A Phase 1, Randomized, Open-label, Dose-Finding Study to Evaluate the Safety, Tolerability, and Reactogenicity of Escalating Doses of the Baiya SARS-CoV-2 Vax 1 Vaccine in Healthy Adults

Baiya Phytopharm Co., Ltd.2 sites in 1 country48 target enrollmentSeptember 11, 2021

ConditionsCoronavirus

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Coronavirus
Sponsor: Baiya Phytopharm Co., Ltd.
Enrollment: 48
Locations: 2
Primary Endpoint: Treatment-emergent Changes in Respiratory Rate
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a phase 1, open-label, randomized, first-in-human clinical trial to evaluate the safety, tolerability and reactogenicity of escalating doses of Baiya SARS-CoV-2 VAX1 vaccine in participants aged 18-60 for adult groups and 61-75 for elderly groups. Each group will consist of three cohorts to evaluate different doses (low, medium, high) of Baiya SARS-CoV-2 VAX vaccine. Participants will be injected with two doses of the investigational product with a 21-day interval.

Registry

clinicaltrials.gov

Start Date

September 11, 2021

End Date

November 4, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Baiya Phytopharm Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy man and woman between 18-60 years old (inclusive) for the adult cohort and between 61-75 years old (inclusive) for the elderly cohort.
•Have a body-mass index of 18.0-30.0 kg/m² at screening
•Give informed consent prior to study enrollment and all study procedures
•Participants must be able to comply with study procedures and be available for all study visits
•Participants must be in general good health based on medical history and physical examination as determined by the investigator(s) at Screening
•Participants must have haematology, clinical chemistry, coagulation, and urinalysis test results that are not deviating from the normal reference range by age and gender, or considered "not clinicallysignificant" per investigator decision based on safety at Screening.
•Males must be surgically sterile (\>30 days since vasectomy with no viable sperm), practice true abstinence, or, if engaged in sexual activities with a female with childbearing potential, use condoms from first vaccination until 60 days after the last vaccination.
•Females of child-bearing potential must practice true abstinence, or, if engaged in sexual activities with a male, agree to use highly effective (failure rate of \<1% per year when used consistently and correctly), double-barrier contraceptive measures throughout the study and intend to continue use of contraception methods for at least 60 days following the last vaccination.
•Female participants of child-bearing potential must have negative serum pregnancy test by beta human chorionic gonadotropin \[β-HCG\] at Screening and a negative urine-based pregnancy test within 24 hours prior to each investigational vaccine administration
•Female participants of childbearing potential must not be pregnant or breastfeeding.

Exclusion Criteria

•Presence of clinically significant medical history, unstable chronic or acute disease, or physical, or laboratory findings that in the opinion of the PI may potentially increase the expected risk of exposure to the investigational vaccine, compromise the safety of the participant, or interfere with any aspect of study conduct or interpretation of results. This will include any thrombocytopenia or bleeding disorder contraindicating IM vaccination.
•Presence of self-reported or medically documented significant medical or psychiatric condition(s) as judged by the investigator(s) that it may not be in the participant's interest to participate in the study.
•Presence of an acute illness, as determined by the participating Study Site investigator(s), with or without fever (forehead temperature measured by validated device ≥ 37.5 ºC) within 72 hours prior to each vaccination
•Presence of birthmarks, tattoos, wound, or other skin conditions over the deltoid region of both arms that in the opinion of the investigator(s), could reasonably obscure and interfere with evaluation of local ISRs
•Inadequate venous access to allow collection of blood samples
•Breastfeeding or planning to breastfeed from the time of the first vaccination to after the last vaccination, or pregnant as confirmed by a positive serum β-HCG pregnancy test at Screening or positive urine pregnancy test at subsequent clinic visits at timepoints as delineated in the schedule of assessments
•Received any prophylactic or therapeutic vaccine, or licensed or unlicensed vaccine, device, or blood product, within 4 weeks of first vaccination or 5 half-lives (whichever is longer), or anticipate to do so in the follow-up period defined for this study
•History of severe allergy (requiring hospital care), anaphylaxis, severe reaction to any drug or prior vaccination, or any known or suspected allergies or sensitivities to any component of the investigational vaccine or tobacco
•Participant is immunosuppressed as caused by disease (such as HIV)
•Chronic use (more than 14 continuous days) of or anticipated need to use, within the next 6 months, of any medications that may be associated with impaired immune responsiveness or with immunosuppression