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Report for Clinical Trial NCT00908687

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Randomized Blinded, LT Dose-ranging Study to Assess the Immunogenicity and Safety of Different Doses of LT Adjuvant Patch Administered in Conjunction With Different Doses of Inactivated Influenza A/H5N1 Vaccine in Healthy Adults

This is a Phase 2, randomized, blinded, clinical trial. Up to 500 eligible subjects will be enrolled and randomized in a 1:2:2:1:2:2 ratio into one of six groups, and vaccinated in this study. Subjects will receive an intramuscular injection of the influenza A/H5N1 (low or high dose) on Day 0 with or without a patch (low or high dose).

NCT00908687 Pandemic Influenza
MeSH:Influenza, Human

4 Interventions

Name: A/H5N1

Description: A/H5N1 Low Dose
Type: Biological
Group Labels: 3

Group 1: 30 µg HA, no LT patch Group 2: 30 µg HA + 50 µg LT patch Group 3: 30 µg HA + 100 µg LT patch

Name: A/H5N1

Description: A/H5N1 High Dose
Type: Biological
Group Labels: 3

Group 4: 45 µg HA, no LT patch Group 5: 45 µg HA + 50 µg LT patch Group 6: 45 µg HA + 100 µg LT patch

Name: LT Adjuvant Patch

Description: LT Adjuvant Patch Low Dose
Type: Biological
Group Labels: 2

Group 2: 30 µg HA + 50 µg LT patch Group 5: 45 µg HA + 50 µg LT patch

Name: LT Adjuvant Patch

Description: LT Adjuvant Patch High Dose
Type: Biological
Group Labels: 2

Group 3: 30 µg HA + 100 µg LT patch Group 6: 45 µg HA + 100 µg LT patch


Primary Outcomes

Description: Seroconversion is defined as either 1) baseline HI titer < 1:10 and a post-vaccination HI titer ≥ 1:40, or 2) baseline HI titer ≥ 1:10 and a minimum four-fold rise. Seroprotection is defined as a post-vaccination HI antibody titer ≥ 1:40.

Measure: Assess the Proportion of Subjects in Each Dose Group Achieving Seroconversion and Seroprotection for HI Antibody Titer Through Day 28.

Time: Day 28

Secondary Outcomes

Measure: Safety of A/H5N1 Vaccine IM Injection With and Without an LT Adjuvant Patch

Time: 6 months

Measure: Safety of a 100μg LT Patch

Time: 6 months

Description: The percent of subjects achieving seroconversion for HI antibody titer should meet or exceed 40% The percent of subjects achieving an HI antibody titer ≥ 1:40 should meet or exceed 70% Geometric mean titer (GMT) fold increase > 2.5

Measure: Evaluate Treatment Group HI Responses Against US FDA Guidance for Industry: Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines (May 2007) and EMA CPMP/BWP/214/96 Criteria for Immunogenicity

Time: Day 28

Other Outcomes

Measure: Adjuvanticity Evaluation: Compare HI Immune Responses Achieved by Antigen and Adjuvant Combinations With Antigen Alone Groups.

Time: 6 months

Measure: Cross-clade HI Antibody Titer Measurement: Compare the Heterologous HI Antibody Responses to the A/Indonesia/05/2005 (Clade 2.1) Strain of the H5N1 Virus.

Time: 6 months

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 R192G

Acceptable forms of birth control are: abstinence, hormonal contraceptives (oral, injectable, implant, patch, ring), double-barrier contraceptives (condom or diaphragm, with spermicide) and IUD Exclusion Criteria: - Clinically significant laboratory abnormalities at screening - Abnormalities at physical examination [as determined by the Toxicity Grading Scale (grade 1-4)] - Known allergies to any component of the vaccine - Known egg protein allergy - Known allergies to adhesives - Known disturbance of coagulation - Participated in research involving investigational product within 45 days before planned date of vaccination - Donated or received blood or blood products such as plasma within the past 45 days - Received any licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to planned date of vaccination - Ever received investigational enterotoxigenic E. coli, or LT (R192G) or NasalFlu, Berna Biotech Ltd - Ever received cholera toxin or vaccine (e.g. --- R192G ---



HPO Nodes