search
Back to results

A Randomized, Phase I Study of DNA Vaccine OC-007 as a Booster Dose of COVID-19 Vaccine (OpenCorona1)

Primary Purpose

COVID-19 Respiratory Infection, COVID-19 Vaccine Adverse Reaction

Status
Recruiting
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
DNA vaccine OC-007
Placebo
Sponsored by
Matti Sällberg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19 Respiratory Infection focused on measuring Covid-19, DNA vaccine, booster dose, in vivo electroporation, adverse reactions, antibody levels, cellular immune response

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Men and women between the ages of 18 and 60 years (at the time of consent). All study subjects have received three doses of registered mRNA vaccine/s, the last dose given ≥ 3 months before inclusion in this study. Healthy participant, according to the investigator's clinical judgment, as established by medical history, vital signs, physical examination, and laboratory assessments. No clinically significant laboratory abnormalities as determined by the investigator at screening. Note: one retest of lab tests is allowed within the screening window. Negative HIV 1/2 antibody/antigen test, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody at screening. Participant with a body mass index (BMI) 20-30.0 kg/m2. Provide written informed consent before initiation of any study procedures. A female participant is eligible for this study if she is one of the following: of non-childbearing potential (i.e., women who have had a hysterectomy or tubal ligation or are postmenopausal, as defined by no menses in greater than or equal to 1 year) of childbearing potential but agrees to practice highly effective contraception or abstinence (if this is the preferred and usual lifestyle of the participant) from 30 days prior to vaccination up to 3 months after vaccination. Highly effective methods of contraception include one or more of the following: male partner who is sterile (vasectomised) prior to the female study subject's entry into the study and is the sole sexual partner for the female subject; hormonal (oral, intravaginal, transdermal, implantable or injectable) an intrauterine hormone-releasing system (IUS) an intrauterine device (IUD) with a documented failure rate of < 1%. A female participant is eligible if she is willing to abstain from donating oocyte from the screening visit up to 3 months after vaccination. A male participant who is sexually active is eligible if he is willing to use a condom from the screening visit up to 3 months after vaccination except if the male participant is sterile (e.g. vasectomised); the unique female sexual partner is postmenopausal, is permanently sterilized (e.g. hysterectomy or tubal ligation), or use a highly effective method of contraception. Able to understand and comply with planned study procedures and willing to be available for all study-required procedures, visits and calls for the duration of the study. Exclusion Criteria: Previous vaccination with investigational or registered non-mRNA vaccines against COVID-19. History of presence of pulmonary disorders (chronic obstructive pulmonary lung disease etc) or asthma (exception of allergic asthma, which is allowed). History or presence of thrombocytopenia and/or bleeding disorders. A positive serum pregnancy test at screening or urine pregnancy test prior to study injection, women who are planning to become pregnant during the study, or women who are breastfeeding. Clinically relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine, inflammatory, autoimmune, central nervous system or neurological diseases. Use of immunosuppressive drugs as e.g. corticosteroids (excluding topical preparations and inhalers) within 3 months prior to vaccination or 6 months for chemotherapies and all along the study. Vaccination within 2 weeks prior to vaccination or planning to receive a licensed vaccine before month 3 (e.g. inactivated influenza vaccine). History of severe adverse reactions to vaccine administration, including anaphylaxis and related symptoms, such as urticaria, respiratory difficulty, angioedema and abdominal pain to vaccines, or history of known or suspected allergic reaction likely to be exacerbated by any component of the Investigational vaccine. Participation in another investigational clinical study within four weeks before the screening visit or planned before the study completion. Subjects with confirmed or suspected immunodeficiency. SARS-CoV-2 infection within the past 2 weeks3 months prior to enrolment, or ongoing symptom of COVID-19. Any condition that in the opinion of the principal investigator (PI) would jeopardize the safety or rights of a person participating in the trial or would render the person unable to comply with the protocol.

Sites / Locations

  • Phase I Study Unit, Karolinska University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active vaccine

Placebo

Arm Description

Plasmid DNA vaccine, OC-007

Sodium chloride solution (0.9 %)

Outcomes

Primary Outcome Measures

Local reactions after the vaccine/placebo dose
Local reactions (pain at the injection site, redness, and swelling) for up to 7 days after the vaccine/placebo dose
Visual analogue scale pain rating scale score
Visual analogue scale (VAS) score to rate the level of pain experienced immediately (0 minutes), and after 5, 15, 30 and 60 minutes post-EP. Scale is continous and the farther right on the scale line the more pain.
Systemic events for 7 days after each vaccine/placebo dose.
Systemic events (fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain) for 7 days after each vaccine/placebo dose.
Unsolicited AEs
Unsolicited AEs from the study dose to 28 days after vaccination.
Serious Adverse Events (SAEs)/SUSARs
Serious Adverse Events (SAEs)/suspected unexpected serious adverse reactions (SUSARs) from the study dose until the study end at 3 months after vaccination.

Secondary Outcome Measures

Change from baseline in antibody levels to the SARS-CoV-2 spike and nucleocapsid protein.
Change from baseline sample (a two-fold increase in endpoint titer or a 50% increase in optical density at a 1:62, 1:125, 1:250, 1:500, or 1:1000 serum dilution) in antibody levels to the SARS-CoV-2 spike and nucleocapsid protein by inhouse and/or commercial assays during the study period.

Full Information

First Posted
January 11, 2023
Last Updated
February 16, 2023
Sponsor
Matti Sällberg
search

1. Study Identification

Unique Protocol Identification Number
NCT05685953
Brief Title
A Randomized, Phase I Study of DNA Vaccine OC-007 as a Booster Dose of COVID-19 Vaccine
Acronym
OpenCorona1
Official Title
A Randomized, Placebo-controlled, Double-blinded Phase I Study to Evaluate Safety and Immunogenicity of DNA Vaccine OC-007 as a Booster Dose of COVID-19 Vaccine
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Matti Sällberg

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a randomized, placebo-controlled, double-blinded phase I study, designed to evaluate the safety including reactogenicity and immunogenicity of this investigational DNA vaccine delivered intramuscularly by in vivo EP in human adults. The vaccine doses will be given to healthy adults aged 18 to 60 years, who have been previously vaccinated against COVID-19 with 3 doses of either Comirnaty® or Spikevax®, or both in any combination ≥3 months ago.
Detailed Description
One dose of the investigational vaccine or placebo will be given as a fourth booster dose. The vaccine will be administered intramuscularly at 3 dose levels or given as placebo (containing a 0.9 % NaCl solution), in combination with in vivo EP. The EP method used in the study is a class IIa "EPS Gun" from IGEA optimized for Electro Gene Transfer (EGT) vaccination and CE marked for the intended use in this clinical trial. Primary objective: • The primary objective of this study is to assess the safety and reactogenicity of the investigational vaccine OC-007 DNA delivered by in vivo EP, as a booster dose given at ≥ 3 months post-initial mRNA vaccination. The secondary objectives: • To investigate the humoral immune response to the investigational vaccine administered as one dose, by measuring changes in spike and of nucleocapsid antibody levels. Exploratory objective: To investigate in more detail the humoral response and analyze the cellular immune response to the investigational vaccine To evaluate the number of SARS-CoV-2 infections documented by positive PCR test during the study period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Respiratory Infection, COVID-19 Vaccine Adverse Reaction
Keywords
Covid-19, DNA vaccine, booster dose, in vivo electroporation, adverse reactions, antibody levels, cellular immune response

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Randomized, placebo-controlled, double-blinded phase I study including three dose levels of the DNA vaccine OC-007.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blinding: subjects, study personnel and outcome assessors are blinded to treatment.
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active vaccine
Arm Type
Experimental
Arm Description
Plasmid DNA vaccine, OC-007
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Sodium chloride solution (0.9 %)
Intervention Type
Biological
Intervention Name(s)
DNA vaccine OC-007
Other Intervention Name(s)
COVID-19 vaccine
Intervention Description
Plasmid DNA vaccine
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
0.9% NaCl solution
Primary Outcome Measure Information:
Title
Local reactions after the vaccine/placebo dose
Description
Local reactions (pain at the injection site, redness, and swelling) for up to 7 days after the vaccine/placebo dose
Time Frame
Up to 7 days after the vaccine/placebo dose
Title
Visual analogue scale pain rating scale score
Description
Visual analogue scale (VAS) score to rate the level of pain experienced immediately (0 minutes), and after 5, 15, 30 and 60 minutes post-EP. Scale is continous and the farther right on the scale line the more pain.
Time Frame
At 0, 5, 15, 30 and 60 minutes post-EP.
Title
Systemic events for 7 days after each vaccine/placebo dose.
Description
Systemic events (fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain) for 7 days after each vaccine/placebo dose.
Time Frame
For 7 days after each vaccine/placebo dose.
Title
Unsolicited AEs
Description
Unsolicited AEs from the study dose to 28 days after vaccination.
Time Frame
From the study dose to 28 days after vaccination.
Title
Serious Adverse Events (SAEs)/SUSARs
Description
Serious Adverse Events (SAEs)/suspected unexpected serious adverse reactions (SUSARs) from the study dose until the study end at 3 months after vaccination.
Time Frame
From the study dose until the study end at 3 months after vaccination.
Secondary Outcome Measure Information:
Title
Change from baseline in antibody levels to the SARS-CoV-2 spike and nucleocapsid protein.
Description
Change from baseline sample (a two-fold increase in endpoint titer or a 50% increase in optical density at a 1:62, 1:125, 1:250, 1:500, or 1:1000 serum dilution) in antibody levels to the SARS-CoV-2 spike and nucleocapsid protein by inhouse and/or commercial assays during the study period.
Time Frame
Day 7, Day 14, 1 Month and 3 Months.
Other Pre-specified Outcome Measures:
Title
Exploratory: In depth humoral and cellular immunological responses
Description
Description of in depth humoral and cellular immunological responses after receiving investigational vaccine at each sampling. Immunoglobulin levels analysed by Enzyme-Linked Immunosorbent Assays (ELISAs). Antibody titer analysed by CPE based microneutralization assay. Isolated Peripheral Blood Mononuclear Cell behavior analysed by enzyme-linked immunospot (ELISpot) assay. Flow cytometry will be used for functional and phenotypic characterization of T-cells.
Time Frame
Day 7, Day 14, 1 Month and 3 Months
Title
Exploratory: SARS-CoV-2 infections
Description
Number and severity of SARS-CoV-2 infections during the study period.
Time Frame
Up to 3 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Men and women between the ages of 18 and 60 years (at the time of consent). All study subjects have received three doses of registered mRNA vaccine/s, the last dose given ≥ 3 months before inclusion in this study. Healthy participant, according to the investigator's clinical judgment, as established by medical history, vital signs, physical examination, and laboratory assessments. No clinically significant laboratory abnormalities as determined by the investigator at screening. Note: one retest of lab tests is allowed within the screening window. Negative HIV 1/2 antibody/antigen test, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody at screening. Participant with a body mass index (BMI) 20-30.0 kg/m2. Provide written informed consent before initiation of any study procedures. A female participant is eligible for this study if she is one of the following: of non-childbearing potential (i.e., women who have had a hysterectomy or tubal ligation or are postmenopausal, as defined by no menses in greater than or equal to 1 year) of childbearing potential but agrees to practice highly effective contraception or abstinence (if this is the preferred and usual lifestyle of the participant) from 30 days prior to vaccination up to 3 months after vaccination. Highly effective methods of contraception include one or more of the following: male partner who is sterile (vasectomised) prior to the female study subject's entry into the study and is the sole sexual partner for the female subject; hormonal (oral, intravaginal, transdermal, implantable or injectable) an intrauterine hormone-releasing system (IUS) an intrauterine device (IUD) with a documented failure rate of < 1%. A female participant is eligible if she is willing to abstain from donating oocyte from the screening visit up to 3 months after vaccination. A male participant who is sexually active is eligible if he is willing to use a condom from the screening visit up to 3 months after vaccination except if the male participant is sterile (e.g. vasectomised); the unique female sexual partner is postmenopausal, is permanently sterilized (e.g. hysterectomy or tubal ligation), or use a highly effective method of contraception. Able to understand and comply with planned study procedures and willing to be available for all study-required procedures, visits and calls for the duration of the study. Exclusion Criteria: Previous vaccination with investigational or registered non-mRNA vaccines against COVID-19. History of presence of pulmonary disorders (chronic obstructive pulmonary lung disease etc) or asthma (exception of allergic asthma, which is allowed). History or presence of thrombocytopenia and/or bleeding disorders. A positive serum pregnancy test at screening or urine pregnancy test prior to study injection, women who are planning to become pregnant during the study, or women who are breastfeeding. Clinically relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine, inflammatory, autoimmune, central nervous system or neurological diseases. Use of immunosuppressive drugs as e.g. corticosteroids (excluding topical preparations and inhalers) within 3 months prior to vaccination or 6 months for chemotherapies and all along the study. Vaccination within 2 weeks prior to vaccination or planning to receive a licensed vaccine before month 3 (e.g. inactivated influenza vaccine). History of severe adverse reactions to vaccine administration, including anaphylaxis and related symptoms, such as urticaria, respiratory difficulty, angioedema and abdominal pain to vaccines, or history of known or suspected allergic reaction likely to be exacerbated by any component of the Investigational vaccine. Participation in another investigational clinical study within four weeks before the screening visit or planned before the study completion. Subjects with confirmed or suspected immunodeficiency. SARS-CoV-2 infection within the past 2 weeks3 months prior to enrolment, or ongoing symptom of COVID-19. Any condition that in the opinion of the principal investigator (PI) would jeopardize the safety or rights of a person participating in the trial or would render the person unable to comply with the protocol.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matti Sällberg, PhD
Phone
+46852483803
Email
matti.sallberg@ki.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matti Sällberg, PhD
Organizational Affiliation
Department of Laboratory Medicine, Karolinska Institute, Stockholm
Official's Role
Study Director
Facility Information:
Facility Name
Phase I Study Unit, Karolinska University Hospital
City
Stockholm
State/Province
Region Stockholm
ZIP/Postal Code
141 86
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soo Aleman, MD, PhD
Phone
+46725957225
Email
soo.aleman@regionstockholm.se
First Name & Middle Initial & Last Name & Degree
Soo Aleman, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

A Randomized, Phase I Study of DNA Vaccine OC-007 as a Booster Dose of COVID-19 Vaccine

We'll reach out to this number within 24 hrs