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About
This is Phase 1 study is to assess tolerability and immunogenicity of three dose levels of the investigational HDT-301 vaccine administered intramuscularly (IM), both in immunization-naïve participants and as a booster for those participants who previously received a SARS-CoV-2 vaccine.
Safety and tolerability will be the primary endpoint assessed by incidence of adverse events at each dose through 12 months after completion of the vaccination regimen (either one dose, or two doses provided 56 days apart). Immunogenicity evaluations will be conducted for pre-specified timepoints as secondary and exploratory endpoints.
Full description
This is an open-label, dose-ranging, study to evaluate the safety and immunogenicity of the investigational HDT-301 vaccine in healthy (vaccinated or unvaccinated) adult subjects, with a 4:3 recruitment of individual aged 18-49 years and 50-65 years, respectively. The study duration is approximately 13 or 14 months for each subject.
Three cohorts of 21 subjects each will be sequentially recruited in the study:
Recruiting and screening of participants will be conducted on a continual basis. Subjects confirmed to be Emergency Use Authorization (EUA) SARS-CoV-2 vaccine recipients will first be placed into either Cohort 1 (Study Days 1 and 57; Two-Dose Regimen) or Cohort 2 (Study Day 1; One-Dose Regimen) then subsequently placed into each of the three dose groups. Subjects in the Cohort 3 (naïve, unimmunized) subset will be placed into each of the three dose groups to receive the study vaccine on Study Days 1 and 57 (Two-Dose Regimen). Each cohort will be divided into 3 groups of 7 participants, that will be provided HDT-301 at either a low-, mid- or high-dose. For each of the three-dose groups, a sentinel group will be initially enrolled and followed through Day 8 post-dose one for safety. If no halting rules are met by Day 8 enrollment will proceed to the remaining subjects. Blood samples will be collected during the study for each participant.
Enrollment
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Inclusion criteria
Each subject must meet ALL of the following criteria in order to participate in this study:
Male or non-pregnant female 18 through 65 years of age at the time of first vaccination.
Known clinical and immunization status versus SARS-CoV-2.
Understands and agrees to comply with the study procedures and provides written informed consent.
In the opinion of the PI or designee, could and would comply with the requirements of the protocol (e.g., completion of Memory Aids, return for follow-up visits, availability for safety calls).
Body mass index ≥18.0 and ≤35.0 kg/m2.
Considered by the PI or designee to be in good general health as determined by medical history, clinical laboratory assessments, vital sign measurements, and physical examination findings at Screening.
Women of childbearing potential1 must agree to use or have practiced true abstinence or use at least one acceptable primary form of contraception. These criteria are applicable to females in a heterosexual relationship and of childbearing potential (i.e., the criteria do not apply to subjects in a same sex relationship).
Female subjects of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on the day of and prior to each study vaccination.
Must agree to refrain from donating blood or plasma during the study (outside of this study).
Exclusion criteria
To participate in this study, all subjects must meet NONE of the exclusion criteria described:
Primary purpose
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63 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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