COVID-19 Respiratory InfectionPhase 1OpenCorona1NCT05685953
A Randomized, Phase I Study of DNA Vaccine OC-007 as a Booster Dose of COVID-19 Vaccine
A Phase 1 study testing DNA vaccine OC-007 in people with COVID-19 Respiratory Infection and COVID-19 Vaccine Adverse Reaction, run by Matti Sällberg at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Respiratory Infection, COVID-19 Vaccine Adverse Reaction
- What is being tested?
- DNA vaccine OC-007
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteSweden
- Study dates
- 8 Feb 2023to 13 Mar 2024
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Phase I Study Unit, Karolinska University Hospital
Stockholm, Region Stockholm, 141 86
About this study
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
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.
Read the 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.
- Being tested
- DNA vaccine OC-007, Placebo
- Keywords
- Covid-19, DNA vaccine, booster dose, in vivo electroporation, adverse reactions, antibody levels, cellular immune response
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA vaccine OC-007Biological
Also called COVID-19 vaccine
Plasmid DNA vaccine
PlaceboOther
0.9% NaCl solution
| Study group | Role | What they receive |
|---|---|---|
| Active vaccine | Experimental | Plasmid DNA vaccine, OC-007 Receives: Biological: DNA vaccine OC-007 |
| Placebo | Placebo comparator | Sodium chloride solution (0.9 %) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: At 0, 5, 15, 30 and 60 minutes post-EP.
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.
Measured: For 7 days after each vaccine/placebo dose.
Unsolicited AEs
Unsolicited AEs from the study dose to 28 days after vaccination.
Measured: 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.
Measured: From the study dose until the study end at 3 months after vaccination.
Secondary outcomes (1)
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.
Measured: Day 7, Day 14, 1 Month and 3 Months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start8 Feb 2023
- Primary completion13 Mar 2024
- Study completion13 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Respiratory InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single group
- Model description
- Randomized, placebo-controlled, double-blinded phase I study including three dose levels of the DNA vaccine OC-007.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Matti Sällberg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Matti Sällberg, Karolinska Institutet
- Investigators
- Matti Sällberg, PhD, Study director, Department of Laboratory Medicine, Karolinska Institute, Stockholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05685953
- Sponsor's protocol ID
- Open Corona 1
- Acronym
- OpenCorona1
- Status last verified
- Mar 2024
- First submitted
- 11 Jan 2023
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05685953
- Acronym / sponsor ID
- OpenCorona1 / Open Corona 1
- Keywords
- Covid-19, DNA vaccine, booster dose, in vivo electroporation, adverse reactions, antibody levels, cellular immune response
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Matti SällbergUniversity, hospital or other
- Study start
- 8 Feb 2023 (actual)
- Primary completion
- 13 Mar 2024 (actual)
- Study completion
- 13 Mar 2024 (actual)
- First posted
- 17 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, placebo-controlled, double-blinded phase I study including three dose levels of the DNA vaccine OC-007.
| Arm | Type | Receives |
|---|---|---|
| Active vaccine | Experimental | Biological: DNA vaccine OC-007Plasmid DNA vaccine, OC-007 |
| Placebo | Placebo comparator | Other: PlaceboSodium chloride solution (0.9 %) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DNA vaccine OC-007Also: COVID-19 vaccinePlasmid DNA vaccine | Biological | Active vaccine |
| Placebo0.9% NaCl solution | Other | Placebo |
Primary outcome
Local reactions after the vaccine/placebo dose
Time frame: Up to 7 days 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
Time frame: At 0, 5, 15, 30 and 60 minutes post-EP.
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.
Time frame: 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
Time frame: From the study dose to 28 days after vaccination.
Unsolicited AEs from the study dose to 28 days after vaccination.
Serious Adverse Events (SAEs)/SUSARs
Time frame: From the study dose until the study end at 3 months after vaccination.
Serious Adverse Events (SAEs)/suspected unexpected serious adverse reactions (SUSARs) from the study dose until the study end at 3 months after vaccination.
1 secondary outcome
Change from baseline in antibody levels to the SARS-CoV-2 spike and nucleocapsid protein.
Time frame: Day 7, Day 14, 1 Month and 3 Months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matti Sällberg, PhD study director
Department of Laboratory Medicine, Karolinska Institute, Stockholm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DNA vaccine OC-007 in people with COVID-19 Respiratory Infection and COVID-19 Vaccine Adverse Reaction, run by Matti Sällberg at 1 site in Sweden.
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 19 inclusion and 12 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 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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. Some participants in this study may receive a placebo. 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?
Local reactions after the vaccine/placebo dose (time frame: Up to 7 days after the vaccine/placebo dose). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2024.