Outcome Measures

Primary Outcomes (4)

• Rates of local and systemic reactogenicity events

  Measured through Day 264

• Development of adverse events at any time point during the study

  Measured through Day 264

• Geometric mean titer (GMT) of H7N9-specific serum hemagglutination inhibition (HAI) and/or microneutralization (MN) antibody responses

  Measured through Day 264

• Rates of H7N9-specific serum HAI and/or MN antibody responses

  Measured through Day 264

Study Arms (5)

Group 1: H7N9 pLAIV + AS03-adjuvanted H7N9 pIIV

EXPERIMENTAL

Participants will receive one dose of approximately 10\^7.0 FFU of H7N9 pLAIV at study entry (Day 0). They will receive one dose of 15 µg of AS03-adjuvanted H7N9 pIIV at Day 84.

Biological: H7N9 pLAIV; Biological: H7N9 pIIV; Biological: AS03 adjuvant

Group 2: AS03-adjuvanted H7N9 pIIV + AS03-adjuvanted H7N9 pIIV

EXPERIMENTAL

Participants will receive one dose of 15 µg of AS03-adjuvanted H7N9 pIIV at study entry (Day 0) and one dose of 15 µg of AS03-adjuvanted H7N9 pIIV at Day 84.

Biological: H7N9 pIIV; Biological: AS03 adjuvant

Group 3: AS03-adjuvanted H7N9 pIIV

EXPERIMENTAL

Participants will receive one dose of 15 µg of AS03-adjuvanted H7N9 pIIV at study entry (Day 0).

Biological: H7N9 pIIV; Biological: AS03 adjuvant

University of Rochester URMC 13-001 Participants

EXPERIMENTAL

Participants received one dose of 10\^7 FFU of H7N9 pLAIV at study entry (Day 0), one dose of 10\^7 FFU of H7N9 pLAIV at Day 28, and one dose of 30 µg of unadjuvanted H7N9 pIIV at Day 84.

Biological: H7N9 pLAIV; Biological: H7N9 pIIV

Johns Hopkins School of Public Health CIR293 Participants

EXPERIMENTAL

Participants received one dose of 10\^7 FFU of H7N9 pLAIV at study entry (Day 0), one dose of 10\^7 FFU of H7N9 pLAIV at Day 28, and one dose of 30 µg of unadjuvanted H7N9 pIIV at Day 84.

Biological: H7N9 pLAIV; Biological: H7N9 pIIV

Interventions

H7N9 pLAIV BIOLOGICAL

10\^7.0 fluorescent focus units (FFU); delivered by an Accuspray device

Also known as: Live Influenza A Vaccine H7N9 (6-2) AA ca Recombinant (A/Anhui/1/2013 (H7N9) x A/Ann Arbor/6/60 ca)

Group 1: H7N9 pLAIV + AS03-adjuvanted H7N9 pIIV; Johns Hopkins School of Public Health CIR293 Participants; University of Rochester URMC 13-001 Participants

H7N9 pIIV BIOLOGICAL

Administered by intramuscular injection in the deltoid.

Group 1: H7N9 pLAIV + AS03-adjuvanted H7N9 pIIV; Group 2: AS03-adjuvanted H7N9 pIIV + AS03-adjuvanted H7N9 pIIV; Group 3: AS03-adjuvanted H7N9 pIIV; Johns Hopkins School of Public Health CIR293 Participants; University of Rochester URMC 13-001 Participants

AS03 adjuvant BIOLOGICAL

Mixed with H7N9 pIIV vaccine; administered by intramuscular injection in the deltoid

Group 1: H7N9 pLAIV + AS03-adjuvanted H7N9 pIIV; Group 2: AS03-adjuvanted H7N9 pIIV + AS03-adjuvanted H7N9 pIIV; Group 3: AS03-adjuvanted H7N9 pIIV

Eligibility Criteria

• Age: 20 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 20 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 childbearing 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 childbearing 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.
• Oral temperature is less than 100.4°F.
• Pulse is 50 to 115 bpm, inclusive.
• Systolic blood pressure is 85 to 150 mm Hg, inclusive.
• Diastolic blood pressure is 55 to 95 mm Hg, inclusive.
• Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 24 hours 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 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 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 or H9 influenza vaccine trial or in any study of an avian influenza vaccine.
• Seropositive to the 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, squalene-based adjuvants, 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

Rochester, New York, 14642, United States

Location

MeSH Terms

Interventions

AS03 adjuvant

Study Officials

• Angela Branche

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2016
• First Posted: November 8, 2016
• Study Start: December 1, 2016
• Primary Completion: June 1, 2018
• Last Updated: October 2, 2018

Record last verified: 2018-10

Locations

US (1)