DMID 24-0009 (Coronavirus Vaccination)

Purpose of this Study

We are doing this study to find out if an experimental vaccine called Cov-RBD-scNP-001 (the study vaccine) provides safe and effective protection against multiple different coronaviruses, including the virus that causes COVID-19. We want to know the effects of the vaccine when it's given at 3 different dose levels.

Who Can Participate?

Eligibility

Adults ages 18-55 who:
  • Are in good general health
  • Have not had a positive test or suspected case of COVID for at least 16 weeks before joining the study
  • Have not received a dose of COVID-19 vaccine for at least 16 weeks before joining the study
  • Do not have a chronic viral infection (e.g., HIV or hepatitis)
  • Do not have any type of immune disorder or autoimmune disease
For more information, contact the study team at dvtustudies@duke.edu.

Age Range

18-55

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
Yes

What is Involved?

Description

If you choose to join this study, you will participate in 1 of 3 groups:
  • Low Dose Cohort: If you are in this group, you will get a 50 mcg (microgram) dose of the study vaccine.
  • Medium Dose Cohort: If you are in this group, you will get a 100 mcg dose of the study vaccine.
  • High Dose Cohort: If you are in this group, you will get a 150 mcg dose of the study vaccine.
The group in which you participate will depend on when you join the study. The low dose cohort will enroll first, then the medium dose cohort, and finally the high dose cohort. The study team can let you know what group is being enrolled before you decide to take part. The study vaccine is given as a shot. You will get 2 shots of the vaccine that are 4 weeks apart. After your second shot of the study vaccine, you will come to our clinic for visits at various times over the next 12 months. During these visits, you will have blood draws, answer questionnaires, and have physical exams. If you have symptoms of COVID-19 or test positive for it while you are in the study, we will schedule extra visits for you to come in for check ups.

Locations

Other

Visit Timing

Weekdays

Compensation

Yes

Spanish Materials Available

No

Study Details

Full Title

A Phase I, dose-escalation study to assess the safety, reactogenicity, and immunogenicity of two doses of an adjuvanted novel pancoronavirus vaccine (Cov-RBD-scNP-001) in 18 through 55-year-old healthy participants

Principal Investigator

Emmanuel
Walter

Protocol Number

PRO00117785

NCT ID

NCT06950177

Phase

I

Enrollment Status

Open to Enrollment
ClinicalTrials.gov