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

NCT05370040 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: COVID-4.015
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (10)

• Phase 1 Safety - Incidence of MAAEs Through 1 Week

  Incidence of medically-attended adverse events (MAAEs)

  through 1 week post final vaccine administration

• Phase 1 Safety - Incidence of MAAEs Through 30 Days

  Incidence of MAAEs

  through 30 days post final vaccine administration

• Phase 1 Safety - Incidence of MAAEs Through 6 Months

  Incidence of MAAEs

  through 6 months post final vaccine administration

• Phase 1 Safety - Incidence of Solicited Local Reactogenicity AEs

  Incidence and severity of solicited local reactogenicity AEs

  through 1 week after each vaccine dose

• Phase 1 Safety - Incidence of Solicited Systemic Reactogenicity AEs

  Incidence and severity of solicited systemic reactogenicity AEs

  through 1 week after each vaccine dose

• Phase 1 Safety - Incidence of Unsolicited AEs Through 1 Week

  Incidence and severity of unsolicited AEs

  through 1 week post final vaccine administration

• Phase 1 Safety - Incidence of Unsolicited AEs Through 30 Days

  Incidence and severity of unsolicited AEs

  through 30 days post final vaccine administration

• Phase 1 Safety - Incidence of SAEs Through 1 Week

  Incidence of serious adverse events (SAEs)

  through 1 week post final vaccine administration

• Phase 1 Safety - Incidence of SAEs Through 30 Days

  Incidence of SAEs

  through 30 days post final vaccine administration

• Phase 1 Safety - Incidence of SAEs Through 6 Months

  Incidence of SAEs

  through 6 months post final vaccine administration

Study Arms (10)

Phase 1 Cohort 1A

EXPERIMENTAL

AAHI-SC2 on Day 1 at dosage 25 μg IM

Biological: AAHI-SC2 Vaccine

Phase 1 Cohort 1B

EXPERIMENTAL

AAHI-SC2 on Day 1 at dosage 50 μg IM

Biological: AAHI-SC2 Vaccine

Phase 1 Cohort 1C

EXPERIMENTAL

AAHI-SC2 on Day 1 at dosage 70 μg IM

Biological: AAHI-SC2 Vaccine

Phase 1 Cohort 2A

EXPERIMENTAL

AAHI-SC3 on Day 1 at dosage 25 μg IM

Biological: AAHI-SC3 Vaccine

Phase 1 Cohort 2B

EXPERIMENTAL

AAHI-SC3 on Day 1 at dosage 50 μg IM

Biological: AAHI-SC3 Vaccine

Phase 1 Cohort 2C

EXPERIMENTAL

AAHI-SC3 on Day 1 at dosage 85 μg IM

Biological: AAHI-SC3 Vaccine

Phase 2 Control arm

PLACEBO COMPARATOR

EUA or approved vaccine on Day 1

Biological: EUA or approved vaccine

Phase 2 Experimental arm 1

EXPERIMENTAL

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

Biological: AAHI-SC2 Vaccine

Phase 2 Experimental arm 2

EXPERIMENTAL

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

Biological: AAHI-SC3 Vaccine

Phase 2 Experimental arm 3

EXPERIMENTAL

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

Biological: AAHI-SC3 Vaccine

Interventions

AAHI-SC2 Vaccine BIOLOGICAL

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

Phase 1 Cohort 1A; Phase 1 Cohort 1B; Phase 1 Cohort 1C; Phase 2 Experimental arm 1

AAHI-SC3 Vaccine 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 2A; Phase 1 Cohort 2B; Phase 1 Cohort 2C; Phase 2 Experimental arm 2; Phase 2 Experimental arm 3

EUA or approved vaccine BIOLOGICAL

Janssen or Pfizer vaccines (control arm)

Phase 2 Control arm

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults ≥ 18 years of age at time of enrollment.
• 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.
• 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, nasopharyngeal \[NP\] swabs) and venous blood per protocol.
• Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
• Temperature \< 38°C.
• 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.
• 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.

You may not qualify if:

• 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.
• Confirmed current COVID-19, previous SARS-CoV-2 infection in the last \< 3 months, or PCR positive for SARS-CoV-2 at screening.
• Vaccinated with an EAU-approved vaccine against COVID-19 in the last \< 3 months.
• Pregnant or breastfeeding women.
• 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.
• Bone marrow or organ transplant recipient
• Extreme obesity (defined as BMI of 40 kg/m2 or higher).
• Chronic kidney disease requiring dialysis.
• History of liver disease.
• Any disease associated with acute fever, or any infection.
• Participants with acquired or hereditary immunodeficiencies other than well-controlled HIV are excluded from enrollment.
• Current diagnosis of active tuberculosis.
• History of hereditary, idiopathic or acquired angioedema.
• No spleen or functional asplenia.
• 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.

Sponsors & Collaborators

• ImmunityBio, Inc.: lead

Study Sites (1)

Wits Vida

Johannesburg, South Africa

Location

MeSH Terms

Conditions

COVID-19

Interventions

Emergency Use Authorization

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

Intervention Hierarchy (Ancestors)

Legislation, Medical; Legislation as Topic; Social Control, Formal; Health Care Economics and Organizations

Limitations and Caveats

The study was terminated early. Only the safety data is provided. Only one adverse event table per AE category was presented to reduce data entry redundancy.

Results Point of Contact

• Title: Lennie Sender, Chief Operating Officer
• Organization: Immunitybio

lennie.sender@immunitybio.com

855-797-9277

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

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 6 Cohort Phase 1 Study leading to Randomized 4 Cohort Phase 2 Study

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 11, 2022
• Study Start: May 5, 2022
• Primary Completion: March 11, 2024
• Study Completion: March 11, 2024
• Last Updated: March 11, 2025
• Results First Posted: May 1, 2024

Record last verified: 2025-02

Locations

ZA (1)