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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05370040
• Other study ID #: COVID-4.015
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: May 5, 2022
• Est. completion date: March 11, 2024

Study information

• Verified date: April 2024
• Source: ImmunityBio, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: March 11, 2024
• Est. primary completion date: March 11, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• AAHI-SC2 Vaccine
AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
• AAHI-SC3 Vaccine
AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
• EUA or approved vaccine
Janssen or Pfizer vaccines (control arm)

Locations

Country	Name	City	State
South Africa	Wits Vida	Johannesburg

Sponsors (1)

Lead Sponsor	Collaborator
ImmunityBio, Inc.

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 1 Safety - Incidence of MAAEs Through 1 Week	Incidence of medically-attended adverse events (MAAEs)	through 1 week post final vaccine administration
Primary	Phase 1 Safety - Incidence of MAAEs Through 30 Days	Incidence of MAAEs	through 30 days post final vaccine administration
Primary	Phase 1 Safety - Incidence of MAAEs Through 6 Months	Incidence of MAAEs	through 6 months post final vaccine administration
Primary	Phase 1 Safety - Incidence of Solicited Local Reactogenicity AEs	Incidence and severity of solicited local reactogenicity AEs	through 1 week after each vaccine dose
Primary	Phase 1 Safety - Incidence of Solicited Systemic Reactogenicity AEs	Incidence and severity of solicited systemic reactogenicity AEs	through 1 week after each vaccine dose
Primary	Phase 1 Safety - Incidence of Unsolicited AEs Through 1 Week	Incidence and severity of unsolicited AEs	through 1 week post final vaccine administration
Primary	Phase 1 Safety - Incidence of Unsolicited AEs Through 30 Days	Incidence and severity of unsolicited AEs	through 30 days post final vaccine administration
Primary	Phase 1 Safety - Incidence of SAEs Through 1 Week	Incidence of serious adverse events (SAEs)	through 1 week post final vaccine administration
Primary	Phase 1 Safety - Incidence of SAEs Through 30 Days	Incidence of SAEs	through 30 days post final vaccine administration
Primary	Phase 1 Safety - Incidence of SAEs Through 6 Months	Incidence of SAEs	through 6 months post final vaccine administration