A Single Center, Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase I Clinical Trial for Safety and Preliminary Immunogenicity of a Whole Virus Inactivated Influenza H5N1 Vaccine in Healthy Adolescents and Adults, on Day 0 and 21 Intramuscularly
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Healthy
- Sponsor
- Jiangsu Province Centers for Disease Control and Prevention
- Locations
- 1
- Primary Endpoint
- the safety of whole virus inactivated influenza H5N1 vaccine in healthy adolescents aged from 12-17 years and adults aged from 18-60 years
- Status
- Withdrawn
- Last Updated
- 13 years ago
Overview
Brief Summary
Influenza is an acute respiratory infection caused by influenza virus with high incidence and serious complications even causing death. According to the announcement released by the World Health Organization (WHO), the number of global annual influenza case was 0.6 to 1.2 billion and 0.5 to 1 million people died. The emergence of a new subtype of influenza virus may cause an influenza pandemic with occurence once every 10 to 50 years which cause serious adverse consequences for human health and social welfare worldwide.
From 1997 to 2003，the H5N1 virus infection has increased highly and gradually spreaded to Europe, Africa and other countries and regions. High mortality caused by H5N1 virus has attracted the WHO and national government great attention. So it is meaningful to develop vaccine to provide effective antibody to reduce the number of infections.
The objective of this study is to evaluate the safety and preliminary immunogenicity of a whole virus inactivated influenza H5N1 vaccine.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy subjects aged from 12 to 60 years old of normal intelligence;
- •The subjects' guardians are able to understand and sign the informed consent;
- •Subjects established as healthy after medical history questioning, physical examination and clinical decision;
- •Subjects who can comply with the requirements of the clinical trial protocol;
- •Subjects who have never received influenza H5N1 vaccine and other preventive products;
- •Subjects with temperature ≤37°C on axillary setting.
Exclusion Criteria
- •Exclusion Criteria for the first dose:
- •Women in pregnancy / lactation or plan to be pregnant during the study;
- •The subject has a history of allergy or is allergic with any Ingredient of vaccine, such as egg, ovalbumin;
- •Had serious adverse reactions in previous vaccination, such as allergies, hives, difficult breath, angioneurotic edema or abdominal pain;
- •Autoimmune diseases or immune deficiency;
- •Had asthma, over the past two years, the condition is unstable in need of emergency treatment, hospitalization and oral or intravenous corticosteroids;
- •Diabete (type I or type II) not including gestational diabete;
- •Thyroidectomy history, or treatment because of thyroid diseases in the past 12 months;
- •Over the past 3 years, severe angioneurotic edema, or need treatment in the past 2 years;
- •Severe hypertension and blood pressure is still more than 150/100 mmHg after drug maintenance therapy;
Outcomes
Primary Outcomes
the safety of whole virus inactivated influenza H5N1 vaccine in healthy adolescents aged from 12-17 years and adults aged from 18-60 years
Time Frame: 21 days after the second dose
Frequency of systemic and local adverse reactions within 21 days after the second doses of whole virus inactivated influenza H5N1 vaccine in healthy adolescents aged from 12-17 years and adults aged from 18-60 years
the immunogenicity of the vaccine after first dose
Time Frame: on day 21±3 days
the seroconversion rate and GMFI of antibodies on day 21 after first dose with different formulation vaccines in healthy adolescents aged from 12-17 years and adults aged from 18-60 years
the immunogenicity of the vaccine after second dose
Time Frame: on day 42±7 days
the seroconversion rate and GMFI of antibodies on day 21 after second dose with different formulation vaccines in healthy adolescents aged from 12-17 years and adults aged from 18-60 years
the immunogenicity of the vaccine after whole immunization
Time Frame: 3 months after second dose (±14 days)
the seroconversion rate and GMFI of antibodies 3 months after the second dose with different formulation vaccines in healthy adolescents aged from 12-17 years and adults aged from 18-60 years
Secondary Outcomes
- abnormal change of hematological examination and the function of liver and kidney after first dose(3 days after first dose)
- abnormal change of hematological examination and the function of liver and kidney after second dose(3 days after second dose)