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

NCT04710303 | Completed Phase 1 Results FDA Drug

• 1 other identifier: AW_001_ProVIVA-SA-1
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (8)

• Number of Participants With Medically Attended Adverse Events (MAAE)

  Number of Participants with MAAEs through 1 week post final vaccine administration

  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

  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

  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

  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

  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

  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

  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

  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.

Study Arms (4)

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

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

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

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

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

Interventions

hAd5-S-Fusion+N-ETSD vaccine BIOLOGICAL

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.

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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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:
• \. 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?
• \. 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.
• \. 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:
• \. 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• ImmunityBio, Inc.: lead

Study Sites (1)

Khayelitsha Clinical Research Site

Khayelitsha, 7784, South Africa

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

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.

Results Point of Contact

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

lennie.sender@immunitybio.com

855-797-9277

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 14, 2021
• Study Start: March 2, 2021
• Primary Completion: August 2, 2022
• Study Completion: August 2, 2022
• Last Updated: November 15, 2024
• Results First Posted: November 15, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)