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Sars-CoV-2 InfectionPhase 1NCT05844202

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

A Phase 1 study testing Alveavax-v1.2 and Janssen Ad26.COV2.S in people with Sars-CoV-2 Infection, run by Alvea Holdings, LLC at 8 sites in South Africa.

Completed

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

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Sars-CoV-2 Infection
What is being tested?
Alveavax-v1.2 and Janssen Ad26.COV2.S
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
8 sitesSouth Africa
Study dates
27 Jun 2022to 2 Mar 2023
Phase
Phase 1
Are there results?
None posted in the registry

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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.
  • Inability to be venipunctured or tolerate venous, IM, SC, or ID puncture.
  • Have a rash, dermatological condition, tattoo, or any other abnormality at the injection site that may interfere with injection site reaction rating. Investigator discretion will be permitted with this exclusion criterion.
  • Use of prophylactic medications (e.g., antihistamines [H1 receptor antagonists], nonsteroidal anti-inflammatory drugs [NSAIDs], systemic glucocorticoids, non-opioid and opioid analgesics) within 24 hours prior to the vaccination to prevent or pre-empt symptoms due to vaccination.
  • Any condition or abnormal baseline findings or any other unspecified reason, which in the Investigator's judgment might increase the risk to the participant or decrease the chance of obtaining satisfactory data needed to achieve the objective of the study.
  • Participants identified as an Investigator or employee of the Investigator or clinical site with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator, or employee with direct involvement in the proposed study, or any employees of the Sponsor company.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

South Africa8 sites

  • JOSHA Research

    Bloemfontein, Free State, 9301

  • NMMM Pharmmedica Health and Clinical Research

    Johannesburg, Gauteng, 2090

  • MERC Kempton Park

    Kempton Park, Gauteng, 1619

  • Ubuntu Clinical Research Center

    Krugersdorp, Gauteng, 1739

  • Ubuntu Clinical Research Center Lenasia

    Lenasia, Gauteng, 1847

  • MERC Research Pty Ltd

    Middelburg, Mpumalanga, 1055

  • Setshaba Research Centre

    Soshanguve, Gauteng, 0152

  • TASK applied Science Brooklyn Chest Hospital

    Ysterplaat, Western Cape, 7405

Other trials in South Africa

About this study

Official title: A Phase 1 Open-label, Active-controlled, Randomized Dose-finding Study to Evaluate Safety, Tolerability, and Immunogenicity of Intradermal and Subcutaneous Application of the Plasmid DNA SARS-CoV-2 Omicron BA.2 Vaccine Alveavax-v1.2 in Primary Ad26.COV2.S Vaccinated Healthy Individuals

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.

Read more

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.
Read the detailed description

This is a first in human, open-label, active-controlled, randomized dose-finding study to evaluate safety, tolerability, and immunogenicity of intradermal (ID) and subcutaneous (SC) application of the plasmid DNA SARS-CoV-2 Omicron BA.2 vaccine Alveavax-v1.2 in primary Ad26.COV2.S vaccinated healthy individuals.

Primary Ad26.COV2.S vaccinated participants will be randomized into one of 5 treatment arms to receive Alveavax-v1.2 or a Ad26.COV2.S control booster vaccine.

Participants will be enrolled at multiple sites in South Africa within 28 days after the initial screening to ensure they meet all the inclusion criteria and none of the exclusion criteria.

Each participant will be administered a booster vaccine on Day 1 of the study and will be monitored afterwards. Solicited local/systemic reactions will be recorded after vaccination in the participant's diary card for up to 7 days (the vaccine administration day and 6 days later).

A total of 130 participants of any sex, aged between 18 and 65 years, who satisfy the inclusion and exclusion criteria are planned to be enrolled in five groups and with vaccine administered according to their dose arm as follows:

Low dose: 0.5 mg Alveavax-v1.2 in one ID injection

Standard dose: 2 mg Alveavax-v1.2 in one ID injection

High dose: 8mg Alveavax-v1.2 in four ID injections

SC injection: 8mg Alveavax-v1.2 in one SC injection

Control: Janssen Ad26.COV2.S in one intramuscular (IM) injection

Being tested
Alveavax-v1.2, Janssen Ad26.COV2.S
Keywords
Sars, Sars-CoV-2, COVID-19, Vaccine, pDNA, plasmid DNA, COVID19
Medical subject headings
COVID-19, Severe Acute Respiratory Syndrome

What participants receive

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

  • Alveavax-v1.2Drug

    Also called Alveavax

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

  • Janssen Ad26.COV2.SDrug

    Also called Janssen

    COVID-19 vaccine by Janssen / Johnson \& Johnson

Study groups in NCT05844202
Study groupRoleWhat they receive
Low doseExperimental0.5 mg Alveavax-v1.2 in one ID injection
Receives: Drug: Alveavax-v1.2
Standard doseExperimental2 mg Alveavax-v1.2 in one ID injection
Receives: Drug: Alveavax-v1.2
High doseExperimental8mg Alveavax-v1.2 in four ID injections
Receives: Drug: Alveavax-v1.2
ComparatorActive comparator0.5ml Janssen Ad26.COV2.S COVID-19 vaccine in one IM injection
Receives: Drug: Janssen Ad26.COV2.S
SubcutaneousExperimental8mg Alveavax-v1.2 in one SC injection
Receives: Drug: Alveavax-v1.2

What is being measured

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

  1. 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

    Measured: Day 7

  2. 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

    Measured: Day 28

  3. 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

    Measured: Day 168

Secondary outcomes (2)

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

    Geometric Mean Titer (GMT) and change in GMT of SARS-CoV-2 BA.2 binding antibodies

    Measured: Day 28

  2. Success rate of intradermal injections

    Absolute number and fraction of ID injections which generated a ≥ 1 mm and ≥ 7 mm in diameter clearly demarcated bleb, clearly visible for at least 20 seconds, for 0.5 mg and 2 mg Alveavax-v1.2 respectively

    Measured: Day 1

Timeline

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

  1. First posted6 May 2023
  2. Study start27 Jun 2022
  3. Primary completion2 Mar 2023
  4. Study completion2 Mar 2023

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05844202
Sponsor's protocol ID
Alvea-VAX-P00001
Other IDs
DOH-27-062022-5157
Status last verified
May 2023
First submitted
2 May 2023
Last updated
6 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Alveavax-v1.2 and Janssen Ad26.COV2.S in people with Sars-CoV-2 Infection, run by Alvea Holdings, LLC at 8 sites 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 8 inclusion and 20 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 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Safety and tolerability of Alveavax-v1.2 in healthy participants compared to a control booster vaccine (Day 7) (time frame: Day 7). The study lists 3 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 NCT05844202.

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 6 May 2023.

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