COVAC COVID-19 Vaccine Booster Dose Study for Healthy Adults
A Phase 1/2 Clinical Trial to Study the Safety, Tolerability, and Immunogenicity of a COVAC-2 Booster Dose in Generally Healthy Adults
What is the purpose of this study?
Vaccines are one way to protect against disease. Vaccines work by preparing the immune system, the system in your body that fights disease, to react quickly against germs, such as viruses or bacteria, should they ever enter the body in the future. Vaccines trigger the body’s defenses to produce disease-fighting antibodies. If a germ enters the body, the immune system will be prepared for it. The immune system will be able to destroy the germ before it can do harm.
VIDO has developed a COVID-19 vaccine called COVAC-2, which contains a portion of the SARS-CoV-2 spike protein, called S1. The spike protein is the part of the virus that is responsible for attaching to the surface of host cells. The vaccine is expected to stimulate the body to make antibodies against the S1 protein. The antibodies will recognize the viral spike protein if the body is exposed to the virus and prevent COVID-19 illness. The COVAC-2 vaccine has been tested in both animals and in approximately 40 people who have not been exposed to either the virus or vaccine for COVID-19 and has been found to be safe and to produce an immune response.
The main purpose of this study is to assess the safety and how well the COVAC‑2 vaccine works when given as a third (booster) dose in people who already had two doses of an authorized vaccine (Pfizer, Moderna, or AstraZeneca). The goal of a booster dose is to restore protection that may have decreased over time to a level that is no longer thought to be protective in people who initially responded adequately to the two previous doses of the vaccine.
Am I eligible for the study?
You can take part in this study if:
- You are at least 18 years of age or older.
- You are available for all the study visits.
- You are in generally good health.
- Your physical examination and blood test at the screening visit are within normal limits.
- You agree to practice adequate contraception (birth control) if you are of child-bearing potential (able to get pregnant).
Other study criteria will be reviewed at the screening visit to determine if you are eligible or not. While you are in this study, you cannot take part in another research study.
What would I be expected to do?
If you consent to participate in the study, then there will be a screening visit to make sure you are eligible to take part in the study. The screening visit can occur up to 30 days before the first vaccine visit. The time commitment for the screening visit will be approximately 1 hour.
At the screening visit, you will be asked about your medical history; such as previous allergies, illnesses, and all medications you are currently taking to ensure that you are eligible to participate in the study. If you are a female who can get pregnant, you will be asked about your method of birth control. You will have a urine sample taken to confirm that you are not pregnant.
The amount of time you will spend participating in the study depends on which study phase you are in.
Depending on which phase of the study you are participating in, your participation in the study will last either 6 (Phase 1) or 12 (Phase 2) months. You will receive at random, either one dose of the COVAC-2 vaccine or the placebo and will be followed up for either 6 (Phase 1) or 12 (Phase 2) months. You will need to visit the study site seven times if you are participating in Phase 1 and eight times if you are participating in Phase 2. This will include a screening visit to make sure you are eligible to participate, one vaccination visit (Day 0), and five (Phase 1) or six (Phase 2) follow-up visits.
Phone 902-470-8141 or 902-266-6510