Study of Self-Amplifying Messenger Ribonucleic Acid (samRNA) Vaccines Against COVID-19 in Healthy Adults and People Living With Human Immunodeficiency Virus (HIV)
- 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.
- Short title
- Study of Self-Amplifying Messenger Ribonucleic Acid (samRNA) Vaccines Against COVID-19 in Healthy Adults and People Living With Human Immunodeficiency Virus (HIV)
- Official title
- 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
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2024-03-06
- First posted
- 2022-06-28
- Registry last updated
- 2024-03-12
- Primary completion date
- 2024-03-06
- Start date
- 2022-02-28
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Gritstone bio, Inc.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05435027
- ClinicalTrials.gov ID
- NCT05435027
- Registry record
- Open registry record
- Allocation
- Not randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- No masking
Number of Participants with One or More Solicited Local Reactogenicity Signs and Symptoms
Timeframe: Up to 7 days after vaccination
Number of Participants with One or More Solicited Systemic Reactogenicity Signs and Symptoms
Timeframe: Up to 7 days after vaccination
Number of Participants with Unsolicited Adverse Events
Timeframe: Up to 7 days after vaccination
Number of Participants with One or More Serious Adverse Events
Timeframe: Up to ~14 months after vaccination
Response Rate of SARS-CoV-2 Specific Antibody Binding and Neutralization Titers in Serum Samples
Timeframe: Up to ~14 months after vaccination
Magnitude of SARS-CoV-2 Specific Antibody Binding and Neutralization Titers in Serum Samples
Timeframe: Up to ~14 months after vaccination
Response Rate of SARS-CoV-2 Specific CD4+ and CD8+ T cells by Intracellular Cytokine Staining (ICS)
Timeframe: Up to ~14 months after vaccination
Magnitude of SARS-CoV-2 Specific CD4+ and CD8+ T cell Response by ICS
Timeframe: Up to ~14 months after vaccination
Functional Profiling of SARS-CoV-2 Specific CD4+ and CD8+ T cells by ICS
Timeframe: Up to ~14 months after vaccination
Response Rate of SARS-CoV-2- Specific CD4+ and CD8+ T cells by Interferon-Gamma Enzyme-linked Immunospot (ELISpot)
Timeframe: Up to ~14 months after vaccination
Magnitude of SARS-CoV-2- Specific CD4+ and CD8+ T cell Response by Interferon-Gamma ELISpot
Timeframe: Up to ~14 months after vaccination
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- Yes
- 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.
- 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.
- Newtown Clinical Research CentreJohannesburg, South Africa
- WITS RHI Shandukani Research CentreJohannesburg, South Africa
- Wits Vaccines & Infections Diseases Analytics (VIDA) Research UnitJohannesburg, South Africa
- Setshaba Research CenterPretoria, South Africa
Related records
Drugs (1)
Lead sponsors (1)
Conditions (2)
- Acquired immunodeficiency
- COVID-19 Primary condition