Study of GRT-R910 COVID-19 Boost Vaccine in Healthy Volunteers

This is an interventional prevention trial for COVID-19 focused on measuring SARS-CoV-2 vaccine, Coronavirus Disease (COVID-19) Read More

Inclusion Criteria:

• For Cohorts 1 and 2, have received AstraZeneca's COVID-19 prime and boost vaccine at least 2 months prior to study participation.
• For Cohorts 3 and 5, have previously received Janssen/Johnson and Johnson or AstraZeneca vaccine with or without booster dose(s) of an authorized vaccine at least 2 months prior to Day 1.
• For Cohorts 4 and 6, have previously received an mRNA COVID-19 vaccine with or without booster dose(s) of an authorized vaccine with the last dose received at least 2 months prior to Day 1.
• Agree to refrain from blood donation during the course of the study.
• Women of childbearing potential (WOCBP)* must agree to avoid pregnancy and be willing to use a highly effective method of contraception** consistently for 30 days prior to the first study vaccine and for at least 60 days after the last study vaccine
• Male participants of childbearing potential must agree to the use of condoms to ensure effective contraception with a female partner from the time of study vaccination until 3 months after vaccination.
• Plan to remain living in the area for the duration of the study.

Exclusion Criteria:

• History of prior confirmed COVID-19 (cohorts 1 and 2).
• Positive for SARS-CoV-2 by lateral flow test (rapid diagnostic test), enzyme-linked immunosorbent assay (ELISA) or by nasal swab polymerase chain reaction (PCR) at screening (Cohorts 3-6).
• Prior receipt of a SARS-CoV-2 vaccine other than AstraZeneca's AZD1222 (Covishield®, Vaxzevria®), JNJ-78436735, Pfizer/BioNTech (Comirnaty®), Moderna (Spikevax®), other approved or investigational adenovirus vectored vaccines, approved or investigational vaccines with a lipid nanoparticle (LNP) component, or any other approved or investigational vaccine likely to impact the interpretation of the trial data.
• On current treatment or prevention agents with activity against SARS-CoV-2.
• Participation in another research study involving receipt of an investigational product in the 60 days preceding enrollment or planned use during the study period.
• Receipt or planned receipt of any live, attenuated vaccine within 28 days before or after study vaccination.
• Receipt or planned receipt of any subunit or killed vaccine within 14 days before or after vaccination.
• Administration of 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.
• Any confirmed or suspected immunosuppressive or immunodeficient state.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including urticaria, respiratory difficulty or abdominal pain.
• Any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema.
• Any history of anaphylaxis, including but not limited to reaction to vaccination.
• History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
• History of serious ongoing, unstable psychiatric condition that in the opinion of the investigator would interfere with study participation.
• Bleeding disorder or prior history of significant bleeding or bruising following IM injections or venipuncture.
• Suspected or known current alcohol abuse that in the opinion of the investigator would impede compliance with the protocol and schedules of assessments.
• Suspected or known drug abuse in the 5 years preceding enrollment.
• Any other condition that in the opinion of the investigator would pose a health risk to the participant if enrolled or could interfere with evaluation of the trial vaccine or interpretation of study results.