Study to Evaluate Safety, Tolerability & Immunogenicity of BNT162b2 in Immunocompromised Participants ≥2 Years

Sponsor

BioNTech SE (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04895982

Collaborator

Pfizer (Industry)

420

Enrollment

Locations

Arm

24.5

Anticipated Duration (Months)

15.6

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a 4 dose study with 420 participants (240 adults, 180 children). 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 and Germany

Condition or Disease	Intervention/Treatment	Phase
SARS-CoV-2 Infection, COVID19	Biological: BNT162b2	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

420 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Oct 15, 2021

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BNT162b2 Intramuscular Injection	Biological: BNT162b2 Intramuscular Injection

Arm

Intervention/Treatment

Experimental: BNT162b2

Intramuscular Injection

Biological: BNT162b2

Intramuscular Injection

Outcome Measures

Primary Outcome Measures

Percentage of participants reporting local reactions [For 7 days after Dose 1, Dose 2, Dose 3 and Dose 4]
Pain at the injection site, redness and swelling, as self reported in electronic diaries
Percentage of participants reporting adverse events [From Dose 1 through 1 month after Dose 2]
As elicited by investigational site staff
Percentage of participants reporting serious adverse events [From Dose 1 through 6 months after Dose 4]
As elicited by investigational site staff
GMTs of all participants, measured by SARS-CoV-2 neutralising titers, without serological or virological evidence of past SARS-CoV-2 infection and with an immunocompromised state, as specified in the protocol [1 month after Dose 3 and Dose 4]
As measured at the central laboratory
Percentage of participants reporting adverse events [From Dose 3 to 1 month after Dose 3]
As elicited by investigational site staff
Percentage of participants reporting systemic events [For 7 days after Dose 1, Dose 2, Dose 3 and Dose 4]
Systemic events (fever, fatigue, headache, chills, vomiting, diarrhoea, new or worsened muscle pain and new or worsened joint pain), as self reported in electronic diaries
Percentage of participants reporting adverse events [From Dose 4 to 1 month after Dose 4]
As elicited by investigational site staff

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

1. Male or female participants who are ≥2 years of age at the time of enrollment (Visit 1).

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.
Life expectancy ≥12 months (365 days) in the opinion of the investigator at enrollment (Visit 1).
Participants or participant's parent(s)/legal guardians, as age appropriate, who are able to be contacted by telephone throughout the study period.
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.
Participants who are immunocompromised by virtue of the following:

Having known 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 (PD-1/PD-L1 inhibitor, CTLA-4 inhibitor) and has undergone at least 1 treatment cycle prior to enrollment (at Visit 1); or
Receiving targeted drug therapy treatment (EGFR, ALK, ROS1, BRAF, RET, MET, NTRK inhibitors) and has undergone at least 1 treatment cycle prior to enrollment (at Visit 1); or
Having known 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 BTK inhibitor, PI3K inhibitor, or 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, 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.

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), as described in Appendix 1, 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 (as defined in Appendix 1) 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 MIS-C.

Participants with active GVHD, transplant rejection, or PTLD, or participants who have had treatment for these conditions within 3 months (84 days) prior to study enrollment (Visit 1).
Participants <18 years of age whose weight is less than the 5th percentile of age-adjusted ideal body weight.
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.
History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
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.
Participants who do not have adequate deltoid muscle mass to allow intramuscular vaccination, in the opinion of the investigator.
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 3.
Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.
Previous participation in other studies involving study intervention containing LNPs.
Participants who are direct descendants (child or grandchild, parent or grandparent) 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.
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Chicago Comer Children's Hospital	Chicago	Illinois	United States	60637
2	University of Chicago Medical Center	Chicago	Illinois	United States	60637
3	Ochsner Clinic Foundation	Jefferson	Louisiana	United States	70121
4	Ochsner Medical Center - Jefferson Highway	New Orleans	Louisiana	United States	70121
5	Henry Ford Health System	Detroit	Michigan	United States	48202
6	Henry Ford Hospital - Research Pharmacy	Detroit	Michigan	United States	48202
7	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45206
8	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229
9	Cincinnati Children's Hospital Vaccine Research Center	Cincinnati	Ohio	United States	45229
10	Cincinnati Children's Hospital	Cincinnati	Ohio	United States	45229
11	Texas Children's Hospital	Houston	Texas	United States	77030
12	Seattle Children's Research Institute: Building Cure	Seattle	Washington	United States	98101
13	Seattle Children's Hospital	Seattle	Washington	United States	98105
14	Obras Sociais Irma Dulce	Salvador	Bahia	Brazil	40.415-000
15	Hospital de Clinicas de Porto Alegre	Porto Alegre	RIO Grande DO SUL	Brazil	90035-903
16	Fundação Faculdade regional de Medicina de São José do Rio Preto	Sao Jose do Rio Preto	SAO Paulo	Brazil	15090-000
17	GRAACC - Grupo de Apoio ao Adolescente e à Criança com Câncer	São Paulo		Brazil	04039-001
18	CEPIC - Centro Paulista de Investigação Clínica	São Paulo		Brazil	04266-010
19	Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)	Berlin		Germany	13353
20	Charité - Universitaetsmedizin	Berlin		Germany	13353
21	Charité Campus Virchow-Klinikum	Berlin		Germany	13353
22	IKF Pneumologie GmbH & Co KG	Frankfurt am Main		Germany	60596
23	Studiengesellschaft BSF Unternehmergesellschaft	Halle (Saale)		Germany	06108
24	Universitätsklinikum Hamburg-Eppendorf	Hamburg		Germany	20359
25	Centro Médico Zambrano Hellion	San Pedro Garza Garcia	Nuevo LEÓN	Mexico	66278
26	Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán	Mexico City	Tlalpan	Mexico	14080
27	Hospital Universitario "Dr. Jose Eleuterio Gonzalez"	Monterrey		Mexico	64460