Safety, Tolerability and Immunogenicity of Alveavax-v1.2, a BA.2/Omicron-optimized, DNA Vaccine for COVID-19 Prevention

NCT05844202 | Completed Phase 1

• 2 other identifiers: Alvea-VAX-P00001DOH-27-062022-5157
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 8

Brief Summary

The investigated product is a Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Booster Vaccine candidate optimized for the Omicron/BA.2 variant. There are currently no licensed, variant-optimized vaccines to prevent infection with SARS-CoV-2 Omicron/BA.2. Approved or authorized SARS-CoV-2 vaccines are expensive, require a stringent cold chain, and have large-scale manufacturing issues, resulting in very limited availability in low- and middle-income countries (LMICs). Given the rapid global spread of the Omicron/BA.2 variant and potential for future novel SARS-CoV-2 variants, the rapid development of an easy-to-manufacture and easy-to-distribute vaccine is of great importance. The objective of the study is to assess the tolerability, safety, and immunogenicity of different doses and routes of administration of the Alveavax-v1.2 vaccine in healthy individuals. The study aims to evaluate:

• the safety and tolerability of Alveavax-v1.2 in healthy participants compared to a control booster vaccine in a dose-finding design;
• the immunogenicity against SARS-CoV-2 BA.2/Omicron after a booster dose of Alveavax-v1.2;
• the clinical efficacy against SARS-CoV-2 after a booster dose of Alveavax-v1.2;
• and the success rate of intradermal (ID) injections.

Conditions

Sars-CoV-2 Infection

Keywords

Sars; Sars-CoV-2; COVID-19; Vaccine; pDNA; plasmid DNA; COVID19

Outcome Measures

Primary Outcomes (3)

• Safety and tolerability of Alveavax-v1.2 in healthy participants compared to a control booster vaccine (Day 7)

  The overall number of participants and incidence proportion of any solicited local and systemic AEs within seven days of dose administration

  Day 7

• Safety and tolerability of Alveavax-v1.2 in healthy participants compared to a control booster vaccine (Day 28)

  The overall number of participants and incidence proportion of unsolicited adverse events (AEs) within 28 days of dose administration

  Day 28

• Safety and tolerability of Alveavax-v1.2 in healthy participants compared to a control booster vaccine

  The overall number of participants and incidence of serious adverse events (SAEs), adverse events of special interest (AESIs), and AEs leading to participant discontinuation throughout the trial

  Day 168

Secondary Outcomes (2)

• Immunogenicity as humoral immune response against SARS-CoV-2 BA.2/Omicron after a booster dose of Alveavax-v1.2

  Day 28

• Success rate of intradermal injections

  Day 1

Study Arms (5)

Low dose

EXPERIMENTAL

0.5 mg Alveavax-v1.2 in one ID injection

Drug: Alveavax-v1.2

Standard dose

EXPERIMENTAL

2 mg Alveavax-v1.2 in one ID injection

Drug: Alveavax-v1.2

High dose

EXPERIMENTAL

8mg Alveavax-v1.2 in four ID injections

Drug: Alveavax-v1.2

Comparator

ACTIVE COMPARATOR

0.5ml Janssen Ad26.COV2.S COVID-19 vaccine in one IM injection

Drug: Janssen Ad26.COV2.S

Subcutaneous

EXPERIMENTAL

8mg Alveavax-v1.2 in one SC injection

Drug: Alveavax-v1.2

Interventions

Alveavax-v1.2 DRUG

BA.2/Omicron optimized plasmid DNA vaccine for the prevention of COVID-19

Also known as: Alveavax

High dose; Low dose; Standard dose; Subcutaneous

Janssen Ad26.COV2.S DRUG

COVID-19 vaccine by Janssen / Johnson \& Johnson

Also known as: Janssen

Comparator

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adult male and female volunteers between 18 and 65 years of age, inclusive.
• Participants who received a primary Janssen Ad26.CoV2.S vaccine ≥ 60 days prior to receiving the study vaccine.
• Body mass index within the range 18 - 32 kg/m2 both inclusive.
• Participants who, judged by the Investigator, are in stable health as determined by their pre-study medical history, physical examination, and clinical laboratory tests.
• Female participants must be either of non-childbearing potential, i.e., surgically sterilized (defined as having undergone hysterectomy and/or bilateral oophorectomy and/or bilateral salpingectomy; tubal ligation alone is not considered sufficient) or one year postmenopausal; or, if of childbearing potential, they must be abstinent or have used adequate contraceptive precautions for 30 days prior to receiving the study vaccination and 84 days post-vaccine.
• Sexually active male participants who are considered sexually fertile must agree to use a barrier method of contraception during sexual activity with a female of childbearing potential from the time of vaccination until at least 84 days after the vaccination.
• Participants must provide written informed consent or their legal representative must understand and give written consent to the procedure.
• Participants must be willing and able to comply with all the required study visits and follow-up required by this protocol, and be able to complete the diary card after vaccination or have a caregiver available to assist with these matters.

You may not qualify if:

• Received any other SARS-CoV-2 vaccination than a single Janssen Ad26.COV2.S vaccine or plans to receive any additional SARS-CoV-2 vaccination within 90 days after the study vaccine (Day 1).
• Recovered from SARS-CoV-2 infection determined by history of a positive SARS-CoV-2 test (e.g. PCR, rapid antigen test, etc.) or suspicion of a SARS-CoV-2 infection based on the (verbal) medical history within less than 60 days from the day of vaccination (Day 1) in this study.
• History of close contact (face-to-face contact within 1 meter or contact in a closed space for more than 15 minutes) without wearing a face-mask with a confirmed active SARS-CoV-2-positive patient within 5 days prior to Day 1.
• Have received any live-virus vaccine within 4 weeks or inactivated vaccine, including influenza vaccine, within 2 weeks (both licensed and investigational vaccines) prior to the study vaccine (Day 1).
• Previous participation in any clinical trial of a SARS-CoV-2 vaccine candidate.
• Have any febrile illness (temperature ≥ 38°C/100.4°F) or any active acute illness or infection (including a positive SARS-CoV-2 PCR test) within 7 days prior to administration of vaccination (Day 1) in this study. Participants may be re-evaluated once all symptoms have resolved.
• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) or contraindications to any component of the study intervention(s).
• History of, or positive screening test for human immunodeficiency virus I or II.
• Any clinically significant finding during screening or check-in that, in the Investigator's judgment, results in an increased safety risk.
• History of cerebral venous sinus thrombosis, antiphospholipid syndrome, or a history of heparin-induced thrombocytopenia and thrombosis (HITT or HIT type 2).
• Any confirmed or suspected immunosuppressive or immunodeficient state; asplenia; recurrent severe infections and use of immunosuppressant medication within the past 3 months, except topical and inhaled steroids, or short-term oral steroids (course lasting ≤14 days or ≤20 mg/day).
• History of receiving blood transfusion, blood products, immunoglobulin, or immune stimulants within 3 months prior to Day 1.
• Is currently participating in any other study or has received any investigational drug in the last 6 weeks or 5× the half-life of the drug (whichever is longer) prior to screening.
• For female participants of childbearing potential who are pregnant (positive pregnancy test at the screening or check-in), currently breastfeeding, or attempting to conceive.
• Any addiction that may interfere with the participant's ability to comply with trial procedures.

Sponsors & Collaborators

• Alvea Holdings, LLC: lead

Study Sites (8)

JOSHA Research

Bloemfontein, Free State, 9301, South Africa

Location

NMMM Pharmmedica Health and Clinical Research

Johannesburg, Gauteng, 2090, South Africa

Location

MERC Kempton Park

Kempton Park, Gauteng, 1619, South Africa

Location

Ubuntu Clinical Research Center

Krugersdorp, Gauteng, 1739, South Africa

Location

Ubuntu Clinical Research Center Lenasia

Lenasia, Gauteng, 1847, South Africa

Location

Setshaba Research Centre

Soshanguve, Gauteng, 0152, South Africa

Location

MERC Research Pty Ltd

Middelburg, Mpumalanga, 1055, South Africa

Location

TASK applied Science Brooklyn Chest Hospital

Ysterplaat, Western Cape, 7405, South Africa

Location

MeSH Terms

Conditions

COVID-19; Severe Acute Respiratory Syndrome

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

Study Officials

• Principal Investigator

  TASK

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 6, 2023
• Study Start: June 27, 2022
• Primary Completion: March 2, 2023
• Study Completion: March 2, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-05

Locations

ZA (8)