i

A global multicenter, randomized, double-blind, placebo-controlled, phase III clinical trial to evaluate the efficacy, safety, and immunogenicity of recombinant COVID-19 vaccine (Sf9 cells), for the prevention of COVID-19 in adults aged 18 years and older

PHRR210712-003704

Unspecified

2021-CT0616

A global multicenter, randomized, double-blind, placebo-controlled, phase III clinical trial to evaluate the efficacy, safety, and immunogenicity of recombinant COVID-19 vaccine (Sf9 cells), for the prevention of COVID-19 in adults aged 18 years and older

This is a Phase III study in a global multicentre, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy, safety and immunogenicity of the Recombinant COVID-19 Vaccine cells (Sf9 cells) produced by WestVac Biopharma Co., Ltd in the 5,000 participants/subject who will be adult participants aged 18 years and older.

 The study will enroll participants/subjects who have no known history of SARS-CoV-2 infection but whose locations or circumstances put them at appreciable risk of acquiring COVID-19 or SARS-CoV-2 infection. Subject’s ≥ 60 years old will account for about 10% of all enrolled subjects. All participants will receive three doses of either study vaccine or placebo on Day 0, Day 21, and Day 42 in a ratio of 1:1.

Regime Classification Priority
2017 - 2022 Research to enhance and extend healthy lives Access to essential medical products, vaccines and technologies
Start Date Duration in Months Target Completion Date Actual Completion Date
2021-07-30 14 2022-09-30 0000-00-00

Ongoing

Institution Classification Region LTO #
WestVac Biopharma Co., Ltd and West China Hospital of Sichuan University Private Business China N/A
Institution Region
WestVac Biopharma Co., Ltd. China
Name E-Mail Institution and Institution Address
Charles Anthony Suarez, RPh regulatoryaffairs@pivot-cro.com 6F Rockwell Business Center Tower 3,Ortigas Avenue Pasig City, 1604 Philippines
Name E-Mail Institution and Institution Address
Charles Anthony Suarez, RPh regulatoryaffairs@pivot-cro.com 6F Rockwell Business Center Tower 3,Ortigas Avenue Pasig City, 1604 Philippines
Name Expertise Affiliation
Andrei Rhoniel M. Rodriguez, MD Clinical Immunology, Rheumatology Makati Medical Center
Anjuli May Jaen Internal Medicine- Pulmonology The Medical City, Iloilo (TMC, Iloilo)
Jemela Anne Osorio-Sanchez, MD Medical Oncology Perpetual Succour Hospital
Joel M Santiaguel Internal Medicine, Pulmonary Medicine Quirino Memorial Medical Center
Loreta Baldovino Zoleta-de Jesus, MD Infectious Disease De La Salle Medical and Health Sciences Institute
Maria Rosario Z. Capeding, MD Infectious Disease Tropical Disease Foundation, Inc.
Marie Grace Dawn Isidro Pulmonary Medicine West Visasyas State University Medical Center
Mario Panaligan Internal Medicine and Infectious Diseases St Luke Medical Center - Global City
Project Location Institutional Ethics Review Board
Makati Medical Center Makati Medical Center Institutional Review Board
The Medical City, Iloilo (TMC, Iloilo) N/A
Perpetual Succour Hospital Perpetual Succour Hospital Institutional Ethics and Review Board
Quirino Memorial Medical Center Quirino Memorial Medical Center Hospital Ethics Committee
De La Salle Medical and Health Sciences Institute N/A
Tropical Disease Foundation, Inc. Tropical Disease Foundation Institutional Review Board
West Visasyas State University Medical Center N/A
St Luke Medical Center - Global City N/A

Prevention of COVID-19 caused by infection with the SARS-CoV-2.

1. Primary Efficacy

  • Virologically confirmed (PCR positive) symptomatic COVID-19 cases first occurring ﹥28 days after completion of 3 doses vaccination, regardless of severity

2. Primary Safety

  • SAEs from Day 0 through 6 months after completion of 3 doses vaccination.
  • MAAEs from Day 0 through 6 months after completion of 3 doses vaccination.
  • AESIs from Day 0 through 6 months after completion of 3 doses vaccination
  • Solicited AEs within 7 days after each dose vaccination.
  •  Unsolicited AEs within 21 days after the first dose and the second dose, and within 28 days after the third dose vaccination

1. Secondary Efficacy

  • Virologically confirmed (PCR positive) symptomatic COVID-19 cases first occurring ﹥14 days after completion of 3 doses vaccination, regardless of severity
  • Severe COVID-19 and death (based on WHO criteria) caused by SARS-CoV-2 infection first occurring ﹥ 14 days after completion of 3 doses vaccination.
  • Severe COVID-19 and death (based on WHO criteria) caused by SARS-CoV-2 infection first occurring ﹥ 28 days after completion of 3 doses vaccination.
  • Virologically confirmed (PCR positive) hospitalised moderate, severe COVID-19 and death caused by SARS-CoV-2 infection first occurring ﹥ 14 days after completion of 3 doses vaccination.
  • Virologically confirmed (PCR positive) hospitalised moderate, severe COVID-19 and death caused by SARS-CoV-2 infection first occurring ﹥ 28 days after completion of 3 doses vaccination
  • Serologically confirmed SARS-CoV-2 infection or virologically confirmed (PCR positive) COVID-19 cases first occurring ﹥ 14 days after completion of 3 doses vaccination, regardless of symptomatology or severity.
  • Serologically confirmed SARS-CoV-2 infection or virologically confirmed (PCR positive) COVID-19 cases first occurring ﹥ 28 days after completion of 3 doses vaccination, regardless of symptomatology or severity.

2. Secondary Safety

  • SAEs, MAAEs and AESIs from Day 0 through 12 months after completion of 3 doses vaccination in all participants.

3. Secondary Immunogenicity

  • The seroconversion rate, GMT and GMI of S-RBD IgG antibody on day 28, month 3, month 6 and month 12 after completion of 3 doses vaccination, measured by ELISA.
  • The seroconversion rate, GMT and GMI of live-virus neutralizing antibody on day 28, month 3, month 6 and month 12 after completion of 3 doses vaccination.

Pending

  • Philippines

Clinical Trial

Unspecified

20210524073053

2021-06-28

0000-00-00

5000

Unspecified

Unspecified

2021-07-30

Inclusion Criteria

  1. Aged 18 years and older
  2. Able and willing (in the investigator’s opinion) to comply with all study requirements.
  3. Willing to allow the investigators to discuss the volunteer’s medical history with their general practitioner/personal doctor and access all medical records which are relevant to study procedures.
  4.  Healthy adults, or stable-healthy adults who may have a pre-existing medical condition that does not meet any exclusion criteria. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment.
  5. For females of childbearing potential only, willingness to practice continuous effective contraception (see glossary) for 90 days after completion of 3 doses vaccination, and have negative pregnancy tests before each dose vaccination
    • Note: Nonchildbearing potential is defined as surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as amenorrhea for ≥ 12 consecutive months prior to Screening without an alternative medical cause). A follicle-stimulating hormone (FSH) level may be measured at the discretion of the investigator to confirm postmenopausal status
  6. Males participating in this study who are involved in heterosexual sexual activity must agree to practice adequate contraception (see glossary) and refrain from donating sperm for 90 days after receiving the study vaccination.
  7. Agreement to refrain from blood donation during the study.
  8. Provide written informed consent form (ICF).

Exclusion criteria for the first dose

  1. Participation in any other COVID-19 prophylactic drug trials during the duration of the study. Note: Participation in COVID-19 treatment trials is allowed in the event of hospitalization due to COVID-19. The study team should be informed as soon as possible.
  2. Positive HIV antibody testing results.
  3.  Participation in SARS-CoV-2 serological surveys where participants are informed of their serostatus during the duration of the study.
    Note: Disclosure of serostatus post enrolment may accidentally unblind participants to group allocation. Participation in this trial can only be allowed if volunteers are kept blinded to their serology results from local/national serological surveys
  4. Planned receipt of any licensed or investigational vaccine, other than the study intervention, within 14 days before and after study vaccination.
  5. Prior receipt of an investigational or licensed COVID-19 vaccine.
  6. Administration of immunoglobulins and/or any blood products within three months prior to the planned administration of the investigational products (IPs).
  7. Any confirmed or suspected immunosuppressive or immunodeficient state; positive HIV status; asplenia; recurrent severe infections and chronic use (more than 14 days) of immunosuppressant medication within the past 6 months. Topical steroids or short-term (course lasting ≤14 days) oral steroids are not an exclusion criteria.
  8. History of allergic disease or reactions likely to be exacerbated by any component of Recombinant COVID-19 Vaccine (Sf9 cells).
  9. Any history of angioedema
  10. Pregnancy, lactation or willingness/intention to become pregnant within 90 days after receiving study vaccine
  11. Current diagnosis or treatment of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
  12. History of serious psychiatric condition likely to affect participation in the study
  13.  Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture
  14. Suspected or known current alcohol or drug dependency
  15.  Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness (mild/moderate well-controlled comorbidities are allowed)
  16. History of laboratory-confirmed COVID-19
  17.  Continuous use of anticoagulants, such as coumarins and related anticoagulants (i.e. warfarin) or novel oral anticoagulants (i.e. apixaban, rivaroxaban, dabigatran and edoxaban)
  18. Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.

Interventional

Recombinant COVID-19 Vaccine (Sf9 cells)

40 mcg/ml- S-RBD protein, 0.42 mg/ml Aluminum Hydroxide (adjuvant) Suspension for Intramuscular (IM) Injection

None

Randomized

Double Blind

Unspecified

Parallel

This is a double-blind, randomized, placebo-controlled study.

Phase III

Utilization Utilization Info
Publication
Oral Presentation
Drug Literature
Posters
Others
©2021 HERDIN PLUS. All rights reserved. | Contact Us | Keep up to date