A Phase 1 Double Blinded, Randomized, Placebo-Controlled Study In Healthy Adult Volunteers In Vietnam To Examine The Safety And Immunogenicity Of A Seasonal Trivalent Inactivated Split Virion Influenza Vaccine (IVACFLU-S) Produced By IVAC
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Influenza, Human
- Sponsor
- Institute of Vaccines and Medical Biologicals, Vietnam
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Number and Percentage of Participants With Serious Adverse Events (SAEs)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This is a phase I, double-blind, randomized, placebo-controlled trial with two groups of subjects to receive seasonal trivalent inactivated split virion influenza vaccine (A/H1N1; A/H3N2 and B strains) or placebo (phosphate buffered saline). A total of 60 healthy male and female adults 18 through 45 years of age will be randomized to receive vaccine (30) or placebo (30).
Detailed Description
This is a phase 1, single center, double blinded, randomized, placebo-controlled study. Sixty (60) healthy male and female adults, 18 to 45 years of age, will be enrolled into the trial. Subjects will be randomized 1:1 to one of two treatment allocations: 30 to vaccine, 30 to placebo. The study will utilize a "randomized block design" to assure a balance of 1:1 vaccine and placebo when all subjects are enrolled. The study will be double blinded, meaning the study subjects, investigators, and the sponsor will be unaware of the treatment allocated to each subject until the clinical trial database is declared final and locked. The study should take about 5 months to complete, with each subject involved for 3 months from the day of injection. The justification for the 3 month follow up, rather than 6 month follow up is that this is an inactivated vaccine that follows very standard manufacturing practices with standard antigens. The safety of inactivated influenza vaccines is well-established. Adding length to the follow up results in delays in future testing of the vaccine for licensure.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female adult 18 through 45 years of age at the enrollment visit.
- •Literate (by self-report) and willing to provide written informed consent.
- •Healthy, as established by the medical history, physical examination, and screening laboratory evaluations.
- •Capable and willing to complete Diary Cards and willing to return for all follow-up visits.
- •For females, willing to utilize reliable birth control measures (e.g., intrauterine device, hormonal contraception, condoms) through the Day 22 visit.
Exclusion Criteria
- •Participation in another clinical trial involving any 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 22 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 22 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 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.
Outcomes
Primary Outcomes
Number and Percentage of Participants With Serious Adverse Events (SAEs)
Time Frame: Over the entire study period (Day 91)
Number of Participants With Immediate Adverse Events
Time Frame: 30-minute post-vaccination period.
Any adverse event occurring within the 30 minute post vaccination period.
Number and Percentage of Participants Reporting Solicited Systemic Reactogenicity
Time Frame: 7-day period (Days 1-7) post-vaccination
Number of subjects reporting solicted systemic reactions (fever, fatigue/malaise, muscle aches, joint aches, chills, nausea, vomiting, and headache) post-vaccination with study vaccine or placebo
Number and Percentage of Participants Reporting Solicited Local Reactogenicity
Time Frame: 7-day period (Days 1-7) post-vaccination.
Number of subjects reporting solicited local reactions (redness, swelling, pain, hardness, and tenderness) at the injection site post-vaccination with study vaccine or placebo.
Number and Percentage of Participants With Unsolicited Adverse Events
Time Frame: Within 21 days post-vaccination
Unsolicited AEs were any AEs that occurred any time after the vaccine/placebo was administered (temporally related to investigational product), whether or not deemed "related" to the product, and are not solicited (specifically asked of the subject). Unsolicited AEs were to be observed by the study center personnel while the subject was at the study center for a study visit or reported by the subject at any time. Any sign or symptom that would normally be considered a "solicited AE" (for example, fever, nausea, injection site pain) starting after 7 days post-vaccination were to be recorded as an "unsolicited AE. In this study, laboratory results were considered AEs when (1) the result was judged to be clinically significant by the Principal Investigator, regardless of grade; or (2) the result is Grade 2 or higher. Note: all unsolicited AEs were mild in intensity. Please see Adverse Events section of this report for detailed information of AEs.
Secondary Outcomes
- Geometric Mean Titers (GMTs) of Serum Hemaggluntination Inhibition (HAI) Antibodies for Each Antigen(Pre- (Day 1) and post-vaccination (Day 22))
- Geometric Mean Neutralization Titers of Neutralizing Antibodies (MNT) Pre- (Day 1) and Post-Vaccination (Day 22) for Each of the 3 Antigens(Pre- (Day 1) and Post-vaccination (Day 22))
- Number and Percentage of Subjects With Seroconversion Against Each of the 3 Antigens(Day 22)
- Number and Percentage of Seroprotected Subjects Against 3 Strains of Influenza Vaccine(Day 1 and Day 22 post vaccination)
- Geometric Mean Fold Rises (GMFRs) of Serum Hemaggluntination Inhibition (HAI) Antibodies(Day 22/Day1)
- Geometric Fold Rises (GMFRs) of Neutralizing Antibodies (MNT) Post-vaccination/Pre-vaccination for Each of the 3 Antigens(Pre- (Day 1) and Post-vaccination (Day 22))