A Clinical Trail Of An Adjuvanted Inactivated H7N9 Influenza Vaccine

Immunogenicity And Safety Of An Alum-Adjuvanted Inactivated H7N9 Influenza Vaccine

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 12-60 years, for a randomized, blind, placebo-controlled, age-stratified clinical study. The investigators designed three dosage groups: 7.5 μg,15 μg and 30 μg of hemagglutinin antigen. According to the age of the subjects, Each group was divided into different age subgroups. Phosphate buffer solution and Aluminum hydroxide adjuvant as placebo controls were both set up in the subgroups.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 were determined.

Study Overview

• Status: Unknown
• Conditions: H7N9 Influenza
• Intervention / Treatment: Biological: 7.5μg H7N9 Vaccine; Biological: 15μg H7N9 Vaccine; Biological: 30μg H7N9 Vaccine; Biological: Aluminum Hydroxide Adjuvant; Biological: Phosphate Buffer Solution

• Study Type: Interventional
• Enrollment (Anticipated): 360
• Phase: Phase 2; Phase 1

Contacts and Locations

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

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 7.5μg H7N9 Vaccine; Participants will receive 2 doses of 7.5μg hemagglutinin antigen of H7N9 vaccine at 21-day intervals.	Biological: 7.5μg 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.
Experimental: 15μg H7N9 Vaccine; Participants will receive 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.
Experimental: 30μg H7N9 vaccine; Participants will receive 2 doses of 30μg hemagglutinin antigen of H7N9 vaccine at 21-day intervals.	Biological: 30μg 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 receive 2 doses of aluminum hydroxide adjuvant at 21-day intervals.	Biological: Aluminum Hydroxide Adjuvant; 0.5ml aluminum hydroxide adjuvant
Placebo Comparator: Phosphate buffer solution; Participants will receive 2 doses of phosphate buffer solution at 21-day intervals.	Biological: Phosphate Buffer Solution; 0.5ml phosphate buffer solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reactogenicity Events	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 solicited SAE(s) with 95% confidence interval	Continuous observation for 30 days after two inoculations

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2017
• Primary Completion (Actual): August 29, 2018
• Study Completion (Anticipated): August 29, 2019

Study Registration Dates

• First Submitted: November 22, 2017
• First Submitted That Met QC Criteria: December 10, 2017
• First Posted (Actual): December 12, 2017

Study Record Updates

• Last Update Posted (Actual): March 22, 2019
• Last Update Submitted That Met QC Criteria: March 20, 2019
• Last Verified: April 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; Vaccines; Aluminum Hydroxide
• Other Study ID Numbers: 2016L09902

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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