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

NCT05844202 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2023-05-06

No results posted yet for this study

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

Interventions

DRUG

Alveavax-v1.2

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

DRUG

Janssen Ad26.COV2.S

COVID-19 vaccine by Janssen / Johnson \& Johnson

Sponsors & Collaborators

  • Alvea Holdings, LLC

    lead INDUSTRY

Principal Investigators

  • Principal Investigator · TASK

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-27
Primary Completion
2023-03-02
Completion
2023-03-02

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05844202 on ClinicalTrials.gov