Immunogenicity and Safety Study of a Booster Vaccination With a Recombinant H5N1 Influenza HA Vaccine in Primed Adults

Phase 2CompletedNCT01195038

UMN Pharma Inc.87 enrolled

Overview

The study is designed to assess the immunogenicity and safety of one booster vaccination with 45 μg of a recombinant H5N1 influenza (A/Indonesia/05/2005) HA vaccine in healthy young adults, previously primed with a two-vaccination of 3 different doses of a recombinant H5N1 influenza (A/Vietnam/1203/2004) HA vaccine in a priming study (JPIP501-01a, NCT00980447).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Influenza

Interventions

Recombinant Influenza HA Vaccine (H5N1)BIOLOGICAL

one booster dose of 45 μg rHA derived from A/Indonesia/05/2005 strain

Eligibility

Sex: ALLMin age: 21 YearsMax age: 41 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects who completed a priming study (JPIP501-01a, NCT00980447) * Male and female healthy adults * Written informed consent obtained from the subject before study entry Exclusion Criteria: * History of H5N1 influenza or vaccination of other H5N1 influenza vaccines * Clinically diagnosed cardiovascular, hematological, psychological, neurological, hepatic, renal, pulmonary (including asthma), endocrinological or gastrointestinal disorder * Confirmed immune deficiency conditions, or diagnosed autoimmune diseases such as rheumatoid arthritis and systemic lupus erythematosus * Severe allergic reactions or anaphylaxis to foods or drugs (including vaccines) * Treatment with disallowed drugs including other study drugs * Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply

Locations (2)

UMN Investigational Site

Osaka, Japan

UMN Investigational Site

Tokyo, Japan

Outcomes

Primary Outcomes

Percentage of subjects achieving seroconversion 21 days after a booster vaccination, as measured by hemagglutination inhibition (HI) assay against H5N1 influenza viruses (A/Indonesia/05/2005 & A/Vietnam/1203/2004)

Time frame: Day 21

Secondary Outcomes

Percentage of subjects achieving seroprotection or significant increase in antibody titer on each blood sampling days after a booster vaccination, as measured by HI and microneutralization assays against the H5N1 influenza viruses

Time frame: Days 7, 21

Incidence of adverse events including solicited local or systemic reactions until 21 days after a booster vaccination

Time frame: 21 days

Data from ClinicalTrials.gov

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