Phase 1b Open-Label Study of the Safety, Reactogenicity, and Immunogenicity of Prophylactic Vaccination With 2nd Generation (E1/E2B/E3-Deleted) Adenoviral-COVID-19 in Normal Healthy Volunteers
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- COVID-19
- Sponsor
- ImmunityBio, Inc.
- Enrollment
- 34
- Locations
- 2
- Primary Endpoint
- Incidence and severity of solicited systemic reactogenicity AEs
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This is a phase 1b, open-label study in adult healthy subjects. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity of the hAd5-S-Fusion+N-ETSD vaccine and select a dose for future studies.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy adults, age 18 - 55 years, inclusive, at time of enrollment.
- •Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
- •Agrees to the collection of biospecimens (eg, nasopharyngeal \[NP\] swabs) and venous blood per protocol.
- •Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
- •Temperature \< 38°C.
- •Negative for SARS-CoV-2 (qPCR or LAMP test) and no known previous COVID-19 exposure or disease.
- •Agreement to practice effective contraception for female subjects of childbearing
- •potential and non-sterile males. Female subjects of childbearing potential must agree to use effective contraception while on study until at least 1 month after the last dose of vaccine. Non-sterile male subjects must agree to use a condom while on study until at least 1 month after the last dose of vaccine. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm) used with spermicide, intrauterine devices (IUDs), oral contraceptives, and abstinence.
Exclusion Criteria
- •Allergy to any component of the investigational vaccine, or a more severe allergic reaction and history of allergies in the past.
- •Pregnant and nursing women. A negative serum or urine pregnancy test during screening and on the day of and prior to each dose must be documented before the vaccine is administered to a female subject of childbearing potential.
- •Live in a nursing home or long-term care facility.
- •Chronic lung disease including chronic obstructive pulmonary disease (COPD) or moderate to severe asthma.
- •Pulmonary fibrosis.
- •Active smoker.
- •Bone marrow or organ transplantation.
- •Obesity (defined as body mass index \[BMI\] of 30 kg/m2 or higher).
- •Chronic kidney disease.
- •Liver disease.
Outcomes
Primary Outcomes
Incidence and severity of solicited systemic reactogenicity AEs
Time Frame: 1 week
Incidence and severity of solicited systemic reactogenicity AEs through 1 week post final vaccine administration
Incidence of abnormal changes of laboratory safety examinations
Time Frame: 30 days
Incidence of abnormal changes of laboratory safety examinations
Vital Signs - Fever
Time Frame: 30 days
Changes in vital signs from Grades 1-4: - Fever - measured in (°C) or (°F)
Vital Signs - Hypertension
Time Frame: 30 Days
Changes in vital signs from Grades 1-4: - Hypertension (systolic/diastolic) - measured in mm Hg
GMT of S-specific, RBD-specific, and N-specific antibodies against 2019 novel coronavirus
Time Frame: Day 387
GMT of S-specific, RBD-specific, and N-specific antibodies against 2019 novel coronavirus tested by ELISA in serum
GMFR in neutralizing antibody
Time Frame: Day 387
GMFR in neutralizing antibody
Incidence of MAAEs and SAEs
Time Frame: 30 days to 6 months
Incidence of MAAEs and SAEs through 30 days and 6 months post final vaccine administration
Vital Signs - Tachycardia
Time Frame: 30 Days
Changes in vital signs from Grades 1-4: - Tachycardia - measured in beats per minute
Vital Signs - Hypotension
Time Frame: 30 Days
Changes in vital signs from Grades 1-4: - Hypotension (systolic) - measured in mm Hg
Vital Signs - Respiratory Rate
Time Frame: 30 Days
Changes in vital signs from Grades 1-4: - Respiratory Rate - measured in how many breaths per minute
GMFR in IgG titer
Time Frame: Day 387
GMFR in IgG titer
Vital Signs - Bradycardia
Time Frame: 30 Days
Changes in vital signs from Grades 1-4: - Bradycardia - measured in how many beats per minute
CD8+ T-Cell activity against SARS-CoV-2 S protein, RBD, and N protein
Time Frame: Day 387
CD8+ T-Cell activity against SARS-CoV-2 S protein, RBD, and N protein measured by ELISPOT assay
CD4+ T-Cell activity against SARS-CoV-2 S protein, RBD, and N protein
Time Frame: Day 387
CD4+ T-Cell activity against SARS-CoV-2 S protein, RBD, and N protein measured by standard immune assay
Incidence and severity of solicited local reactogenicity AEs
Time Frame: 1 week
Incidence and severity of solicited local reactogenicity AEs through 1 week post final vaccine administration
Incidence and severity of unsolicited AEs
Time Frame: 30 days
Incidence and severity of unsolicited AEs through 30 days post final vaccine administration
Percentage of subjects who seroconverted
Time Frame: Day 387
Percentage of subjects who seroconverted (as defined as 4-fold change in antibody titer relative to baseline)
GMT
Time Frame: Day 387
GMT of neutralizing antibody
Seroconversion rate of neutralizing antibody
Time Frame: Day 387
Seroconversion rate of neutralizing antibody (as defined as 4-fold change in antibody titer relative to baseline)