Assess the Safety & Immunogenicity of Stored Inactivated Influenza H5N1 Virus Vaccine Given With & Without Stored MF59 Adjuvant

Biomedical Advanced Research and Development Authority (BARDA)

Status and phase: Completed; Phase 2

Conditions: A/Vietnam/H5N1 Influenza Virus

Treatments: Biological: 90 mcg H5N1 (stored in vials); Biological: 15 mcg H5N1 (stored as monobulk); Other: MF59 (stored as monobulk); Other: MF59; Biological: 90 mcg H5N1 (stored as monobulk); Biological: 7.5 mcg H5N1 (stored as monobulk)

Study type: Interventional

Funder types: Other U.S. Federal agency; Industry

Identifiers

NCT02680002

BARDA CSN 15-0001

Details and patient eligibility

About

The main purpose of this study is to assess the usability of long-term stored H5N1 antigen and adjuvant. The study is designed to assist in stockpile management by assessing the safety, reactogenicity, and immunogenicity long-term stored influenza A/Vietnam/H5N1 vaccine when administered with or without MF59® adjuvant.

Full description

This study is a randomized, double-blinded, Phase 2 study to assess the safety and immunogenicity of 2 doses of long-term stored inactivated monovalent influenza A/Vietnam/H5N1 virus vaccine administered intramuscularly with or without MF59 adjuvant in healthy males and nonpregnant females, aged 18 to 49 years, inclusive. This study is designed to assist in stockpile management and will assess the usability of long-term stored H5N1 antigen (ie, stored >10 years) and adjuvant (ie, stored >5 years).

Enrollment: 422 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or nonpregnant female
• Provide written informed consent prior to study-related procedures
• Stable health status
• Access to consistent and reliable means of telephone contact
• Able to understand and comply with planned study procedures
• Agree to stay in contact with site, and no plans to move from study area for study duration

Exclusion criteria

• Allergic to eggs, other vaccine components, or squalene-based adjuvants
• Women with positive pregnancy test within 24 hours of vaccination, or are breastfeeding
• Females of childbearing potential who refuse acceptable birth control, if sexually active, have not used birth control for 2 months prior to study entry
• Have immunosuppression or use anticancer chemotherapy or radiation therapy within preceding 36 months
• Have an active neoplastic disease or history of hematologic malignancy
• Have long term use (≥14 consecutive days) of glucocorticoids (>20 mg/day) or high-dose inhaled steroids (>800 mcg/day) within preceding 6 months
• Diagnosis of schizophrenia, bipolar disease, or major psychiatric diagnosis
• Have been hospitalized for psychiatric illness, attempted suicide or deemed danger to self or others within past 10 years

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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422 participants in 6 patient groups

7.5 mcg H5N1 (monobulk) Plus MF59 (monobulk)

Experimental group

Description:

Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg hemagglutinin (HA) antigen stored long-term as monobulk inactivated

Treatment:

Biological: 7.5 mcg H5N1 (stored as monobulk)

Other: MF59 (stored as monobulk)

15 mcg H5N1 (monobulk) Plus MF59 (monobulk)

Experimental group

Description:

Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long-term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long-term as monobulk MF59 adjuvant

Treatment:

Other: MF59 (stored as monobulk)

Biological: 15 mcg H5N1 (stored as monobulk)

7.5 mcg H5N1 (monobulk) Plus MF59 (vials)

Experimental group

Description:

Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg HA antigen stored long-term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short-term in vials as MF59 adjuvant

Treatment:

Biological: 7.5 mcg H5N1 (stored as monobulk)

Other: MF59

15 mcg H5N1 (monobulk) Plus MF59 (vials)

Experimental group

Description:

Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long-term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short-term in vials as MF59 adjuvant

Treatment:

Other: MF59

Biological: 15 mcg H5N1 (stored as monobulk)

90 mcg H5N1 (monobulk) without MF59

Experimental group

Description:

Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long-term as monobulk inactivated A/Vietnam/H5N1 antigen formulated and filled in 2015, administered without MF59

Treatment:

Biological: 90 mcg H5N1 (stored as monobulk)

90 mcg H5N1 (vials) without MF59

Experimental group

Description:

Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long-term in vials as inactivated A/Vietnam/H5N1 vaccine, administered without MF59

Treatment:

Biological: 90 mcg H5N1 (stored in vials)