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THEMBA II T-Cell Vaccine: Vaccination With saRNA COVID-19 Vaccines

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05370040
Recruitment Status : Recruiting
First Posted : May 11, 2022
Last Update Posted : January 6, 2023
Sponsor:
Information provided by (Responsible Party):
ImmunityBio, Inc.

Study Description
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Brief Summary:
This is a phase 1/2 open-label study assessing the safety, reactogenicity, and immunogenicity of saRNA COVID-19 boost vaccines in participants that have been previously vaccinated against or previously infected with COVID-19.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: AAHI-SC2 Vaccine Biological: AAHI-SC3 Vaccine Biological: EUA or approved vaccine Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Open label 6 Cohort Phase 1 Study leading to Randomized 4 Cohort Phase 2 Study
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: THEMBA II T-CELL Vaccine: A Phase 1/2 Study of the Safety, Reactogenicity, and Immunogenicity of Vaccination With saRNA COVID-19 Vaccines
Actual Study Start Date : May 9, 2022
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Phase 1 Cohort 1A
AAHI-SC2 on Day 1 at dosage 25 μg IM
 Biological: AAHI-SC2 Vaccine
AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
Experimental: Phase 1 Cohort 1B
AAHI-SC2 on Day 1 at dosage 50 μg IM
 Biological: AAHI-SC2 Vaccine
AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
Experimental: Phase 1 Cohort 1C
AAHI-SC2 on Day 1 at dosage 70 μg IM
 Biological: AAHI-SC2 Vaccine
AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
Experimental: Phase 1 Cohort 2A
AAHI-SC3 on Day 1 at dosage 25 μg IM
 Biological: AAHI-SC3 Vaccine
AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
Experimental: Phase 1 Cohort 2B
AAHI-SC3 on Day 1 at dosage 50 μg IM
 Biological: AAHI-SC3 Vaccine
AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
Experimental: Phase 1 Cohort 2C
AAHI-SC3 on Day 1 at dosage 85 μg IM
 Biological: AAHI-SC3 Vaccine
AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
Placebo Comparator: Phase 2 Control arm
EUA or approved vaccine on Day 1
 Biological: EUA or approved vaccine
Janssen or Pfizer vaccines (control arm)
Experimental: Phase 2 Experimental arm 1
AAHI-SC2 on Day 1 Dose TBD as determined in phase 1 study
 Biological: AAHI-SC2 Vaccine
AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
Experimental: Phase 2 Experimental arm 2
AAHI-SC3 on Day 1 Dose TBD as determined in phase 1 study
 Biological: AAHI-SC3 Vaccine
AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
Experimental: Phase 2 Experimental arm 3
AAHI-SC3 on Day 1 and 29 Dose TBD as determined in phase 1 study
 Biological: AAHI-SC3 Vaccine
AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine


Outcome Measures
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Primary Outcome Measures :
  1. Phase 1 Safety - Incidence of medically-attended MAAEs and SAEs [ Time Frame: through 1 week post final vaccine administration ]
    Incidence of medically-attended adverse events (MAAEs) and serious adverse events (SAEs)

  2. Phase 1 Safety - Incidence of MAAEs and SAEs through 30 days [ Time Frame: through 30 days post final vaccine administration ]
    Incidence of MAAEs and SAEs

  3. Phase 1 Safety - Incidence of MAAEs and SAEs through 6 months [ Time Frame: through 6 months post final vaccine administration ]
    Incidence of MAAEs and SAEs

  4. Phase 1 Safety - Incidence of local reactogenicity AEs [ Time Frame: through 1 week after each vaccine dose ]
    Incidence and severity of solicited local reactogenicity AEs

  5. Phase 1 Safety - Incidence of solicited systemic reactogenicity AEs [ Time Frame: through 1 week after each vaccine dose ]
    Incidence and severity of solicited systemic reactogenicity AEs

  6. Phase 1 Safety - Incidence of unsolicited AEs through 1 week [ Time Frame: through 1 week post final vaccine administration ]
    Incidence and severity of unsolicited AEs

  7. Phase 1 Safety - Incidence of unsolicited AEs through 30 days [ Time Frame: through 30 days post final vaccine administration ]
    Incidence and severity of unsolicited AEs

  8. Phase 1 Safety - Incidence of abnormal changes of laboratory safety examinations [ Time Frame: Day 365 ]
    Incidence of abnormal changes of laboratory safety examinations

  9. Phase 1 Safety - Vital Sign - Temperature [ Time Frame: Day 365 ]

    Changes in vital signs from Grades 1-4:

    measured in (°C) or (°F)


  10. Phase 1 Safety - Vital Sign - Heart Rate [ Time Frame: Day 365 ]

    Changes in vital signs from Grades 1-4:

    measured by how many heart beats per minute


  11. Phase 1 Safety - Vital Sign - Blood Pressure [ Time Frame: Day 365 ]

    Changes in vital signs from Grades 1-4:

    systolic/diastolic - measured in mm Hg


  12. Phase 1 Safety - Vital Sign - Respiratory Rate [ Time Frame: Day 365 ]

    Changes in vital signs from Grades 1-4:

    measured in how many breaths per minute


  13. Phase 2 Humoral Immunogenicity - GMT of S-specific and N-specific IgG antibodies [ Time Frame: Day 365 ]
    GMT of S-specific and N-specific IgG antibodies against 2019 novel coronavirus tested by ELISA in serum

  14. Phase 2 Humoral Immunogenicity - GMT of neutralizing antibody [ Time Frame: Day 365 ]
    GMT of neutralizing antibody

  15. Phase 2 Cellular Immunogenicity - T cell activity [ Time Frame: Day 365 ]
    T cell activity against SARS-CoV-2 S protein and N protein as assayed by the ELISpot assay


Secondary Outcome Measures :
  1. Phase 1 Humoral Immunogenicity - GMT of S-specific and N-specific IgG antibodies [ Time Frame: Day 365 ]
    Geometric mean titer (GMT) of S-specific and N-specific IgG antibodies against 2019 novel coronavirus tested by ELISA in serum

  2. Phase 1 Humoral Immunogenicity - GMT of neutralizing antibody [ Time Frame: Day 365 ]
    GMT of neutralizing antibody

  3. Phase 1 Cellular Immunogenicity - T cell activity [ Time Frame: Day 365 ]
    T cell activity against SARS-CoV-2 S protein and N protein as assayed by ELISpot

  4. Phase 2 Safety - Incidence of MAAEs and SAEs [ Time Frame: through 30 days post final vaccine administration ]
    Incidence of MAAEs and SAEs

  5. Phase 2 Safety - Incidence of Incidence of MAAEs and SAEs through 6 months [ Time Frame: through 6 months post final vaccine administration ]
    Incidence of MAAEs and SAEs

  6. Phase 2 Safety - Incidence of solicited local reactogenicity AEs [ Time Frame: through 1 week after each vaccine dose ]
    Incidence and severity of solicited local reactogenicity AEs

  7. Phase 2 Safety - Incidence of solicited systemic reactogenicity AEs [ Time Frame: through 1 week after each vaccine dose ]
    Incidence and severity of solicited systemic reactogenicity AEs

  8. Phase 2 Safety - Incidence of unsolicited AEs [ Time Frame: through 30 days post final vaccine administration ]
    Incidence and severity of unsolicited AEs


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy adults ≥ 18 years of age at time of enrollment.
  2. Vaccinated with an EUA or approved vaccine against COVID-19 ≥ 3 months prior to enrollment on study or infection with COVID-19 ≥ 3 months prior to enrollment on study.
  3. Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
  4. Agrees to the collection of biospecimens (eg, nasopharyngeal [NP] swabs) and venous blood per protocol.
  5. Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
  6. Temperature < 38°C.
  7. Agreement to practice effective contraception for female participants of childbearing potential and non-sterile males. Female participants 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 participants 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), intrauterine devices (IUDs), oral contraceptives, injectable contraceptives, patches, implants and abstinence.
  8. HIV-positive participants must have been on anti-retroviral therapy for ≥ 4 weeks and have HIV-1 viral load < 1,000 copies/mL at the time of enrollment.

Exclusion Criteria:

  1. Serious adverse reaction to any vaccine, any unrelated medication or any component of the investigational vaccine, including a history of anaphylaxis and symptoms of a severe allergic reaction and history of allergies in the past.
  2. Confirmed current COVID-19, previous SARS-CoV-2 infection in the last < 3 months, or PCR positive for SARS-CoV-2 at screening.
  3. Vaccinated with an EAU-approved vaccine against COVID-19 in the last < 3 months.
  4. Pregnant or breastfeeding women.
  5. Chronic lung disease (included COPD) as evidenced by one or more exacerbations requiring a course of steroids in the last year, or the requiring chronic low dose oral steroids to prevent exacerbations. Uncontrolled asthma, defined as requiring reliever inhaler (short-acting beta agonist or ipratromium bromide) more than twice a week is also excluded.
  6. Bone marrow or organ transplant recipient
  7. Extreme obesity (defined as BMI of 40 kg/m2 or higher).
  8. Chronic kidney disease requiring dialysis.
  9. History of liver disease.
  10. Any disease associated with acute fever, or any infection.
  11. Participants with acquired or hereditary immunodeficiencies other than well-controlled HIV are excluded from enrollment.
  12. Current diagnosis of active tuberculosis.
  13. History of hereditary, idiopathic or acquired angioedema.
  14. No spleen or functional asplenia.
  15. Chronic use (more than 14 continuous days) of any medications that may be associated with impaired immune responsiveness including, but not limited to, systemic corticosteroids exceeding 10 mg/day of prednisone equivalent, allergy injections, immunoglobulin, interferon, or immunomodulators. The use of low dose topical, ophthalmic, inhaled and intranasal steroid preparations will be permitted.
  16. According to the judgement of the investigator any medical, psychiatric, psychological, social, occupational or other conditions that could affect the participants ability to sign informed consent, provide safety assessment data or comply with the requirements of the study protocol.
  17. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05370040


Contacts
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Contact: Lennie Sender, MD 714-615-2350 lennie.sender@immunitybio.com

Locations
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South Africa
Wits Vida Recruiting
Johannesburg, South Africa
Contact: Anthonet Koen, MD    27 84 744 4196    Anthonet.koen@wits-vida.org   
Principal Investigator: Anthonet Koen, MD         
Sponsors and Collaborators
ImmunityBio, Inc.
More Information
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Responsible Party: ImmunityBio, Inc.
ClinicalTrials.gov Identifier: NCT05370040    
Other Study ID Numbers: COVID-4.015
First Posted: May 11, 2022    Key Record Dates
Last Update Posted: January 6, 2023
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs