COVID-19
Conditions
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.
Interventions
BIOLOGICALAAHI-SC2 Vaccine
AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
BIOLOGICALAAHI-SC3 Vaccine
AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
BIOLOGICALEUA or approved vaccine
Janssen or Pfizer vaccines (control arm)
Sponsors
ImmunityBio, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Open label 6 Cohort Phase 1 Study leading to Randomized 4 Cohort Phase 2 Study
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1 Safety - Incidence of MAAEs Through 30 Days | through 30 days post final vaccine administration | Incidence of MAAEs |
| Phase 1 Safety - Incidence of MAAEs Through 6 Months | through 6 months post final vaccine administration | Incidence of MAAEs |
| Phase 1 Safety - Incidence of Solicited Local Reactogenicity AEs | through 1 week after each vaccine dose | Incidence and severity of solicited local reactogenicity AEs |
| Phase 1 Safety - Incidence of MAAEs Through 1 Week | through 1 week post final vaccine administration | Incidence of medically-attended adverse events (MAAEs) |
| Phase 1 Safety - Incidence of Solicited Systemic Reactogenicity AEs | through 1 week after each vaccine dose | Incidence and severity of solicited systemic reactogenicity AEs |
| Phase 1 Safety - Incidence of Unsolicited AEs Through 1 Week | through 1 week post final vaccine administration | Incidence and severity of unsolicited AEs |
| Phase 1 Safety - Incidence of Unsolicited AEs Through 30 Days | through 30 days post final vaccine administration | Incidence and severity of unsolicited AEs |
| Phase 1 Safety - Incidence of SAEs Through 1 Week | through 1 week post final vaccine administration | Incidence of serious adverse events (SAEs) |
| Phase 1 Safety - Incidence of SAEs Through 30 Days | through 30 days post final vaccine administration | Incidence of SAEs |
| Phase 1 Safety - Incidence of SAEs Through 6 Months | through 6 months post final vaccine administration | Incidence of SAEs |
Countries
South Africa
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Phase 1 Cohort 1A AAHI-SC2 on Day 1 at dosage 25 μg IM
AAHI-SC2 Vaccine: AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine | 10 |
| Phase 1 Cohort 1B AAHI-SC2 on Day 1 at dosage 50 μg IM
AAHI-SC2 Vaccine: AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine | 10 |
| Phase 1 Cohort 1C AAHI-SC2 on Day 1 at dosage 70 μg IM
AAHI-SC2 Vaccine: AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine | 10 |
| Phase 1 Cohort 2A AAHI-SC3 on Day 1 at dosage 25 μg IM
AAHI-SC3 Vaccine: AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine | 10 |
| Phase 1 Cohort 2B AAHI-SC3 on Day 1 at dosage 50 μg IM
AAHI-SC3 Vaccine: AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine | 10 |
| Phase 1 Cohort 2C AAHI-SC3 on Day 1 at dosage 85 μg IM
AAHI-SC3 Vaccine: AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine | 10 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Phase 1 Cohort 1A | Phase 1 Cohort 1B | Phase 1 Cohort 1C | Phase 1 Cohort 2A | Phase 1 Cohort 2B | Phase 1 Cohort 2C | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 35.4 years STANDARD_DEVIATION 12.52 | 28.7 years STANDARD_DEVIATION 7.53 | 32.6 years STANDARD_DEVIATION 9 | 37.2 years STANDARD_DEVIATION 7.1 | 32.7 years STANDARD_DEVIATION 11.44 | 29.3 years STANDARD_DEVIATION 7.48 | 32.7 years STANDARD_DEVIATION 9.51 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 10 Participants | 10 Participants | 10 Participants | 10 Participants | 10 Participants | 60 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Healthy adults vaccinated with an EUA or approved vaccine against COVID-19 ≥3 months prior to enroll | 10 Participants | 10 Participants | 10 Participants | 10 Participants | 10 Participants | 10 Participants | 60 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 10 Participants | 10 Participants | 10 Participants | 10 Participants | 10 Participants | 60 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 8 Participants | 8 Participants | 8 Participants | 5 Participants | 6 Participants | 10 Participants | 45 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 2 Participants | 5 Participants | 4 Participants | 0 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk | EG018 affected / at risk | EG019 affected / at risk | EG020 affected / at risk | EG021 affected / at risk | EG022 affected / at risk | EG023 affected / at risk | EG024 affected / at risk | EG025 affected / at risk | EG026 affected / at risk | EG027 affected / at risk | EG028 affected / at risk | EG029 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 9 / 10 | 9 / 10 | 9 / 10 | 8 / 10 | 9 / 10 | 9 / 10 | 9 / 10 | 10 / 10 | 10 / 10 | 8 / 10 | 9 / 10 | 9 / 10 | 5 / 10 | 2 / 10 | 5 / 10 | 4 / 10 | 5 / 10 | 7 / 10 | 5 / 10 | 3 / 10 | 2 / 10 | 2 / 10 | 2 / 10 | 2 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 | 1 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
Outcome results
Primary
Phase 1 Safety - Incidence of MAAEs Through 1 Week
Incidence of medically-attended adverse events (MAAEs)
Time frame: through 1 week post final vaccine administration
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 1 Cohort 1A | Phase 1 Safety - Incidence of MAAEs Through 1 Week | 1 Participants |
| Phase 1 Cohort 1B | Phase 1 Safety - Incidence of MAAEs Through 1 Week | 2 Participants |
| Phase 1 Cohort 1C | Phase 1 Safety - Incidence of MAAEs Through 1 Week | 1 Participants |
| Phase 1 Cohort 2A | Phase 1 Safety - Incidence of MAAEs Through 1 Week | 0 Participants |
| Phase 1 Cohort 2B | Phase 1 Safety - Incidence of MAAEs Through 1 Week | 0 Participants |
| Phase 1 Cohort 2C | Phase 1 Safety - Incidence of MAAEs Through 1 Week | 0 Participants |
Primary
Phase 1 Safety - Incidence of MAAEs Through 30 Days
Incidence of MAAEs
Time frame: through 30 days post final vaccine administration
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 1 Cohort 1A | Phase 1 Safety - Incidence of MAAEs Through 30 Days | 2 Participants |
| Phase 1 Cohort 1B | Phase 1 Safety - Incidence of MAAEs Through 30 Days | 2 Participants |
| Phase 1 Cohort 1C | Phase 1 Safety - Incidence of MAAEs Through 30 Days | 2 Participants |
| Phase 1 Cohort 2A | Phase 1 Safety - Incidence of MAAEs Through 30 Days | 2 Participants |
| Phase 1 Cohort 2B | Phase 1 Safety - Incidence of MAAEs Through 30 Days | 0 Participants |
| Phase 1 Cohort 2C | Phase 1 Safety - Incidence of MAAEs Through 30 Days | 1 Participants |
Primary
Phase 1 Safety - Incidence of MAAEs Through 6 Months
Incidence of MAAEs
Time frame: through 6 months post final vaccine administration
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 1 Cohort 1A | Phase 1 Safety - Incidence of MAAEs Through 6 Months | 5 Participants |
| Phase 1 Cohort 1B | Phase 1 Safety - Incidence of MAAEs Through 6 Months | 3 Participants |
| Phase 1 Cohort 1C | Phase 1 Safety - Incidence of MAAEs Through 6 Months | 2 Participants |
| Phase 1 Cohort 2A | Phase 1 Safety - Incidence of MAAEs Through 6 Months | 2 Participants |
| Phase 1 Cohort 2B | Phase 1 Safety - Incidence of MAAEs Through 6 Months | 2 Participants |
| Phase 1 Cohort 2C | Phase 1 Safety - Incidence of MAAEs Through 6 Months | 2 Participants |
Primary
Phase 1 Safety - Incidence of SAEs Through 1 Week
Incidence of serious adverse events (SAEs)
Time frame: through 1 week post final vaccine administration
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 1 Cohort 1A | Phase 1 Safety - Incidence of SAEs Through 1 Week | 0 Participants |
| Phase 1 Cohort 1B | Phase 1 Safety - Incidence of SAEs Through 1 Week | 0 Participants |
| Phase 1 Cohort 1C | Phase 1 Safety - Incidence of SAEs Through 1 Week | 0 Participants |
| Phase 1 Cohort 2A | Phase 1 Safety - Incidence of SAEs Through 1 Week | 0 Participants |
| Phase 1 Cohort 2B | Phase 1 Safety - Incidence of SAEs Through 1 Week | 0 Participants |
| Phase 1 Cohort 2C | Phase 1 Safety - Incidence of SAEs Through 1 Week | 0 Participants |
Primary
Phase 1 Safety - Incidence of SAEs Through 30 Days
Incidence of SAEs
Time frame: through 30 days post final vaccine administration
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 1 Cohort 1A | Phase 1 Safety - Incidence of SAEs Through 30 Days | 0 Participants |
| Phase 1 Cohort 1B | Phase 1 Safety - Incidence of SAEs Through 30 Days | 0 Participants |
| Phase 1 Cohort 1C | Phase 1 Safety - Incidence of SAEs Through 30 Days | 0 Participants |
| Phase 1 Cohort 2A | Phase 1 Safety - Incidence of SAEs Through 30 Days | 1 Participants |
| Phase 1 Cohort 2B | Phase 1 Safety - Incidence of SAEs Through 30 Days | 0 Participants |
| Phase 1 Cohort 2C | Phase 1 Safety - Incidence of SAEs Through 30 Days | 0 Participants |
Primary
Phase 1 Safety - Incidence of SAEs Through 6 Months
Incidence of SAEs
Time frame: through 6 months post final vaccine administration
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 1 Cohort 1A | Phase 1 Safety - Incidence of SAEs Through 6 Months | 0 Participants |
| Phase 1 Cohort 1B | Phase 1 Safety - Incidence of SAEs Through 6 Months | 0 Participants |
| Phase 1 Cohort 1C | Phase 1 Safety - Incidence of SAEs Through 6 Months | 0 Participants |
| Phase 1 Cohort 2A | Phase 1 Safety - Incidence of SAEs Through 6 Months | 1 Participants |
| Phase 1 Cohort 2B | Phase 1 Safety - Incidence of SAEs Through 6 Months | 0 Participants |
| Phase 1 Cohort 2C | Phase 1 Safety - Incidence of SAEs Through 6 Months | 0 Participants |
Primary
Phase 1 Safety - Incidence of Solicited Local Reactogenicity AEs
Incidence and severity of solicited local reactogenicity AEs
Time frame: through 1 week after each vaccine dose
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 1 Cohort 1A | Phase 1 Safety - Incidence of Solicited Local Reactogenicity AEs | 9 Participants |
| Phase 1 Cohort 1B | Phase 1 Safety - Incidence of Solicited Local Reactogenicity AEs | 9 Participants |
| Phase 1 Cohort 1C | Phase 1 Safety - Incidence of Solicited Local Reactogenicity AEs | 9 Participants |
| Phase 1 Cohort 2A | Phase 1 Safety - Incidence of Solicited Local Reactogenicity AEs | 8 Participants |
| Phase 1 Cohort 2B | Phase 1 Safety - Incidence of Solicited Local Reactogenicity AEs | 9 Participants |
| Phase 1 Cohort 2C | Phase 1 Safety - Incidence of Solicited Local Reactogenicity AEs | 9 Participants |
Primary
Phase 1 Safety - Incidence of Solicited Systemic Reactogenicity AEs
Incidence and severity of solicited systemic reactogenicity AEs
Time frame: through 1 week after each vaccine dose
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 1 Cohort 1A | Phase 1 Safety - Incidence of Solicited Systemic Reactogenicity AEs | 9 Participants |
| Phase 1 Cohort 1B | Phase 1 Safety - Incidence of Solicited Systemic Reactogenicity AEs | 10 Participants |
| Phase 1 Cohort 1C | Phase 1 Safety - Incidence of Solicited Systemic Reactogenicity AEs | 10 Participants |
| Phase 1 Cohort 2A | Phase 1 Safety - Incidence of Solicited Systemic Reactogenicity AEs | 8 Participants |
| Phase 1 Cohort 2B | Phase 1 Safety - Incidence of Solicited Systemic Reactogenicity AEs | 9 Participants |
| Phase 1 Cohort 2C | Phase 1 Safety - Incidence of Solicited Systemic Reactogenicity AEs | 9 Participants |
Primary
Phase 1 Safety - Incidence of Unsolicited AEs Through 1 Week
Incidence and severity of unsolicited AEs
Time frame: through 1 week post final vaccine administration
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 1 Cohort 1A | Phase 1 Safety - Incidence of Unsolicited AEs Through 1 Week | 4 Participants |
| Phase 1 Cohort 1B | Phase 1 Safety - Incidence of Unsolicited AEs Through 1 Week | 1 Participants |
| Phase 1 Cohort 1C | Phase 1 Safety - Incidence of Unsolicited AEs Through 1 Week | 1 Participants |
| Phase 1 Cohort 2A | Phase 1 Safety - Incidence of Unsolicited AEs Through 1 Week | 1 Participants |
| Phase 1 Cohort 2B | Phase 1 Safety - Incidence of Unsolicited AEs Through 1 Week | 1 Participants |
| Phase 1 Cohort 2C | Phase 1 Safety - Incidence of Unsolicited AEs Through 1 Week | 3 Participants |
Primary
Phase 1 Safety - Incidence of Unsolicited AEs Through 30 Days
Incidence and severity of unsolicited AEs
Time frame: through 30 days post final vaccine administration
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 1 Cohort 1A | Phase 1 Safety - Incidence of Unsolicited AEs Through 30 Days | 5 Participants |
| Phase 1 Cohort 1B | Phase 1 Safety - Incidence of Unsolicited AEs Through 30 Days | 2 Participants |
| Phase 1 Cohort 1C | Phase 1 Safety - Incidence of Unsolicited AEs Through 30 Days | 5 Participants |
| Phase 1 Cohort 2A | Phase 1 Safety - Incidence of Unsolicited AEs Through 30 Days | 4 Participants |
| Phase 1 Cohort 2B | Phase 1 Safety - Incidence of Unsolicited AEs Through 30 Days | 5 Participants |
| Phase 1 Cohort 2C | Phase 1 Safety - Incidence of Unsolicited AEs Through 30 Days | 7 Participants |