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BNT162a1
A Trial Investigating the Safety and Effects of Four BNT162 Vaccines Against COVID-19 in Healthy and Immunocompromised Adults
Ensayo de BioNTech SE en Infections, Respiratory · Virus Diseases · Infection Viral · Vaccine Adverse Reaction · RNA Virus Infections · Protection Against COVID-19 and Infections With SARS CoV 2 (del registro, en inglés).
- Fase
- Fase 1/2
- Estado
- Completado
- Participantes
- 512
- Centros
- 5
- Fin del objetivo primario
- jun 2021
Qué significa cada fase y cada estado.
Estudio de intervención, no aleatorizado, abierto. Comenzó en abr 2020.
Qué mide
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. (From Day 1 to Day 8 for Dose 1 (Prime Immunization) and from Day 22 to Day 29 for Dose 2 (Boost Immunization)) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroOriginally, 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.
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|---|---|---|---|
| BNT164a1 | Fase 1/2 | En marcha, sin reclutar | mar 2026 (real) |
| BNT162b2 Vaccine | Fase 3 | En marcha, sin reclutar | jul 2026 (prevista, ya pasada: sin actualizar en el registro) |
| BNT314 | Fase 1 | En marcha, sin reclutar | ago 2026 (real) |
| BNT163 | Fase 1 | En marcha, sin reclutar | oct 2026 (prevista) |
| RO7198457 intravenous | Fase 2 | En marcha, sin reclutar | nov 2026 (prevista) |
| BNT351 | Fase 1 | Reclutando pacientes | nov 2026 (prevista) |
Todos los de BNTX, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT04380701), actualizada en ene 2024.