Infections, RespiratoryPhase 1/2NCT04380701
A Trial Investigating the Safety and Effects of Four BNT162 Vaccines Against COVID-19 in Healthy and Immunocompromised Adults
A Phase 1/2 study testing BNT162a1, BNT162b1 and BNT162b2 in people with Infections, Respiratory and Virus Diseases, run by BioNTech SE at 5 sites in Germany.
Trial summary
Originally, the study was planned to include two parts, i.e., Part A and Part B, however Part B was cancelled due to changes in the overall clinical development plan. 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… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Infections, Respiratory, Virus Diseases, Infection Viral
- What is being tested?
- BNT162a1, BNT162b1 and BNT162b2
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 512 participants
- Where
- 5 sitesGermany
- Study dates
- 23 Apr 2020to 13 Apr 2022
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Contract Research Organization
Berlin
Universitäts Klinikum
Frankfurt am Main
Universitäts Klinikum
Heidelberg
Contract Research Organization
Kiel
Contract Research Organization
Mannheim
About this study
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-19 Using Different Dosing Regimens in Healthy and Immunocompromised Adults
Originally, the study was planned to include two parts, i.e., Part A and Part B, however Part B was cancelled due to changes in the overall clinical development plan. 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).
The conducted Part A was a dose-finding part to investigate the optimal dose of four different vaccines (BNT162a1, BNT162b1, BNT162b2, and BNT162c2), allowing dose adjustments upwards and downwards in younger participants. Doses tested in older participants and expansion cohorts were chosen based on acceptability of dosing in younger participants.
The vaccines BNT162a1, BNT162b1, BNT162b2, and BNT162c2 were administered using a Prime/Boost (P/B) regimen with two doses given ~21 days apart. The vaccine BNT162c2 was also administered using a Single dose (SD) regimen. Four additional expansion cohorts (cohorts 11, 12, 13, and 14) aged from 18 to 85 years received BNT162b2 using a P/B regimen only. In cohort 11, participants received BNT162b2 using one 3 μg prime dose (Dose 1) and one 30 μg boost dose (Dose 2) of BNT162b2. Participants in cohorts 12, 13, and 14 received two doses of BNT162b2 30 µg, each.
Read the detailed description
This study was a multi-site, Phase I/II, open-label, dose-escalation study. The study included the first-in-human (FIH) dose and dose ranging groups for all four vaccines in healthy younger participants (aged 18 to 55 years [years]) and older participants (aged 56 to 85 years). The conducted Part A followed a dose escalation design. Discretionary dose de-escalation and refinement was also planned. Study participants with the FIH immunization and any subsequent dose escalation cohorts were immunized using a sentinel dosing/subject staggering. For any dose de-escalation or dose-refinement cohorts in younger adults, i.e., cohorts with doses lower than previously tested, participants were dosed using a subject staggering process. Cohorts in older participants were optional and dependent on acceptability of dosing in younger participants. Part A consisted of a treatment phase and a follow-up phase.
For the BNT162a1 3 µg arm, the Safety Review Committee (SRC) decided to stop dosing after 6 treated participants and to not administer the boost immunization (Dose 2). For the BNT162b1 60 µg arm, the SRC decided to not administer the boost immunization (Dose 2) for the 12 participants.
- Conditions
- Infections, Respiratory, Virus Diseases, Infection Viral, Vaccine Adverse Reaction, RNA Virus Infections, Protection Against COVID-19 and Infections With SARS CoV 2
- Being tested
- BNT162a1, BNT162b1, BNT162b2, BNT162c2
- Keywords
- SARS-CoV-2, Severe Acute Respiratory Syndrome (SARS), Coronavirus Disease 2019, COVID-2019, Virus Diseases
- Medical subject headings
- Respiratory Tract Infections, Virus Diseases, RNA Virus Infections, Severe Acute Respiratory Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BNT162a1Biological
Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection.
BNT162b1Biological
Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection.
BNT162b2Biological
Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection.
BNT162c2Biological
Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection.
| Study group | Role | What they receive |
|---|---|---|
| BNT162a1 (P/B) - Part A 18-55 years of age | Experimental | Escalating dose levels Receives: Biological: BNT162a1 |
| BNT162b1 (P/B) - Part A 18-55 years of age | Experimental | Escalating dose levels Receives: Biological: BNT162b1 |
| BNT162b2 (P/B) - Part A 18-55 years of age | Experimental | Escalating dose levels Receives: Biological: BNT162b2 |
| BNT162c2 (P/B) - Part A 18-55 years of age | Experimental | Escalating dose levels Receives: Biological: BNT162c2 |
| BNT162c2 (prime only) - Part A 18-55 years of age | Experimental | Single dose Receives: Biological: BNT162c2 |
| BNT162b1 (P/B) - Part A 56-85 years of age | Experimental | Escalating dose levels Receives: Biological: BNT162b1 |
| BNT162b2 (P/B) - Part A 56-85 years of age | Experimental | Escalating dose levels Receives: Biological: BNT162b2 |
| BNT162b2 (P/B) - Part A 18-85 years of age (Expansion cohorts 11 to 13) | Experimental | Fixed doses used; cohort 11: alternative posology dose group expansion cohort; cohort 12: adaptive immune response dose group expansion cohort; cohort 13: immunocompromised (IC) participants expansion cohort Receives: Biological: BNT162b2 |
| BNT162b2 (P/B) - Part A 18-85 years of age (Expansion cohort 14) | Experimental | fixed doses used; B-cell immune response dose group expansion cohort Receives: Biological: BNT162b2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose.
Solicited local reactions at the injection site (pain, tenderness, erythema/redness, and induration/swelling) were monitored and graded using criteria based on the guidance given in US FDA Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials". The reporting of local reactions was based on the participant's assessments via daily solicited reports in the participant diaries.
Measured: From Day 1 to Day 8 for Dose 1 (Prime Immunization) and from Day 22 to Day 29 for Dose 2 (Boost Immunization)
Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose.
Solicited systemic reactions (nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, loss of appetite, malaise, and fever) were monitored and graded using criteria based on the guidance given in US FDA Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials". The reporting of systemic reactions was based on the participant's assessments via daily solicited reports in the participant diaries.
Measured: From Day 1 to Day 8 for Dose 1 (Prime Immunization) and from Day 22 to Day 29 for Dose 2 (Boost Immunization)
The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1.
TEAEs without AEs based on solicited reporting via diaries, were analyzed by vaccine, age group, dose level, and for each IMP dose. The percentage of participants reporting at least one TEAE was summarized by adverse event types (any TEAE and any grade >=3 TEAE) using the Safety Set.
Measured: 28 days following Dose 1 or up to Dose 2 (whichever was first)
The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2)
TEAEs, without AEs based on solicited reporting via diaries, were analyzed by vaccine, age group, dose level, and for each IMP dose. The percentage of participants reporting at least one TEAE was summarized by adverse event types (any TEAE and any grade >=3 TEAE) using the Safety Set.
Measured: 28 days following Dose 2 or Dose 1 (if no Dose 2 was given)
Secondary outcomes (9)
Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B)
At Day 1 (Baseline = Pre-Prime Immunization) and at 7 and 21 days after Dose 1 (Prime Immunization) and at 7, 21, 28, 63, and 162 days after Dose 2 (Boost Immunization).
Measured: up to 183 days following Dose 1
Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B)
At 7 and 21 days after Dose 1 (Prime Immunization) and at 7, 21, 28, 63, and 162 days after Dose 2 (Boost Immunization).
Measured: up to 183 days following Dose 1
Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B)
At 7 and 21 days after Dose 1 (Prime Immunization) and at 7, 21, 28, 63, and 162 days after Dose 2 (Boost Immunization).
Measured: up to 183 days following Dose 1
Functional Antibody Responses (Titers) for BNT162c2 (SD)
At Day 1 (Baseline = Pre Immunization) and at 7, 21, 28, 42, 84, and 183 days after Dose 1 (Prime Immunization).
Measured: up to 183 days following Dose 1
Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD)
At 7, 21, 28, 42, 84, and 183 days after Dose 1 (Prime Immunization).
Measured: up to 183 days following Dose 1
Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD)
At 7, 21, 28, 42, 84, and 183 days after Dose 1 (Prime Immunization).
Measured: up to 183 days following Dose 1
Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B)
At Day 1 (Baseline = Pre-Prime Immunization) and at 7, 14, and 21 days after Dose 1 (Prime Immunization) and at 7, 14, 21, 28, 63, 162, and 343 days after Dose 2 (Boost Immunization).
Measured: up to 1 year following Dose 1
Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B)
At 7, 14, and 21 days after Dose 1 (Prime Immunization) and at 7, 14, 21, 28, 63, 162, and 343 days after Dose 2 (Boost Immunization).
Measured: up to 1 year following Dose 1
Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B)
At 7, 14, and 21 days after Dose 1 (Prime Immunization) and at 7, 14, 21, 28, 63, 162, and 343 days after Dose 2 (Boost Immunization).
Measured: up to 1 year following Dose 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start23 Apr 2020
- Primary completion30 Jun 2021
- Study completion13 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Infections, RespiratoryStudies of the same condition, open and under way.
- More trials run by BioNTech SEThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 512 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioNTech SE
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- BioNTech Responsible Person, Study director, BioNTech SE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04380701
- Sponsor's protocol ID
- BNT162-01
- Other IDs
- 2020-001038-36, U1111-1249-4220
- Status last verified
- Jan 2024
- First submitted
- 6 May 2020
- Last updated
- 12 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Muik A, Wallisch AK, Sanger B, Swanson KA, Muhl J, Chen W, Cai H, Maurus D, Sarkar R, Tureci O, Dormitzer PR, Sahin U. Neutralization of SARS-CoV-2 lineage B.1.1.7 pseudovirus by BNT162b2 vaccine-elicited human sera. Science. 2021 Mar 12;371(6534):1152-1153. doi: 10.1126/science.abg6105. Epub 2021 Jan 29.
PubMed 33514629Sahin U, Muik A, Derhovanessian E, Vogler I, Kranz LM, Vormehr M, Baum A, Pascal K, Quandt J, Maurus D, Brachtendorf S, Lorks V, Sikorski J, Hilker R, Becker D, Eller AK, Grutzner J, Boesler C, Rosenbaum C, Kuhnle MC, Luxemburger U, Kemmer-Bruck A, Langer D, Bexon M, Bolte S, Kariko K, Palanche T, Fischer B, Schultz A, Shi PY, Fontes-Garfias C, Perez JL, Swanson KA, Loschko J, Scully IL, Cutler M, Kalina W, Kyratsous CA, Cooper D, Dormitzer PR, Jansen KU, Tureci O. COVID-19 vaccine BNT162b1 elicits human antibody and TH1 T cell responses. Nature. 2020 Oct;586(7830):594-599. doi: 10.1038/s41586-020-2814-7. Epub 2020 Sep 30.
PubMed 32998157Sahin U, Muik A, Vogler I, Derhovanessian E, Kranz LM, Vormehr M, Quandt J, Bidmon N, Ulges A, Baum A, Pascal KE, Maurus D, Brachtendorf S, Lorks V, Sikorski J, Koch P, Hilker R, Becker D, Eller AK, Grutzner J, Tonigold M, Boesler C, Rosenbaum C, Heesen L, Kuhnle MC, Poran A, Dong JZ, Luxemburger U, Kemmer-Bruck A, Langer D, Bexon M, Bolte S, Palanche T, Schultz A, Baumann S, Mahiny AJ, Boros G, Reinholz J, Szabo GT, Kariko K, Shi PY, Fontes-Garfias C, Perez JL, Cutler M, Cooper D, Kyratsous CA, Dormitzer PR, Jansen KU, Tureci O. BNT162b2 vaccine induces neutralizing antibodies and poly-specific T cells in humans. Nature. 2021 Jul;595(7868):572-577. doi: 10.1038/s41586-021-03653-6. Epub 2021 May 27.
PubMed 34044428Vogel 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.
PubMed 33524990Ji RR, Qu Y, Zhu H, Yang Y, Vogel AB, Sahin U, Qin C, Hui A. BNT162b2 Vaccine Encoding the SARS-CoV-2 P2 S Protects Transgenic hACE2 Mice against COVID-19. Vaccines (Basel). 2021 Apr 1;9(4):324. doi: 10.3390/vaccines9040324.
PubMed 33915773Li J, Hui A, Zhang X, Yang Y, Tang R, Ye H, Ji R, Lin M, Zhu Z, Tureci O, Lagkadinou E, Jia S, Pan H, Peng F, Ma Z, Wu Z, Guo X, Shi Y, Muik A, Sahin U, Zhu L, Zhu F. Safety and immunogenicity of the SARS-CoV-2 BNT162b1 mRNA vaccine in younger and older Chinese adults: a randomized, placebo-controlled, double-blind phase 1 study. Nat Med. 2021 Jun;27(6):1062-1070. doi: 10.1038/s41591-021-01330-9. Epub 2021 Apr 22.
PubMed 33888900Muik A, Lui BG, Wallisch AK, Bacher M, Muhl J, Reinholz J, Ozhelvaci O, Beckmann N, Guimil Garcia RC, Poran A, Shpyro S, Finlayson A, Cai H, Yang Q, Swanson KA, Tureci O, Sahin U. Neutralization of SARS-CoV-2 Omicron by BNT162b2 mRNA vaccine-elicited human sera. Science. 2022 Feb 11;375(6581):678-680. doi: 10.1126/science.abn7591. Epub 2022 Jan 18.
PubMed 35040667Quandt 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.
PubMed 35653438Pather S, Charpentier N, van den Ouweland F, Rizzi R, Finlayson A, Salisch N, Muik A, Lindemann C, Khanim R, Abduljawad S, Smith ER, Gurwith M, Chen RT; Benefit-Risk Assessment of VAccines by TechnolOgy Working Group (BRAVATO; ex-V3SWG). A Brighton Collaboration standardized template with key considerations for a benefit-risk assessment for the Comirnaty COVID-19 mRNA vaccine. Vaccine. 2024 Sep 17;42(22):126165. doi: 10.1016/j.vaccine.2024.126165. Epub 2024 Aug 27.
PubMed 39197299Muik A, Lui BG, Bacher M, Wallisch AK, Toker A, Finlayson A, Kruger K, Ozhelvaci O, Grikscheit K, Hoehl S, Ciesek S, Tureci O, Sahin U. Omicron BA.2 breakthrough infection enhances cross-neutralization of BA.2.12.1 and BA.4/BA.5. Sci Immunol. 2022 Nov 25;7(77):eade2283. doi: 10.1126/sciimmunol.ade2283. Epub 2022 Nov 18.
PubMed 36125366
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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-19 Using Different Dosing Regimens in Healthy and Immunocompromised Adults
- ClinicalTrials.gov ID
- NCT04380701
- Acronym / sponsor ID
- BNT162-01
- Conditions
- 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
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 512 participants (actual)
- Lead sponsor
- BioNTech SEIndustry (pharma, biotech, devices)
- Study start
- 23 Apr 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 13 Apr 2022 (actual)
- First posted
- 8 May 2020 (actual)
- Results
- Posted 12 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Originally, the study was planned to include two parts, i.e., Part A and Part B, however Part B was cancelled due to changes in the overall clinical development plan. 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).
The conducted Part A was a dose-finding part to investigate the optimal dose of four different vaccines (BNT162a1, BNT162b1, BNT162b2, and BNT162c2), allowing dose adjustments upwards and downwards in younger participants. Doses tested in older participants and expansion cohorts were chosen based on acceptability of dosing in younger participants.
The vaccines BNT162a1, BNT162b1, BNT162b2, and BNT162c2 were administered using a Prime/Boost (P/B) regimen with two doses given ~21 days apart. The vaccine BNT162c2 was also administered using a Single dose (SD) regimen. Four additional expansion cohorts (cohorts 11, 12, 13, and 14) aged from 18 to 85 years received BNT162b2 using a P/B regimen only. In cohort 11, participants received BNT162b2 using one 3 μg prime dose (Dose 1) and one 30 μg boost dose (Dose 2) of BNT162b2. Participants in cohorts 12, 13, and 14 received two doses of BNT162b2 30 µg, each.
Detailed description
This study was a multi-site, Phase I/II, open-label, dose-escalation study. The study included the first-in-human (FIH) dose and dose ranging groups for all four vaccines in healthy younger participants (aged 18 to 55 years [years]) and older participants (aged 56 to 85 years). The conducted Part A followed a dose escalation design. Discretionary dose de-escalation and refinement was also planned. Study participants with the FIH immunization and any subsequent dose escalation cohorts were immunized using a sentinel dosing/subject staggering. For any dose de-escalation or dose-refinement cohorts in younger adults, i.e., cohorts with doses lower than previously tested, participants were dosed using a subject staggering process. Cohorts in older participants were optional and dependent on acceptability of dosing in younger participants. Part A consisted of a treatment phase and a follow-up phase.
For the BNT162a1 3 µg arm, the Safety Review Committee (SRC) decided to stop dosing after 6 treated participants and to not administer the boost immunization (Dose 2). For the BNT162b1 60 µg arm, the SRC decided to not administer the boost immunization (Dose 2) for the 12 participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| BNT162a1 (P/B) - Part A 18-55 years of age | Experimental | Biological: BNT162a1Escalating dose levels |
| BNT162b1 (P/B) - Part A 18-55 years of age | Experimental | Biological: BNT162b1Escalating dose levels |
| BNT162b2 (P/B) - Part A 18-55 years of age | Experimental | Biological: BNT162b2Escalating dose levels |
| BNT162c2 (P/B) - Part A 18-55 years of age | Experimental | Biological: BNT162c2Escalating dose levels |
| BNT162c2 (prime only) - Part A 18-55 years of age | Experimental | Biological: BNT162c2Single dose |
| BNT162b1 (P/B) - Part A 56-85 years of age | Experimental | Biological: BNT162b1Escalating dose levels |
| BNT162b2 (P/B) - Part A 56-85 years of age | Experimental | Biological: BNT162b2Escalating dose levels |
| BNT162b2 (P/B) - Part A 18-85 years of age (Expansion cohorts 11 to 13) | Experimental | Biological: BNT162b2Fixed doses used; cohort 11: alternative posology dose group expansion cohort; cohort 12: adaptive immune response dose group expansion cohort; cohort 13: immunocompromised (IC) participants expansion cohort |
| BNT162b2 (P/B) - Part A 18-85 years of age (Expansion cohort 14) | Experimental | Biological: BNT162b2fixed doses used; B-cell immune response dose group expansion cohort |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (43 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BNT162a1Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection. | Biological | BNT162a1 (P/B) - Part A 18-55 years of age |
| BNT162b1Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection. | Biological | BNT162b1 (P/B) - Part A 18-55 years of age, BNT162b1 (P/B) - Part A 56-85 years of age |
| BNT162b2Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection. | Biological | BNT162b2 (P/B) - Part A 18-55 years of age, BNT162b2 (P/B) - Part A 18-85 years of age (Expansion cohort 14), BNT162b2 (P/B) - Part A 18-85 years of age (Expansion cohorts 11 to 13), BNT162b2 (P/B) - Part A 56-85 years of age |
| BNT162c2Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection. | Biological | BNT162c2 (P/B) - Part A 18-55 years of age, BNT162c2 (prime only) - Part A 18-55 years of age |
Primary outcome
Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose.
Time frame: From Day 1 to Day 8 for Dose 1 (Prime Immunization) and from Day 22 to Day 29 for Dose 2 (Boost Immunization)
Solicited local reactions at the injection site (pain, tenderness, erythema/redness, and induration/swelling) were monitored and graded using criteria based on the guidance given in US FDA Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials". The reporting of local reactions was based on the participant's assessments via daily solicited reports in the participant diaries.
Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose.
Time frame: From Day 1 to Day 8 for Dose 1 (Prime Immunization) and from Day 22 to Day 29 for Dose 2 (Boost Immunization)
Solicited systemic reactions (nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, loss of appetite, malaise, and fever) were monitored and graded using criteria based on the guidance given in US FDA Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials". The reporting of systemic reactions was based on the participant's assessments via daily solicited reports in the participant diaries.
The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Dose 1 (Prime Immunization) up to Dose 2 (Boost Immunization) or 28 Days After Dose 1.
Time frame: 28 days following Dose 1 or up to Dose 2 (whichever was first)
TEAEs without AEs based on solicited reporting via diaries, were analyzed by vaccine, age group, dose level, and for each IMP dose. The percentage of participants reporting at least one TEAE was summarized by adverse event types (any TEAE and any grade >=3 TEAE) using the Safety Set.
The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring After Dose 1 up to 28 Days After Dose 2 (Boost Immunization) or After Dose 1 (Prime Immunization) (if no Dose 2)
Time frame: 28 days following Dose 2 or Dose 1 (if no Dose 2 was given)
TEAEs, without AEs based on solicited reporting via diaries, were analyzed by vaccine, age group, dose level, and for each IMP dose. The percentage of participants reporting at least one TEAE was summarized by adverse event types (any TEAE and any grade >=3 TEAE) using the Safety Set.
9 secondary outcomes
Functional Antibody Responses (Titers) for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B)
Time frame: up to 183 days following Dose 1
Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B)
Time frame: up to 183 days following Dose 1
Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162a1, BNT162b1, BNT162b2 (Younger and Older Dose Ranging Cohorts), and BNT162c2 (P/B)
Time frame: up to 183 days following Dose 1
Functional Antibody Responses (Titers) for BNT162c2 (SD)
Time frame: up to 183 days following Dose 1
Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD)
Time frame: up to 183 days following Dose 1
Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162c2 (SD)
Time frame: up to 183 days following Dose 1
Functional Antibody Responses (Titers) for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B)
Time frame: up to 1 year following Dose 1
Fold Increase in Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B)
Time frame: up to 1 year following Dose 1
Number of Participants With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline for BNT162b2 (Expansion Cohorts 11, 12, 13, and 14; P/B)
Time frame: up to 1 year following Dose 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 33514629Muik A, Wallisch AK, Sanger B, Swanson KA, Muhl J, Chen W, Cai H, Maurus D, Sarkar R, Tureci O, Dormitzer PR, Sahin U. Neutralization of SARS-CoV-2 lineage B.1.1.7 pseudovirus by BNT162b2 vaccine-elicited human sera. Science. 2021 Mar 12;371(6534):1152-1153. doi: 10.1126/science.abg6105. Epub 2021 Jan 29.
- Background: PubMed 32998157Sahin U, Muik A, Derhovanessian E, Vogler I, Kranz LM, Vormehr M, Baum A, Pascal K, Quandt J, Maurus D, Brachtendorf S, Lorks V, Sikorski J, Hilker R, Becker D, Eller AK, Grutzner J, Boesler C, Rosenbaum C, Kuhnle MC, Luxemburger U, Kemmer-Bruck A, Langer D, Bexon M, Bolte S, Kariko K, Palanche T, Fischer B, Schultz A, Shi PY, Fontes-Garfias C, Perez JL, Swanson KA, Loschko J, Scully IL, Cutler M, Kalina W, Kyratsous CA, Cooper D, Dormitzer PR, Jansen KU, Tureci O. COVID-19 vaccine BNT162b1 elicits human antibody and TH1 T cell responses. Nature. 2020 Oct;586(7830):594-599. doi: 10.1038/s41586-020-2814-7. Epub 2020 Sep 30.
- Background: PubMed 34044428Sahin U, Muik A, Vogler I, Derhovanessian E, Kranz LM, Vormehr M, Quandt J, Bidmon N, Ulges A, Baum A, Pascal KE, Maurus D, Brachtendorf S, Lorks V, Sikorski J, Koch P, Hilker R, Becker D, Eller AK, Grutzner J, Tonigold M, Boesler C, Rosenbaum C, Heesen L, Kuhnle MC, Poran A, Dong JZ, Luxemburger U, Kemmer-Bruck A, Langer D, Bexon M, Bolte S, Palanche T, Schultz A, Baumann S, Mahiny AJ, Boros G, Reinholz J, Szabo GT, Kariko K, Shi PY, Fontes-Garfias C, Perez JL, Cutler M, Cooper D, Kyratsous CA, Dormitzer PR, Jansen KU, Tureci O. BNT162b2 vaccine induces neutralizing antibodies and poly-specific T cells in humans. Nature. 2021 Jul;595(7868):572-577. doi: 10.1038/s41586-021-03653-6. Epub 2021 May 27.
- Background: PubMed 33524990Vogel 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.
- Background: PubMed 33915773Ji RR, Qu Y, Zhu H, Yang Y, Vogel AB, Sahin U, Qin C, Hui A. BNT162b2 Vaccine Encoding the SARS-CoV-2 P2 S Protects Transgenic hACE2 Mice against COVID-19. Vaccines (Basel). 2021 Apr 1;9(4):324. doi: 10.3390/vaccines9040324.
- Background: PubMed 33888900Li J, Hui A, Zhang X, Yang Y, Tang R, Ye H, Ji R, Lin M, Zhu Z, Tureci O, Lagkadinou E, Jia S, Pan H, Peng F, Ma Z, Wu Z, Guo X, Shi Y, Muik A, Sahin U, Zhu L, Zhu F. Safety and immunogenicity of the SARS-CoV-2 BNT162b1 mRNA vaccine in younger and older Chinese adults: a randomized, placebo-controlled, double-blind phase 1 study. Nat Med. 2021 Jun;27(6):1062-1070. doi: 10.1038/s41591-021-01330-9. Epub 2021 Apr 22.
- Background: PubMed 35040667Muik A, Lui BG, Wallisch AK, Bacher M, Muhl J, Reinholz J, Ozhelvaci O, Beckmann N, Guimil Garcia RC, Poran A, Shpyro S, Finlayson A, Cai H, Yang Q, Swanson KA, Tureci O, Sahin U. Neutralization of SARS-CoV-2 Omicron by BNT162b2 mRNA vaccine-elicited human sera. Science. 2022 Feb 11;375(6581):678-680. doi: 10.1126/science.abn7591. Epub 2022 Jan 18.
- Background: PubMed 35653438Quandt 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.
- Derived from this study: PubMed 39197299Pather S, Charpentier N, van den Ouweland F, Rizzi R, Finlayson A, Salisch N, Muik A, Lindemann C, Khanim R, Abduljawad S, Smith ER, Gurwith M, Chen RT; Benefit-Risk Assessment of VAccines by TechnolOgy Working Group (BRAVATO; ex-V3SWG). A Brighton Collaboration standardized template with key considerations for a benefit-risk assessment for the Comirnaty COVID-19 mRNA vaccine. Vaccine. 2024 Sep 17;42(22):126165. doi: 10.1016/j.vaccine.2024.126165. Epub 2024 Aug 27.
- Derived from this study: PubMed 36125366Muik A, Lui BG, Bacher M, Wallisch AK, Toker A, Finlayson A, Kruger K, Ozhelvaci O, Grikscheit K, Hoehl S, Ciesek S, Tureci O, Sahin U. Omicron BA.2 breakthrough infection enhances cross-neutralization of BA.2.12.1 and BA.4/BA.5. Sci Immunol. 2022 Nov 25;7(77):eade2283. doi: 10.1126/sciimmunol.ade2283. Epub 2022 Nov 18.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BioNTech Responsible Person study director
BioNTech SE
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BNT162a1, BNT162b1 and BNT162b2 in people with Infections, Respiratory and Virus Diseases, run by BioNTech SE at 5 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose. (time frame: From Day 1 to Day 8 for Dose 1 (Prime Immunization) and from Day 22 to Day 29 for Dose 2 (Boost Immunization)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04380701, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.