This is a first-in-human study of safety and immunogenicity of an A/H5N1 inactivated whole cell vaccine when given in two injections in two doses (low and high) compared to a placebo in 76 healthy adult subjects in Vietnam. Vaccine and placebo are manufactured by the IVAC in Vietnam.
This is a phase 1, double blinded, randomized, placebo-controlled study. Seventy-six healthy male and female adults, 18 to 30 years of age, will be enrolled into the trial. Subjects will be randomized to one of three treatment allocations: 32 subjects to 7.5 mcg/dose vaccine (low dose), 32 subjects to 15 mcg/dose vaccine (high dose) and 12 subjects to placebo. This sample size was selected to enable at least 30 evaluable subjects in each of the groups receiving active vaccine. The study will utilize a "block randomization" to assure a balance of 8:8:3 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. Since this is a first-in-human study, all injections of study product will be sequential and staggered and there will be a safety evaluation between a sentinel cohort of 19 subjects and the remaining 57 study subjects for both the 1st and 2nd doses in the study. A sentinel group of 19 participants' enrollment and vaccination will precede the remainder of the study group by approximately 2-3 weeks. Product administration for both injections of vaccine or placebo will be sequential and staggered.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
75
Contains 7.5 mcg HA and 0.6 mg of aluminum hydroxide adjuvant per 0.5 mL dose.
Contains 15 mcg HA and 0.6 mg of aluminum hydroxide adjuvant per 0.5 mL dose
PBS, pH 7.2 in 0.5 mL single-dose vials.
Ben Luc Health Center
Bến Lức, Long An Province, Vietnam
Immediate Reactions Occurring Within 60 Minutes of Administration of Any Dose
Data presented are after 1st and 2nd vaccination combined. All participants were observed for immediate reactions for 60 minutes after administration of study product, with appropriate medical treatment readily available in case of an anaphylactic reaction following the administration of study product.
Time frame: 60 min post injection
Number of Participants With at Least One Solicted Reactogenicity After Both Injections
Data presented are after 1st and 2nd vaccination combined. Solicted reactogenicity are local and systemic events that are expected after injection and specifically asked of the participant. Only reported reactogenicity is presented. If not shown, then no participant reported that reaction in any study group. Local reactions are redness, swelling, pain, tenderness, and hardness. Systemic reactions are actual and subjective fever, chills, cough, difficulty breathing, runny nose, nasal congestion, sore throat, hoarseness of voice, headache, confusion. convulsions/seizures, fatigue/malaise, muscle aches (generalized), joint pain, pink or red eyes, sore eyes, itchy eyes, drainage from eyes. ear pain or discharge, rash, abdominal pain, diarrhea, vomiting, and jaundice.
Time frame: Within 7 days after injection
Number of Participants With at Least One Unsolicited AE
Summary of number of participants with at least one unsolicited AE after 1st and 2nd vaccination combined. Please see the adverse event section of this report for full details.
Time frame: Within 7 weeks of injection
All Serious Adverse Events (SAEs) Occurring Within 3 Weeks of Receipt of Any Dose
Summary data. Data presented are after 1st and 2nd injections combined. Please see AE reporting section of this report for full details.
Time frame: Within 3 weeks of any injection
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The Proportion of Subjects Achieving a Hemagglutination Inhibition (HAI) Titer ≥ 1:40 Pre-vaccination (Day 0) to Post 2nd Vaccination (Day 49)
Time frame: Day 0 to Day 49
The Proportion of Subjects Achieving a Four-fold Rise in HAI Between Doses or From Baseline to Post-Injection 2
Time frame: Days 21 and 42
Geometric Mean Titer (GMT) of Hemagglutination Inhibition After Each Dose
Time frame: Days 0, 21 and 42
Geometric Mean Titer (GMT) of Neutralizing Antibody After Each Dose
Time frame: Days 0, 21, and 42