Trial to Describe the Safety, Tolerability, and Immunogenicity of Trumenba When Administered to Immunocompromised Participants ≥10 Years of Age

A PHASE 4, OPEN-LABEL, SINGLE-ARM TRIAL TO DESCRIBE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF TRUMENBA(REGISTERED) WHEN ADMINISTERED TO IMMUNOCOMPROMISED PARTICIPANTS ≥10 YEARS OF AGE

The aim of this study is to evaluate the safety, tolerability, and immunogenicity of 2 doses of Trumenba® (on a 0- and 6-month schedule) in immunocompromised participants by functionally assessing antibody production in asplenic and complement-deficient individuals ≥10 years of age.

Study Overview

• Status: Completed
• Conditions: Meningococcal Vaccine
• Intervention / Treatment: Biological: Trumenba

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Phase 4

Contacts and Locations

Study Locations

• Czechia
  • Brno, Czechia, 613 00
    • Fakultni Nemocnice Brno - Detska Nemocnice - Klinika Detskych Infekcnich Nemoci Center 3
  • Brno 2, Czechia, 61300
    • Fakultni Nemocnice Brno - Detska Nemocnice - Klinika Detskych Infekcnich Nemoci Center 3
  • Praha 5, Czechia, 150 06
    • Fakultni nemocnice v Motole
• Poland
  • Bydgoszcz, Poland, 85-048
    • IN-VIVO sp. z o.o.
  • Krakow, Poland, 30-348
    • Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o.
  • Warszawa, Poland, 00-728
    • WIP Warsaw IBD Point Profesor Kierkus
  • Warszawa, Poland, 01-809
    • Szpital Bielański im. Ks. Jerzego Popiełuszki SPZOZ
• Turkey
  • Adana, Turkey, 01130
    • Acibadem Adana Hastanesi
  • Adana, Turkey, 01240
    • Baskent Universitesi Dr. Turgut Noyan Adana Uygulama ve Arastirma Merkezi
  • Adana, Turkey, 01120
    • Baskent Universitesi Dr. Turgut Noyan Adana Uygulama ve Arastirma Merkezi
  • Ankara, Turkey, 06230
    • Hacettepe Universitesi Tip Fakultesi
  • Mersin, Turkey, 33343
    • Mersin Universitesi Tip Fakultesi Hastanesi
  • Yüreği̇r
    • Adana, Yüreği̇r, Turkey
      • Baskent Universitesi Dr. Turgut Noyan Adana Uygulama ve Arastirma Merkezi
    • Adana, Yüreği̇r, Turkey, 01120
      • Baskent Universitesi Dr. Turgut Noyan Adana Uygulama ve Arastirma Merkezi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male or female participants ≥10 years of age at the time of consent.
• Participants with an increased risk for meningococcal disease due to anatomic asplenia or functional asplenia (eg, sickle cell anemia) or complement deficiencies.
• Negative urine pregnancy test for all female participants.

Exclusion Criteria:

• Previous vaccination with any meningococcal serogroup B vaccine.
• Participants who are receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
• History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae.
• Significant neurological disorder or history of seizure (excluding simple febrile seizure).
• Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
• Any confirmed or suspected human immunodeficiency virus infection.
• Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
• Receipt of immunoglobulin infusion or injection during the 42 days preceding enrollment.
• Current chronic use of systemic antibiotics.
• Previous receipt or current use of complement inhibitors (eg, eculizumab, ravulizumab).
• Participation in other studies involving investigational drug(s) within 28 days prior to study entry and/or during study participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Arm; Bivalent recombinant lipoprotein 2086 vaccine	Biological: Trumenba; Bivalent recombinant lipoprotein 2086 vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer => Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Neisseria Meningitidis Serogroup B (MnB) Test Strains at Baseline	Four primary MnB strains were PMB80 (A22), PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44). The percentage of participants who achieved an hSBA titer PMB80 (A22) more than or equal to (=>)1:16, and hSBA titer PMB2001 (A56), PMB2001 (B24), and PMB2707 (B44) =>1:8 are reported. Evaluable immunogenicity population (EIP) included all participants who were eligible through 1 month after Vaccination 2, received the study vaccination at Visit 1 and Visit 3 as planned, had blood drawn for assay testing within the required time frames at Visit 1 (before Vaccination 1) and 1 month after Vaccination 2 (28-42 days after Visit 3), had at least 1 valid and determinate assay result 1 month after Vaccination 2, received no prohibited vaccines or medications through Visit 4, and had no major protocol deviations through Visit 4.	Baseline (Before Vaccination 1 on Day 1/Month 0)
Percentage of Participants With hSBA Titer => LLOQ for Each of the 4 Primary MnB Test Strains at 1 Month After Vaccination 2	Four primary MnB strains were PMB80 (A22), PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44). The percentage of participants who achieved an hSBA titer PMB80 (A22) =>1:16, and hSBA titer PMB2001 (A56), PMB2001 (B24), and PMB2707 (B44) =>1:8 were reported.	1 Month after Vaccination 2 (Vaccination 2 at Month 6)
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 1	Local reactions (redness, swelling, and pain) at the site of investigational product administration were recorded in electronic diary (e-diary). Redness and swelling were measured and recorded in caliper units. Each caliper unit = 0.5 centimeter (cm). Redness and swelling were graded as mild (more than [>]2.0 to 5.0cm), moderate (>5.0 to 10.0cm) and severe (>10.0cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).	Within 7 Days after Vaccination 1 (Vaccination 1 on Day 1/Month 0)
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 2	Local reactions (redness, swelling, and pain) at the site of investigational product administration were recorded in electronic diary (e-diary). Redness and swelling were measured and recorded in caliper units. Each caliper unit = 0.5 cm. Redness and swelling were graded as mild (>2.0 to 5.0cm), moderate (>5.0 to 10.0cm) and severe (>10.0cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).	Within 7 Days after Vaccination 2 (Vaccination 2 at Month 6)
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 1	Systemic events included: fever, fatigue, headache, chills, muscle pain, joint pain, vomiting, and diarrhea. Fever classified as =>38.0 degree Celsius (C), 38.0-38.4, >38.4-38.9, >38.9 40.0 and >40.0-degree C. Fatigue, headache, chills, muscle pain and joint pain graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Vomiting graded as mild (1-2 times in 24 hours [hrs]), moderate (>2 times in 24 hrs) and severe (required intravenous [IV] hydration). Diarrhea graded as mild (2-3 loose stools in 24 hrs), moderate (4-5 loose stools in 24 hrs) and severe (=>6 in 24 hrs).	Within 7 Days after Vaccination 1 (Vaccination 1 on Day 1/Month 0)
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 2	Systemic events included: fever, fatigue, headache, chills, muscle pain, joint pain, vomiting, and diarrhea. Fever classified as =>38.0 degree C, 38.0-38.4, >38.4-38.9, >38.9 40.0 and >40.0-degree C. Fatigue, headache, chills, muscle pain and joint pain graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Vomiting graded as mild (1-2 times in 24 hrs), moderate (>2 times in 24 hrs) and severe (required IV hydration). Diarrhea graded as mild (2-3 loose stools in 24 hrs), moderate (4-5 loose stools in 24 hrs) and severe (=>6 in 24 hrs).	Within 7 Days after Vaccination 2 (Vaccination 2 at Month 6)
Percentage of Participants Reporting Use of Antipyretic Medication Within 7 Days After Vaccination 1		Within 7 Days after Vaccination 1 (Vaccination 1 on Day 1/Month 0)
Percentage of Participants Reporting Use of Antipyretic Medication Within 7 Days After Vaccination 2		Within 7 Days after Vaccination 2 (Vaccination 2 at Month 6)
Percentage of Participants Reporting Adverse Events (AEs) During 30 Days After Vaccination 1	An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs excluded local reactions and systematic events.	30 Days after Vaccination 1 (Vaccination 1 on Day 1/Month 0)
Percentage of Participants Reporting AEs During 30 Days After Vaccination 2	An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs excluded local reactions and systematic events.	30 Days after Vaccination 2 (Vaccination 2 at Month 6)
Percentage of Participants Reporting AEs During 30 Days After Any Vaccination	An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs excluded local reactions and systematic events.	30 Days after any Vaccination
Percentage of Participants Reporting AEs During the Vaccination Phase	An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs excluded local reactions and systematic events.	Vaccination Phase: From Vaccination 1 through one Month after Vaccination 2 (approximately 7 Months)
Percentage of Participants Reporting Serious Adverse Events (SAEs) During 30 Days After Vaccination 1	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect or that was considered to be an important medical event.	30 Days after Vaccination 1 (Vaccination 1 on Day 1/Month 0)
Percentage of Participants Reporting SAEs During 30 Days After Vaccination 2	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect or that was considered to be an important medical event.	30 Days after Vaccination 2 (Vaccination 2 at Month 6)
Percentage of Participants Reporting SAEs During 30 Days After Any Vaccination	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect or that was considered to be an important medical event.	30 Days after any Vaccination
Percentage of Participants Reporting SAEs During the Vaccination Phase	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect or that was considered to be an important medical event.	Vaccination Phase: From Vaccination 1 through 1 Month after Vaccination 2 (approximately 7 Months)
Percentage of Participants Reporting SAEs During the Follow-up Phase	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect or that was considered to be an important medical event.	Follow-up Phase: From 1 Month after Vaccination 2 through 6 Months after Vaccination 2 (approximately 5 Months)
Percentage of Participants Reporting SAEs During the Entire Study	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.	Entire Study: From Vaccination 1 through 6 Months after Vaccination 2 (approximately 12 Months)
Percentage of Participants Reporting Medically Attended Adverse Event (MAEs) During 30 Days After Vaccination 1	MAEs was defined as a nonserious AE that resulted in an evaluation at a medical facility.	30 Days after Vaccination 1 (Vaccination 1 on Day 1/Month 0)
Percentage of Participants Reporting MAEs During 30 Days After Vaccination 2	MAEs was defined as a nonserious AE that resulted in an evaluation at a medical facility.	30 Days after Vaccination 2 (Vaccination 2 at Month 6)
Percentage of Participants Reporting MAEs During 30 Days After Any Vaccination	MAEs was defined as a nonserious AE that resulted in an evaluation at a medical facility.	30 Days after any Vaccination
Percentage of Participants Reporting MAEs During the Vaccination Phase	MAEs was defined as a nonserious AE that resulted in an evaluation at a medical facility.	Vaccination Phase: From Vaccination 1 through 1 Month after Vaccination 2 (approximately 7 Months)
Percentage of Participants Reporting MAEs During the Follow-up Phase	MAEs was defined as a nonserious AE that resulted in an evaluation at a medical facility.	Follow-up Phase: From 1 Month after Vaccination 2 through 6 Months after Vaccination 2 (approximately 5 Months)
Percentage of Participants Reporting MAEs During the Entire Study	MAEs was defined as a nonserious AE that resulted in an evaluation at a medical facility.	Entire Study: From Vaccination 1 through 6 Months after Vaccination 2 (approximately 12 Months)
Percentage of Participants Reporting Immediate AEs After Vaccination 1	Immediate AE was defined as AE occurring within the first 30 minutes after study intervention administration.	30 Minutes post Vaccination 1 (Vaccination 1 on Day 1/Month 0)
Percentage of Participants Reporting Immediate AEs After Vaccination 2	Immediate AE was defined as AE occurring within the first 30 minutes after study intervention administration.	30 Minutes post Vaccination 2 (Vaccination 2 at Month 6)
Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) During the Vaccination Phase	A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.	Vaccination Phase: From Vaccination 1 through 1 Month after Vaccination 2 (approximately 7 Months)
Percentage of Participants With NDCMC During the Follow-up Phase	A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.	Follow-up Phase: From 1 Month after Vaccination 2 through 6 Months after Vaccination 2 (approximately 5 Months)
Percentage of Participants With NDCMC During the Entire Study	A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.	Entire Study: From Vaccination 1 through 6 Months after Vaccination 2 (approximately 12 Months)
Mean Number of Days Participants Missed School or Work Because of AEs During the Vaccination Phase	An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	Vaccination Phase: From Vaccination 1 through 1 Month after Vaccination 2 (approximately 7 Months)

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2021
• Primary Completion (Actual): September 6, 2023
• Study Completion (Actual): September 6, 2023

Study Registration Dates

• First Submitted: May 14, 2021
• First Submitted That Met QC Criteria: May 18, 2021
• First Posted (Actual): May 20, 2021

Study Record Updates

• Last Update Posted (Actual): October 16, 2024
• Last Update Submitted That Met QC Criteria: October 11, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Asplenia; Meningococcal Vaccine; Sickle cell anemia; Meningitis Vaccine; Complement deficiencies
• Other Study ID Numbers: B1971060; 2018-002588-24 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No