drugset / Trial / NCT05303402
A Phase IIb/III Clinical Trial to Assess Safety and Immunogenicity of a COVID-19 Vaccine Booster Dose in Immunosupressed Adults.
Phase 2/3
Completed
241 enrolled
Hipra Scientific, S.L.U
Asphalion · collabFundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia · collabInstitut d'Investigació Biomèdica de Girona Dr. Josep Trueta · collabVeristat, Inc. · collab
NaSingle-groupOpen-labelPrevention
Summary
A phase IIb/III, open label, single arm, multi-centre, trial to assess the immunogenicity and safety of an additional dose vaccination with a recombinant protein RBD fusion heterodimer candidate (PHH-1V) against SARS-CoV-2, in adults with pre-existing immunosuppressive conditions vaccinated against COVID-19
Timeline
- Start
- 2022-05-12
- Primary completion
- 2023-07-29
- Completion
- 2023-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PHH-1V | Vaccine | 40 ug | Intramuscular |