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
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.

Detailed Description

Not Provided

Terminated
COVID-19

Biological: AAHI-SC2 Vaccine

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

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

Biological: EUA or approved vaccine

Janssen or Pfizer vaccines (control arm)

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 55 Years
Countries
South Africa
Locations

Wits Vida
Johannesburg, South Africa

Not Provided

ImmunityBio, Inc.
NCT Number
MeSH Terms
COVID-19
Vaccines