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A Phase 1/2 Safety and Immunogenicity Trial of COVID-19 Vaccine COVIVAC

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ClinicalTrials.gov Identifier: NCT04830800
Recruitment Status : Recruiting
First Posted : April 5, 2021
Last Update Posted : April 5, 2021
Sponsor:
Collaborators:
National Institute of Hygiene and Epidemiology, Vietnam
Hanoi Medical University
Center for Disease Control of Thai Binh Province
Information provided by (Responsible Party):
Institute of Vaccines and Medical Biologicals, Vietnam

Brief Summary:

This prospective, single-center, randomized, placebo-controlled, observer-blind Phase 1/2 study includes two separate parts.

Part 1 is a first-in-human, Phase 1 study designed to evaluate the safety, tolerability and immunogenicity of the COVIVAC vaccine at three different dose levels (1, 3, and 10 µg) without adjuvant, and at one dose level (1 µg) with the adjuvant CpG 1018, in a total of 120 subjects aged 18-59 years.

In Part 2 of this combined Phase 1/2 study, 300 adults aged 18-75 years will be randomized (2:5:5) to placebo, or one of two selected formulations of COVIVAC being evaluated in Phase 1


Condition or disease Intervention/treatment Phase
COVID-19 Disease SARS Pneumonia Pneumonia, Viral COVID-19 Vaccine Biological: COVIVAC Biological: Phosphate-buffered saline Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: In Phase 1 is dose escalation design, eligible participants will be randomized to received study vaccine or placebo from low dose to higher dose and later to the formulation with CpG adjuvant. In phase 2, eligible participants will received 2 selected doses (from phase 1) or placebo.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 1/2 Randomized, Placebo-controlled, Observer-blind Trial to Assess the Safety and Immunogenicity of COVIVAC Vaccine Produced by IVAC in Adults Aged 18-75 Years in Vietnam
Actual Study Start Date : March 10, 2021
Estimated Primary Completion Date : May 30, 2022
Estimated Study Completion Date : September 30, 2022

Arm Intervention/treatment
Experimental: COVIVAC 1mcg
1mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
Biological: COVIVAC
COVIVAC vaccine, manufactured by IVAC with or without adjuvant CpG1018 for prevention of COVID-19

Experimental: COVIVAC 3mcg
3mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
Biological: COVIVAC
COVIVAC vaccine, manufactured by IVAC with or without adjuvant CpG1018 for prevention of COVID-19

Experimental: COVIVAC 10mcg
10mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
Biological: COVIVAC
COVIVAC vaccine, manufactured by IVAC with or without adjuvant CpG1018 for prevention of COVID-19

Experimental: COVIVAC 1mcg + CpG1018 1.5mg
1mcg + CpG1018 IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
Biological: COVIVAC
COVIVAC vaccine, manufactured by IVAC with or without adjuvant CpG1018 for prevention of COVID-19

Placebo Comparator: Placebo
Phosphate buffered saline (pH 7.2) for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
Biological: Phosphate-buffered saline
Phosphate buffer solution (pH 7.2), manufactured by IVAC




Primary Outcome Measures :
  1. Number and severity of solicited local and systemic adverse events (AEs) [ Time Frame: During the first 7 days after each vaccination ]
    Safety outcome measurement

  2. Number, severity, and relatedness of clinically significant hematological and biochemical measurements [ Time Frame: At 7 days post each vaccination ]
    Safety outcome measurement

  3. Number, severity and relatedness of all unsolicited AEs [ Time Frame: During the first 28 days after each vaccination ]
    Safety outcome measurement

  4. Number, severity and relatedness of serious adverse events (SAEs) [ Time Frame: Through study completion, up to Day 365 ]
    Safety outcome measurement

  5. Number, severity and relatedness of medically-attended AEs (MAAEs) [ Time Frame: Through study completion, up to Day 365 ]
    Safety outcome measurement

  6. Number, severity and relatedness of adverse events of special interest (AESI) , including AESI relevant to COVID-19, and potential immune-mediated medical conditions (PIMMC) [ Time Frame: Through study completion, up to Day 365 ]
    Safety outcome measurement


Secondary Outcome Measures :
  1. 50% and 80% neutralizing antibody (NT50 and NT80) geometric mean titer (GMT) against SARS-CoV-2 pseudovirus [ Time Frame: At 28 days after the first vaccination, and 14 days, 6 months and 12 months after the second vaccination in subjects who are anti-S IgG seronegative at baseline ]
    Immunogenicity outcome measurement

  2. Geometric mean fold rise (GMFR) (from baseline) in NT50 and NT80 against SARS-CoV-2 pseudovirus [ Time Frame: At 28 days after the first vaccination, and 14 days, 6 months and 12 months after the second vaccination in subjects who are anti-S IgG seronegative at baseline ]
    Immunogenicity outcome measurement

  3. Percentage of subjects with NT50 and NT80 seroresponses against SARS-CoV-2 pseudovirus as defined by (1) a ≥ 4-fold increase from baseline, and (2) a ≥ 10-fold increase from baseline [ Time Frame: At 28 days after the first vaccination, and 14 days, 6 months and 12 months after the second vaccination in subjects who are anti-S IgG seronegative at baseline ]
    Immunogenicity outcome measurement



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Phase 1 Only:

  1. Adult 18 through 59 years of age inclusive at the time of randomization.
  2. Healthy, as defined by absence of clinically significant medical condition, either acute or chronic, as determined by medical history, physical examination, screening laboratory test results, and clinical assessment of the investigator.

Phase 2 Only:

  1. Adult 18 through 75 years of age inclusive at the time of randomization.
  2. Having no clinically significant acute medical condition, and no chronic medical condition that has not been controlled within 90 days of randomization, as determined by medical history, physical examination, screening laboratory test results, and clinical assessment of the investigator.

    Both Phase 1 and Phase 2:

  3. Has provided written informed consent prior to performance of any study-specific procedure.
  4. Has a body mass index (BMI) of 17 to 40 kg/m2, inclusive, at screening.
  5. Resides in study site area and is able and willing to adhere to all protocol visits and procedures.
  6. If a woman is of childbearing potential, must not be breastfeeding or be pregnant (based on a negative urine pregnancy test at screening and during the 24 hours prior to receipt of the first dose of IP), must plan to avoid pregnancy for at least 28 days after the last dose of IP, and be willing to use an adequate method of contraception consistently and have a repeated pregnancy test prior to the second (last) dose of IP.

Exclusion Criteria:

  1. Use of any investigational medicinal product within 90 days prior to randomization or planned use of such a product during the period of study participation.
  2. History of administration of any non-study vaccine within 28 days prior to administration of study vaccine or planned vaccination within 3 months after enrolment.

    Note: receipt of any COVID-19 vaccine that is licensed or granted Emergency Use Authorization in Vietnam during the course of study participation is not exclusionary if administered after Visit 5.

  3. Previous receipt of investigational vaccine for SARS or MERS, or any investigational or licensed vaccine that may have an impact on interpretation of the trial results
  4. History of hypersensitivity reaction to any prior vaccination or known hypersensitivity to any component of the study vaccine
  5. History of egg or chicken allergy
  6. History of angioedema
  7. History of anaphylaxis
  8. Acute illness (moderate or severe) and/or fever (body temperature measured orally ≥38°C)
  9. Any abnormal vital sign deemed clinically relevant by the PI
  10. Abnormality in screening laboratory test deemed exclusionary by the PI in consultation with the Sponsor
  11. A positive serologic test for hepatitis B (HBsAg) or hepatitis C (HCV Ab)
  12. History of confirmed HIV
  13. History of laboratory-confirmed COVID-19
  14. History of malignancy, excluding non-melanoma skin and cervical carcinoma in situ
  15. Any confirmed or suspected immunosuppressive or immunodeficient state
  16. Administration of immunoglobulin or any blood product within 90 days prior to first study injection or planned administration during the study period.
  17. Administration of any long-acting immune-modifying drugs (e.g., infliximab or rituximab) or the chronic administration (defined as more than 14 days) of immunosuppressants within six months prior to first study injection, or planned administration during the study period (includes systemic corticosteroids at doses equivalent to ≥ 0.5 mg/kg/day of prednisone; the use of topical steroids including inhaled and intranasal steroids is permitted).
  18. History of known disturbance of coagulation or blood disorder that could cause anemia or excess bleeding. (e.g, thalassemia, coagulation factor deficiencies).
  19. Recent history (within the past year) or signs of alcohol or substance abuse.
  20. Any medical, psychiatric or behavior condition that in the opinion of the PI may interfere with the study objectives, pose a risk to the subject, or prevent the subject from completing the study follow-up.
  21. Employee of any person employed by the Sponsor, the contract research organization (CRO), the PI, study site personnel, or site.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04830800


Contacts
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Contact: Be V Le, MD 84-903501529 ivaclevanbe@gmail.com
Contact: Thang C Tran, MD 84-913301883 thangtran@path.org

Locations
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Vietnam
Hanoi Medical University Recruiting
Hanoi, Vietnam, 10000
Contact: Anh V Pham Thi, MD, Associate Prof    84-915595690    phamthivananh.hmu@gmail.com   
Contact: Mai N Dang, MD    84-916381234    dangngocmai.hmu@gmail.com   
Principal Investigator: Anh D Dang, Prof         
Sub-Investigator: Thiem D Vu, MD, Assoc Prof         
Sub-Investigator: Van T Ta, MD, Prof         
Sub-Investigator: Anh V Pham Thi, MD, Assoc Prof         
Thai Binh Center of Disease Control Not yet recruiting
Thai Binh, Vietnam
Contact: Thiem D Vu, MD, Assoc Prof    84-913304649    vdt@nihe.org.vn   
Contact: Ha H Vu, MD, PhD    84-868889698    dr.vuhaiha@yahoo.com   
Sponsors and Collaborators
Institute of Vaccines and Medical Biologicals, Vietnam
National Institute of Hygiene and Epidemiology, Vietnam
Hanoi Medical University
Center for Disease Control of Thai Binh Province
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Responsible Party: Institute of Vaccines and Medical Biologicals, Vietnam
ClinicalTrials.gov Identifier: NCT04830800    
Other Study ID Numbers: COVIVAC-0102
First Posted: April 5, 2021    Key Record Dates
Last Update Posted: April 5, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There should be an agreement and approval by IRB before sharing IDP

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institute of Vaccines and Medical Biologicals, Vietnam:
COVID-19
COVIVAC
COVID-19 disease
SARS-CoV-2
COVID-19 vaccine
Additional relevant MeSH terms:
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Pneumonia, Viral
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases