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

NCT ID: NCT05370040

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-05
• Study Completion Date: 2024-03-11

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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Phase 1 Cohort 1A

AAHI-SC2 on Day 1 at dosage 25 μg IM

Group Type: EXPERIMENTAL

AAHI-SC2 Vaccine

Intervention Type: BIOLOGICAL

AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine

Phase 1 Cohort 1B

AAHI-SC2 on Day 1 at dosage 50 μg IM

Group Type: EXPERIMENTAL

AAHI-SC2 Vaccine

Intervention Type: BIOLOGICAL

AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine

Phase 1 Cohort 1C

AAHI-SC2 on Day 1 at dosage 70 μg IM

Group Type: EXPERIMENTAL

AAHI-SC2 Vaccine

Intervention Type: BIOLOGICAL

AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine

Phase 1 Cohort 2A

AAHI-SC3 on Day 1 at dosage 25 μg IM

Group Type: EXPERIMENTAL

AAHI-SC3 Vaccine

Intervention Type: BIOLOGICAL

AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine

Phase 1 Cohort 2B

AAHI-SC3 on Day 1 at dosage 50 μg IM

Group Type: EXPERIMENTAL

AAHI-SC3 Vaccine

Intervention Type: BIOLOGICAL

AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine

Phase 1 Cohort 2C

AAHI-SC3 on Day 1 at dosage 85 μg IM

Group Type: EXPERIMENTAL

AAHI-SC3 Vaccine

Intervention Type: BIOLOGICAL

AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine

Phase 2 Control arm

EUA or approved vaccine on Day 1

Group Type: PLACEBO_COMPARATOR

EUA or approved vaccine

Intervention Type: BIOLOGICAL

Janssen or Pfizer vaccines (control arm)

Phase 2 Experimental arm 1

AAHI-SC2 on Day 1 Dose TBD as determined in phase 1 study

Group Type: EXPERIMENTAL

AAHI-SC2 Vaccine

Intervention Type: BIOLOGICAL

AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine

Phase 2 Experimental arm 2

AAHI-SC3 on Day 1 Dose TBD as determined in phase 1 study

Group Type: EXPERIMENTAL

AAHI-SC3 Vaccine

Intervention Type: BIOLOGICAL

AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine

Phase 2 Experimental arm 3

AAHI-SC3 on Day 1 and 29 Dose TBD as determined in phase 1 study

Group Type: EXPERIMENTAL

AAHI-SC3 Vaccine

Intervention Type: BIOLOGICAL

AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine

Interventions

AAHI-SC2 Vaccine

AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine

Intervention Type: 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

Intervention Type: BIOLOGICAL

EUA or approved vaccine

Janssen or Pfizer vaccines (control arm)

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ImmunityBio, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Wits Vida

Johannesburg, , South Africa

Countries

South Africa

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan: part 1

View Document

Document Type: Study Protocol and Statistical Analysis Plan: part 2

View Document

Other Identifiers

COVID-4.015

Identifier Type: -

Identifier Source: org_study_id