COVID-19 Supplemental Vaccine Boost to Enhance T Cell Protection in Those Who Have Already Received EUA S-Based Vaccines

NCT04843722 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: COVID-4.006
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a phase 1/2 study in adult healthy subjects that have previously been vaccinated with an FDA-authorized vaccine against COVID-19. This clinical trial is designed to assess the safety, efficacy, reactogenicity, and immunogenicity of hAd5-S-Fusion+N-ETSD formulated for subcutaneous, sublingual, and oral (capsule) administration.

Conditions

Covid19

Outcome Measures

Primary Outcomes (12)

• Phase 1 Safety: Incidence of MAAEs and SAEs

  Incidence of MAAEs and SAEs through 1 week post final vaccine administration

  through 1 week post final vaccine administration

• Phase 1 Safety: Incidence and severity of solicited local reactogenicity AEs

  Incidence and severity of solicited local reactogenicity AEs through 1 week post final vaccine administration

  through 1 week post final vaccine administration

• Phase 1 Safety: Incidence and severity of solicited systemic reactogenicity AEs

  Incidence and severity of solicited systemic reactogenicity AEs through 1 week post final vaccine administration

  through 1 week post final vaccine administration

• Phase 1 Safety: Incidence and severity of unsolicited AEs

  Incidence and severity of unsolicited AEs through 1 week post final vaccine administration

  through 1 week post final vaccine administration

• Phase 1 Safety: Incidence of MAAEs and SAEs

  Incidence of MAAEs and SAEs through 30 days and 6 months post final vaccine administration

  through 30 days and 6 months post final vaccine administration

• Phase 1 Safety: Incidence and severity of unsolicited AEs

  Incidence and severity of unsolicited AEs through 30 days post final vaccine administration

  through 30 days post final vaccine administration

• Phase 1 Safety: Incidence of changes of laboratory safety examinations

  Incidence of abnormal changes of laboratory safety examinations

  Day 365

• Phase 1 Safety: Vital Sign - Temperature

  Changes in vital signs from Grades 1-4: measured in (°C) or (°F)

  Day 365

• Phase 1 Safety: Vital Sign - Heart Rate

  Changes in vital signs from Grades 1-4: measured by how many heart beats per minute

  Day 365

• Phase 1 Safety: Vital Sign - Blood Pressure

  Changes in vital signs from Grades 1-4: systolic/diastolic - measured in mm Hg

  Day 365

• Phase 1 Safety: Vital Sign - Respiratory Rate

  Changes in vital signs from Grades 1-4: measured in how many breaths per minute

  Day 365

• Phase 2 Efficacy: Percent of subjects that show an increase in N-reactive T cells

  Percent of subjects that show an increase in N-reactive T cells as assayed by N-Tiferon assay (≥ 25 pg/mL increase in cytokine concentration from baseline)

  from baseline to Day 365

Secondary Outcomes (21)

• Phase 1 Humoral Immunogenicity: GMT of S-specific and N-specific antibodies

  Day 365

• Phase 1 Humoral Immunogenicity: GMT of neutralizing antibody

  Day 365

• Phase 1 Mucosal Immunogenicity: GMT of IgA antibody levels

  Day 365

• Phase 1 Cellular Immunogenicity: T cell activity

  Day 365

• Phase 2 Efficacy: Incidence and severity of COVID-19 ≥14 days after vaccination

  ≥14 days after vaccination

Study Arms (2)

Cohort 1: hAd5-S-Fusion+N-ETSD at 5 × 10e10 IU/dose Subcutaneous

EXPERIMENTAL

Cohort 1 (n=20): hAd5-S-Fusion+N-ETSD at 5 × 10e10 IU/dose Subcutaneous on Day 1

Biological: hAd5-S-Fusion+N-ETSD vaccine

Cohort 2: hAd5-S-Fusion+N-ETSD at 5 × 10e10 IU/dose Subcutaneous and 1 × 10e10 IU/dose Sublingual

EXPERIMENTAL

Cohort 2 (n=20): hAd5-S-Fusion+N-ETSD at 5 × 10e10 IU/dose Subcutaneous and 1 × 10e10 IU/dose Sublingual on Day 1

Biological: hAd5-S-Fusion+N-ETSD vaccine

Interventions

hAd5-S-Fusion+N-ETSD vaccine BIOLOGICAL

Vaccine containing both full length wild type SARS-CoV-2 spike gene optimized for better spike protein expression, and full length wild type SARS-CoV-2 nucleocapsid gene modified to also contain an enhanced T cell stimulation domain (ETSD) to enhance cell-mediated immunity.

Cohort 1: hAd5-S-Fusion+N-ETSD at 5 × 10e10 IU/dose Subcutaneous; Cohort 2: hAd5-S-Fusion+N-ETSD at 5 × 10e10 IU/dose Subcutaneous and 1 × 10e10 IU/dose Sublingual

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults, age ≥ 18 years, inclusive, at time of enrollment, that have previously received an FDA-authorized COVID-19 vaccine (both prime and boost) ≥14 days and
• ≤ 6 months before 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, NP swabs and/or saliva sample) 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.
• 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, IUDs, oral contraceptives, and abstinence.

You may not qualify if:

• Persistent grade ≥ 2 AEs related to previous COVID-19 vaccination at the time of enrollment.
• 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.
• Chronic lung disease including chronic obstructive pulmonary disease (COPD) or moderate to severe asthma.
• Pulmonary fibrosis.
• Bone marrow or organ transplantation.
• Extreme obesity (defined as BMI of 35 kg/m2 or higher).
• Diabetes.
• Chronic kidney disease.
• Liver disease.
• Sickle cell disease.
• Thalassemia.
• Any disease associated with acute fever, or any infection.
• Self-reported history of SARS.
• History of hepatitis B or hepatitis C.

Sponsors & Collaborators

• ImmunityBio, Inc.: lead

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label 2 Cohort Phase 1 Study leading to Randomized Phase 2 Study

Study Record Dates

• First Submitted: April 9, 2021
• First Posted: April 13, 2021
• Study Start: December 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 14, 2021
• Last Updated: February 21, 2025

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share