Clinical trial NCT04895982: Study to Evaluate Safety, Tolerability & Immunogenicity of BNT162b2 in Immunocompromised Participants ≥2 Years
Official title: A PHASE 2b, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF VACCINE CANDIDATE BNT162b2 IN IMMUNOCOMPROMISED PARTICIPANTS ≥2 YEARS OF AGE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: SARS-CoV-2 Infection, COVID19
Keywords: COVID19
Coronavirus
Vaccine
SARS-CoV-2
RNA Vaccine
Lead sponsor: BioNTech SE
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2021-05-21
Enrollment: 124
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is a 4 dose study with 124 participants (7 adults ,117 children). Adults are considered to be participants 18 years of age or older. Participants are going to be enrolled based on conditions that make them immunocompromised. Participants are going to be followed up for 6 months after dose 4, and each participant is projected to be on the study for approximately 15 months. This study will be conducted in the United States, Brazil, Germany and Mexico.


Eligibility criteria: Inclusion Criteria:

1. Male or female participants who are ≥2 years of age at the time of enrollment (Visit 1).
2. Participants or participants' parent(s)/legal guardians, as age appropriate, who sign consent, and are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
3. Life expectancy ≥12 months (365 days) in the opinion of the investigator at enrollment (Visit 1).
4. Participants or participant's parent(s)/legal guardians, as age appropriate, who are able to be contacted by telephone throughout the study period.
5. Female participant of childbearing potential or male participant able to father children who is willing to use a highly effective method of contraception as outlined in this protocol for at least 28 days after the last dose of study intervention if at risk of pregnancy with her/his partner; or female participant not of childbearing potential or male participant not able to father children.
6. Participants who are immunocompromised by virtue of the following:

   * Having known non-small cell lung cancer (NSCLC) and is ≥18 years of age with at least 1 of the following:

     * Who received chemotherapy at least 2 weeks (14 days) before enrollment (or is treatment naïve), and is not expected to receive chemotherapy within at least 2 weeks (14 days) after dose administration; and/or
     * Receiving checkpoint inhibitor treatment (programmed cell death protein 1 (PD-1)/ programmed death-ligand 1 (PD-L1) inhibitor, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitor) and has undergone at least 1 treatment cycle prior to enrollment (at Visit 1); or
     * Receiving targeted drug therapy treatment (epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), proto-oncogene tyrosine-protein kinase (ROS1), v-raf murine sarcoma viral oncogene homolog B1 (BRAF),rearranged during transfection (RET),hepatocyte growth factor receptor (MET), neurotrophic tyrosine kinase (NTRK) inhibitors) and has undergone at least 1 treatment cycle prior to enrollment (at Visit 1); or
   * Having known chronic lymphocytic leukemia (CLL) and is ≥18 years of age with at least 1 of the following:

     * Has asymptomatic disease (eg, Rai stage \<3, Binet stage A or B) and is undergoing observation and does not receive any treatment for CLL; or
     * Receiving B-cell inhibitory monoclonal antibody treatment (anti-CD20) and has received at least 3 cycles prior to enrollment; and/or
     * Receives a Bruton tyrosine kinase (BTK) inhibitor, phosphoinositide 3-kinase (PI3K) inhibitor, or B-cell lymphoma-2 (BCL-2) inhibitor; or
   * Is currently undergoing maintenance hemodialysis treatment secondary to end-stage renal disease and is ≥18 years of age; or
   * Is on active immunomodulator therapy (eg, tumor necrosis factor alpha (TNFα) inhibitor, or tofacitinib or methotrexate) for an autoimmune or inflammatory disease disorder (eg, inflammatory arthritis, such as rheumatoid arthritis, psoriatic arthritis, and juvenile idiopathic arthritis, and inflammatory bowel disease, such as ulcerative colitis and Crohn's disease) at a stable\* dose

     \*Stable dose is defined as receiving the same dose for at least 3 months (84 days) with no changes in the 28 days prior to Visit 1; or
   * Receiving a solid organ transplant at least 3 months (84 days) prior to enrollment (Visit 1) and with no acute rejection episodes within 2 months (60 days) prior to enrollment (Visit 1), and is ≥2 to \<18 years of age; or
   * Has had an autologous or allogenic bone marrow or stem cell transplant at least 6 months (182 days) prior to enrollment (Visit 1), with adequate immune reconstitution for immunization, in the investigator's opinion, and is ≥2 to \<18 years of age
7. The participant or participant's parent(s)/legal guardian is capable of giving signed informed consent, and assent (as appropriate), which includes compliance with the requirements and restrictions listed in the ICD and in this protocol. The investigator, or a person designated by the investigator, will obtain written informed consent (and assent, as appropriate) from each study participant or participant's parent(s)/legal guardian before any study-specific activity is performed. All parent(s)/legal guardians should be fully informed, and participants should be informed to the fullest extent possible, about the study in language and terms they are able to understand. The investigator will retain the original copy of each participant's signed consent (and assent, as appropriate) document(s).

Exclusion Criteria:

1. Past clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID-19, or a past clinical diagnosis of multisystem inflammatory syndrome in children (MIS-C).
2. Participants with active graft-vs-host disease (GVHD), transplant rejection, or posttransplant lymphoproliferative disorder (PTLD), or participants who have had treatment for these conditions within 3 months (84 days) prior to study enrollment (Visit 1).
3. Participants \<18 years of age whose weight is less than the 5th percentile of age-adjusted ideal body weight.
4. 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.
5. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
6. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
7. Participant who is pregnant or breastfeeding.
8. Participants who may be ineligible because of the number of phlebotomy assessments during this study, in the opinion of the investigator.
9. Participants who do not have adequate deltoid muscle mass to allow intramuscular vaccination, in the opinion of the investigator.
10. Previous vaccination with any coronavirus vaccine.
11. Ongoing, or history of, treatment with blood/plasma products or immunoglobulins within 3 months (84 days) prior to Dose 1 or planned receipt of these medications prior to Dose 4.
12. Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.
13. Previous participation in other studies involving study intervention containing lipid nanoparticle (LNPs).
14. Participants who are direct descendants (child or grandchild) of investigational site staff members or Pfizer/BioNTech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
15. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

Primary outcomes:
measure: Geometric Mean Titers (GMTs) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV 2) Neutralizing Titers at 1 Month After Vaccination 3 in Participants Aged >=2 to <5 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection
timeFrame: 1 Month after Vaccination 3
measure: GMTs of SARS-CoV-2 Neutralizing Titers at 1 Month After Vaccination 3 in Participants Aged >=5 to <12 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection
timeFrame: 1 Month after Vaccination 3
measure: GMTs of SARS-CoV-2 Neutralizing Titers at 1 Month After Vaccination 3 in Participants Aged 12 to <18 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection
timeFrame: 1 Month after Vaccination 3
measure: GMTs of SARS-CoV-2 Neutralizing Titers at 1 Month After Vaccination 3 in Participants Aged >=18 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection
timeFrame: 1 Month after Vaccination 3
measure: GMTs of SARS-CoV-2 Neutralizing Titers at 1 Month After Vaccination 4 in Participants Aged >=2 to <5 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection
timeFrame: 1 Month after Vaccination 4
measure: GMTs of SARS-CoV-2 Neutralizing Titers at 1 Month After Vaccination 4 in Participants Aged >=5 to <12 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection
timeFrame: 1 Month after Vaccination 4
measure: GMTs of SARS-CoV-2 Neutralizing Titers at 1 Month After Vaccination 4 in Participants Aged 12 to <18 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection
timeFrame: 1 Month after Vaccination 4
measure: GMTs of SARS-CoV-2 Neutralizing Titers at 1 Month After Vaccination 4 in Participants Aged >=18 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection
timeFrame: 1 Month after Vaccination 4
measure: Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
timeFrame: Day 1 to Day 7 after Vaccination 1
measure: Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
timeFrame: Day 1 to Day 7 after Vaccination 1
measure: Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
timeFrame: Day 1 to Day 7 after Vaccination 1
measure: Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
timeFrame: Day 1 to Day 7 after Vaccination 1
measure: Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
timeFrame: Day 1 to Day 7 after Vaccination 2
measure: Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
timeFrame: Day 1 to Day 7 after Vaccination 2
measure: Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
timeFrame: Day 1 to Day 7 after Vaccination 2
measure: Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
timeFrame: Day 1 to Day 7 after Vaccination 2
measure: Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
timeFrame: Day 1 to Day 7 after Vaccination 3
measure: Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
timeFrame: Day 1 to Day 7 after Vaccination 3
measure: Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
timeFrame: Day 1 to Day 7 after Vaccination 3
measure: Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
timeFrame: Day 1 to Day 7 after Vaccination 3
measure: Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
timeFrame: Day 1 to Day 7 after Vaccination 4
measure: Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
timeFrame: Day 1 to Day 7 after Vaccination 4
measure: Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
timeFrame: Day 1 to Day 7 after Vaccination 4
measure: Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
timeFrame: Day 1 to Day 7 after Vaccination 4
measure: Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=2 to <5 Years
timeFrame: Day 1 to Day 7 after Vaccination 1
measure: Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=5 to <12 Years
timeFrame: Day 1 to Day 7 after Vaccination 1
measure: Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=12 to <18 Years
timeFrame: Day 1 to Day 7 after Vaccination 1
measure: Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Participants Aged >=18 Years
timeFrame: Day 1 to Day 7 after Vaccination 1
measure: Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=2 to <5 Years
timeFrame: Day 1 to Day 7 after Vaccination 2
measure: Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=5 to <12 Years
timeFrame: Day 1 to Day 7 after Vaccination 2
measure: Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=12 to <18 Years
timeFrame: Day 1 to Day 7 after Vaccination 2
measure: Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Participants Aged >=18 Years
timeFrame: Day 1 to Day 7 after Vaccination 2
measure: Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=2 to <5 Years
timeFrame: Day 1 to Day 7 after Vaccination 3
measure: Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=5 to <12 Years
timeFrame: Day 1 to Day 7 after Vaccination 3
measure: Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=12 to <18 Years
timeFrame: Day 1 to Day 7 after Vaccination 3
measure: Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Participants Aged >=18 Years
timeFrame: Day 1 to Day 7 after Vaccination 3
measure: Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=2 to <5 Years
timeFrame: Day 1 to Day 7 after Vaccination 4
measure: Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=5 to <12 Years
timeFrame: Day 1 to Day 7 after Vaccination 4
measure: Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=12 to <18 Years
timeFrame: Day 1 to Day 7 after Vaccination 4
measure: Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Participants Aged >=18 Years
timeFrame: Day 1 to Day 7 after Vaccination 4
measure: Percentage of Participants Reporting at Least 1 Adverse Event (AE) After Vaccination 1 to 1 Month After Vaccination 2 in Participants Aged >=2 to <5 Years
timeFrame: From Vaccination 1 to 1 month after Vaccination 2
measure: Percentage of Participants Reporting at Least 1 Adverse Event After Vaccination 1 to 1 Month After Vaccination 2 in Participants Aged >=5 to <12 Years
timeFrame: From Vaccination 1 to 1 month after Vaccination 2
measure: Percentage of Participants Reporting at Least 1 Adverse Event After Vaccination 1 to 1 Month After Vaccination 2 in Participants Aged >=12 to <18 Years
timeFrame: From Vaccination 1 to 1 month after Vaccination 2
measure: Percentage of Participants Reporting at Least 1 Adverse Event After Vaccination 1 to 1 Month After Vaccination 2 in Participants Aged >=18 Years
timeFrame: From Vaccination 1 to 1 month after Vaccination 2
measure: Percentage of Participants Reporting at Least 1 Adverse Event From Vaccination 3 to 1 Month After Vaccination 3 in Participants Aged >=2 to <5 Years
timeFrame: From Vaccination 3 to 1 month after Vaccination 3
measure: Percentage of Participants Reporting at Least 1 Adverse Event From Vaccination 3 to 1 Month After Vaccination 3 in Participants Aged >=5 to <12 Years
timeFrame: From Vaccination 3 to 1 month after Vaccination 3
measure: Percentage of Participants Reporting at Least 1 Adverse Event From Vaccination 3 to 1 Month After Vaccination 3 in Participants Aged >=12 to <18 Years
timeFrame: From Vaccination 3 to 1 month after Vaccination 3
measure: Percentage of Participants Reporting at Least 1 Adverse Event After Vaccination 3 to 1 Month After Vaccination 3 in Participants Aged >=18 Years
timeFrame: From Vaccination 3 to 1 month after Vaccination 3
measure: Percentage of Participants Reporting at Least 1 Adverse Event From Vaccination 4 to 1 Month After Vaccination 4 in Participants Aged >=2 to <5 Years
timeFrame: From Vaccination 4 to 1 month after Vaccination 4
measure: Percentage of Participants Reporting at Least 1 Adverse Event From Vaccination 4 to 1 Month After Vaccination 4 in Participants Aged >=5 to <12 Years
timeFrame: From Vaccination 4 to 1 month after Vaccination 4
measure: Percentage of Participants Reporting at Least 1 Adverse Event From Vaccination 4 to 1 Month After Vaccination 4 in Participants Aged >=12 to <18 Years
timeFrame: From Vaccination 4 to 1 month after Vaccination 4
measure: Percentage of Participants Reporting at Least 1 Adverse Event After Vaccination 4 to 1 Month After Vaccination 4 in Participants Aged >=18 Years
timeFrame: From Vaccination 4 to 1 month after Vaccination 4
measure: Percentage of Participants Reporting Serious Adverse Events (SAEs) From Vaccination 1 Through the Duration of the Study in Participants Aged >=2 to <5 Years
timeFrame: From Vaccination 1 to 6 months after Vaccination 4 (approximately 14 months)
measure: Percentage of Participants Reporting SAEs From Vaccination 1 Through the Duration of the Study in Participants Aged >=5 to <12 Years
timeFrame: From Vaccination 1 to 6 months after Vaccination 4 (approximately 14 months)
measure: Percentage of Participants Reporting SAEs From Vaccination 1 Through the Duration of the Study in Participants Aged >=12 to <18 Years
timeFrame: From Vaccination 1 to 6 months after Vaccination 4 (approximately 14 months)
measure: Percentage of Participants Reporting SAEs From Dose 1 Through the Duration of the Study in Participants Aged >=18 Years
timeFrame: From Vaccination 1 to 6 months after Vaccination 4 (approximately 14 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Jefferson
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Jefferson
country: United States
facility: Ochsner Medical Center - Jefferson Highway
state: Louisiana
city: Kenner
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Kenner
country: United States
facility: Ochsner Medical Center Kenner
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Medical Center - Jefferson Highway
state: Louisiana
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital - Research Pharmacy
state: Michigan
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Vaccine Research Center
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Seattle
country: United States
facility: Seattle Children's Research Institute: Building Cure
state: Washington
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: RIO Grande DO SUL
city: Sao Jose do Rio Preto
country: Brazil
facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto
state: SAO Paulo
city: São Paulo
country: Brazil
facility: GRAACC - Grupo de Apoio ao Adolescente e à Criança com Câncer
city: São Paulo
country: Brazil
facility: CEPIC - Centro Paulista de Investigação Clínica
city: Berlin
country: Germany
facility: Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)
city: Berlin
country: Germany
facility: Charité - Universitaetsmedizin
city: Berlin
country: Germany
facility: Charité Campus Virchow-Klinikum
city: Frankfurt am Main
country: Germany
facility: IKF Pneumologie GmbH & Co KG
city: Halle (Saale)
country: Germany
facility: Studiengesellschaft BSF UG.
city: Halle (Saale)
country: Germany
facility: Studiengesellschaft BSF Unternehmergesellschaft
city: Halle(Saale)
country: Germany
facility: Studiengesellschaft BSF Unternehmergesellschaft
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Monterrey
country: Mexico
facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez" de la Universidad Autonoma de Nuevo Leon
state: N.l.
city: San Pedro Garza Garcia
country: Mexico
facility: Centro Médico Zambrano Hellion
state: Nuevo LEÓN
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: