A Ph 2 Trial With an Oral Tableted COVID-19 Vaccine
- Conditions
- COVID-19
- Interventions
- Drug: VXA-CoV2-1.1-SOther: Placebo Tablets
- Registration Number
- NCT05067933
- Lead Sponsor
- Vaxart
- Brief Summary
Part 1: An open label, dose and age escalation phase to evaluate the safety and immunogenicity of VXA-CoV2-1.1-S with a repeat-dose vaccination schedule in healthy adults aged 18 - 75 years old that are either vaccine naive or have received prior vaccination with an mRNA (messenger ribonucleic acid) vaccine for the prevention of COVID-19.
Part 2: This phase will assess the efficacy of prophylactic VXA-CoV2-1.1-S against confirmed COVID-19 occurring from 7 days after second dose with a repeat-dose vaccination schedule in healthy adults compared to placebo. Safety and immunogenicity of VXA-CoV2-1.1-S will also be evaluated in this phase.
- Detailed Description
Part 1: This is an open-label, dose-ranging phase of the study to determine the safety and immunogenicity of an orally administered adenoviral-vector based vaccine (VXA-COV2-1.1-S) expressing a SARS-CoV-2 antigen and dsRNA adjuvant. Post screening activities, healthy adult volunteers, either naïve or prior vaccinated with an mRNA COVID-19 vaccine, aged 18 - 55 yrs old, and then 56 - 75 yrs old, will be enrolled into the study in 8 subgroups. Participants will receive either a low or a high dose of an oral tableted vaccine at Days 1 and Day 29. The total study period will last \~ 2 months during the active phase, with a total 12 month safety follow-up period post last vaccination. Safety, reactogenicity and immunogenicity assessments will be performed at set times during the study active and follow-up periods. Subjects will be monitored for symptoms of COVID-19 throughout the duration of the study follow-up period. An independent data monitoring committee (IDMC) will provide safety oversight through the duration of the trial. Safety and immunogenicity data will inform on the dose selection for Part 2.
Part 2: This will be a placebo-controlled phase with the vaccine dose level selected from Part 1. Subjects will receive two doses of vaccine or placebo at Days 1 and 29. Subjects will be followed as in Part 1 for safety and immunogenicity. They will also be followed for 6 months for efficacy.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1 Cohort 2a (Prior vaccinated, low dose, young adult) VXA-CoV2-1.1-S 1E10 repeat-dose vaccinations with VXA-CoV2-1.1-S at Days 1 and 29 in young adults (18-55 yrs) who have received prior vaccinations with an mRNA vaccine Part 1 Cohort 1a (Naïve, low dose, young adult) VXA-CoV2-1.1-S 1E10 repeat-dose vaccinations with VXA-CoV2-1.1-S at Days 1 and 29 in young adults (18-55 yrs) who are vaccine naïve Part 1 Cohort 1b (Naïve, high dose, young adult) VXA-CoV2-1.1-S 1E11 repeat-dose vaccinations with VXA-CoV2-1.1-S at Days 1 and 29 in young adults (18-55 yrs) who are vaccine naïve Part 1 Cohort 2c (Prior vaccinated, low dose, older adult) VXA-CoV2-1.1-S 1E10 repeat-dose vaccinations with VXA-CoV2-1.1-S at Days 1 and 29 in older adults (56-75 yrs) who have received prior vaccinations with an mRNA vaccine Part 1 Cohort 1c (Naïve, low dose, older adult) VXA-CoV2-1.1-S 1E10 repeat-dose vaccinations with VXA-CoV2-1.1-S at Days 1 and 29 in older adults (56-75 yrs) who are vaccine naïve Part 1 Cohort 2d (Prior vaccinated, high dose, older adult) VXA-CoV2-1.1-S 1E11 repeat-dose vaccinations with VXA-CoV2-1.1-S at Days 1 and 29 in older adults (56-75 yrs) who have received prior vaccinations with an mRNA vaccine Part 2 Healthy Adults: Placebo control Placebo Tablets Repeat dose administration with matching placebo tablets in healthy male and female adult volunteers 18 to 75 years old Part 1 Cohort 1d (Naïve, high dose, older adult) VXA-CoV2-1.1-S 1E11 repeat-dose vaccinations with VXA-CoV2-1.1-S at Days 1 and 29 in older adults (56-75 yrs) who are vaccine naïve Part 1 Cohort 2b (Prior vaccinated, high dose, young adult) VXA-CoV2-1.1-S 1E11 repeat-dose vaccinations with VXA-CoV2-1.1-S at Days 1 and 29 in young adults (18-55 yrs) who have received prior vaccinations with an mRNA vaccine Part 2 Healthy Adults: Active vaccine VXA-CoV2-1.1-S Repeat dose vaccinations with VXA-CoV2-1.1-S at dose selected from Part 1 in healthy male and female adult volunteers 18 to 75 years old
- Primary Outcome Measures
Name Time Method Rate of Unsolicited Adverse Events (Part 1 and Part 2) Up to Day 57 Treatment emergent unsolicited adverse events will be collected for 28 days following second vaccination (boost) at Day 29
Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) Monitoring for one year post last dose administration Active monitoring for SAEs and MAAEs including monitoring for COVID-19 and vaccine-associated enhanced disease (VAED)
Rate of Solicited Symptoms of Reactogenicity Collected via a Diary Card (Part 1 and Part 2) Up to Day 36 To assess the safety and tolerability of an oral tableted vaccine by collection of solicited symptoms of vaccine reactogenicity recorded daily using a subject diary card for 1 week post second vaccination (boost) at Day 29.
- Secondary Outcome Measures
Name Time Method To assess the induction of neutralizing antibodies to SARS-CoV-2 by ELISA Change from Baseline at Day 57 The change from baseline in neutralizing antibo8)dy titers to SARS-CoV-2 will be evaluated at 4 weeks post second vaccination (Day 57)
To assess the induction of SARS-CoV2-specific Immunoglobulin A (IgA) antibody levels by MSD assay Change from Baseline at Day 29 The change from baseline in SARS-CoV2-specific IgA by MSD assay will be evaluated at four weeks post initial immunization (Day 29)
To assess the induction of SARS-CoV2-specific IgA antibody levels by MSD assay Change from Baseline at Day 57 The change from baseline in SARS-CoV2-specific IgA by MSD assay will be evaluated at four weeks post second immunization (Day 57)
To assess the induction of ASC IgG in (PBMCs) Change from Baseline at Day 36 The change from baseline in ASC IgG levels in PBMCs will be evaluated at 1 week post second vaccination (Day 36)
To assess the induction of ASC IgA in (PBMCs) Change from Baseline at Day 36 The change from baseline in ASC IgA levels in PBMCs will be evaluated at 1 week post second vaccination (Day 36)
To assess the induction of SARS-CoV2-specific Immunoglobulin G (IgG) by Mesoscale Discovery (MSD) assay Change from Baseline at Day 57 The change from baseline in SARS-CoV2-specific IgG by MSD assay will be evaluated at four weeks post second immunization (Day 57)
To assess the induction of antibody secreting cells (ASC) IgG in peripheral blood mononuclear cells (PBMCs) Change from Baseline at Day 8 The change from baseline in ASC IgG levels in PBMCs will be evaluated at 1 week post initial vaccination (Day 8)
Trial Locations
- Locations (4)
Velocity Clinical Research, Inc,
🇺🇸Cleveland, Ohio, United States
AMR Knoxville
🇺🇸Knoxville, Tennessee, United States
AMR Wichita East
🇺🇸Wichita, Kansas, United States
Ark Clinical Research
🇺🇸Long Beach, California, United States