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

COMPLETEDPHASE1

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

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

NCT05844202•Alvea Holdings, LLC

View on ClinicalTrials.gov

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.

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

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Healthy adult male and female volunteers between 18 and 65 years of age, inclusive.
•2. Participants who received a primary Janssen Ad26.CoV2.S vaccine ≥ 60 days prior to receiving the study vaccine.
•3. Body mass index within the range 18 - 32 kg/m2 both inclusive.
•4. Participants who, judged by the Investigator, are in stable health as determined by their pre-study medical history, physical examination, and clinical laboratory tests.
•5. 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.
•6. 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.
•7. Participants must provide written informed consent or their legal representative must understand and give written consent to the procedure.
•8. 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.

Exclusion Criteria

•1. 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).
•2. 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.
•3. 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.
•4. 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).
•5. Previous participation in any clinical trial of a SARS-CoV-2 vaccine candidate.
•6. 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.
•7. 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).
•8. History of, or positive screening test for human immunodeficiency virus I or II.
•9. Any clinically significant finding during screening or check-in that, in the Investigator's judgment, results in an increased safety risk.
•10. History of cerebral venous sinus thrombosis, antiphospholipid syndrome, or a history of heparin-induced thrombocytopenia and thrombosis (HITT or HIT type 2).
+10 more criteria

Locations (8)

JOSHA Research

Bloemfontein, Free State, South Africa

NMMM Pharmmedica Health and Clinical Research

Johannesburg, Gauteng, South Africa

MERC Kempton Park

Kempton Park, Gauteng, South Africa

Ubuntu Clinical Research Center

Krugersdorp, Gauteng, South Africa

Ubuntu Clinical Research Center Lenasia

Lenasia, Gauteng, South Africa

Setshaba Research Centre

Soshanguve, Gauteng, South Africa

MERC Research Pty Ltd

Middelburg, Mpumalanga, South Africa

TASK applied Science Brooklyn Chest Hospital

Ysterplaat, Western Cape, South Africa

Key Dates

Start Date

June 27, 2022

Primary Completion Date

March 2, 2023

Completion Date

March 2, 2023

Last Updated

May 6, 2023

Enrollment

130

ACTUAL participants

Conditions

Sars-CoV-2 Infection

Interventions

Alveavax-v1.2

DRUG

Janssen Ad26.COV2.S

DRUG

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Long COVIDSars-CoV-2 Infection+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 6, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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