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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- COVID-19 Respiratory Infection
- Sponsor
- Matti Sällberg
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Systemic events for 7 days after each vaccine/placebo dose.
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Matti Sällberg
Study Sponsor
Karolinska Institutet
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/m
- •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)
Exclusion Criteria
- •Previous vaccination with investigational or registered non-mRNA vaccines against COVID-
- •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.
Outcomes
Primary Outcomes
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.
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.
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.
Secondary Outcomes
- Change from baseline in antibody levels to the SARS-CoV-2 spike and nucleocapsid protein.(Day 7, Day 14, 1 Month and 3 Months.)