Influenza A/H5N1 Vaccine Clinical Trial (IVACFLU-A/H5N1) - Phase 1
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|ClinicalTrials.gov Identifier: NCT02171819|
Recruitment Status : Completed
First Posted : June 24, 2014
Results First Posted : March 14, 2019
Last Update Posted : March 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Influenza A Subtype H5N1 Infection||Biological: IVACFLU-A/H5N1, 7.5 mcg Biological: IVACFLU-A/H5N1, 15 mcg Other: Placebo Comparator||Phase 1|
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 (Clinical Trial)|
|Actual Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 1 Double Blinded, Randomized, Placebo-Controlled Study to Examine the Safety and Immunogenicity of an Inactivated A/H5N1 Influenza Vaccine (IVACFLU-A/H5N1) Produced by IVAC in Healthy Adult Volunteers in Vietnam|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
Experimental: IVACFLU-A/H5N1, 7.5 mcg
IVACFLU-A/H5N1, 7.5 mcg HA per dose
Biological: IVACFLU-A/H5N1, 7.5 mcg
Contains 7.5 mcg HA and 0.6 mg of aluminum hydroxide adjuvant per 0.5 mL dose.
Experimental: IVACFLU-A/H5N1, 15 mcg
IVACFLU-A/H5N1, 15 mcg HA per dose.
Biological: IVACFLU-A/H5N1, 15 mcg
Contains 15 mcg HA and 0.6 mg of aluminum hydroxide adjuvant per 0.5 mL dose
Placebo Comparator: Placebo
Phosphate buffered saline
Other: Placebo Comparator
PBS, pH 7.2 in 0.5 mL single-dose vials.
Other Name: Phosphate Buffered Saline
- Immediate Reactions Occurring Within 60 Minutes of Administration of Any Dose [ Time Frame: 60 min post injection ]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.
- Number of Participants With at Least One Solicted Reactogenicity After Both Injections [ Time Frame: Within 7 days after injection ]
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.
- Number of Participants With at Least One Unsolicited AE [ Time Frame: Within 7 weeks of injection ]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.
- All Serious Adverse Events (SAEs) Occurring Within 3 Weeks of Receipt of Any Dose [ Time Frame: Within 3 weeks of any injection ]Summary data. Data presented are after 1st and 2nd injections combined. Please see AE reporting section of this report for full details.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02171819
|Ben Luc Health Center|
|Bến Lức, Long An Province, Vietnam|
|Principal Investigator:||Le Hoang San, MD||Pasteur Institute, Ho Chi Minh City|