H7N9 Mix and Match With MF59 in Healthy Elderly Persons

NCT02213354 | Completed Phase 2

• 2 other identifiers: 13-0034HHSN272201300016I
• Study Type: interventional
• Target: 479
• Locations: 1 country
• Sites: 10

Brief Summary

This is a Phase II randomized, partially-blinded, controlled trial in 360 (up to 600) males and females, 65 years of age and older, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity of a monovalent inactivated influenza A/H7N9 virus vaccine manufactured by Sanofi Pasteur administered intramuscularly at different intervals and dosages (3.75, 7.5, or 15 mcg of HA/0.5 mL dose) given with MF59 adjuvant manufactured by Novartis Vaccines and Diagnostics. Subjects will receive three doses of the vaccine. Safety, reactogenicity, and immunogenicity data will be collected at standard time points with safety follow-up to continue through one year post dose 2. Study Duration is approximately 30 months and Subject Participation is approximately 18 months. The primary objectives are to (1) assess the safety and reactogenicity of different dosages (3.75, 7.5, and 15 mcg of HA/0.5 mL dose) of an MF59-adjuv

Conditions

Avian Influenza

Keywords

Influenza, H7N9, Elderly, Vaccine, MF59 Adjuvant

Outcome Measures

Primary Outcomes (4)

• Percentage of subjects achieving a serum HAI antibody titer of 1:40 or greater against the A/H7N9 antigen contained in the study vaccine

  28 days after the second study vaccination

• Percent of subjects achieving HAI seroconversion against the A/H7N9 antigen contained in the study vaccine (either a pre-vaccine HAI titer < 1:10 and a post-vaccine HAI titer > /= 1:40 or a pre-vaccine HAI titer > /=1:10 and a min 4-fold rise in post-vac

  28 days after the second study vaccination

• Occurrence of study vaccine-related serious adverse events

  Through Day 1 to 12 months after the last study vaccination

• Occurrence of solicited injection site and systemic reactogenicity events

  Through 8 days after each study vaccination

Secondary Outcomes (7)

• Occurrence of study vaccine-related unsolicited non-serious adverse events

  28 days after each study vaccination

• Occurrence of new-onset chronic medical conditions

  Through Day 1 to 12 months after the last study vaccination

• Percentage of subjects achieving Neut seroconversion against A/H7N9 antigen (either prevaccination Neut titer < 1:10 and postvaccination Neut titer > /=1:40 or prevaccination Neut titer > /=1:10 and minimum fourfold rise in post-vaccination Neut

  28 days after the second and third study vaccinations

• Geometric Mean Titers of serum HAI and Neut antibodies against the A/H7N9 antigen

  Baseline and 28 days after the second and third study vaccinations

• Percentage of subjects achieving a serum HAI antibody titer of 1:40 or greater against the A/H7N9 antigen contained in the study vaccine

  Baseline and 28 days after the third study vaccination

Study Arms (6)

Group 2

EXPERIMENTAL

60 subjects receive Sanofi A/H7N9 antigen 3.75 mcg plus Novartis MF59 adjuvant IM on Day 1, Day 57, and Day 169

Drug: MF59; Biological: Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013

Group 6

EXPERIMENTAL

60 subjects receive Sanofi A/H7N9 antigen 15 mcg plus Novartis MF59 adjuvant IM on Day 1, Day 57, and Day 169

Drug: MF59; Biological: Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013

Group 5

EXPERIMENTAL

60 subjects receive Sanofi A/H7N9 antigen 15 mcg plus Novartis MF59 adjuvant IM on Day 1, Day 29 and Day 169

Drug: MF59; Biological: Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013

Group 4

EXPERIMENTAL

60 subjects receive Sanofi A/H7N9 antigen 7.5 mcg plus Novartis MF59 adjuvant IM on Day 1, Day 57, and Day 169

Drug: MF59; Biological: Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013

Group I

EXPERIMENTAL

60 subjects receive Sanofi A/H7N9 antigen 3.75 mcg plus Novartis MF59 adjuvant intramuscularly (IM) on Day 1, Day 29 and Day 169

Drug: MF59; Biological: Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013

Group 3

EXPERIMENTAL

60 subjects receive Sanofi A/H7N9 antigen 7.5 mcg plus Novartis MF59 adjuvant IM on Day 1, Day 29 and Day 169

Drug: MF59; Biological: Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013

Interventions

MF59 DRUG

Microfluoridized adjuvant 59 (MF59) is an oil-in-water emulsion. Group 1-6 receive 3.75 mcg, 7.5 mcg and 15 mcg.

Group 2; Group 3; Group 4; Group 5; Group 6; Group I

Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013 BIOLOGICAL

Monovalent inactivated split influenza virus vaccine made with HA antigen derived from the influenza A/Shanghai/2/2013 virus. Monovalent influenza A/H7N9 virus vaccine. Group 1-6 receive 3.75 mcg, 7.5 mcg and 15 mcg.

Group 2; Group 3; Group 4; Group 5; Group 6; Group I

Eligibility Criteria

• Age: 65 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Provide written informed consent prior to initiation of any study procedures.
• Are able to understand and comply with planned study procedures and be available for all study visits.
• Are males or females, 65 years of age and older.

You may not qualify if:

• Oral temperature is less than 100.0 degrees F.
• Pulse is 50 to 115 bpm, inclusive.
• Systolic blood pressure is 85 to 160 mm Hg, inclusive.
• Diastolic blood pressure is 55 to 95 mm Hg, inclusive
• \. Have an acute illness2, as determined by the site principal investigator or appropriate sub-investigator, within 72 hours prior to study vaccination.
• An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site principal investigator or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol.
• \. Have any medical disease or condition that, in the opinion of the site principal investigator or appropriate sub-investigator, is a contraindication to study participation3.
• Including acute or chronic medical disease or condition, defined as persisting 3 months (defined as 90 days) or longer, that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this study.
• \. Reside in a nursing home4 or other skilled nursing facility or have a requirement for skilled nursing care.
• An ambulatory subject who does not require skilled nursing care and is a resident of a retirement home or community is eligible for this clinical trial.
• \. Inability to provide informed consent or complete study activities, for example, due to dementia or other impairment.
• \. Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior to study vaccination.
• \. Have known active neoplastic disease or a history of any hematologic malignancy.
• \. Have known HIV, hepatitis B, or hepatitis C infection. 8. Have known hypersensitivity or allergy to eggs, egg or chicken protein, squalene-based adjuvants, or other components of the study vaccine.
• \. Have a history of severe reactions following previous immunization with licensed or unlicensed influenza virus vaccines.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (10)

Emory Vaccine Center - The Hope Clinic

Decatur, Georgia, 30030-1705, United States

Location

University of Iowa - Vaccine Research and Education Unit

Iowa City, Iowa, 52242-2600, United States

Location

University of Maryland School of Medicine - Center for Vaccine Development - Baltimore

Baltimore, Maryland, 21201-1509, United States

Location

Saint Louis University - Center for Vaccine Development

St Louis, Missouri, 63104-1015, United States

Location

Duke Human Vaccine Institute - Duke Clinical Vaccine Unit

Durham, North Carolina, 27704, United States

Location

Cincinnati Children's Hospital Medical Center - Infectious Diseases

Cincinnati, Ohio, 45229-3026, United States

Location

Vanderbilt University Medical Center - Vanderbilt Institute for Clinical and Translational Research - Clinical Research Center (VICTR-CRC)

Nashville, Tennessee, 37232-0011, United States

Location

University of Texas Medical Branch - Sealy Center for Vaccine Development - Clinical Trials Group

Galveston, Texas, 77555-1119, United States

Location

Baylor College of Medicine - Molecular Virology and Microbiology

Houston, Texas, 77030-3411, United States

Location

Group Health Research Institute - Seattle - Vaccines and Infectious Diseases

Seattle, Washington, 98101-1466, United States

Location

MeSH Terms

Conditions

Influenza in Birds; Influenza, Human

Interventions

MF59 oil emulsion; Influenza Vaccines

Condition Hierarchy (Ancestors)

Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Infections; Bird Diseases; Animal Diseases; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2014
• First Posted: August 11, 2014
• Study Start: October 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 6, 2017

Record last verified: 2016-04

Locations

US (10)