Influenza Vaccination for Flu Prevention in Patients With Plasma Cell Disorders

NCT04080531 | Completed Phase 4 Results DMC FDA Drug

• 4 other identifiers: IRB00111721NCI-2019-03734Winship4709-19P30CA138292
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 2

Brief Summary

This phase IV trial studies how well influenza vaccination works in preventing infections such as influenza in patients with plasma cell disorders. Influenza infections may theoretically support the growth of tumor cells and improving protection against influenza may improve the status of patients' plasma cell disorder. Giving influenza vaccination may reduce influenza-related complications including infections, hospitalizations, and deaths, and improve the status of plasma cell disorders.

Conditions

Plasma Cell Neoplasm

Outcome Measures

Primary Outcomes (1)

• Seroprotection Based on Hemagglutination Antibody Inhibition (HAI)

  HAI in blood at week 21 for all variants

  21 weeks

Study Arms (2)

Arm I (trivalent influenza vaccine, Prevnar)

EXPERIMENTAL

Patients receive trivalent influenza vaccine IM at weeks 1, 9, and 17, and pneumococcal 13-valent conjugate vaccine IM at week 5 in the absence of disease progression or unacceptable toxicity.

Biological: Pneumococcal 13-valent Conjugate Vaccine; Biological: Trivalent Influenza Vaccine

Arm II (trivalent influenza vaccine, Prevnar)

EXPERIMENTAL

Patients receive trivalent influenza vaccine IM at week 1 and pneumococcal 13-valent conjugate vaccine IM at week 5 in the absence of disease progression or unacceptable toxicity.

Biological: Pneumococcal 13-valent Conjugate Vaccine; Biological: Trivalent Influenza Vaccine

Interventions

Pneumococcal 13-valent Conjugate Vaccine BIOLOGICAL

Given IM

Also known as: PCV13, Prevnar 13

Arm I (trivalent influenza vaccine, Prevnar); Arm II (trivalent influenza vaccine, Prevnar)

Trivalent Influenza Vaccine BIOLOGICAL

Given IM

Also known as: Flu shot, Flu vaccination, Fluzone, Fluzone HD, Fluzone High-dose, Influenza Vaccine, Influenza Virus Vaccine, Trivalent, Types A and B, TIV

Arm I (trivalent influenza vaccine, Prevnar); Arm II (trivalent influenza vaccine, Prevnar)

Eligibility Criteria

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

You may qualify if:

• Patient must have a plasma cell dyscrasia that fits in the International Myeloma Working Group (IMWG) diagnostic criteria.
• Both men and women of all races and ethnic groups are eligible for this study.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3 (Karnofsky ≥ 30%) is required for eligibility.
• Patient must be eligible to receive standard of care influenza vaccination. If the patient has a history of egg allergy with symptoms more severe than urticaria, e.g. angioedema, respiratory distress, lightheadedness, or recurrent emesis, they remain eligible to receive influenza vaccination but must receive the vaccine in a facility able to recognize and manage severe allergic reactions. Persons who are able to eat lightly cooked egg (e.g., scrambled egg) without reaction are unlikely to be allergic, although egg-allergic persons might tolerate egg in baked products.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Patients who have already received the seasonal influenza vaccine in the current season.
• History of Guillain-Barré syndrome.
• Patients with a previous severe allergic reaction to influenza vaccination or pneumococcal 13-valent conjugate vaccine (PCV13).
• Expected survival \< 9 months.
• Prisoners.

Sponsors & Collaborators

• Emory University: lead
• Sanofi: collaborator
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Neoplasms, Plasma Cell

Interventions

13-valent pneumococcal vaccine; Influenza Vaccines; Fluzone High-Dose

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Craig C. Hofmeister, MD, MPH
• Organization: Emory University

craig.hofmeister@emory.edu

404-778-0519

Study Officials

• Craig Hofmeister, MD, MPH

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: September 6, 2019
• Study Start: October 18, 2019
• Primary Completion: May 11, 2021
• Study Completion: December 15, 2022
• Last Updated: February 28, 2025
• Results First Posted: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)