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Home , H5N1 vaccine, Influenza vaccine

Abstract Minimum information:

Title of Trial A Phase 2/3 double-blinded, randomized, -controlled study in healthy adult volunteers in to examine the safety and of an inactivated A/H5N1 (IVACFLU-A/H5N1) produced by IVAC Clinical Trial registration site if applicable (e.g. ClinicalTrials.gov): NCT02612909, IVACFLU-H5N1-II/III1

Authors/sponsors: IVAC/Government of Vietnam, WHO, PATH

Study Design: This was a Phase 2/3, double-blinded, randomized, placebo-controlled study designed to test the safety and immunogenicity of two doses of IVACFLU-A/. Phase 2 was a dose selection studye. Subjects were randomized to one of the three groups (15 mcg IVACFLU-A/H5N1 vaccine, 30 mcg IVACFLU-A/H5N1 vaccine or placebo) at a 1:1:1 ratio

Vaccine: Manufacturer: Institute of and Medical Biologicals (IVAC), Vietnam

Type (whole virus/subvirion/subunit/live/recombinant/DNA/vector): Inactivated whole virion vaccine

Adjuvant: Al(ON)3

Delivery system/site: intramuscular

Doses ( and adjuvant): 15or 30 mcg mcg of virus proteins per dose; Two doses at day 0, 21

Study population:

Age range: Health status: 300 healthy volunteers aged 18-49 yearsy

Specific inclusion/exclusion criteria: Inclusion Criteria: Subjects were eligible for inclusion into the study if they met each of the following criteria: Aged 18 through 60 years on the day of screening/enrollment. Literate (by self-report) and willing to provide written informed consent. Able to attend all scheduled visits and to comply with all study procedures. Healthy or medically stable, as established by medical history and physical examination. For individuals with medical conditions, symptoms/signs, if present, must have been stable, under control or unchanged for the past 3 months. If medication was used to treat the condition, the medication dose must have been stable for at least 1 month preceding . For female subjects: Not breastfeeding or pregnant (based on negative urine test) or plan to become pregnant up to Day 22. Women who were not surgically sterile (hysterectomy or tubal ligation) or postmenopausal for more than 1 year must have had a negative pregnancy test and be willing to utilize reliable birth control measures (intrauterine device, hormonal contraception, condom or diaphragm with spermicide) through the Day 22 visit.

Clinical Endpoints Assessed:

Safety assessments: The number and proportion of subjects reporting the following events: A. Solicited local adverse events (AEs), including redness/erythema, swelling/induration, pain within 30 minutes of vaccination and over a 7-day period (Days 1 to 7) post-vaccination B. Solicited systemic AEs, including , fatigue/malaise, muscle aches, joint aches, chills, nausea, vomiting, and headache within 30 minutes of vaccination and over a 7-day period (Days 1 to 7) post- vaccination C. Unsolicited AEs occurring within 21 days post-vaccination D. Serious adverse events (SAEs) occurring during the entire study period (Days 1 to 91).

Immunogenicity assessments: Study endpoints for HAI titers were as follows: Proportion of subjects with at least a four-fold rise in HAI titer on Day 43. Geometric Mean Titer of Day 43 as determined by the HAI. Geometric Mean Titer Ratio of Day 43/Day 1 as determined by the HAI.

Results: Safety: Serious AEs were reported for 2.0% of subjects in the placebo group and 1.4% of subjects in the 15 mcg vaccine group. No individual SAE was reported by more than one subject in a group. There were no deaths

Immunogenicity

GMT Ratios (post:pre): Fold increase in HI after 2 doses: 11.1 15 µg 10.4 30µg "

Per cent responding (4 fold or greater rise and definition for reporting): : HI≥4 fold increase after 2 doses: 93% 15 µg 94% 30µg

Per cent responders at specified tite : HI≥40 after 2 doses: 83% 15µg 82% 30µg

Others assays:

Status of trial (ongoing/completed): Completed, 2015-2016