A Study of An Adjuvanted Inactivated H7N9 Influenza Vaccine

Immunogenicity and Safety of an Alum-adjuvanted Inactivated H7N9 Influenza Vaccine: a Randomized, Blind, Placebo-controlled, a Phase II Clinical Trial

The aim of this study is to investigate the immunogenicity and safety of the inactivated whole-virion vaccine for teenagers and adults.

The investigators will test the vaccine in participants aged above 12 years, for a randomized, blind, placebo-controlled, clinical study. The investigators designed one dosage groups: 15 μg of hemagglutinin antigen. Control group is designed to inoculate seasonal influence vaccine and aluminum hydroxide adjuvant. Participants will receive 2 doses of vaccine at 21-day intervals. Safety up to 6 months and changes in hemagglutinin inhibition (HI) titers at 21 days after each vaccination will be determined.

Study Overview

• Status: Unknown
• Conditions: H7N9 Influenza
• Intervention / Treatment: Biological: 15μg H7N9 Vaccine; Biological: Aluminum Hydroxide Adjuvant

• Study Type: Interventional
• Enrollment (Anticipated): 560
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Chen Ze, PhD; Phone Number: +86-021-62826658; Email: chenze2005@hotmail.com

Study Locations

• China
  • Henan
    • Zhumadian, Henan, China, 463100
      • Suiping Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Over the age of 12 years, healthy population
• Subjects/ (and the guardian) informed consent, voluntarily participated and signed the informed consent form, with the ability to use thermometers, scales and to fill in diary cards as required
• To comply with the requirements of clinical trial program, receive blood test before and after immunization and cooperate with follow-up

Exclusion Criteria:

• A history of influenza A (H7N9) virus infection or suspected infection Abnormal blood routine, blood biochemistry and urine routine examination indexes
• Allergy to any component in the vaccine (allergy history of any previous vaccination), especially for egg allergy
• History of asthma, history of thyroid resection, vascular nerve edema, diabetes mellitus, hypertension can not be controlled by medicine, liver and kidney diseases or malignant tumor history
• Suffered from any serious illness, such as cancer, autoimmune disease, progressive atherosclerotic disease or complications of diabetes, chronic obstructive pulmonary disease, need oxygen therapy for acute or progressive liver or kidney disease, congestive heart-failure etc.
• History of signs disease or symptoms of neurological symptoms
• Suffering from severe chronic diseases (such as Down's syndrome, diabetes, sicklemia or neurological disorders, Green's Barre syndrome)
• Acute attacks of various acute or chronic diseases in the past 7 days
• Known or suspected of respiratory disease, acute infection or chronic disease active period, HIV infection, cardiovascular disease, severe hypertension, malignant tumor during treatment, skin diseases
• Congenital malformations or developmental disorders, genetic defects, severe malnutrition etc
• No spleen, functional absence of spleen, and splenectomy or splenectomy without any condition
• Autoimmune diseases or immunodeficiency have been treated with immunosuppressive agents in the past 6 months
• History of epilepsy, convulsions, or a family history of psychosis
• Abnormal coagulation function (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities), or obvious bruising or coagulopathy
• The blood products were received within 3 months prior to the acceptance of the vaccine
• Received a live vaccine within 14 days prior to receiving the vaccine, or received a subunit or inactivated vaccine within 7 days
• Fever within 3 days prior to vaccination, axillary temperature ≥38 ℃
• Being febrile When inoculating vaccine, axillary temperature >37.0 ℃
• Women are pregnant or in the near future planned pregnancy or pregnancy test positive
• Participants in another clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 15μg H7N9 Vaccine; Participants will be inoculated with 2 doses of 15μg hemagglutinin antigen of H7N9 vaccine at 21-day intervals.	Biological: 15μg H7N9 Vaccine; The vaccine was a inactivated, whole virion preparation of the influenza A/Shanghai/2/2013(H7N9) virus, propagated in embryonated chicken eggs，mixed with aluminum hydroxide adjuvant.
Placebo Comparator: Aluminum hydroxide adjuvant; Participants will be first inoculated with one dose of seasonal influenza vaccine and followed with one dose of aluminum hydroxide adjuvant at 21-day intervals.	Biological: Aluminum Hydroxide Adjuvant; The seasonal influenza vaccine was a inactivated, split virion preparation of the influenza virus, propagated in embryonated chicken eggs. The aluminum hydroxide adjuvant was 0.5ml aluminum hydroxide adjuvant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects Reporting Solicited and Unsolicited Adverse Events (AEs)	For each group the incidence rate of subjects with solicited AE(s) with 95% confidence interval; For each group the incidence rate of subjects with unsolicited AE(s) with 95% confidence interval	Continuous observation for 30 days after two inoculations

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric mean of Hemagglutination-inhibition titre post first study injection	Geometric mean of Hemagglutination-inhibition test titre will be calculated for the different groups of participants post first study injection.; Participants will be collected blood post first study injection, when blood samples will be taken for HI testing.	21 days after two inoculations
Number of participants that presented seroconversion post injection	Seroconvertion is defined as: prevaccination Hemagglutination-inhibition test (HI) antibody titer ≤1:10 and postvaccination HI antibody titer ≥1:40, or prevaccination HI antibody titer ≥1:10 and a postvaccination increase by a factor of four or more.; Participants will be collected blood post first study injection, when blood samples will be taken for HI testing	21 days after two inoculations
Number of participants that presented seroprotection post injection	Seroprotection is defined as postvaccination Hemagglutination-inhibition test (HI) antibody titer ≥ 1:40.; Participants will be collected blood post first study injection, when blood samples will be taken for HI testing	21 days after two inoculations

Collaborators and Investigators

• Sponsor: Shanghai Institute Of Biological Products
• Investigators: Principal Investigator: Xia Shengli, PhD, Henan Center for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2018
• Primary Completion (Anticipated): May 1, 2019
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: November 14, 2018
• First Submitted That Met QC Criteria: November 25, 2018
• First Posted (Actual): November 28, 2018

Study Record Updates

• Last Update Posted (Actual): November 29, 2018
• Last Update Submitted That Met QC Criteria: November 27, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: H7N9
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Influenza in Birds; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Immunologic Factors; Gastrointestinal Agents; Adjuvants, Immunologic; Antacids; Aluminum Hydroxide
• Other Study ID Numbers: 2016L09902/3-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No