NCT05435027CompletedPhase 1
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
Source: ClinicalTrials.gov · Last updated 12 Mar 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 342 (actual)
- First submitted
- 24 Jun 2022
- Start date
- 28 Feb 2022
- Primary completion date
- 6 Mar 2024
- Lead sponsor
- Gritstone bio, Inc.
- Diseases
- HIV
- NCT number
- NCT05435027
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 342
- From 28 Feb 2022 to the primary completion date, 6 Mar 2024
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently receiving treatment or prevention agents with activity against SARS-CoV-2.
- 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.
- 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.
Other illness
- Current active infection with COVID-19.
- Currently active viral infection of hepatitis B virus or hepatitis C virus.
- Additional exclusion criteria for PLWH:
- History of opportunistic illness indicative of Stage 3 HIV infection.
Lab values
- Screening CD4+ T cell count ≤200 cells/mcL.
Other
- Positive for SARS-CoV-2 by nasal swab polymerase chain reaction (PCR) at screening.
- Breastfeeding, pregnant, or planning to become pregnant during the course of the study.
- Viral load ≥10,000 virus particles/mL.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Wits Vaccines & Infections Diseases Analytics (VIDA) Research Unit Coordinator of this site? Confirm its status | Johannesburg | South Africa | Unknown status |
| WITS RHI Shandukani Research Centre Coordinator of this site? Confirm its status | Johannesburg | South Africa | Unknown status |
| Newtown Clinical Research Centre Coordinator of this site? Confirm its status | Johannesburg | South Africa | Unknown status |
| Setshaba Research Center Coordinator of this site? Confirm its status | Pretoria | South Africa | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.