drugset / Trial / NCT05435027

Study of Self-Amplifying Messenger Ribonucleic Acid (samRNA) Vaccines Against COVID-19 in Healthy Adults and People Living With Human Immunodeficiency Virus (HIV)

NCT05435027 ↗

Phase 1 Completed 342 enrolled Gritstone bio, Inc.
Non-randomizedParallel-groupOpen-labelPrevention

Summary

The primary objective is to assess the safety and tolerability of samRNA vaccines GRT-R912, GRT-R914, and GRT-R918 when administered as prime and/or boost in healthy adult participants naïve to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), SARS-CoV-2 convalescent, previously vaccinated, or non-vaccinated participants, and people living with HIV (PLWH) or HIV-negative.

Timeline

Start
2022-02-28
Primary completion
2024-03-06
Completion
2024-03-06

Drugs

EvaluationDrugModalityDoseRoute
Subject GRT-R912 Small activating RNA (saRNA) — Intramuscular
Subject GRT-R914 Small activating RNA (saRNA) 3 ug Intramuscular
Subject GRT-R914 Small activating RNA (saRNA) 10 ug Intramuscular
Subject GRT-R914 Small activating RNA (saRNA) 30 ug Intramuscular
Subject GRT-R918 Small activating RNA (saRNA) — Intramuscular

Indications