Safety and Immunogenicity of a Monovalent Inactivated Influenza H3N2 Variant (H3N2v) Vaccine in Adult and Elderly Populations

NCT01746082 | Completed Phase 2

• 2 other identifiers: 12-0011HHSN272200800002C
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 4

Brief Summary

This is a Phase II open-label study in approximately 200, and up to 240, healthy males and non-pregnant females, aged 18 years and older. This study is designed to assess the safety, reactogenicity, and immunogenicity of an unadjuvanted subvirion monovalent inactivated influenza H3N2v vaccine manufactured by Sanofi Pasteur. Subjects will be stratified by age (approximately 100 (up to 120) subjects 18-64 years old and approximately 100 (up to 120) subjects \>/= 65 years old) to receive two doses of vaccine, delivered intramuscularly as 15mcg HA/0.5mL dose, 21 days apart. The duration of the study for each subject will be approximately 7 months.

Conditions

Influenza

Keywords

influenza, H3N2, H3N2v, vaccine, unadjuvanted, Parent Protocol

Outcome Measures

Primary Outcomes (4)

• Percentage of subjects, stratified by age, achieving seroconversion (defined as either a pre-vaccination HAI titer <1:10 and a post-vac. HAI titer >/= 1:40 or a pre-vac. HAI titer >/= 1:10 and a minimum four-fold rise in post-vac. HAI antibody titer).

  21 days following the first vaccination

• Safety: Occurrence of solicited injection site and systemic reactogenicity on the day of each H3N2v vaccination through 7 days after each H3N2v vaccination.

  Through Day 7 following each vaccination

• Immunogenicity: Proportion of subjects, stratified by age, achieving a serum HAI antibody titer of 1:40 or greater approximately 21 days following receipt of the first dose of H3N2v MIV against the H3N2v antigen contained in the H3N2v MIV.

  21 days following the first vaccination

• Safety: Occurrence of H3N2v MIV-related serious adverse events from the time of first H3N2v vaccination through 7 months after the first H3N2v vaccination.

  Through 7 months following the first vaccination

Secondary Outcomes (5)

• Percentage of subjects, stratified by age, achieving either a pre-vaccination Neut titer <1:10 and a post-vaccination Neut titer >/=1:40 or a pre-vaccination Neut titer >/=1:10 and a minimum four-fold rise in post-vaccination Neut antibody titer.

  8, 21, 29 and 42 days following the first vaccination

• Immunogenicity: Proportion of subjects, stratified by age, achieving a serum HAI antibody titer of 1:40 or greater approximately 8, 29 and 42 days following receipt of the first dose of H3N2v MIV against the H3N2v antigen contained in the H3N2v MIV.

  8, 29 and 42 days following the first vaccination

• Immunogenicity: Geometric Mean Titers of serum HAI and Neut antibody at baseline, and approximately 8, 21, 29 and 42 days after the first H3N2v vaccination.

  Baseline, 8, 21, 29 and 42 days following the first vaccination

• Percentage of subjects, stratified by age, achieving seroconversion (defined as either a pre-vaccination HAI titer <1:10 and a post-vac. HAI titer >/=1:40 or a pre-vac. HAI titer >/=1:10 and a minimum four-fold rise in post-vac. HAI antibody titer).

  8, 29 and 42 days following the first vaccination

• Immunogenicity: Proportion of subjects, stratified by age, achieving a serum Neut antibody titer of 1:40 or greater approximately 8, 21, 29 and 42 days following receipt of the first dose of H3N2v MIV against the H3N2v antigen contained in the H3N2v MIV.

  8, 21, 29 and 42 days following the first vaccination

Study Arms (2)

Subjects 18 - 64 years

EXPERIMENTAL

100 (up to 120) subjects 18 - 64 years old receive two doses of monovalent inactivated influenza H3N2 variant (MIV), delivered intramuscularly as 15 micrograms (mcg) of hemagglutinin (HA)/0.5 milliliter (mL) dose, 21 days apart.

Biological: Influenza A/H3N2 variant Vaccine

Subjects > /= 65 years

EXPERIMENTAL

100 (up to 120) subjects greater than or equal to 65 years old receive two doses of monovalent inactivated influenza H3N2 variant (MIV), delivered intramuscularly as 15 micrograms (mcg) of hemagglutinin (HA)/0.5 milliliter (mL) dose, 21 days apart.

Biological: Influenza A/H3N2 variant Vaccine

Interventions

Influenza A/H3N2 variant Vaccine BIOLOGICAL

Investigational influenza virus H3N2v vaccine, a monovalent type A inactivated vaccine (H3N2v MIV) for intramuscular use, is a sterile clear and slightly opalescent suspension prepared from influenza virus propagated in embryonated chicken eggs. The H3N2v MIV contains no preservative. Subjects will be stratified by age (approximately 100 (up to 120) subjects 18-64 years old and approximately 100 (up to 120) subjects \>/=65 years old) to receive two doses of H3N2v MIV, delivered intramuscularly as 15 micrograms (mcg) of hemagglutinin (HA)/0.5 milliliter (mL) dose, 21 days apart

Subjects 18 - 64 years; Subjects > /= 65 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), 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 non-pregnant females, aged 18 years or older, inclusive.

You may not qualify if:

• Oral temperature is less than 100.4°F.
• Pulse is 50 to 100 bpm.
• Systolic blood pressure is 90 to 150 mm Hg.
• Diastolic blood pressure is 60 to 100 mmHg.
• Women of childbearing potential (not surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who are not postmenopausal for greater than or equal to 1 year) must agree to practice adequate contraception (abstinence from sexual intercourse with men, monogamous relationship with a vasectomized partner who was vasectomized at least 6 months prior to the subject receiving the first H3N2v vaccination, barrier methods such as condoms or diaphragms with spermicide or foam, effective intrauterine devices NuvaRing®, successful Essure® placement (permanent, non-surgical, non-hormonal sterilization) with documented confirmation test at least 3 months after the procedure), licensed hormonal methods such as implants, injectables or oral contraceptives (the pill), and any other Food and Drug Administration (FDA) approved birth control method) for at least 30 days prior to the first H3N2v vaccination through at least 30 days after the last H3N2v vaccination . Method of contraception will be captured on the appropriate data collection form.
• Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to each H3N2v vaccination.
• Have an acute illness, including an oral temperature greater than or equal to 100.4°F, within 3 days prior to each H3N2v vaccination.
• Have any condition that, in the opinion of the site principal investigator or appropriate sub-investigator, would place the subject at an unacceptable risk of injury, render them unable to meet the requirements of the protocol or confound the interpretation of results.
• Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy (cytotoxic) within the preceding 36 months.
• Have known active neoplastic disease or a history of any hematologic malignancy.
• Have known HIV, hepatitis B, or hepatitis C infection.
• Have a known allergy to eggs, egg or chicken protein, or other components of the H3N2v MIV (including octylphenol ethoxylate (Triton® X-100), gelatin, formaldehyde, and phosphate buffered saline).
• Have a history of severe reactions following previous immunization with licensed influenza virus vaccines.
• Have a history of Guillain-Barre Syndrome.
• Have a history of alcohol or drug abuse in the last 5 years.

Sponsors & Collaborators

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

Study Sites (4)

Emory Vaccine Center - The Hope Clinic

Decatur, Georgia, 30030-1705, United States

Location

University of Iowa - Infectious Disease Clinic

Iowa City, Iowa, 52242-1009, United States

Location

Baylor College of Medicine - Molecular Virology and Microbiology

Houston, Texas, 77030-3411, United States

Location

Group Health Research Institute - Seattle

Seattle, Washington, 98101-1466, United States

Location

Related Publications (1)

• Keitel WA, Jackson LA, Edupuganti S, Winokur PL, Mulligan MJ, Thornburg NJ, Patel SM, Rouphael NG, Lai L, Bangaru S, McNeal MM, Bellamy AR, Hill HR; VTEU H3N2v Vaccine Study Work Group. Safety and Immunogenicity of a Subvirion Monovalent Unadjuvanted Inactivated Influenza A(H3N2) Variant Vaccine in Healthy Persons >/=18 Years Old. J Infect Dis. 2015 Aug 15;212(4):552-61. doi: 10.1093/infdis/jiv056. Epub 2015 Feb 3.

  PMID: 25649171 DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2012
• First Posted: December 10, 2012
• Study Start: January 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: February 28, 2014

Record last verified: 2014-01

Locations

US (4)