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

NCT05685953 | Completed Phase 1 DMC

• 1 other identifier: Open Corona 1
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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

  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.

  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.

  For 7 days after each vaccine/placebo dose.

• Unsolicited AEs

  Unsolicited AEs from the study dose to 28 days after vaccination.

  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.

  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.

  Day 7, Day 14, 1 Month and 3 Months.

Other Outcomes (2)

• Exploratory: In depth humoral and cellular immunological responses

  Day 7, Day 14, 1 Month and 3 Months

• Exploratory: SARS-CoV-2 infections

  Up to 3 Months

Study Arms (2)

Active vaccine

EXPERIMENTAL

Plasmid DNA vaccine, OC-007

Biological: DNA vaccine OC-007

Placebo

PLACEBO COMPARATOR

Sodium chloride solution (0.9 %)

Other: Placebo

Interventions

DNA vaccine OC-007 BIOLOGICAL

Plasmid DNA vaccine

Also known as: COVID-19 vaccine

Active vaccine

Placebo OTHER

0.9% NaCl solution

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women between the ages of 18 and 60 years (at the time of consent).
• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Matti Sällberg: lead

Study Sites (1)

Phase I Study Unit, Karolinska University Hospital

Stockholm, Region Stockholm, 141 86, Sweden

Location

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Matti Sällberg, PhD

  Department of Laboratory Medicine, Karolinska Institute, Stockholm

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blinding: subjects, study personnel and outcome assessors are blinded to treatment.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study Sponsor

Model Details: Randomized, placebo-controlled, double-blinded phase I study including three dose levels of the DNA vaccine OC-007.

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: January 17, 2023
• Study Start: February 8, 2023
• Primary Completion: March 13, 2024
• Study Completion: March 13, 2024
• Last Updated: March 27, 2024

Record last verified: 2024-03

Locations

SE (1)