Study of GRT-R910 SARS-CoV-2 boost vaccine in healthy volunteers [COVID-19]
Research type
Research Study
Full title
A Phase 1 Trial to Evaluate the Safety, Immunogenicity, and Reactogenicity of a Self-Amplifying mRNA Prophylactic Vaccine Boost Against SARS-CoV-2 in Previously Vaccinated Healthy Elderly Adults
IRAS ID
302043
Contact name
Amy Walia
Contact email
Sponsor organisation
Gritstone bio, Inc
Eudract number
2020-004138-39
Duration of Study in the UK
1 years, 1 months, 0 days
Research summary
Research Summary:
The ongoing outbreak of COVID-19 is caused by a novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), that can cause serious respiratory infections.SARS-CoV-2 (COVID-19) has a high age-related mortality rate and has rapidly spread worldwide with over 151 million cases of infection and over 3 million deaths reported as of April 2021.
While vaccines have recently been made available under emergency use authorisations in a limited number of countries, no fully licensed vaccine is available yet in the US or UK for SARS-CoV-2.
In addition, new variants of SARS-CoV-2 are being reported as the pandemic continues and may continue to emerge.
GRT-R910, a self-amplifying mRNA (SAM) is an investigational product being developed by Gritstone bio as a SARS-CoV-2 vaccine boost.
The GRT-R910 vaccine is a newer type of mRNA vaccine that may be able to induce stronger immune responses with fewer side effects than the COVID-19 mRNA vaccines currently being given under the national vaccine deployment program. The immune system is the part of the body that fights infection. This study will examine the body’s immune response to this study vaccine. The vaccine is designed with the goal of providing additional protection against COVID-19.
The purpose of the study is to assess the safety and tolerability of two different doses (10 or 30 µg) of GRT-R910 when administered as a boost in healthy elderly volunteers over the age of 60, at least 4 months after previously being vaccinated with the AstraZeneca's COVID-19 vaccine.
Up to 20 males and females (10 for each dose cohort), will be enrolled to a single site in the United Kingdom and will be followed-up for 12 months after receiving the study vaccine as an injection into the upper arm muscle.
Lay summary of study results:
Safety Results: In this study, researchers looked at any negative medical events or side effects that happened while participants were getting treatment. These events are called adverse events (AEs). They could be related to the treatment or not. If an event happened after starting treatment, it was called a treatment-emergent adverse event (TEAE).
Researchers kept track of all AEs that participants had during the study. Out of the 40 people who were treated, no vaccine related AEs were observed.
Also, a few participants had medical events that needed attention during the study, including 6 people in Group 1 (out of 10), 5 people in Group 2 (out of 7) and Group 3 (out of 10), 8 people in Group 4 (out of 10), and 2 people in Group 6 (out of 3).
In addition, some participants in each group reported new onset chronic medical conditions (NOCMs) that were not vaccine related:
In Group 1, 5 people had NOCMs.
In Group 2, 3 people had NOCMs.
In Group 3, 2 people had NOCMs.
In Group 4, 3 people had NOCMs.
In Group 6, 1 person had NOCMs.
Researchers tracked the number of participants who had certain side effects after getting the vaccination. These side effects were mild to moderate which included pain, tenderness, redness, and swelling at the spot where the vaccination was given. After the first dose of GRT-R910, the number of people who reported these side effects was 8 in Group 1, 6 in Group 2, 10 in Group 3, 10 for Group 4, and 3 for Group 6. After the second dose, the number of people who reported these side effects was 6 in Group 1, 4 in Group 2, 8 in Group 3, 6 in Group 4, and 3 in Group 6.
Researchers also looked at other side effects that affected the whole body which were mild to moderate, like headaches, fatigue, muscle aches, nausea, and fever. After the first dose, the number of people who reported these side effects was 8 in Group 1, 7 in Group 2, 10 in Group 3, 9 for Group 4, and 3 for Group 6. After the second dose, the number of people who reported these side effects was 4 in Group 1, 4 in Group 2, 8 in Group 3, 6 in Group 4, and 3 in Group 6.
Additionally, researchers checked for any unexpected side effects . After the first shot, the number of people who reported these side effects was 5 in Group 1, 6 in Group 2, 7 in Group 3, 8 for Group 4, and 3 for Group 6. After the second dose, the number of people who reported these side effects was 4 in Group 1, 4 in Group 2, 4 in Group 3, 4 in Group 4, and 2 in Group 6.
Researchers noticed small changes in white blood cells (they protect you against illness or disease), platelets (tiny blood cells that help your body form clots to stop bleeding), hemoglobin (hemoglobin is a part of blood cells that transport oxygen in the blood) and liver function test (tests that use a sample of blood to measure several substances made by your liver) from the starting point (baseline) and on Day 8 (one week after the first dose of GRT-R910) in participants in all groups.
Immunogenicity Results:
Upon receiving the GRT-R910 vaccine, study participants’ immune cells made antibodies that help fight off the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) virus causing the COVID-19 disease. This happened in all the different groups of people who received the vaccine, and post vaccination, the levels of these antibodies in the body stayed high for 6- or 12-months. These data suggest that GRT-R910 may be able to induce long-lasting protection against SARS-CoV-2.
The high and sustained antibody levels suggest that these participants could be protected from different variants of the SARS-CoV-2 virus. Researchers also looked at the response of immune cells called T cells after vaccination, which may be another important way the body fights SARS-CoV-2. T cells may help the body make antibodies against SARS-CoV-2 and eliminate the SARS-CoV-2 virus after infecting cells in the body. After a booster injection of the GRT-R910 vaccine, the number of T cells that could recognize the SARS-CoV-2 virus increased and could last up to at least 6 to 12 months.REC name
London - West London & GTAC Research Ethics Committee
REC reference
21/FT/0105
Date of REC Opinion
1 Sep 2021
REC opinion
Further Information Favourable Opinion