Immune Response to Influenza Vaccine in Adults With B-cell Malignancies Treated With Idelalisib

NCT03701438 | Terminated

• 2 other identifiers: GS-US-313-41002017-003055-30
• Study Type: observational
• Target: 2
• Locations: 2 countries
• Sites: 2

Brief Summary

The primary objective of this study is to assess the immune response to an influenza vaccine in adults with B-cell malignancies who are currently receiving treatment with idelalisib in a Gilead-sponsored study (parent study).

Conditions

B-cell Malignancies

Outcome Measures

Primary Outcomes (1)

• Seroconversion Rate: Proportion of Participants with Either a Pre-Vaccination Hemagglutination Inhibition (HI) Titer < 1:10 and a Post-Vaccination HI titer ≥ 1:40, or a Pre-Vaccination HI titer ≥ 1:10 and a ≥ 4-fold Increase in Post-Vaccination HI Titer

  28 days [± 7 days] post-vaccination

Secondary Outcomes (3)

• Seroprotection Rate: Proportion of Participants with HI titer ≥ 1:40 Post-Vaccination

  28 days [± 7 days] post-vaccination

• Geometric Mean Titers (GMTs) of Antibodies: Pre- and Post-Vaccination GMTs of HI Antibodies Evaluated Prior to and 28 days (± 7 Days) After Vaccination

  Prior to and 28 days (± 7 days) after vaccination

• Percentage of Participants with Adverse Events or Serious Adverse Events From Time of Baseline Blood Draw Until Day 28 (Post Vaccination) Visit

  Baseline Blood Draw; Day 28 (± 7 days)

Study Arms (1)

Idelalisib

Participants currently enrolled in a Gilead-sponsored study, who are currently being treated with 100 or 150 mg of idelalisib twice daily for at least 7 consecutive days prior to receiving an influenza vaccine.

Biological: Influenza Vaccine

Interventions

Influenza Vaccine BIOLOGICAL

Administered per standard of care using a vaccine licensed and recommended in the site's country

Idelalisib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with B-cell malignancies currently receiving or initiating treatment with idelalisib in a Gilead-sponsored study.

You may qualify if:

• Currently enrolled in a Gilead-sponsored study, receiving or scheduled to initiate treatment with idelalisib for at least 7 consecutive days prior to receiving an influenza vaccine
• Will be receiving an influenza vaccine per standard of care
• Willing to comply with scheduled visits, laboratory tests, other study procedures, and study restrictions
• Signed informed consent form, indicating that the subject has been informed of the procedures to be followed, potential risks and discomforts, and other pertinent aspects of study participation

You may not qualify if:

• Administration of systemic steroids for more than 2 consecutive weeks within the past 3 months (i.e., 12 weeks) prior to receiving an influenza vaccination. Up to 3 single doses of systemic corticosteroids (e.g., given as a premedication) are permitted within 30 days prior to receiving an influenza vaccine, however none of these doses may be administered within 7 days prior to influenza vaccination. Topical and inhaled steroids are permitted
• Intravenous immunoglobulin (IVIG) therapy within the past 3 months (i.e., 12 weeks) prior to receiving an influenza vaccination, and/or planned administration during the study period
• Cytotoxic chemotherapy and chronic administration (more than 14 days) of immunosuppressants within 30 days of vaccination
• Vaccination against influenza within the last 24 weeks prior to vaccination in this study, and/or planned administration of a second dose of influenza vaccine during the study period.
• Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following trial vaccination
• History of severe allergic or hypersensitivity reaction that is likely to be exacerbated by any component of an influenza vaccine including egg and chicken protein, or history of hypersensitivity to a previous dose of an influenza vaccine
• Acute disease and/or fever at the time of baseline blood draw (fever is defined as temperature ≥ 38°C in an oral setting)
• Presence of any condition that could, in the opinion of the investigator, compromise the subject's ability to participate in the study, such as history of substance abuse or psychiatric condition
• Females who are pregnant or lactating (refer to the Gilead-sponsored parent study's definition of 'child-bearing potential' to determine if pregnancy testing is required. If a pregnancy test has been performed in the Gilead-sponsored parent study ≤ 6 weeks prior to the baseline blood draw, it may be used for eligibility purposes.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (2)

Fakultni nemocnice Kralovske Vinohrady, Interni hematologicka klinika

Prague, 100 34, Czechia

Location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood Samples

MeSH Terms

Interventions

Influenza Vaccines

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: October 10, 2018
• Study Start: October 23, 2018
• Primary Completion: October 9, 2019
• Study Completion: October 9, 2019
• Last Updated: February 20, 2020

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 18 months after study completion
• Access Criteria: A secured external environment with username, password, and RSA code.

Locations

ES (1); CZ (1)