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A Trial Investigating the Safety and Effects of Four BNT162 Vaccines Against COVID-2019 in Healthy and Immunocompromised Adults

Primary Purpose

Infections, Respiratory, Virus Diseases, Infection Viral

Status
Active
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
BNT162a1
BNT162b1
BNT162b2
BNT162c2
Sponsored by
BioNTech SE
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infections, Respiratory focused on measuring SARS-CoV-2, Severe Acute Respiratory Syndrome (SARS), Coronavirus Disease 2019, COVID-2019, Virus Diseases

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Have given informed consent by signing the informed consent form (ICF) before initiation of any trial-specific procedures.
  • They must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, lifestyle restrictions (e.g., to practice social distancing and to follow good practices to reduce their chances of being infected or spreading COVID-19), and other requirements of the trial.
  • They must be able to understand and follow trial-related instructions.
  • For younger adult cohorts, volunteers must be aged 18 to 55 years, have a body mass index (BMI) over 19 kg/m^2 and under 30 kg/m^2, and weigh at least 50 kg at Visit 0. OR For older adult cohorts, volunteers must be aged 56 to 85 years, have a BMI over 19 kg/m^2 and under 30 kg/m^2, and weigh at least 50 kg at Visit 0. OR For the immunocompromised adult cohort (Cohort 13), volunteers must be aged 18 to 85 years, have a BMI over 19 kg/m^2 and under 30 kg/m^2, and weigh at least 50 kg at Visit 0.
  • They must be healthy, in the clinical judgment of the investigator, based on medical history, physical examination, 12-lead electrocardiogram (ECG), vital signs (systolic/diastolic blood pressure, pulse rate, body temperature, respiratory rate), and clinical laboratory tests (blood chemistry, hematology, and urine chemistry) at Visit 0. Note: Healthy volunteers with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included. OR For the immunocompromised cohort (Cohort 13); volunteers who have previously received solid organ transplant, or peripheral blood stem cell transplantation ≥6 months after transplantation, or individuals with human immunodeficiency virus (HIV) infection with a CD4+ T-cell count of ≥200 x 10^6 /L at Visit 0. Individuals with lower T-cell counts will be excluded from the trial on the basis that this represents a significant medical complication. In the clinical judgment of the investigator, volunteers must be immunocompromised but otherwise healthy. After consultation with the Medical Monitor, this may include individuals receiving immunosuppressant therapy due to another confounding disease at least 2 weeks prior to enrollment and/or at least 6 weeks following immunization with BNT162b2, and/or individuals with immunosuppressive treatment of an autoimmune disease if the disease is stable.
  • Women of childbearing potential (WOCBP) must have a negative beta-human chorionic gonadotropin urine test at Visit 0 and Visit 1. Women that are postmenopausal or permanently sterilized will be considered as not having reproductive potential.
  • WOCBP must agree to practice a highly effective form of contraception during the trial, starting after Visit 0 and continuously until 60 days after receiving the last immunization. WOCBP must agree to require their male partners to use condoms during sexual contact (unless male partners are sterilized or infertile).
  • WOCBP must confirm that they practice at least one highly effective form of contraception for the 14 days prior to Visit 0.
  • WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during trial, starting after Visit 0 and continuously until 60 days after receiving the last immunization.
  • Men who are sexually active with a WOCBP and have not had a vasectomy must agree to practice a highly effective form of contraception with their female partner of childbearing potential during the trial, starting after Visit 0 and continuously until 60 days after receiving the last immunization.
  • Men must be willing to refrain from sperm donation, starting after Visit 0 and continuously until 60 days after receiving the last immunization.
  • They must have confirmation of their health insurance coverage prior to Visit 0.
  • They must agree to not be vaccinated during the trial, starting after Visit 0 and continuously until 28 days after receiving the last immunization.

Exclusion Criteria:

  • Have had any acute illness, as determined by the investigator, with or without fever, within 72 hours prior to the first immunization. An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the investigator, the residual symptoms will not compromise their well-being if they participate as trial subjects in the trial, or that could prevent, limit, or confound the protocol-specified assessments.
  • Are breastfeeding on the day of Visit 0 or who plan to breastfeed during the trial, starting after Visit 0 and continuously until at least 90 days after receiving the last immunization.
  • Have a known allergy, hypersensitivity, or intolerance to the planned investigational medicinal product (IMP) including any excipients of the IMP.
  • Had any medical condition or any major surgery (e.g., requiring general anesthesia) within the past 5 years which, in the opinion of the investigator, could compromise their well-being if they participate as trial subjects in the trial, or that could prevent, limit, or confound the protocol-specified assessments.
  • Have any surgery planned during the trial, starting after Visit 0 and continuously until at least 90 days after receiving the last immunization.
  • Had any chronic use (more than 21 continuous days) of any systemic medications, including immunosuppressant's or other immune-modifying drugs (except for Cohort 13), within the 6 months prior to Visit 0 unless in the opinion of the investigator, the medication would not prevent, limit, or confound the protocol-specified assessments or could compromise subject safety. Note: Healthy volunteers with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included.
  • Had any vaccination within the 28 days prior to Visit 0.
  • Had administration of any immunoglobulins and/or any blood products within the 3 months prior to Visit 0.
  • Had administration of another investigational medicinal product including vaccines within 60 days or 5 half-lives (whichever is longer), prior to Visit 0.
  • Have a known history of active or ongoing hepatitis B or hepatitis C infection; or except for Cohort 13: HIV-1 or HIV-2 infection within the 30 days prior to Visit 0.
  • Have a positive polymerase chain reaction (PCR)-based test for SARS-CoV-2 within the 30 days prior to Visit 1.
  • Have a positive drugs of abuse (for amphetamines, benzodiazepines, barbiturates, cocaine, cannabinoids, opiates, methadone, methamphetamines, phencyclidine, and tricyclic antidepressants) result at Visit 0 or Visit 1.
  • Have a positive breath alcohol test at Visit 0 or Visit 1.
  • Previously participated in an investigational trial involving lipid nanoparticles.
  • Are subject to exclusion periods from other investigational trials or simultaneous participation in another clinical trial. When entering the follow-up phase, i.e., after completing the end of treatment (EoT) visit, subjects are allowed to participate in other clinical trials not investigating COVID-19 vaccines or treatments; subjects immunized with BNT162 vaccines in this clinical trial are allowed to participate in other clinical trials involving immunization with BNT162b2.
  • Have any affiliation with the trial site (e.g., are close relative of the investigator or dependent person, such as an employee or student of the trial site).
  • Have a history (within the past 5 years) of substance abuse or known medical, psychological, or social conditions which, in the opinion of the investigator, could compromise their well-being if they participate as trial subjects in the trial, or that could prevent, limit, or confound the protocol-specified assessments.
  • Have a history of hypersensitivity or serious reactions to previous vaccinations.
  • Have a history of Guillain-Barré Syndrome within 6 weeks following a previous vaccination.
  • Have a history of narcolepsy.
  • Have history of alcohol abuse or drug addiction within 1 year before Visit 0.
  • (Except for Cohort 13) Have a history of or suspected immunosuppressive condition, acquired or congenital, as determined by medical history and/or physical examination at Visit 0.
  • Have any abnormality or permanent body art (e.g., tattoo) that, in the opinion of the investigator, would obstruct the ability to observe local reactions at the injection site.
  • Have had any blood loss >450 mL, e.g., due to donation of blood or blood products or injury, within the 7 days prior to Visit 0 or plan to donate blood during the trial, starting after Visit 0 and continuously until at least 7 days after receiving the last immunization.
  • Have symptoms of COVID-19, e.g., respiratory symptoms, fever, cough, shortness of breath and breathing difficulties.
  • Have had contact with persons diagnosed with COVID-19 or who tested positive for SARS-CoV-2 by any diagnostic test within the 30 days prior to Visit 1.
  • Are soldiers, volunteers in detention, contract research organization (CRO) or sponsor staff or their family members.
  • Regular receipt of inhaled/nebulized corticosteroids (except for Cohort 13).
  • For older volunteers and for Cohort 13 only: Have a condition known to put them at high risk for severe COVID-19, including those with any of the following risk factors:
  • Uncontrolled hypertension.
  • Diabetes mellitus (HbA1c >8.5% ≥3 months, according to the medical history reported by the subject).
  • Chronic obstructive pulmonary disease.
  • Asthma.
  • Chronic liver disease.
  • Known Stage 3 or worse chronic kidney disease (glomerular filtration rate <60 mL/min/1.73 m^2); Except for post-renal transplant patients who should have (estimated) GFR ≥40 mL/min/1.73 m^2.
  • Serious heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies.
  • Sickle cell disease.
  • Cancer (except for Cohort 13).
  • Are immune compromised due to stem cell or organ-transplantation with significant medical complications such as acute or chronic graft rejection or graft versus host disease requiring intensive immunosuppressive treatment, transplant failure or infectious complications or other conditions that would be considered a contraindication for vaccination.
  • Are immune compromised due to HIV infection with a CD4+ count of < 200 x 10^6 /L at screening or significant medical complications such as opportunistic infections, malignant complications (e.g., lymphoma, Kaposi sarcoma), other organ manifestations consistent with advanced AIDS or other conditions that would be considered a contraindication for vaccination.
  • Resident in a long term facility.
  • Current vaping or smoking (occasional smoking is acceptable).
  • History of chronic smoking within the prior year.

Sites / Locations

  • Contract Research Organization
  • Universitäts Klinikum
  • Universitäts Klinikum
  • Contract Research Organization
  • Contract Research Organization

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

BNT162a1 (P/B) - Part A 18-55 years of age

BNT162b1 (P/B) - Part A 18-55 years of age

BNT162b2 (P/B) - Part A 18-55 years of age

BNT162c2 (P/B) - Part A 18-55 years of age

BNT162c2 (prime only) - Part A 18-55 years of age

BNT162b1 (P/B) - Part A 56-85 years of age

BNT162b2 (P/B) - Part A 56-85 years of age

BNT162b2 (P/B) - Part A 18-85 years of age (Expansion cohorts 11 to 13)

BNT162b2 (P/B) - Part A 18-85 years of age (Expansion cohort 14)

Arm Description

Escalating dose levels

Escalating dose levels

Escalating dose levels

Escalating dose levels

Single dose

Escalating dose levels

Escalating dose levels

Escalating dose levels

Biomarker (B cell and plasma cell immunity)

Outcomes

Primary Outcome Measures

Solicited local reactions at the injection site (pain, tenderness, erythema/redness, induration/swelling) recorded up to 7 days after each immunization.
Solicited systemic reactions (nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, loss of appetite, malaise, and fever) recorded up to 7 days after each immunization.
The proportion of subjects with at least 1 unsolicited treatment emergent adverse event (TEAE):
For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (P/B): occurring up to 21 days after the prime immunization.
The proportion of subjects with at least 1 unsolicited treatment emergent adverse event (TEAE):
For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (P/B): occurring up to 28 days after the boost immunization. For BNT162c2 (SD): The proportion of subjects with at least 1 unsolicited TEAE occurring up to 28 days after the immunization.

Secondary Outcome Measures

For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (P/B):
Functional antibody responses (titers) as compared to baseline at 7 and 21 days after primary immunization and at 7, 14, 21, 28, 63, and 162 days after the boost immunization.
For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (P/B):
Fold increase in functional antibody titers as compared to baseline at 7 and 21 days after primary immunization and at 7, 14, 21, 28, 63, and 162 days after the boost immunization.
For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (P/B):
Number of subjects with seroconversion defined as a minimum of 4-fold increase of functional antibody titers as compared to baseline at 7 and 21 days after primary immunization and at 7, 14, 21, 28, 63, and 162 days after the boost immunization.
For BNT162c2 (SD):
Functional antibody responses (titers) as compared to baseline at 7, 21, 28, 42, 84, and 183 days after the primary immunization.
For BNT162c2 (SD):
Fold increase in functional antibody titers as compared to baseline at 7, 21, 28, 42, 84, and 183 days after the primary immunization.
For BNT162c2 (SD):
Number of subjects with seroconversion defined as a minimum of 4-fold increase of functional antibody titers as compared to baseline at 7, 21, 28, 42, 84, and 183 days after the primary immunization.
For BNT162b2 (P/B):
Functional antibody responses (titers) as compared to baseline at 7, 14, and 21 days after the primary immunization and at 7, 28, and 162 days after the boost immunization.
For BNT162b2 (P/B):
Fold increase in functional antibody titers as compared to baseline at 7, 14, and 21 days after primary immunization and at 7, 28, and 162 days after the boost immunization.
For BNT162b2 (P/B):
Number of subjects with seroconversion defined as a minimum of 4-fold increase of functional antibody titers as compared to baseline at 7, 14, and 21 days after primary immunization and at 7, 28, and 162 days after the boost immunization.

Full Information

First Posted
May 6, 2020
Last Updated
January 12, 2022
Sponsor
BioNTech SE
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1. Study Identification

Unique Protocol Identification Number
NCT04380701
Brief Title
A Trial Investigating the Safety and Effects of Four BNT162 Vaccines Against COVID-2019 in Healthy and Immunocompromised Adults
Official Title
A Multi-site, Phase I/II, 2-Part, Dose-Escalation Trial Investigating the Safety and Immunogenicity of Four Prophylactic SARS-CoV-2 RNA Vaccines Against COVID-2019 Using Different Dosing Regimens in Healthy and Immunocompromised Adults
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 23, 2020 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioNTech SE

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This trial has two parts. Part A and Part B. Due to changes in the overall clinical development plan, Part B will no longer be conducted. The objectives originally described for Part B have been implemented in the ongoing development via a pivotal Phase I/II/III trial BNT162-02/C4591001 (ClinicalTrials.gov NCT: 04368728). Part A is for dose ranging of four different vaccines (BNT162a1, BNT162b1, BNT162b2, and BNT162c2) which will be undertaken with dose escalation and de-escalation plus the evaluation of interim dose levels. It also includes dose ranging in older participants. The vaccines BNT162a1, BNT162b1, BNT162b2, and BNT162c2 will be administered using a Prime/Boost (P/B) regimen. The vaccine BNT162c2 will also be administered using a Single dose (SD) regimen. Three additional cohorts aged from 18 to 85 years receiving BNT162b2 only. BNT162b2 has entered a Phase II/III evaluation of efficacy, with the intent to support an application for marketing authorization. The dosing regimen under investigation is two BNT162b2 doses given ~21 d apart.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Respiratory, Virus Diseases, Infection Viral, Vaccine Adverse Reaction, RNA Virus Infections, Protection Against COVID-19 and Infections With SARS CoV 2
Keywords
SARS-CoV-2, Severe Acute Respiratory Syndrome (SARS), Coronavirus Disease 2019, COVID-2019, Virus Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
512 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BNT162a1 (P/B) - Part A 18-55 years of age
Arm Type
Experimental
Arm Description
Escalating dose levels
Arm Title
BNT162b1 (P/B) - Part A 18-55 years of age
Arm Type
Experimental
Arm Description
Escalating dose levels
Arm Title
BNT162b2 (P/B) - Part A 18-55 years of age
Arm Type
Experimental
Arm Description
Escalating dose levels
Arm Title
BNT162c2 (P/B) - Part A 18-55 years of age
Arm Type
Experimental
Arm Description
Escalating dose levels
Arm Title
BNT162c2 (prime only) - Part A 18-55 years of age
Arm Type
Experimental
Arm Description
Single dose
Arm Title
BNT162b1 (P/B) - Part A 56-85 years of age
Arm Type
Experimental
Arm Description
Escalating dose levels
Arm Title
BNT162b2 (P/B) - Part A 56-85 years of age
Arm Type
Experimental
Arm Description
Escalating dose levels
Arm Title
BNT162b2 (P/B) - Part A 18-85 years of age (Expansion cohorts 11 to 13)
Arm Type
Experimental
Arm Description
Escalating dose levels
Arm Title
BNT162b2 (P/B) - Part A 18-85 years of age (Expansion cohort 14)
Arm Type
Experimental
Arm Description
Biomarker (B cell and plasma cell immunity)
Intervention Type
Biological
Intervention Name(s)
BNT162a1
Intervention Description
Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection.
Intervention Type
Biological
Intervention Name(s)
BNT162b1
Intervention Description
Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection.
Intervention Type
Biological
Intervention Name(s)
BNT162b2
Intervention Description
Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection.
Intervention Type
Biological
Intervention Name(s)
BNT162c2
Intervention Description
Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection.
Primary Outcome Measure Information:
Title
Solicited local reactions at the injection site (pain, tenderness, erythema/redness, induration/swelling) recorded up to 7 days after each immunization.
Time Frame
up to 7 days following each dose administration
Title
Solicited systemic reactions (nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, loss of appetite, malaise, and fever) recorded up to 7 days after each immunization.
Time Frame
up to 7 days following each dose administration
Title
The proportion of subjects with at least 1 unsolicited treatment emergent adverse event (TEAE):
Description
For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (P/B): occurring up to 21 days after the prime immunization.
Time Frame
21 days following dose administration
Title
The proportion of subjects with at least 1 unsolicited treatment emergent adverse event (TEAE):
Description
For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (P/B): occurring up to 28 days after the boost immunization. For BNT162c2 (SD): The proportion of subjects with at least 1 unsolicited TEAE occurring up to 28 days after the immunization.
Time Frame
28 days following dose administration
Secondary Outcome Measure Information:
Title
For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (P/B):
Description
Functional antibody responses (titers) as compared to baseline at 7 and 21 days after primary immunization and at 7, 14, 21, 28, 63, and 162 days after the boost immunization.
Time Frame
up to 162 days following dose administration
Title
For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (P/B):
Description
Fold increase in functional antibody titers as compared to baseline at 7 and 21 days after primary immunization and at 7, 14, 21, 28, 63, and 162 days after the boost immunization.
Time Frame
up to 162 days following dose administration
Title
For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (P/B):
Description
Number of subjects with seroconversion defined as a minimum of 4-fold increase of functional antibody titers as compared to baseline at 7 and 21 days after primary immunization and at 7, 14, 21, 28, 63, and 162 days after the boost immunization.
Time Frame
up to 162 days following dose administration
Title
For BNT162c2 (SD):
Description
Functional antibody responses (titers) as compared to baseline at 7, 21, 28, 42, 84, and 183 days after the primary immunization.
Time Frame
up to 183 days following dose administration
Title
For BNT162c2 (SD):
Description
Fold increase in functional antibody titers as compared to baseline at 7, 21, 28, 42, 84, and 183 days after the primary immunization.
Time Frame
up to 183 days following dose administration
Title
For BNT162c2 (SD):
Description
Number of subjects with seroconversion defined as a minimum of 4-fold increase of functional antibody titers as compared to baseline at 7, 21, 28, 42, 84, and 183 days after the primary immunization.
Time Frame
up to 183 days following dose administration
Title
For BNT162b2 (P/B):
Description
Functional antibody responses (titers) as compared to baseline at 7, 14, and 21 days after the primary immunization and at 7, 28, and 162 days after the boost immunization.
Time Frame
up to 162 days following dose administration
Title
For BNT162b2 (P/B):
Description
Fold increase in functional antibody titers as compared to baseline at 7, 14, and 21 days after primary immunization and at 7, 28, and 162 days after the boost immunization.
Time Frame
up to 162 days following dose administration
Title
For BNT162b2 (P/B):
Description
Number of subjects with seroconversion defined as a minimum of 4-fold increase of functional antibody titers as compared to baseline at 7, 14, and 21 days after primary immunization and at 7, 28, and 162 days after the boost immunization.
Time Frame
up to 162 days following dose administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Have given informed consent by signing the informed consent form (ICF) before initiation of any trial-specific procedures. They must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, lifestyle restrictions (e.g., to practice social distancing and to follow good practices to reduce their chances of being infected or spreading COVID-19), and other requirements of the trial. They must be able to understand and follow trial-related instructions. For younger adult cohorts, volunteers must be aged 18 to 55 years, have a body mass index (BMI) over 19 kg/m^2 and under 30 kg/m^2, and weigh at least 50 kg at Visit 0. OR For older adult cohorts, volunteers must be aged 56 to 85 years, have a BMI over 19 kg/m^2 and under 30 kg/m^2, and weigh at least 50 kg at Visit 0. OR For the immunocompromised adult cohort (Cohort 13), volunteers must be aged 18 to 85 years, have a BMI over 19 kg/m^2 and under 30 kg/m^2, and weigh at least 50 kg at Visit 0. They must be healthy, in the clinical judgment of the investigator, based on medical history, physical examination, 12-lead electrocardiogram (ECG), vital signs (systolic/diastolic blood pressure, pulse rate, body temperature, respiratory rate), and clinical laboratory tests (blood chemistry, hematology, and urine chemistry) at Visit 0. Note: Healthy volunteers with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included. OR For the immunocompromised cohort (Cohort 13); volunteers who have previously received solid organ transplant, or peripheral blood stem cell transplantation ≥6 months after transplantation, or individuals with human immunodeficiency virus (HIV) infection with a CD4+ T-cell count of ≥200 x 10^6 /L at Visit 0. Individuals with lower T-cell counts will be excluded from the trial on the basis that this represents a significant medical complication. In the clinical judgment of the investigator, volunteers must be immunocompromised but otherwise healthy. After consultation with the Medical Monitor, this may include individuals receiving immunosuppressant therapy due to another confounding disease at least 2 weeks prior to enrollment and/or at least 6 weeks following immunization with BNT162b2, and/or individuals with immunosuppressive treatment of an autoimmune disease if the disease is stable. Women of childbearing potential (WOCBP) must have a negative beta-human chorionic gonadotropin urine test at Visit 0 and Visit 1. Women that are postmenopausal or permanently sterilized will be considered as not having reproductive potential. WOCBP must agree to practice a highly effective form of contraception during the trial, starting after Visit 0 and continuously until 60 days after receiving the last immunization. WOCBP must agree to require their male partners to use condoms during sexual contact (unless male partners are sterilized or infertile). WOCBP must confirm that they practice at least one highly effective form of contraception for the 14 days prior to Visit 0. WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during trial, starting after Visit 0 and continuously until 60 days after receiving the last immunization. Men who are sexually active with a WOCBP and have not had a vasectomy must agree to practice a highly effective form of contraception with their female partner of childbearing potential during the trial, starting after Visit 0 and continuously until 60 days after receiving the last immunization. Men must be willing to refrain from sperm donation, starting after Visit 0 and continuously until 60 days after receiving the last immunization. They must have confirmation of their health insurance coverage prior to Visit 0. They must agree to not be vaccinated during the trial, starting after Visit 0 and continuously until 28 days after receiving the last immunization. Exclusion Criteria: Have had any acute illness, as determined by the investigator, with or without fever, within 72 hours prior to the first immunization. An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the investigator, the residual symptoms will not compromise their well-being if they participate as trial subjects in the trial, or that could prevent, limit, or confound the protocol-specified assessments. Are breastfeeding on the day of Visit 0 or who plan to breastfeed during the trial, starting after Visit 0 and continuously until at least 90 days after receiving the last immunization. Have a known allergy, hypersensitivity, or intolerance to the planned investigational medicinal product (IMP) including any excipients of the IMP. Had any medical condition or any major surgery (e.g., requiring general anesthesia) within the past 5 years which, in the opinion of the investigator, could compromise their well-being if they participate as trial subjects in the trial, or that could prevent, limit, or confound the protocol-specified assessments. Have any surgery planned during the trial, starting after Visit 0 and continuously until at least 90 days after receiving the last immunization. Had any chronic use (more than 21 continuous days) of any systemic medications, including immunosuppressant's or other immune-modifying drugs (except for Cohort 13), within the 6 months prior to Visit 0 unless in the opinion of the investigator, the medication would not prevent, limit, or confound the protocol-specified assessments or could compromise subject safety. Note: Healthy volunteers with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included. Had any vaccination within the 28 days prior to Visit 0. Had administration of any immunoglobulins and/or any blood products within the 3 months prior to Visit 0. Had administration of another investigational medicinal product including vaccines within 60 days or 5 half-lives (whichever is longer), prior to Visit 0. Have a known history of active or ongoing hepatitis B or hepatitis C infection; or except for Cohort 13: HIV-1 or HIV-2 infection within the 30 days prior to Visit 0. Have a positive polymerase chain reaction (PCR)-based test for SARS-CoV-2 within the 30 days prior to Visit 1. Have a positive drugs of abuse (for amphetamines, benzodiazepines, barbiturates, cocaine, cannabinoids, opiates, methadone, methamphetamines, phencyclidine, and tricyclic antidepressants) result at Visit 0 or Visit 1. Have a positive breath alcohol test at Visit 0 or Visit 1. Previously participated in an investigational trial involving lipid nanoparticles. Are subject to exclusion periods from other investigational trials or simultaneous participation in another clinical trial. When entering the follow-up phase, i.e., after completing the end of treatment (EoT) visit, subjects are allowed to participate in other clinical trials not investigating COVID-19 vaccines or treatments; subjects immunized with BNT162 vaccines in this clinical trial are allowed to participate in other clinical trials involving immunization with BNT162b2. Have any affiliation with the trial site (e.g., are close relative of the investigator or dependent person, such as an employee or student of the trial site). Have a history (within the past 5 years) of substance abuse or known medical, psychological, or social conditions which, in the opinion of the investigator, could compromise their well-being if they participate as trial subjects in the trial, or that could prevent, limit, or confound the protocol-specified assessments. Have a history of hypersensitivity or serious reactions to previous vaccinations. Have a history of Guillain-Barré Syndrome within 6 weeks following a previous vaccination. Have a history of narcolepsy. Have history of alcohol abuse or drug addiction within 1 year before Visit 0. (Except for Cohort 13) Have a history of or suspected immunosuppressive condition, acquired or congenital, as determined by medical history and/or physical examination at Visit 0. Have any abnormality or permanent body art (e.g., tattoo) that, in the opinion of the investigator, would obstruct the ability to observe local reactions at the injection site. Have had any blood loss >450 mL, e.g., due to donation of blood or blood products or injury, within the 7 days prior to Visit 0 or plan to donate blood during the trial, starting after Visit 0 and continuously until at least 7 days after receiving the last immunization. Have symptoms of COVID-19, e.g., respiratory symptoms, fever, cough, shortness of breath and breathing difficulties. Have had contact with persons diagnosed with COVID-19 or who tested positive for SARS-CoV-2 by any diagnostic test within the 30 days prior to Visit 1. Are soldiers, volunteers in detention, contract research organization (CRO) or sponsor staff or their family members. Regular receipt of inhaled/nebulized corticosteroids (except for Cohort 13). For older volunteers and for Cohort 13 only: Have a condition known to put them at high risk for severe COVID-19, including those with any of the following risk factors: Uncontrolled hypertension. Diabetes mellitus (HbA1c >8.5% ≥3 months, according to the medical history reported by the subject). Chronic obstructive pulmonary disease. Asthma. Chronic liver disease. Known Stage 3 or worse chronic kidney disease (glomerular filtration rate <60 mL/min/1.73 m^2); Except for post-renal transplant patients who should have (estimated) GFR ≥40 mL/min/1.73 m^2. Serious heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies. Sickle cell disease. Cancer (except for Cohort 13). Are immune compromised due to stem cell or organ-transplantation with significant medical complications such as acute or chronic graft rejection or graft versus host disease requiring intensive immunosuppressive treatment, transplant failure or infectious complications or other conditions that would be considered a contraindication for vaccination. Are immune compromised due to HIV infection with a CD4+ count of < 200 x 10^6 /L at screening or significant medical complications such as opportunistic infections, malignant complications (e.g., lymphoma, Kaposi sarcoma), other organ manifestations consistent with advanced AIDS or other conditions that would be considered a contraindication for vaccination. Resident in a long term facility. Current vaping or smoking (occasional smoking is acceptable). History of chronic smoking within the prior year.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BioNTech Responsible Person
Organizational Affiliation
BioNTech SE
Official's Role
Study Director
Facility Information:
Facility Name
Contract Research Organization
City
Berlin
Country
Germany
Facility Name
Universitäts Klinikum
City
Frankfurt am Main
Country
Germany
Facility Name
Universitäts Klinikum
City
Heidelberg
Country
Germany
Facility Name
Contract Research Organization
City
Kiel
Country
Germany
Facility Name
Contract Research Organization
City
Mannheim
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35653438
Citation
Quandt J, Muik A, Salisch N, Lui BG, Lutz S, Kruger K, Wallisch AK, Adams-Quack P, Bacher M, Finlayson A, Ozhelvaci O, Vogler I, Grikscheit K, Hoehl S, Goetsch U, Ciesek S, Tureci O, Sahin U. Omicron BA.1 breakthrough infection drives cross-variant neutralization and memory B cell formation against conserved epitopes. Sci Immunol. 2022 Sep 16;7(75):eabq2427. doi: 10.1126/sciimmunol.abq2427. Epub 2022 Sep 16.
Results Reference
derived
PubMed Identifier
33524990
Citation
Vogel AB, Kanevsky I, Che Y, Swanson KA, Muik A, Vormehr M, Kranz LM, Walzer KC, Hein S, Guler A, Loschko J, Maddur MS, Ota-Setlik A, Tompkins K, Cole J, Lui BG, Ziegenhals T, Plaschke A, Eisel D, Dany SC, Fesser S, Erbar S, Bates F, Schneider D, Jesionek B, Sanger B, Wallisch AK, Feuchter Y, Junginger H, Krumm SA, Heinen AP, Adams-Quack P, Schlereth J, Schille S, Kroner C, de la Caridad Guimil Garcia R, Hiller T, Fischer L, Sellers RS, Choudhary S, Gonzalez O, Vascotto F, Gutman MR, Fontenot JA, Hall-Ursone S, Brasky K, Griffor MC, Han S, Su AAH, Lees JA, Nedoma NL, Mashalidis EH, Sahasrabudhe PV, Tan CY, Pavliakova D, Singh G, Fontes-Garfias C, Pride M, Scully IL, Ciolino T, Obregon J, Gazi M, Carrion R Jr, Alfson KJ, Kalina WV, Kaushal D, Shi PY, Klamp T, Rosenbaum C, Kuhn AN, Tureci O, Dormitzer PR, Jansen KU, Sahin U. BNT162b vaccines protect rhesus macaques from SARS-CoV-2. Nature. 2021 Apr;592(7853):283-289. doi: 10.1038/s41586-021-03275-y. Epub 2021 Feb 1.
Results Reference
derived

Learn more about this trial

A Trial Investigating the Safety and Effects of Four BNT162 Vaccines Against COVID-2019 in Healthy and Immunocompromised Adults

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