THEMBA II T-Cell Vaccine: Vaccination With saRNA COVID-19... | NCT05370040 | Trialant
NCT05370040
Sponsor
ImmunityBio, Inc.
Status
Terminated
Last Update Posted
Mar 11, 2025Actual
Enrollment
60Actual
Phase
Phase 1Phase 2
Conditions
COVID-19
Interventions
AAHI-SC2 Vaccine
AAHI-SC3 Vaccine
EUA or approved vaccine
Countries
South Africa
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT05370040
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
COVID-4.015
Secondary IDs
Not provided
Brief Title
THEMBA II T-Cell Vaccine: Vaccination With saRNA COVID-19 Vaccines
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
Acronym
Not provided
Organization
ImmunityBio, Inc.INDUSTRY
Status Module
Record Verification Date
Feb 2025
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Discontinued prior to enroll in Phase 2
Expanded Access Info
No
Start Date
May 5, 2022Actual
Primary Completion Date
Mar 11, 2024Actual
Completion Date
Mar 11, 2024Actual
First Submitted Date
May 9, 2022
First Submission Date that Met QC Criteria
May 9, 2022
First Posted Date
May 11, 2022Actual
Results Waived
Not provided
Results First Submitted Date
Apr 9, 2024
Results First Submitted that Met QC Criteria
Apr 9, 2024
Results First Posted Date
May 1, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 28, 2025
Last Update Posted Date
Mar 11, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
ImmunityBio, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Yes
FDAAA801 Violation
Not provided
Description Module
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
Conditions Module
Conditions
COVID-19
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
60Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
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
Interventions
Name
Type
Description
Arm Group Labels
Other Names
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
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
55 Years
Standard Ages
Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Wits Vida
Johannesburg
South Africa
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
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
FG001
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
FG002
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
FG003
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
FG004
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
FG005
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
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG00010 subjects
FG00110 subjects
FG00210 subjects
FG00310 subjects
FG00410 subjects
FG00510 subjects
COMPLETED
FG00010 subjects
FG00110 subjects
FG0029 subjects
FG00310 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
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
BG001
Phase 1 Cohort 1B
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Phase 1 Safety - Incidence of MAAEs Through 1 Week
Incidence of medically-attended adverse events (MAAEs)
Posted
Count of Participants
Participants
through 1 week post final vaccine administration
ID
Title
Description
OG000
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
OG001
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
Adverse Events Module
Frequency Threshold
5
Time Frame
For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
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
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abscess limb
Infections and infestations
Systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Injection site pain
General disorders
Systematic Assessment
More Info Module
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.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Point of Contact
Title
Organization
Phone
Extension
Email
Lennie Sender, Chief Operating Officer
Immunitybio
855-797-9277
lennie.sender@immunitybio.com
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan: part 1
Open label 6 Cohort Phase 1 Study leading to Randomized 4 Cohort Phase 2 Study
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantCare ProviderInvestigator
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
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
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
9 subjects
FG00510 subjects
1 subjects
FG0050 subjects
0 subjects
FG0041 subjects
FG0050 subjects
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
BG002
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
BG003
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
BG004
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
BG005
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
BG006
Total
Total of all reporting groups
10
BG00110
BG00210
BG00310
BG00410
BG00510
BG00660
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00035.4± 12.52
BG00128.7± 7.53
BG00232.6± 9.00
BG00337.2± 7.10
BG00432.7± 11.44
BG00529.3± 7.48
BG00632.7± 9.51
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0008
BG0018
BG0028
BG0035
BG0046
BG00510
BG00645
Male
BG0002
BG0012
BG0022
BG0035
BG004
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Not Hispanic or Latino
BG00010
BG00110
BG00210
BG00310
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Asian
BG0000
BG0010
BG0020
BG0030
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG004
Black or African American
BG00010
BG00110
BG00210
BG00310
BG004
White
BG0000
BG0010
BG0020
BG0030
BG004
More than one race
BG0000
BG0010
BG0020
BG0030
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Healthy adults vaccinated with an EUA or approved vaccine against COVID-19 ≥3 months prior to enroll
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
BG00010
BG00110
BG00210
BG00310
BG00410
BG00510
BG00660
OG002
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
OG003
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
OG004
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
OG005
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
Units
Counts
Participants
OG00010
OG00110
OG00210
OG00310
OG00410
OG00510
Title
Denominators
Categories
Title
Measurements
OG0001
OG0012
OG0021
OG0030
OG0040
OG0050
Primary
Phase 1 Safety - Incidence of MAAEs Through 30 Days
Incidence of MAAEs
Posted
Count of Participants
Participants
through 30 days post final vaccine administration
ID
Title
Description
OG000
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
OG001
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
OG002
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
OG003
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
OG004
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
OG005
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
Units
Counts
Participants
OG00010
OG00110
OG00210
OG003
Title
Denominators
Categories
Title
Measurements
OG0002
OG0012
OG0022
OG003
Primary
Phase 1 Safety - Incidence of MAAEs Through 6 Months
Incidence of MAAEs
Posted
Count of Participants
Participants
through 6 months post final vaccine administration
ID
Title
Description
OG000
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
OG001
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
OG002
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
OG003
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
OG004
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
OG005
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
Units
Counts
Participants
OG00010
OG00110
OG00210
OG003
Title
Denominators
Categories
Title
Measurements
OG0005
OG0013
OG0022
OG003
Primary
Phase 1 Safety - Incidence of Solicited Local Reactogenicity AEs
Incidence and severity of solicited local reactogenicity AEs
Posted
Count of Participants
Participants
through 1 week after each vaccine dose
ID
Title
Description
OG000
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
OG001
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
OG002
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
OG003
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
OG004
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
OG005
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
Units
Counts
Participants
OG00010
OG00110
OG00210
OG003
Title
Denominators
Categories
Title
Measurements
OG0009
OG0019
OG0029
OG003
Primary
Phase 1 Safety - Incidence of Solicited Systemic Reactogenicity AEs
Incidence and severity of solicited systemic reactogenicity AEs
Posted
Count of Participants
Participants
through 1 week after each vaccine dose
ID
Title
Description
OG000
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
OG001
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
OG002
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
OG003
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
OG004
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
OG005
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
Units
Counts
Participants
OG00010
OG00110
OG00210
OG003
Title
Denominators
Categories
Title
Measurements
OG0009
OG00110
OG00210
OG003
Primary
Phase 1 Safety - Incidence of Unsolicited AEs Through 1 Week
Incidence and severity of unsolicited AEs
Posted
Count of Participants
Participants
through 1 week post final vaccine administration
ID
Title
Description
OG000
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
OG001
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
OG002
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
OG003
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
OG004
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
OG005
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
Units
Counts
Participants
OG00010
OG00110
OG00210
OG003
Title
Denominators
Categories
Title
Measurements
OG0004
OG0011
OG0021
OG003
Primary
Phase 1 Safety - Incidence of Unsolicited AEs Through 30 Days
Incidence and severity of unsolicited AEs
Posted
Count of Participants
Participants
through 30 days post final vaccine administration
ID
Title
Description
OG000
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
OG001
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
OG002
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
OG003
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
OG004
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
OG005
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
Units
Counts
Participants
OG00010
OG00110
OG00210
OG003
Title
Denominators
Categories
Title
Measurements
OG0005
OG0012
OG0025
OG003
Primary
Phase 1 Safety - Incidence of SAEs Through 1 Week
Incidence of serious adverse events (SAEs)
Posted
Count of Participants
Participants
through 1 week post final vaccine administration
ID
Title
Description
OG000
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
OG001
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
OG002
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
OG003
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
OG004
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
OG005
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
Units
Counts
Participants
OG00010
OG00110
OG00210
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Phase 1 Safety - Incidence of SAEs Through 30 Days
Incidence of SAEs
Posted
Count of Participants
Participants
through 30 days post final vaccine administration
ID
Title
Description
OG000
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
OG001
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
OG002
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
OG003
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
OG004
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
OG005
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
Units
Counts
Participants
OG00010
OG00110
OG00210
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Phase 1 Safety - Incidence of SAEs Through 6 Months
Incidence of SAEs
Posted
Count of Participants
Participants
through 6 months post final vaccine administration
ID
Title
Description
OG000
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
OG001
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
OG002
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
OG003
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
OG004
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
OG005
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
Units
Counts
Participants
OG00010
OG00110
OG00210
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
0
10
0
10
0
10
EG001
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
0
10
0
10
0
10
EG002
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
0
10
0
10
0
10
EG003
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
0
10
1
10
0
10
EG004
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
0
10
0
10
0
10
EG005
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
0
10
0
10
0
10
EG006
Group 1: Cohort 1A
Incidence of Solicited Local Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration
0
10
0
10
9
10
EG007
Group 1: Cohort 1B
Incidence of Solicited Local Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration
0
10
0
10
9
10
EG008
Group 1: Cohort 1C
Incidence of Solicited Local Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration
0
10
0
10
9
10
EG009
Group 1: Cohort 2A
Incidence of Solicited Local Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration
0
10
0
10
8
10
EG010
Group 1: Cohort 2B
Incidence of Solicited Local Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration
0
10
0
10
9
10
EG011
Group 1: Cohort 2C
Incidence of Solicited Local Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration
0
10
0
10
9
10
EG012
Group 2: Cohort 1A
Incidence of Solicited Systemic Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration
0
10
0
10
9
10
EG013
Group 2: Cohort 1B
Incidence of Solicited Systemic Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration
0
10
0
10
10
10
EG014
Group 2: Cohort 1C
Incidence of Solicited Systemic Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration
0
10
0
10
10
10
EG015
Group 2: Cohort 2A
Incidence of Solicited Systemic Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration
0
10
0
10
8
10
EG016
Group 2: Cohort 2B
Incidence of Solicited Systemic Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration
0
10
0
10
9
10
EG017
Group 2: Cohort 2C
Incidence of Solicited Systemic Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration
0
10
0
10
9
10
EG018
Group 3: Cohort 1A
Incidence of Unsolicited Adverse Events Through 30 Days Post Final Vaccine Administration
0
10
0
10
5
10
EG019
Group 3: Cohort 1B
Incidence of Unsolicited Adverse Events Through 30 Days Post Final Vaccine Administration
0
10
0
10
2
10
EG020
Group 3: Cohort 1C
Incidence of Unsolicited Adverse Events Through 30 Days Post Final Vaccine Administration
0
10
0
10
5
10
EG021
Group 3: Cohort 2A
Incidence of Unsolicited Adverse Events Through 30 Days Post Final Vaccine Administration
0
10
0
10
4
10
EG022
Group 3: Cohort 2B
Incidence of Unsolicited Adverse Events Through 30 Days Post Final Vaccine Administration
0
10
0
10
5
10
EG023
Group 3: Cohort 2C
Incidence of Unsolicited Adverse Events Through 30 Days Post Final Vaccine Administration
0
10
0
10
7
10
EG024
Group 4: Cohort 1A
Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration
0
10
0
10
5
10
EG025
Group 4: Cohort 1B
Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration
0
10
0
10
3
10
EG026
Group 4: Cohort 1C
Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration
0
10
0
10
2
10
EG027
Group 4: Cohort 2A
Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration
0
10
0
10
2
10
EG028
Group 4: Cohort 2B
Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration
0
10
0
10
2
10
EG029
Group 4: Cohort 2C
Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration