COVID-19Phase 1NCT05435027
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 study testing GRT-R912, samRNA-Spikebeta-TCE11, GRT-R914, samRNA-Spikebeta-TCE9 and GRT-R918, samRNA-SpikeOmicron-N-TCE11 in people with COVID-19 and SARS-CoV-2, run by Gritstone bio, Inc. at 4 sites in South Africa.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, SARS-CoV-2
- What is being tested?
- GRT-R912, samRNA-Spikebeta-TCE11, GRT-R914, samRNA-Spikebeta-TCE9 and GRT-R918, samRNA-SpikeOmicron-N-TCE11
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 342 participants
- Where
- 4 sitesSouth Africa
- Study dates
- 28 Feb 2022to 6 Mar 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country.
South Africa4 sites
Newtown Clinical Research Centre
Johannesburg
WITS RHI Shandukani Research Centre
Johannesburg
Wits Vaccines & Infections Diseases Analytics (VIDA) Research Unit
Johannesburg
Setshaba Research Center
Pretoria
About this study
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
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.
Read the 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
- Being tested
- GRT-R912, samRNA-Spikebeta-TCE11, GRT-R914, samRNA-Spikebeta-TCE9, GRT-R918, samRNA-SpikeOmicron-N-TCE11
- Keywords
- SARS-CoV-2 vaccine, Coronavirus Disease (COVID-19), Self-amplifying mRNA (samRNA), Human Immunodeficiency Virus (HIV)
- Medical subject headings
- COVID-19, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GRT-R912, samRNA-Spikebeta-TCE11Drug
IM injection of GRT-R912. Doses will be decided after safety review of Part A.
GRT-R914, samRNA-Spikebeta-TCE9Drug
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.
GRT-R918, samRNA-SpikeOmicron-N-TCE11Drug
IM injection of GRT-R918. Doses will be decided after safety review of Part A.
| Study group | Role | What they receive |
|---|---|---|
| GRT-R914, HIV-negative (Part A) | Experimental | Participants in this ≥18 to 65-year-old Part A are naïve to SARS-CoV-2 (Cohorts A1, A2, and A3) or SARS-CoV-2 convalescent (Cohorts A4, A5, A6). Cohorts will receive doses of GRT-R914 administered as prime and boost on Days 1 and Day 29, or as boost 6 months after primary SARS-CoV-2 infection. Receives: Drug: GRT-R914, samRNA-Spikebeta-TCE9 |
| GRT-R912, HIV-negative (Part B) | Experimental | Participants in this ≥18 to 65-year-old Part B are naïve to SARS-CoV-2 (Cohorts B1, B2) or SARS-CoV-2 convalescent (Cohorts B3, B4). Cohorts will receive doses of GRT-R912 administered as prime and boost on Days 1 and 29, or as boost 6 months after primary SARS-CoV-2 infection. Parts B, C, and D will be run in parallel. Receives: Drug: GRT-R912, samRNA-Spikebeta-TCE11 |
| GRT-R912 or GRT-R914, People Living with HIV (PLWH) (Part C) | Experimental | Participants in this ≥18 to 65-year-old Part C are people living with HIV but naïve to SARS-CoV-2 (Cohorts C1, C4) or living with HIV but SARS-CoV-2 convalescent (Cohorts C2, C3, C5, C6). Cohorts will receive doses of GRT-R912 or GRT-R914 administered as prime and boost on Days 1 and 29, or as boost 6 months after primary SARS-CoV-2 infection. Parts B, C, and D will be run in parallel. Receives: Drug: GRT-R912, samRNA-Spikebeta-TCE11; Drug: GRT-R914, samRNA-Spikebeta-TCE9 |
| GRT-R918, HIV-negative and PLWH, With and Without Prior Vaccination (Part D) | Experimental | Participants will be ≥18 and <60 years or ≥60 years, HIV-Negative and PLWH with no prior vaccination to SARS-CoV-2 (Cohorts D1, D2, D5, D6) or with prior vaccination to SARS-CoV-2 (Cohorts D3, D4, D7, D8). Cohorts will receive doses of GRT-R918 administered as prime and boost on Days 1 and 29, or as boost ≥2 months after prior SARS-CoV-2 vaccination. Parts B, C, and D will be run in parallel. Receives: Drug: GRT-R918, samRNA-SpikeOmicron-N-TCE11 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with One or More Solicited Local Reactogenicity Signs and Symptoms
Measured: Up to 7 days after vaccination
Number of Participants with One or More Solicited Systemic Reactogenicity Signs and Symptoms
Measured: Up to 7 days after vaccination
Number of Participants with Unsolicited Adverse Events
Measured: Up to 7 days after vaccination
Number of Participants with One or More Serious Adverse Events
Measured: Up to ~14 months after vaccination
Secondary outcomes (7)
Response Rate of SARS-CoV-2 Specific Antibody Binding and Neutralization Titers in Serum Samples
Measured: Up to ~14 months after vaccination
Magnitude of SARS-CoV-2 Specific Antibody Binding and Neutralization Titers in Serum Samples
Measured: Up to ~14 months after vaccination
Response Rate of SARS-CoV-2 Specific CD4+ and CD8+ T cells by Intracellular Cytokine Staining (ICS)
Measured: Up to ~14 months after vaccination
Magnitude of SARS-CoV-2 Specific CD4+ and CD8+ T cell Response by ICS
Measured: Up to ~14 months after vaccination
Functional Profiling of SARS-CoV-2 Specific CD4+ and CD8+ T cells by ICS
Measured: 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)
Measured: Up to ~14 months after vaccination
Magnitude of SARS-CoV-2- Specific CD4+ and CD8+ T cell Response by Interferon-Gamma ELISpot
Measured: Up to ~14 months after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start28 Feb 2022
- Primary completion6 Mar 2024
- Study completion6 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gritstone bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elizabeth Martin, DO, Study director, Gritstone bio, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05435027
- Sponsor's protocol ID
- GO-012
- Status last verified
- Mar 2024
- First submitted
- 24 Jun 2022
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05435027
- Acronym / sponsor ID
- GO-012
- Conditions
- COVID-19, SARS-CoV-2
- Keywords
- SARS-CoV-2 vaccine, Coronavirus Disease (COVID-19), Self-amplifying mRNA (samRNA), Human Immunodeficiency Virus (HIV)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- Gritstone bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 6 Mar 2024 (actual)
- Study completion
- 6 Mar 2024 (actual)
- First posted
- 28 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GRT-R914, HIV-negative (Part A) | Experimental | Drug: GRT-R914, samRNA-Spikebeta-TCE9Participants in this ≥18 to 65-year-old Part A are naïve to SARS-CoV-2 (Cohorts A1, A2, and A3) or SARS-CoV-2 convalescent (Cohorts A4, A5, A6). Cohorts will receive doses of GRT-R914 administered as prime and boost on Days 1 and Day 29, or as boost 6 months after primary SARS-CoV-2 infection. |
| GRT-R912, HIV-negative (Part B) | Experimental | Drug: GRT-R912, samRNA-Spikebeta-TCE11Participants in this ≥18 to 65-year-old Part B are naïve to SARS-CoV-2 (Cohorts B1, B2) or SARS-CoV-2 convalescent (Cohorts B3, B4). Cohorts will receive doses of GRT-R912 administered as prime and boost on Days 1 and 29, or as boost 6 months after primary SARS-CoV-2 infection. Parts B, C, and D will be run in parallel. |
| GRT-R912 or GRT-R914, People Living with HIV (PLWH) (Part C) | Experimental | Drug: GRT-R912, samRNA-Spikebeta-TCE11, Drug: GRT-R914, samRNA-Spikebeta-TCE9Participants in this ≥18 to 65-year-old Part C are people living with HIV but naïve to SARS-CoV-2 (Cohorts C1, C4) or living with HIV but SARS-CoV-2 convalescent (Cohorts C2, C3, C5, C6). Cohorts will receive doses of GRT-R912 or GRT-R914 administered as prime and boost on Days 1 and 29, or as boost 6 months after primary SARS-CoV-2 infection. Parts B, C, and D will be run in parallel. |
| GRT-R918, HIV-negative and PLWH, With and Without Prior Vaccination (Part D) | Experimental | Drug: GRT-R918, samRNA-SpikeOmicron-N-TCE11Participants will be ≥18 and <60 years or ≥60 years, HIV-Negative and PLWH with no prior vaccination to SARS-CoV-2 (Cohorts D1, D2, D5, D6) or with prior vaccination to SARS-CoV-2 (Cohorts D3, D4, D7, D8). Cohorts will receive doses of GRT-R918 administered as prime and boost on Days 1 and 29, or as boost ≥2 months after prior SARS-CoV-2 vaccination. Parts B, C, and D will be run in parallel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- Serum positive HIV test or history of HIV infection.
- On anti-retroviral therapy for at least 3 months before screening and clinically stable.
Key exclusion criteria (16 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GRT-R912, samRNA-Spikebeta-TCE11IM injection of GRT-R912. Doses will be decided after safety review of Part A. | Drug | GRT-R912 or GRT-R914, People Living with HIV (PLWH) (Part C), GRT-R912, HIV-negative (Part B) |
| GRT-R914, samRNA-Spikebeta-TCE9Part 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-R912 or GRT-R914, People Living with HIV (PLWH) (Part C), GRT-R914, HIV-negative (Part A) |
| GRT-R918, samRNA-SpikeOmicron-N-TCE11IM injection of GRT-R918. Doses will be decided after safety review of Part A. | Drug | GRT-R918, HIV-negative and PLWH, With and Without Prior Vaccination (Part D) |
Primary outcome
Number of Participants with One or More Solicited Local Reactogenicity Signs and Symptoms
Time frame: Up to 7 days after vaccination
Number of Participants with One or More Solicited Systemic Reactogenicity Signs and Symptoms
Time frame: Up to 7 days after vaccination
Number of Participants with Unsolicited Adverse Events
Time frame: Up to 7 days after vaccination
Number of Participants with One or More Serious Adverse Events
Time frame: Up to ~14 months after vaccination
7 secondary outcomes
Response Rate of SARS-CoV-2 Specific Antibody Binding and Neutralization Titers in Serum Samples
Time frame: Up to ~14 months after vaccination
Magnitude of SARS-CoV-2 Specific Antibody Binding and Neutralization Titers in Serum Samples
Time frame: Up to ~14 months after vaccination
Response Rate of SARS-CoV-2 Specific CD4+ and CD8+ T cells by Intracellular Cytokine Staining (ICS)
Time frame: Up to ~14 months after vaccination
Magnitude of SARS-CoV-2 Specific CD4+ and CD8+ T cell Response by ICS
Time frame: Up to ~14 months after vaccination
Functional Profiling of SARS-CoV-2 Specific CD4+ and CD8+ T cells by ICS
Time frame: 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)
Time frame: Up to ~14 months after vaccination
Magnitude of SARS-CoV-2- Specific CD4+ and CD8+ T cell Response by Interferon-Gamma ELISpot
Time frame: Up to ~14 months after vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Martin, DO study director
Gritstone bio, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GRT-R912, samRNA-Spikebeta-TCE11, GRT-R914, samRNA-Spikebeta-TCE9 and GRT-R918, samRNA-SpikeOmicron-N-TCE11 in people with COVID-19 and SARS-CoV-2, run by Gritstone bio, Inc. at 4 sites in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with One or More Solicited Local Reactogenicity Signs and Symptoms (time frame: Up to 7 days after vaccination). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.