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

Phase 1

Completed

Conditions: Covid19

Interventions: Biological: hAd5-S-Fusion+N-ETSD vaccine

Registration Number: NCT04710303

Lead Sponsor: ImmunityBio, Inc.

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 41

Inclusion Criteria

Not provided

Exclusion Criteria

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.
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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 2 (n = 10): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP per dose	hAd5-S-Fusion+N-ETSD vaccine	hAd5-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	hAd5-S-Fusion+N-ETSD vaccine	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
Cohort 1 (n = 10): hAd5-S-Fusion+N-ETSD at 5 × 10e10 Viral Particles (VP) per dose	hAd5-S-Fusion+N-ETSD vaccine	hAd5-S-Fusion+N-ETSD at 5 × 10e10 Viral Particles (VP) per dose on Days 1 and 22
Cohort 6 (n=10):hAd5-S-Fusion+N-ETSD at 4 × 10e10 VP per dose	hAd5-S-Fusion+N-ETSD vaccine	hAd5-S-Fusion+N-ETSD at 2 × 10e10 VP per nostril (or 4 × 10e10 VP per dose) on Day 1

Primary Outcome Measures

Name	Time	Method
Number of Participants With Medically Attended Adverse Events (MAAE)	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 Solicited Local Reactogenicity AEs	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	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	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