Covid19Phase 1NCT04710303

COVID-19 Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenoviral Platform in Healthy South African Adults

A Phase 1 study testing hAd5-S-Fusion+N-ETSD vaccine in people with Covid19, run by ImmunityBio, Inc. at 1 site in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a phase 1b, open-label study in adult healthy participants. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity of the hAd5-S-Fusion+N-ETSD vaccine and select a dose for future studies. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Covid19
What is being tested?: hAd5-S-Fusion+N-ETSD vaccine
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 41 participants
Where: 1 siteSouth Africa
Study dates: 2 Mar 2021to 2 Aug 2022
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Adults, age 18 - 50 years, inclusive, at time of first study vaccination.
Able to understand and provide a signed informed consent that fulfils the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
Agrees to the collection of biospecimens (e.g. 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.
Body mass index (BMI) < 30.00 kg/m2
Temperature < 38.0°C on day of first study vaccination.

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Good general health as shown by medical history, physical exam, and screening laboratory tests
Screen negative for Tuberculosis per local screening guidelines
Male participants should all be at low risk of HIV acquisition based on pre-specified, validated criteria(Laher 2014) i.e. answering YES to any of the following questions:
1. Are you sexually abstinent? 2. Are you in a mutually monogamous relationship with a known HIV-uninfected partner? 3. Have you had only one partner in the preceding 12 months who is believed to be HIV-uninfected and with whom condoms were used regularly?
Laboratory Inclusion Values/ Results:
10. Alanine aminotransferase (ALT) <1.1 times the upper limit of normal 11. Serum Creatinine <80 umol/L in females and <106 umol/L in males 12. Haemoglobin >12.0g/dL in females and >13.5g/dL in males 13. Platelets >150 x 109/L in all participants 14. No serological evidence of chronic infection with Hepatitis B (hepatitis B surface antigen (HepBSAg) negative by a locally approved assay) done during the screening period 15. No serological evidence of chronic infection with Hepatitis C (hepatitis C antibody(anti-HCV) negative by a locally approved assay) done during the screening period 16. Negative for SARS-CoV-2 (qPCR test) on NP swab(or other appropriate respiratory specimen) within 3 days prior to the first study vaccination 17. No serological evidence of prior infection with SARS-CoV-2 (by a locally approved assay) done during the screening period 18. A negative serum or urine pregnancy test during screening and on the day of and prior to each dose must be documented before the vaccine is administered to a female participant.
19. Negative for HIV-1 and -2 on blood test(by either 2 rapid tests or an ELISA, both must be locally approved assays) done during the screening period.
Reproductive Status:
20. Female participants of childbearing potential must agree to use effective contraception for sexual activity that may lead to pregnancy while on study until at least 30 days after the last dose of the study vaccine. Effective contraception for female participants includes:
Intrauterine device (IUD), or
Hormonal contraception (oral/ injectable/ implant/ transdermal etc.) Or; 21. Non-sterile male participants must agree to use a condom while on study until at least 30 days after the last dose of the study vaccine.
Or; 22. Participant must not be of reproductive potential or sterile(as verified by medical records), such as:
Having been diagnosed with menopause(with no menses for 1 year)
Having undergone hysterectomy, bilateral oophorectomy or orchidectomy
Having undergone surgical sterilization (e.g., vasectomy, tubal ligation)

Who cannot join

A history of illness compatible with COVID-19 disease since March 2020.
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.
Pregnant or breastfeeding women.
Live in a nursing home or long-term care facility.
Chronic lung disease or moderate to severe asthma.
Bone marrow or organ transplantation recipients.

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Diabetes.
Chronic kidney disease undergoing dialysis.
Liver disease.
Any disease associated with acute fever, or any infection.
Self-reported history of severe acute respiratory syndrome (SARS).
Chronic hepatitis B or hepatitis C infection.
HIV positive or other acquired or hereditary immunodeficiency.
Serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension without controllable drugs, etc.
History of hereditary, idiopathic or acquired angioedema.
Urticaria in the last 12 months prior to screening.
No spleen or functional asplenia.
Platelet disorder or other bleeding disorder that may cause injection contraindication.
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, immunomodulators. The use of low dose topical, ophthalmic, inhaled and intranasal steroid preparations will be permitted.)
Prior administration of blood products within 120 days before first study vaccination.
Prior administration of other research medicines or investigational product within 30 days before first study vaccination.
Prior administration of attenuated vaccine within 30 days before first study vaccination..
Prior administration of inactivated vaccine within 14 days before first study vaccination.
Current treatment with investigational agents for prophylaxis of COVID-19.
Have a household contact that has been diagnosed with COVID-19 within 14 days before fist study vaccine.
Current anti-tuberculosis prophylaxis or therapy.
Currently receiving treatment for cancer or history of cancer in the last five years (except basal cell carcinoma of the skin and cervical carcinoma in situ).
According to the judgement of 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.

Trial locations and contacts

1 site in 1 country.

South Africa1 site

Khayelitsha Clinical Research Site
Khayelitsha, 7784

Other trials in South Africa

About this study

Official title: Phase 1b Open-Label Study of the Safety, Reactogenicity, and Immunogenicity of a Prophylactic COVID-19 Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenoviral Platform in Healthy South African Adults (ProVIVA-SA-1)

Conditions: Covid19
Being tested: hAd5-S-Fusion+N-ETSD vaccine
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

hAd5-S-Fusion+N-ETSD vaccineBiological
The hAd5-S-Fusion+N-ETSD vaccine is a hAd5 [E1-, E2b-, E3-] vector-based targeting vaccine encoding the SARS-CoV-2 S and N proteins. The hAd5-S-Fusion+N-ETSD vaccine is designed to induce both humoral and cellular responses even in individuals with pre-existing adenoviral immunity.

Study groups in NCT04710303
Study group	Role	What they receive
Cohort 1 (n = 10): hAd5-S-Fusion+N-ETSD at 5 × 10e10 Viral Particles (VP) per dose	Experimental	hAd5-S-Fusion+N-ETSD at 5 × 10e10 Viral Particles (VP) per dose on Days 1 and 22 Receives: Biological: hAd5-S-Fusion+N-ETSD vaccine
Cohort 2 (n = 10): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP per dose	Experimental	hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP per dose on Days 1 and 22 Receives: Biological: hAd5-S-Fusion+N-ETSD vaccine
Cohort 3 (n = 10): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP per dose	Experimental	hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP per dose (or 5 × 10e10 VP per dose if safety concerns identified at higher dose) on Day 1 Receives: Biological: hAd5-S-Fusion+N-ETSD vaccine
Cohort 6 (n=10):hAd5-S-Fusion+N-ETSD at 4 × 10e10 VP per dose	Experimental	hAd5-S-Fusion+N-ETSD at 2 × 10e10 VP per nostril (or 4 × 10e10 VP per dose) on Day 1 Receives: Biological: hAd5-S-Fusion+N-ETSD vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Medically Attended Adverse Events (MAAE)
Number of Participants with MAAEs through 1 week post final vaccine administration
Measured: From first dose of study treatment through 1 week post final vaccine administration; up to 29 days for Cohorts 1 and 2, and up to 8 days for Cohorts 3 and 6.
Number of Participants With Solicited Local Reactogenicity AEs
Number of Participants with solicited local reactogenicity AEs through 1 week post final vaccine administration
Measured: From first dose of study treatment through 1 week post final vaccine administration; up to 29 days for Cohorts 1 and 2, and up to 8 days for Cohorts 3 and 6.
Number of Participants With Solicited Systemic Reactogenicity AEs
Number of Participants with solicited systemic reactogenicity AEs through 1 week post final vaccine administration
Measured: From first dose of study treatment through 1 week post final vaccine administration; up to 29 days for Cohorts 1 and 2, and up to 8 days for Cohorts 3 and 6.
Number of Participants With Unsolicited AEs
Number of Participants with unsolicited AEs through 1 week post final vaccine administration
Measured: From first dose of study treatment through 1 week post final vaccine administration; up to 29 days for Cohorts 1 and 2, and up to 8 days for Cohorts 3 and 6.
Number of Participants With Medically Attended Adverse Events (MAAE)
Number of Participants with MAAEs through 30 days post final vaccine administration
Measured: From first dose of study treatment through 30 days post final vaccine administration; up to 52 days for Cohorts 1 and 2 and up to 31 days for Cohorts 3 and 6.
Number of Participants With Unsolicited AEs
Number of Participants with unsolicited AEs through 30 days post final vaccine administration
Measured: From first dose of study treatment through 30 days post final vaccine administration; up to 52 days for Cohorts 1 and 2 and up to 31 days for Cohorts 3 and 6.
Number of Participants With Medically Attended Adverse Events (MAAE)
Number of Participants with MAAEs through 6 months post final vaccine administration
Measured: From first dose of study treatment through 6 months post final vaccine administration; up to 202 days for Cohorts 1 and 2, and up to 181 days for Cohorts 3 and 6.
Number of Participants With Unsolicited AEs
Number of Participants with unsolicited AEs through 6 months post final vaccine administration
Measured: From first dose of study treatment through 6 months post final vaccine administration; up to 202 days for Cohorts 1 and 2, and up to 181 days for Cohorts 3 and 6.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Mar 20212 Aug 2022

First posted14 Jan 2021
Study start2 Mar 2021
Primary completion2 Aug 2022
Study completion2 Aug 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Covid19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04710303
Sponsor's protocol ID: AW_001_ProVIVA-SA-1
Status last verified: Apr 2024
First submitted: 13 Jan 2021
Last updated: 15 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Post-Acute COVID-19 Syndrome
RecruitingPhase 2
SARS-CoV-2 and Herpesvirus Inhibition for Ending Long COVID Dysfunction
Post-acute Sequelae of COVID-19, Long COVID
Active, not recruitingObservational study
A Study to Learn About COVID-19 Antivirals in People With SARS-CoV-2 Infection From 2023-2026
COVID-19 SARS-CoV-2 Infection
RecruitingPhase 4
Comparative Immunogenicity of Respiratory Virus Vaccines (CIRV2) Study
COVID -19, COVID - 19
Enrolling by invitation
Fareon Open Label Device Clinical Trial
Cognitive Dysfunction, Acquired Brain Injury

All Covid19 trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1b Open-Label Study of the Safety, Reactogenicity, and Immunogenicity of a Prophylactic COVID-19 Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenoviral Platform in Healthy South African Adults (ProVIVA-SA-1)
ClinicalTrials.gov ID: NCT04710303
Acronym / sponsor ID: AW_001_ProVIVA-SA-1
Conditions: Covid19
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: ImmunityBio, Inc.Industry (pharma, biotech, devices)
Study start: 2 Mar 2021 (actual)
Primary completion: 2 Aug 2022 (actual)
Study completion: 2 Aug 2022 (actual)
First posted: 14 Jan 2021 (actual)
Results: Posted 15 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Cohort 1 (n = 10): hAd5-S-Fusion+N-ETSD at 5 × 10e10 Viral Particles (VP) per dose	Experimental	Biological: hAd5-S-Fusion+N-ETSD vaccinehAd5-S-Fusion+N-ETSD at 5 × 10e10 Viral Particles (VP) per dose on Days 1 and 22
Cohort 2 (n = 10): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP per dose	Experimental	Biological: hAd5-S-Fusion+N-ETSD vaccinehAd5-S-Fusion+N-ETSD at 1 × 10e11 VP per dose on Days 1 and 22
Cohort 3 (n = 10): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP per dose	Experimental	Biological: hAd5-S-Fusion+N-ETSD vaccinehAd5-S-Fusion+N-ETSD at 1 × 10e11 VP per dose (or 5 × 10e10 VP per dose if safety concerns identified at higher dose) on Day 1
Cohort 6 (n=10):hAd5-S-Fusion+N-ETSD at 4 × 10e10 VP per dose	Experimental	Biological: hAd5-S-Fusion+N-ETSD vaccinehAd5-S-Fusion+N-ETSD at 2 × 10e10 VP per nostril (or 4 × 10e10 VP per dose) on Day 1

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (21 listed)

Adults, age 18 - 50 years, inclusive, at time of first study vaccination.
Able to understand and provide a signed informed consent that fulfils the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
Agrees to the collection of biospecimens (e.g. 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.
Body mass index (BMI) < 30.00 kg/m2

Key exclusion criteria (29 listed)

A history of illness compatible with COVID-19 disease since March 2020.
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.
Pregnant or breastfeeding women.
Live in a nursing home or long-term care facility.
Chronic lung disease or moderate to severe asthma.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
hAd5-S-Fusion+N-ETSD vaccineThe hAd5-S-Fusion+N-ETSD vaccine is a hAd5 [E1-, E2b-, E3-] vector-based targeting vaccine encoding the SARS-CoV-2 S and N proteins. The hAd5-S-Fusion+N-ETSD vaccine is designed to induce both humoral and cellular responses even in individuals with pre-existing adenoviral immunity.	Biological	Cohort 1 (n = 10): hAd5-S-Fusion+N-ETSD at 5 × 10e10 Viral Particles (VP) per dose, Cohort 2 (n = 10): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP per dose, Cohort 3 (n = 10): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP per dose, Cohort 6 (n=10):hAd5-S-Fusion+N-ETSD at 4 × 10e10 VP per dose

Primary outcome

Number of Participants With Medically Attended Adverse Events (MAAE)
Time frame: From first dose of study treatment through 1 week post final vaccine administration; up to 29 days for Cohorts 1 and 2, and up to 8 days for Cohorts 3 and 6.
Number of Participants with MAAEs through 1 week post final vaccine administration
Number of Participants With Solicited Local Reactogenicity AEs
Time frame: From first dose of study treatment through 1 week post final vaccine administration; up to 29 days for Cohorts 1 and 2, and up to 8 days for Cohorts 3 and 6.
Number of Participants with solicited local reactogenicity AEs through 1 week post final vaccine administration
Number of Participants With Solicited Systemic Reactogenicity AEs
Time frame: From first dose of study treatment through 1 week post final vaccine administration; up to 29 days for Cohorts 1 and 2, and up to 8 days for Cohorts 3 and 6.
Number of Participants with solicited systemic reactogenicity AEs through 1 week post final vaccine administration
Number of Participants With Unsolicited AEs
Time frame: From first dose of study treatment through 1 week post final vaccine administration; up to 29 days for Cohorts 1 and 2, and up to 8 days for Cohorts 3 and 6.
Number of Participants with unsolicited AEs through 1 week post final vaccine administration
Number of Participants With Medically Attended Adverse Events (MAAE)
Time frame: From first dose of study treatment through 30 days post final vaccine administration; up to 52 days for Cohorts 1 and 2 and up to 31 days for Cohorts 3 and 6.
Number of Participants with MAAEs through 30 days post final vaccine administration
Number of Participants With Unsolicited AEs
Time frame: From first dose of study treatment through 30 days post final vaccine administration; up to 52 days for Cohorts 1 and 2 and up to 31 days for Cohorts 3 and 6.
Number of Participants with unsolicited AEs through 30 days post final vaccine administration
Number of Participants With Medically Attended Adverse Events (MAAE)
Time frame: From first dose of study treatment through 6 months post final vaccine administration; up to 202 days for Cohorts 1 and 2, and up to 181 days for Cohorts 3 and 6.
Number of Participants with MAAEs through 6 months post final vaccine administration
Number of Participants With Unsolicited AEs
Time frame: From first dose of study treatment through 6 months post final vaccine administration; up to 202 days for Cohorts 1 and 2, and up to 181 days for Cohorts 3 and 6.
Number of Participants with unsolicited AEs through 6 months post final vaccine administration

Results and safety

Results posted to the registry on 15 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1 (n = 10): hAd5-S-Fusion+N-ETSD at 5 × 10e10 Viral Particles (VP) Per Dose	10	10
Cohort 2 (n = 11): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP Per Dose	11	7
Cohort 3 (n = 10): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP Per Dose	10	10
Cohort 6 (n=10):hAd5-S-Fusion+N-ETSD at 4 × 10e10 VP Per Dose	10	10

Primary outcome: Number of Participants With Medically Attended Adverse Events (MAAE)

Time frame: From first dose of study treatment through 1 week post final vaccine administration; up to 29 days for Cohorts 1 and 2, and up to 8 days for Cohorts 3 and 6.. Count of participants. Unit: Participants

Measure	Cohort 1 (n = 10): hAd5-S-Fusion+N-ETSD at 5 × 10e10 Viral Particles (VP) Per Dose n = 10	Cohort 2 (n = 11): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP Per Dose n = 11	Cohort 3 (n = 10): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP Per Dose n = 10	Cohort 6 (n=10):hAd5-S-Fusion+N-ETSD at 4 × 10e10 VP Per Dose n = 10
Value	0	0	0	1

Primary outcome: Number of Participants With Solicited Local Reactogenicity AEs

Measure	Cohort 1 (n = 10): hAd5-S-Fusion+N-ETSD at 5 × 10e10 Viral Particles (VP) Per Dose n = 10	Cohort 2 (n = 11): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP Per Dose n = 11	Cohort 3 (n = 10): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP Per Dose n = 10	Cohort 6 (n=10):hAd5-S-Fusion+N-ETSD at 4 × 10e10 VP Per Dose n = 10
Value	9	5	7	2

Primary outcome: Number of Participants With Solicited Systemic Reactogenicity AEs

Measure	Cohort 1 (n = 10): hAd5-S-Fusion+N-ETSD at 5 × 10e10 Viral Particles (VP) Per Dose n = 10	Cohort 2 (n = 11): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP Per Dose n = 11	Cohort 3 (n = 10): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP Per Dose n = 10	Cohort 6 (n=10):hAd5-S-Fusion+N-ETSD at 4 × 10e10 VP Per Dose n = 10
Value	6	5	6	4

Primary outcome: Number of Participants With Unsolicited AEs

Measure	Cohort 1 (n = 10): hAd5-S-Fusion+N-ETSD at 5 × 10e10 Viral Particles (VP) Per Dose n = 10	Cohort 2 (n = 11): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP Per Dose n = 11	Cohort 3 (n = 10): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP Per Dose n = 10	Cohort 6 (n=10):hAd5-S-Fusion+N-ETSD at 4 × 10e10 VP Per Dose n = 10
Value	3	4	2	4

Adverse events

Time frame: Solicited AEs: From first dose to 1 week post final vaccine; up to 29 days for Cohorts 1 and 2, and up to 8 days for Cohorts 3 and 6. Unsolicited AEs: From first dose to 30 days post final vaccine; up to 52 days for Cohorts 1 and 2 and up to 31 days for Cohorts 3 and 6. Medically Attended AEs and Serious AEs: From first dose to 6 months post final vaccine; up to 202 days for Cohorts 1 and 2, and up to 181 days for Cohorts 3 and 6. SAEs related to treatment were reported any time, up to 1 year.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1: Cohort 1	0 of 10 (0%)	9 of 10 (90%)	0 of 10
Group 1: Cohort 2	0 of 11 (0%)	5 of 11 (45.5%)	0 of 11
Group 1: Cohort 3	0 of 10 (0%)	7 of 10 (70%)	0 of 10
Group 1: Cohort 6	0 of 10 (0%)	2 of 10 (20%)	0 of 10
Group 2: Cohort 1	0 of 10 (0%)	6 of 10 (60%)	0 of 10
Group 2: Cohort 2	0 of 11 (0%)	5 of 11 (45.5%)	0 of 11
Group 2: Cohort 3	0 of 10 (0%)	6 of 10 (60%)	0 of 10
Group 2: Cohort 6	0 of 10 (0%)	4 of 10 (40%)	0 of 10
Group 3: Cohort 1	0 of 10 (0%)	5 of 10 (50%)	0 of 10
Group 3: Cohort 2	0 of 11 (0%)	9 of 11 (81.8%)	0 of 11
Group 3: Cohort 3	0 of 10 (0%)	4 of 10 (40%)	0 of 10
Group 3: Cohort 6	0 of 10 (0%)	6 of 10 (60%)	0 of 10
Group 4: Cohort 1	0 of 10 (0%)	2 of 10 (20%)	0 of 10
Group 4: Cohort 2	0 of 11 (0%)	3 of 11 (27.3%)	0 of 11
Group 4: Cohort 3	0 of 10 (0%)	2 of 10 (20%)	0 of 10
Group 4: Cohort 6	0 of 10 (0%)	4 of 10 (40%)	0 of 10

Limitations and caveats (from the sponsor): Cohort 4 (sublingual 1x10e11 VP per dose on Day 1) and Cohort 5 (sublingual and subcutaneous 1x10e11 VP for each dose on Day 1) did not enroll any subjects. Only one AE table per AE category was presented to reduce data entry redundancy. Only safety data is provided due to low enrollment.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing hAd5-S-Fusion+N-ETSD vaccine in people with Covid19, run by ImmunityBio, Inc. at 1 site in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Medically Attended Adverse Events (MAAE) (time frame: From first dose of study treatment through 1 week post final vaccine administration; up to 29 days for Cohorts 1 and 2, and up to 8 days for Cohorts 3 and 6.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04710303.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.