EUCTR2020-001038-36-DE进行中（未招募）1 期
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 - Phase I/II Trial Investigating the Safety and Effects of Four BNT162 Vaccines Against COVID-19
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- BioNTech SE
- 入组人数
- 638
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Have given informed consent by signing the informed consent form (ICF) before initiation of any trial-specific procedures.
- •2. 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.
- •3. They must be able to understand and follow trial-related instructions.
- •4. For younger subject cohorts, volunteers must be aged 18 to 55 years, have a BMI over 19 kg/m2 and under 30 kg/m2, and weigh at least 50 kg at Visit 0.
- •For older adult cohorts, volunteers must be aged 56 to 85 years, have a BMI over 19 kg/m2 and under 30 kg/m2, and weigh at least 50 kg at Visit 0.
- •For the immunocompromised adult cohort (Cohort 13), volunteers must be aged 18 to 85 years, have a BMI over 19 kg/m2 and under 30 kg/m2, and weigh at least 50 kg at Visit 0.
- •5. They must be healthy, in the clinical judgment of the investigator, based on medical history, physical examination, 12-lead 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 wks before enrollment, can be included.
- •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 HIV infection with a CD4+ T-cell count of =200 x 106 /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 wks prior to enrollment and/or at least 6 wks following immunization with BNT162b2, and/or individuals with immunosuppressive treatment of an autoimmune disease if the disease is stable.
- •6. 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.
- •7. WOCBP must agree to practice a highly effective form of contraception during the trial, starting after Visit 0 and continuously until 60 d 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).
- •8. WOCBP must confirm that they practiced at least one highly effective form of contraception for the 14 d prior to Visit 0.
- •9. 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 d after receiving the last immunization.
- •10. 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, start
排除标准
- •Volunteers are excluded from the trial if they meet or present any of the following criteria:
- •1. Have had any acute illness, as determined by the investigator, with or without fever, within 72 h 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 wellbeing if they participate as trial subjects in the trial, or that could prevent, limit, or confound the protocol-specified assessments.
- •2. 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 d after receiving the last immunization.
- •3. Have a known allergy, hypersensitivity, or intolerance to the planned IMP including any excipients of the IMP.
- •4. 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 wellbeing if they participate as trial subjects in the trial, or that could prevent, limit, or confound the protocol-specified assessments. See the inclusion criteria 5 for non-excluded medical conditions for Cohort 13.
- •5. Have any surgery planned during the trial, starting after Visit 0 and continuously until at least 90 d after receiving the last immunization.
- •6. Had any chronic use (more than 21 continuous days) of any systemic medications, including immunosuppressants 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 wks before enrollment, can be included.
- •7. Received any vaccination within the 28 d prior to Visit 0.
- •8. Had administration of any immunoglobulins and/or any blood products within the 3 months prior to Visit 0.
- •9. Had administration of another investigational medicinal product including vaccines within 60 d or 5 half-lives (whichever is longer), prior to Visit 0.
- •10. 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 d prior to Visit 0
- •11. Have a positive PCR-based test for SARS-CoV-2 within the 30 d prior to Visit 1.
- •12. 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.
- •13. Have a positive breath alcohol test at Visit 0 or Visit 1.
- •14. Previously participated in an investigational trial involving lipid nanoparticles.
- •15. 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 EoT visit, subjects are allowed to participate in other clinical trials not investigating COVID-19 vaccines or treatments.
- •16. 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).
- •17. Have a history (within the past 5
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