Influenza A/H5N1 Clinical Trial
Official title:
A Phase 2 Double Blinded, Randomized, Placebo-controlled Study in Healthy Adult Volunteers in Vietnam to Examine the Safety and Immunogenicity of an Inactivated A/H5N1 Influenza Vaccine (IVACFLU-A/H5N1) Produced by IVAC
Influenza is one of the major infectious disease threats to the human population due to both
the adverse health impact of annual influenza epidemics and the detrimental global
consequences of influenza pandemics. Since 1997, highly pathogenic A/H5N1 avian viruses have
caused both widespread outbreaks in poultry with high mortality and sporadic, severe, and
fatal disease in humans. Southeast Asian countries, including Vietnam, have been affected by
influenza A/H5N1. From 2003 through March 2015, 826 confirmed human cases of A/H5N1
influenza infection have been reported by the World Health Organization; including 440 fatal
cases. Southeast Asian countries accounted for 42% of all confirmed influenza A/H5N1 cases
reported since 2003, and influenza A/H5N1 infection in animals is now thought to be endemic
in the region. As of March 2015, Vietnam has reported 127 confirmed human cases and 64
deaths. In 2014, 2 cases of A/H5N1 avian influenza were reported in Vietnam. Therefore, the
risk of transmission to human is still present.
Currently, no influenza A/H5N1 vaccine has been licensed in Vietnam. If a pandemic emerged,
vaccine demand could be huge.
This is a Phase 2, double-blind, randomized, placebo-controlled trial to test the safety and
immunogenicity of two doses given 21 days apart of the IVAC A/H5N1 vaccine.
| Status | Recruiting |
| Enrollment | 300 |
| Est. completion date | August 2016 |
| Est. primary completion date | June 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 60 Years |
| Eligibility |
Inclusion Criteria: - Male or female adult 18 through 60 years of age at the enrollment visit. - Literate (by self-report) and willing to provide written informed consent. - Healthy adults, as established by the medical history and screening evaluations, including physical examination, capable and willing to complete Diary Cards, and willing to return for all follow-up visits. - For females able to become pregnant, willing to utilize reliable birth control measures (intrauterine device, hormonal contraception, condoms) through the Day 43 visit. Exclusion Criteria: - Participation in another clinical trial involving any vaccine or therapy within the previous three months, or planned enrollment in such a trial during the period of this study. - Receipt of any non-study vaccine within 4 weeks prior to enrollment or refusal to postpone receipt of such vaccines until after the Day 43 visit. - Current or recent (within 2 weeks of enrollment) acute illness with or without fever. - Receipt of immune globulin or other blood products within 3 months prior to study enrollment or planned receipt of such products prior to the Day 43 visit. - Chronic administration (defined as more than 14 consecutively-prescribed days) of immunosuppressants or other immune-modulating therapy within six months prior to study enrollment. (For corticosteroids, this means prednisone or equivalent, = 0.5 mg per kg per day; topical or intranasal steroids are allowed.) - History of asthma. - Hypersensitivity after previous administration of any vaccine. - Suspected or known hypersensitivity to any of the study vaccine components, including chicken or egg protein, antibiotics, and rubber (from the vaccine vial stoppers). - Acute or chronic clinically significant pulmonary, cardiovascular, hepatobiliary, metabolic, neurologic, psychiatric, or renal functional abnormality, as determined by medical history, physical examination, or clinical laboratory screening tests, which in the opinion of the investigator, might interfere with the study objectives. - History of any blood or solid organ cancer. - History of thrombocytopenic purpura or known bleeding disorder. - History of seizures. - Known or suspected immunosuppressed or immune deficient condition of any kind. - Known HBV or HCV infection by self-report (Phase 3) or a positive test for either Hepatitis B virus surface antigen (HBsAg) or HCV antibody using anti-HCV test (Phase 2). - Known HIV infection (self-report)" - Known active tuberculosis or symptoms of active tuberculosis (self-report). - History of chronic alcohol abuse and/or illegal drug use. - Pregnancy or lactation (a negative pregnancy test will be required before administration of study product for all women of childbearing potential). - History of Guillain-Barre Syndrome. - Any condition in the opinion of the investigator that would increase the health risk of the subject if he/she participates in the study or interfere with the evaluation of the study objectives. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Vietnam | Khanh Hoa Health Service | Nha Trang | Khanh Hoa |
| Lead Sponsor | Collaborator |
|---|---|
| National Institute of Hygiene and Epidemiology, Vietnam | Institute of Vaccines and Medical Biologicals, Vietnam, PATH |
Vietnam,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of subjects with solicited local and systemic adverse events within 7 days after each vaccination dose | Number of subjects with solicited local adverse events such as redness, swelling, pain, induration, tenderness over 7-days after each vaccine dose Number of subjects with solicited systemic adverse events including (fever, fatigue/malaise, muscle aches (generalized), joint aches, chills, nausea, vomiting, headache) over 7-days after each vaccination dose | 7 days after each vaccination dose | Yes |
| Secondary | Number of subjects with serious adverse events (SAEs) occurring over the entire study period | Number of subjects with serious adverse events (SAEs) occurring over 91 days after the first dose | 91 days after the first dose | Yes |
| Secondary | Number of subjects with solicited local and systemic adverse events within 30 minutes of each vaccination dose | Number of subjects with solicited local and systemic adverse events within 30 minutes of each vaccination dose | within 30min of each vaccination dose | Yes |
| Secondary | Number of subjects with unsolicited local and systemic adverse events within 7-days after each vaccination dose | Number of subjects with unsolicited local and systemic adverse events within 7-days after each vaccination dose | 7 days after each vaccination dose | Yes |
| Secondary | percentage of subjects with a serum HAI titer = 1:40 after vaccination | percentage of subjects with a serum HAI titer = 1:40 21-days post-vaccination | 21 days post-vaccination | No |
| Secondary | percentage of subjects achieving a seroresponse (at least a four-fold increase in post-vaccination titer) 21 days after each vaccine dose by Haemagglutination inhibition assay (HAI) | percentage of subjects achieving at least a four-fold increase in HAI antibody titer 21 days after each vaccination dose | 21 days after each dose | No |
| Secondary | percentage of subjects achieving a seroresponse (at least a four-fold increase in post-vaccination titer) 21 days after each dose by microneutralization assay | percentages of subjects achieving at least a four-fold increase in neutralising antibody titer 21 days after each dose | 21 days after each dose | No |
| Secondary | Geometric Mean Titer (GMT) 21 days after the first dose as determined by the HAI and MN tests. | Geometric Mean Titer (GMT) 21 days after the first dose as determined by the HAI and MN tests. | 21 days after the first vaccine dose | No |
| Secondary | Geometric Mean Titer (GMT) 42 days after the first dose as determined by the HAI and MN tests. | Geometric Mean Titer (GMT) 42 days after the first dose as determined by the HAI and MN tests. | 42 days after the first vaccine dose | No |