Phase 1b Open-Label Study of the Safety, Reactogenicity, and Immunogenicity of Subcutaneously and Orally Administered Prophylactic Vaccination With 2nd Generation (E1/E2B/E3-Deleted) Adenoviral COVID-19 in Normal Healthy Volunteers
Overview
- Phase
- Phase 1
- Intervention
- hAd5-S-Fusion+N-ETSD (Suspension for injection)
- Conditions
- Covid19
- Sponsor
- ImmunityBio, Inc.
- Enrollment
- 28
- Locations
- 2
- Primary Endpoint
- Incidence of MAAEs
- Status
- Terminated
- Last Updated
- last year
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 the combination of hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+N-ETSD (Oral capsule) and to select an optimal combination 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.
- •Ability to swallow a capsule.
- •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.
- •Current or former smoker.
- •Bone marrow or organ transplantation.
- •Obesity (defined as body mass index \[BMI\] of 30 kg/m2 or higher).
- •Chronic kidney disease.
- •Liver disease.
Arms & Interventions
Cohort 1- hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+ N-ETSD (Oral capsule)
For subjects in cohort 1, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Suspension for injection) again on day 22 (boost).
Intervention: hAd5-S-Fusion+N-ETSD (Suspension for injection)
Cohort 1- hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+ N-ETSD (Oral capsule)
For subjects in cohort 1, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Suspension for injection) again on day 22 (boost).
Intervention: hAd5-SFusion+ N-ETSD (Oral capsule)
Cohort 2- hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+ N-ETSD (Oral capsule)
For subjects in cohort 2, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Oral capsule) on day 22 (boost).
Intervention: hAd5-S-Fusion+N-ETSD (Suspension for injection)
Cohort 2- hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+ N-ETSD (Oral capsule)
For subjects in cohort 2, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Oral capsule) on day 22 (boost).
Intervention: hAd5-SFusion+ N-ETSD (Oral capsule)
Cohort 3 - hAd5-S-Fusion+N-ETSD (Oral capsule)
For subjects in cohort 3, hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on days 1 (prime) and on day 22 (boost).
Intervention: hAd5-SFusion+ N-ETSD (Oral capsule)
Cohort 4 - hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+N-ETSD (Oral capsule)
For subjects in cohort 4, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-SFusion+N-ETSD (Oral capsule) will be administered on days 15 (boost) and 22 (boost).
Intervention: hAd5-S-Fusion+N-ETSD (Suspension for injection)
Cohort 4 - hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+N-ETSD (Oral capsule)
For subjects in cohort 4, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-SFusion+N-ETSD (Oral capsule) will be administered on days 15 (boost) and 22 (boost).
Intervention: hAd5-SFusion+ N-ETSD (Oral capsule)
Outcomes
Primary Outcomes
Incidence of MAAEs
Time Frame: 6 Months post final vaccine administration
Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration
Incidence of Serious AEs
Time Frame: 6 Months Post Final Vaccine
Incidence of Serious Adverse Events Through 6 Months Post- Final Vaccine Administration
Incidence of Solicited Local Reactogenicity AEs
Time Frame: 1 week post final vaccine administration
Incidence of Solicited Local Treatment-Related Reactogenicity Adverse Events Through 1 Week Post Final Vaccine
Incidence of Solicited Systemic Treatment-Related Reactogenicity AEs
Time Frame: 1 week post final vaccine administration
Incidence of Solicited Systemic Treatment-Related Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration
Incidence of Unsolicited AEs
Time Frame: 30 days post final vaccine
Incidence of Unsolicited Adverse Events Through 30 Days Post Final Vaccine Administration
Incidence of Unsolicited Treatment-Related AEs
Time Frame: 30 Days Post Final
Incidence of Unsolicited Treatment-Related Adverse Events Through 30 Days Post Final Vaccine Administration