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

NCT05435027 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 342

Last updated 2024-03-12

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Gritstone bio, Inc.

    lead INDUSTRY

Principal Investigators

  • Elizabeth Martin, DO · Gritstone bio, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05435027 on ClinicalTrials.gov