SARS-CoV-2 Infection
Conditions
Keywords
COVID-19
Brief summary
The purpose of this clinical trial is to Evaluate the Safety and Immunogenicity of PTX-COVID19-B Administered as Booster Vaccination in Previously Vaccinated Adults Aged 18 Years and Older. This study is seeking participants who are: Adult males and females 18 years of age or older; In efficacy cohort : Subjects who were previously vaccinated with 2 doses of Comirnaty® administered at least 3 months prior to the booster dose.. All participants in this efficacy cohort will receive 1 of the 2 study vaccines: PTX-COVID19-B or Comirnaty®. All participants in efficacy cohort will receive a single 40 microgram dose PTX-COVID19-B of the study vaccine or one dose of Comirnaty® at the first study clinic and will return to the study clinic 6 more times. At each clinic visit, a blood sample will be taken. They study is about 6 months long for each participant. In safety cohort: Subjects who have previously received any primary series approved by WHO Emergency Use Authorization at least 3 months prior to enrollment or subjects who have already received one authorized booster vaccination and planned to receive PTX-COVID19-B as the 4th shot will be enrolled. All participants in this safety cohort will receive 1 dose vaccines: PTX-COVID19-B. All participants in safety cohort will receive a single 40 microgram dose of the study vaccine at the first study clinic and will return to the study clinic 5 more times. At each clinic visit, a blood sample will be taken. They study is about 6 months long for each participant.
Interventions
BIOLOGICALPTX-COVID19-B
The vaccine product, PTX-COVID19-B, is a preservative-free, sterile mRNA-lipid nanoparticle (mRNA-LNP) dispersion in an aqueous cryoprotectant buffer intended for IM injection.
BIOLOGICALComirnaty®
0.45 mL concentrate in a 2 mL clear multidose vial (type I glass) with a stopper (synthetic Bromo-butyl rubber) and a purple flip-off plastic cap with aluminum seal. Each vial contains 6 doses.
Sponsors
Everest Medicines (Singapore) Pte. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Efficacy cohort and safety cohort are parallel conducted.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
\- Efficacy Cohort: Each subject must meet all of the following criteria to be enrolled into the Efficacy Cohort: 1. Subject is able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments. 2. Adult males and females 18 years of age or older on the day of signing the ICF (or the legal age of consent in the jurisdiction in which the study is taking place) 3. Had document of previous primary vaccination of 2 doses of Comirnaty® at least 3 months on the day of signing the ICF 4. SARS-CoV-2 Reverse transcription-polymerase chain reaction (RT-PCR)-negative at screening. 5. Body mass index of ≥ 18 and ≤ 30 kg/m2 at screening. 6. Women of childbearing potential (WOCBP) and men whose sexual partners are WOCBP must be able and willing to use at least 1 highly effective method of contraception (i.e., including hysterectomy, bilateral salpingectomy, and bilateral oophorectomy, hormonal oral \[in combination with male condoms with spermicide\], transdermal, implant, or injection, barrier \[i.e., condom, diaphragm with spermicide\]; intrauterine device; vasectomized partner \[6 months minimum\], clinically sterile partner; or abstinence) during the study or 6 months after the last study vaccine, whichever later. * A female subject is considered a WOCBP after menarche and until she is in a postmenopausal state for 12 consecutive months (without an alternative medical cause) or otherwise permanently sterile. * Subjects not of childbearing potential are not required to use any other forms of contraception during the study. Non-childbearing potential is defined as subject confirmed: i. Surgical sterilization (e.g., bilateral oophorectomy, bilateral salpingectomy, bilateral occlusion by cautery \[Essure System® is not acceptable\], hysterectomy, or tubal ligation). ii. Postmenopausal (defined as permanent cessation of menstruation for at least 12 consecutive months prior to screening); if postmenopausal status is unclear, pregnancy tests will be performed prior to vaccinations. 7. WOCBP must have a negative pregnancy test before vaccination. If menopausal status is unclear, a pregnancy test is required. Safety Cohort: Each subject must meet all of the following criteria to be enrolled into the Safety Cohort: 1. Subject is able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments. 2. Adult males and females 18 years of age or older on the day of signing the ICF (or the legal age of consent in the jurisdiction in which the study is taking place) in general good health before study participation with no clinically relevant abnormalities (at Investigator's discretion) that could interfere with study assessments. Subjects may have stable comorbidities (no change in medications, exacerbations, or hospitalizations in the past 3 months). 3. Have previously received any full primary series approved by WHO Emergency Use Authorization at least 3 months prior to enrollment or who have already received one authorized booster vaccination and planned to receive PTX-COVID19-B as the 4th shot. 4. SARS-CoV-2 Reverse transcription-polymerase chain reaction (RT-PCR)-negative at screening. 5. Body mass index of ≥ 18 and ≤ 30 kg/m2 at screening. 6. Women of childbearing potential (WOCBP) and men whose sexual partners are WOCBP must be able and willing to use at least 1 highly effective method of contraception (i.e., including hysterectomy, bilateral salpingectomy, and bilateral oophorectomy, hormonal oral \[in combination with male condoms with spermicide\], transdermal, implant, or injection, barrier \[i.e., condom, diaphragm with spermicide\]; intrauterine device; vasectomized partner \[6 months minimum\], clinically sterile partner; or abstinence) during the study or 6 months after the last study vaccine, whichever later. * A female subject is considered a WOCBP after menarche and until she is in a postmenopausal state for 12 consecutive months (without an alternative medical cause) or otherwise permanently sterile. * Subjects not of childbearing potential are not required to use any other forms of contraception during the study. Non-childbearing potential is defined as subject confirmed: i. Surgical sterilization (e.g., bilateral oophorectomy, bilateral salpingectomy, bilateral occlusion by cautery \[Essure System® is not acceptable\], hysterectomy, or tubal ligation). ii. Postmenopausal (defined as permanent cessation of menstruation for at least 12 consecutive months prior to screening); if postmenopausal status is unclear, pregnancy tests will be performed prior to vaccinations. 7. WOCBP must have a negative pregnancy test before vaccination. If menopausal status is unclear, a pregnancy test is required.
Exclusion criteria
\- Efficacy Cohort: Subjects will not be eligible for Efficacy Cohort participation if they meet any of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To demonstrate that the immune response of a single booster dose of PTX-COVID19-B is non inferior to that of Comirnaty® | Day15 | The 50% neutralizing antibody titers (NT50), as measured by pseudovirusbased neutralization assay (PBNA), at Day 15 |
| To assess safety of booster vaccination of PTX-COVID19-B in Safety Cohort | Incidence of solicited AEs Day1-Day8; Incidence of unsolicited AEs Day1-Day29; Incidence of SAEs, MAAEs, NOCD, AESI, and PIMMC Day1-Day181 | * Incidence of solicited AEs; * Incidence of unsolicited AEs; * Incidence of SAEs, MAAEs, NOCD, AESI, and PIMMC |
Outcome results
None listed