Open-Label Influenza Vaccine Evaluation

Immune Response Clinical Trial

— OLIVE  

Official title:

Open-Label, Randomized Study of Immune Response to Licensed Influenza Vaccines in Adults 65-74 Years of Age (US Flu Vaccine Effectiveness Serologic Study, 2016-17 and 2017-18)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02872311
• Other study ID #: MCL10416
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: September 2018

Study information

• Verified date: December 2019
• Source: Marshfield Clinic Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open-label, randomized trial in up to 210 adults aged 65-74 years to evaluate the immune response to consecutive influenza vaccination across 2 seasons. Participants will be randomized to receive 1 of 3 licensed and recommended vaccines in the first year; 2 arms will receive the same vaccination in the second year and the third arm will be randomized again to 1 of 3 licensed vaccines. All participants will have pre and post-vaccination serum blood draws for a total of 6 draws over 18 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: September 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 74 Years

Eligibility

Inclusion Criteria:

• Age 65-74 years at the time of study enrollment and are ambulatory and live in selected Wisconsin community or surrounding communities.

• Willing and able to give informed consent prior to study enrollment

• Able to comply with study requirements.

Exclusion Criteria:

• Prior receipt of 2016-17 influenza vaccine

• Current participation in another clinical trial

• Presence of a contraindication to influenza vaccine

Related Conditions & MeSH terms

• Immune Response
• Influenza, Human

Intervention

Biological:
• High Dose Influenza vaccine
Licensed and FDA approved Fluzone HD vaccine to be administered to study participants
• Adjuvanted Influenza vaccine
Licensed and FDA approved FluAd vaccine to be administered to study participants
• Standard Dose Influenza vaccine
Licensed and FDA approved Fluvirin vaccine to be administered to study participants
• Recombinant Influenza vaccine
Licensed and FDA approved FluBlok vaccine to be administered to study participants

Locations

Country	Name	City	State
United States	Marshfield Clinic - Marshfield Center	Marshfield	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Marshfield Clinic Research Foundation	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HI Titers, HD vs. AD, Yr 1 Day 28 Post Vaccination	Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 28 days post vaccination 2016-17	Year 1, Day 28 post vaccination
Primary	HI Titers, HD vs. AD, Yr 1 Day 182 Post Vaccination	Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 182 days post vaccination 2016-17	Year 1, Day 182 post vaccination
Primary	HI Titers, HD vs. AD, Yr 1 Day 365 Post Vaccination	Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 365 days post vaccination 2016-17	Year 1, Day 365 post vaccination
Primary	HI Titers, HD vs. AD, Yr 2 Day 28 Post Vaccination	Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 28 days post vaccination 2017-18	Year 2, Day 28 post vaccination
Primary	HI Titers, HD vs. AD, Yr 2 Day 182 Post Vaccination	Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 182 days post vaccination 2017-18	Year 2, Day 182 post vaccination
Secondary	HI Response by Prior Season Vaccination, Yr 1, Day 28 Post Vaccination	Hemagglutination inhibition (HI) Titers by prior season (2015-16) vaccination status among adjuvant and high dose vaccine recipients 28 days post vaccination, 2016-17	Year 1, Day 28 post vaccination
Secondary	HI Response by Prior Season Vaccination, Yr 1, Day 182 Post Vaccination	Hemagglutination inhibition (HI) Titers by prior season (2015-16) vaccination status among adjuvant and high dose vaccine recipients 182 days post vaccination, 2016-17	Year 1, Day 182 post vaccination
Secondary	HI Response by Prior Season Vaccination, Yr 1, Day 365 Post Vaccination	Hemagglutination inhibition (HI) Titers by prior season (2015-16) vaccination status among adjuvant and high dose vaccine recipients 365 days post vaccination, 2016-17	Year 1, Day 365 post vaccination
Secondary	MN Titers, HD vs. AD, Year 1, Day 28 Post Vaccination	Microneutralization antibody titers to vaccine and drifted viruses among high dose and adjuvanted vaccine recipients 28 days post vaccination, 2016-17	Year 1, Day 28 post vaccination
Secondary	MN Titers, HD vs. AD, Year 1, Day 182 Post Vaccination	Microneutralization antibody titers to vaccine and drifted viruses among high dose and adjuvanted vaccine recipients 182 days post vaccination, 2016-17	Year 1, Day 182 post vaccination
Secondary	MN Titers, HD vs. AD, Year 1, Day 365 Post Vaccination	Microneutralization antibody titers to vaccine and drifted viruses among high dose and adjuvanted vaccine recipients 365 days post vaccination, 2016-17	Year 1, Day 365 post vaccination
Secondary	MN Titers (A/Hong Kong (Siat Cell)), HD vs. AD, Year 2, Day 28 Post Vaccination	Microneutralization antibody titers to vaccine virus (A/Hong Kong (siat cell) among high dose and adjuvanted vaccine recipients 28 days post vaccination, 2017-18	Year 2, Day 28 post vaccination
Secondary	HI Titers, HD vs. AD vs. RIV With Prior Season Standard (IIV) Dose, Year 2, Day 28 Post Vaccination	Hemagglutination Inhibition (HI) titers to vaccine viruses among adjuvant, high dose and recombinant recipients with prior season standard dose vaccine at 28 days post vaccination 2017-18	Year 2, Day 28 post vaccination
Secondary	HI Titers, HD vs. AD vs. RIV With Prior Season Standard (IIV) Dose, Year 2, Day 182 Post Vaccination	Hemagglutination Inhibition (HI) titers to vaccine viruses among adjuvant, high dose and recombinant recipients with prior season standard dose vaccine at 182 days post vaccination 2017-18	Year 2, Day 182 post vaccination
Secondary	HI Titers, IIV+AD or HD vs. Sequential AD or HD, Year 2, Day 28 Post Vaccination	Hemagglutination inhibition (HI) titers among HD and AD based on prior season vaccination (standard or sequential same vaccination) at 28 days after vaccination, 2017-18	Year 2, Day 28 post vaccination
Secondary	HI Titers, IIV+AD or HD vs. Sequential AD or HD, Year 2, Day 182 Post Vaccination	Hemagglutination inhibition (HI) titers among HD and AD based on prior season vaccination (standard or sequential same vaccination) at 182 days after vaccination, 2017-18	Year 2, Day 182 post vaccination
Secondary	Number of Participants With Vaccine Failure, Year 1	Number of Participants with Vaccine Failure in Year 1 by vaccine type	Year 1, Post season
Secondary	Number of Participants With Vaccine Failure, Year 2	Number of Participants with Vaccine Failure in Year 2 by two-year vaccine history	Year 2, Post season