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

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Gritstone bio, Inc.

Criteria

Inclusion Criteria:

• Male or non-pregnant female at least 18 years and no more than 65 years of age at enrollment (Parts A, B, and C only).

• No previous SARS-CoV-2 infection or recovered.

• HIV-negative status confirmed by laboratory testing.

Additional inclusion criteria for PLWH:

• Serum positive HIV test or history of HIV infection.

• On anti-retroviral therapy for at least 3 months before screening and clinically stable.

Additional inclusion criteria for Part D (GRT-R918):

• Male or non-pregnant female between 18 and <60 years of age at enrollment.

• Male or non-pregnant female greater than or equal to 60 years of age at enrollment.

• Received any authorized SARS-CoV-2 vaccine series at least 2 months prior to study vaccine.

Exclusion Criteria:

• Current active infection with COVID-19.

• Positive for SARS-CoV-2 by nasal swab polymerase chain reaction (PCR) at screening.

• Currently receiving treatment or prevention agents with activity against SARS-CoV-2.

• Breastfeeding, pregnant, or planning to become pregnant during the course of the study.

• Received or plans to receive any non-study provided SARS-CoV-2 vaccine (including boost) during the study period (except for Part D).

• Received or plans to receive any live, attenuated vaccine within 28 days before or after study vaccination.

• Received or plans to receive any subunit or killed vaccine within 14 days before or after vaccination.

• Received or plans to receive immunoglobulins and/or any blood products within the 3 months preceding the planned administration of first study vaccination or at any time during the study.

• Currently active viral infection of hepatitis B virus or hepatitis C virus.

Additional exclusion criteria for PLWH:

• Screening CD4+ T cell count ≤200 cells/mcL.

• Viral load ≥10,000 virus particles/mL.

• History of opportunistic illness indicative of Stage 3 HIV infection.

• Acute febrile illness within 4 weeks before the first vaccination.

Additional exclusion criterion for Part D (GRT-R918) Cohorts D3, D4, D7, and D8:

• Received last dose of any authorized SARS-CoV-2 vaccine series within 2 months prior to study vaccine.