Safety and Effects of an Investigational COVID-19 Vaccine as Booster in Healthy People
第1相
完了
NCT05541861
| 対象疾患 | SARS-CoV-2 Infection, COVID-19 |
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| 相 | 第1相 |
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| スポンサー | BioNTech SE |
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| ステータス | 完了 |
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| 参加者数 | 383 名 |
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| 介入（薬剤） | BNT162b2 Bivalent (original/Omicron BA.4/BA.5) 30 mcg, BNT162b4 5 mcg, BNT162b4 10 mcg, BNT162b4 15 mcg, BNT162b4 30 mcg |
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| 開始日 | 2022年11月8日 |
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| 完了日 | 2024年11月22日 |
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| 結果公開日 | 2026年1月13日 |
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概要
This was an exploratory Phase I, randomized, observer-blind, active-controlled, dose-escalation trial to evaluate four dose levels (DLs) of BNT162b4 given in combination with BNT162b2 Bivalent (original/Omicron BA.4/BA.5) to select a safe and tolerable dose and to evaluate BNT162b4 + BNT162b2 Bivalent (original/Omicron BA.4/BA.5) when given as Dose 1 and Dose 2 (booster) in Cohorts 1 and 2 and BNT162b4 + BNT162b2 Monovalent (OMI XBB.1.5) when given as Dose 2 (booster) in Cohorts 3a, 3b, 4a, and 4b, and 30 microgram (mcg) BNT162b4 when given alone as Dose 1 and Dose 2 in Cohort 5. The trial used a staggered dosing process schema, i.e., enrollment into the next higher dose level was done sequentially and subject to safety data from the previous dose levels, with sentinel participants in Cohorts 1, 2, 3a, and 4a. Cohort 3b investigating the same dose level as cohort 3a but in participants aged \>55 years was opened after safety data for participants aged 18-55 years in Cohort 3a had been reviewed. Enrollment into Cohorts 4a and 4b was opened after safety data for Cohort 3a and 3b had been reviewed. Cohort 5 participants were not randomized and received two doses of BNT162b4 alone afte
Number of Participants With Solicited Local Reactions- Post Dose 1
Up to 7 days post-dose1 · Participants
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | 30 Participants |
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| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | 30 Participants |
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| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | 29 Participants |
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| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | 30 Participants |
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| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | 41 Participants |
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| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | 33 Participants |
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Number of Participants With Solicited Local Reactions- Post Dose 2
Up to 7 days post-dose 2 · Participants
| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | 23 Participants |
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| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | 18 Participants |
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| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | 23 Participants |
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| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | 29 Participants |
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| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | 24 Participants |
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| Cohort 5: BNT162b4 30 mcg (Aged 18-55 Years) | 11 Participants |
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Number of Participants With Solicited Systemic Events- Post Dose 1
Up to 7 days post-dose 1 · Participants
| Cohort 1: BNT162b2 Bivalent 30 mcg + BNT162b4 5 mcg (Aged 18-55 Years) | 1 Participants |
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| Cohort 2: BNT162b2 Bivalent 30 mcg + BNT162b4 10 mcg (Aged 18-55 Years) | 0 Participants |
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| Cohort 3a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged 18-55 Years) | 0 Participants |
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| Cohort 3b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 15 mcg (Aged >55 Years) | 2 Participants |
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| Cohort 4a: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged 18-55 Years) | 0 Participants |
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| Cohort 4b: BNT162b2 Bivalent/Monovalent 30 mcg + BNT162b4 30 mcg (Aged >55 Years) | 0 Participants |
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