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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
342
IM injection of GRT-R912. Doses will be decided after safety review of Part A.
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.
IM injection of GRT-R918. Doses will be decided after safety review of Part A.
Newtown Clinical Research Centre
Johannesburg, South Africa
WITS RHI Shandukani Research Centre
Johannesburg, South Africa
Wits Vaccines & Infections Diseases Analytics (VIDA) Research Unit
Johannesburg, South Africa
Setshaba Research Center
Pretoria, South Africa
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
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)
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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