NCT05435027

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

A Phase 1 SARS-CoV-2 Vaccine Study to Assess the Safety and Tolerability of GRT-R912, GRT-R914, and GRT-R918 Administered as Prime and/or Boost in Healthy Adult Participants and People Living With HIV

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 342 (actual)
• Sponsor: Gritstone bio, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

This Phase 1 clinical trial (CORAL-CEPI) will assess the potential of second-generation Coronavirus Disease 2019 (COVID-19) vaccines. These vaccines use a codon optimized Spike (S) cassette with additional T cell epitopes (TCE) (cassette S-TCE) covering multiple epitopes from non-spike proteins to safely drive strong, broad, and durable B cell and T cell immune responses to SARS-CoV-2. This trial will assess the potential to generate B cell and T cell responses against SARS-CoV-2 in both people living with HIV (PLWH) and HIV-negative participants, in participants who have previously been infected by SARS-CoV-2, and those who are naive to SARS-CoV-2, meaning they have neither been infected with nor vaccinated against SARS-CoV-2. GRT-R912, GRT-R914, and GRT-R918 are vaccines using a samRNA vector based and administered as either a single dose or two dose regimen, providing an option for a potent, single-modality approach.

Conditions

• COVID-19
• SARS-CoV-2

Interventions

Type	Name	Description
DRUG	GRT-R912, samRNA-Spikebeta-TCE11	IM injection of GRT-R912. Doses will be decided after safety review of Part A.
DRUG	GRT-R914, samRNA-Spikebeta-TCE9	Part A: 3 microgram (mcg), 10 mcg, or 30 mcg intramuscular (IM) injection of GRT-R914. Part C: IM injection of GRT-R914. Doses decided after safety review of Part A.
DRUG	GRT-R918, samRNA-SpikeOmicron-N-TCE11	IM injection of GRT-R918. Doses will be decided after safety review of Part A.

Timeline

• Start date: 2022-02-28
• Primary completion: 2024-03-06
• Completion: 2024-03-06
• First posted: 2022-06-28
• Last updated: 2024-03-12

Locations

4 sites across 1 country: South Africa