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A Multi-center, Randomized, Double-blind, Placebo-controlled Phase II/III Clinical Trial to Evaluate the Safety and Immunogenicity of a SARS-CoV-2 Inactivated (Vero Cell) Vaccine in the Elderly 60-80 Years of Age, Coronovac ENCOV19 Study

PHRR210210-003308

Unspecified

2020-CT0570

A Multi-center, Randomized, Double-blind, Placebo-controlled Phase II/III Clinical Trial to Evaluate the Safety and Immunogenicity of a SARS-CoV-2 Inactivated (Vero Cell) Vaccine in the Elderly 60-80 Years of Age, Coronovac ENCOV19 Study

This is a randomized, double-blind, phase II/III study to evaluate the safety, and immunogenicity of an investigational inactivated SARS-CoV-2 vaccine, in volunteers aged 60 to 80 years.

A total of 352 subjects will be enrolled and randomized in a 3:1 ratio to receive investigational vaccine and placebo. All participants will be assessed for immunogenicity and safety endpoints.

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
2021-04-06 14 2022-06-06 2022-06-06

Ongoing

Institution Classification Region LTO #
IP Biotech, Inc. Private Business NCR LTO-3000005072551
Institution Region
IP Biotech, Inc. NCR
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
Jacqueline C. Dominguez, MD Adult Neurology St. Luke's Medical Center - Quezon City
Lulu C. Bravo, MD Infectious Disease National Institutes of Health - University of the Philippines - Manila
Maria Rosario Z. Capeding, MD Infectious Disease Tropical Disease Foundation, Inc.
Project Location Institutional Ethics Review Board
St. Luke's Medical Center - Quezon City St. Luke's Medical Center Institutional Ethics Review Board
National Institutes of Health - University of the Philippines - Manila National Institutes of Health
Tropical Disease Foundation, Inc. Tropical Disease Foundation Institutional Review Board

COVID 19 Vaccine

  1. To evaluate the safety of SARS-CoV-2 inactivated (Vero Cell) vaccine; and
  2. To evaluate the immunogenicity of a two dose regimen of SARS-CoV-2 inactivated (Vero Cell) vaccine.

To evaluate the immunogenicity of a two dose regimen of SARS-CoV-2 inactivated (Vero Cell) vaccine in participants with underlying health conditions, such as, diabetes, obesity, dyslipidemia, hypertension and cardiovascular diseases, etc.

Pending

  • Philippines

Clinical Trial

Unspecified

20201019065706

2021-01-15

0000-00-00

352

Unspecified

Unspecified

2021-04-06

Inclusion Criteria:

  1. Ability to provide written informed consent and availability to fulfill the study requirements.
  2. Elderly, 60-80 years of age, male or female.
  3. Participants with good general health or participants with stable medical conditions, as determined by the discretion of the investigator upon medical examination and history taking. A stable medical condition is defined as a disease not requiring significant change in maintenance therapy or hospitalization, or no worsening of preexisting disease during the 3 months before enrolment. Therefore- mild/moderate medically well-controlled comorbidities/underlying/pre-existing conditions are allowed;
  4. Agree to periodic contacts by telephone;
  5. Demonstrate intention to participate in the study, documented by the participant's signing the Voluntary Informed Consent Form.
  6. For a female participant of child-bearing potential, planning to avoid becoming pregnant (use of an effective method of contraception or abstinence) from the time of study enrolment until at least eight weeks after the last vaccination.
  7. Agrees not to participate in another clinical trial at any time during the study period.
  8. Agrees not to take any COVID-19 licensed vaccination for the entire duration of the study.
  9.   Agrees to remain in the study area for the entire duration of the study.
  10.   Willing to allow storage and future use of biological samples for future research.

 Exclusion Criteria:

  1. History of confirmed COVID-19 infection (based on a positive SARS-CoV-2 nucleic acid amplification test or rapid antigen test result);
  2. Have history of experiencing or being diagnosed with COVID-19 or influenza-like symptoms, including fever during the previous 14 days prior to enrolment;
  3. Severe and/or uncontrolled diabetes, hypertension, cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological illness
  4. For females who are not yet menopausal (section 3.4.3) : Pregnancy (confirmed by positive β-hCG test), breastfeeding and/or expressing intention to have sexual practices with reproductive potential without using contraceptive methods in the three months following vaccination;
  5. Diseases with impaired immune system including: neoplasms (except basal cell carcinoma), congenital or acquired immunodeficiencies and autoimmune diseases not controlled according to anamnesis or physical examination. Significant changes in treatment or hospitalizations due to worsening of the condition in the last three months are indicators of uncontrolled disease;
  6. Any alcohol or drug abuse in the last 12 months prior to inclusion in the study that has caused medical, professional or family problems, as indicated by clinical history;
  7. History of severe allergic reaction or anaphylaxis to the vaccine or components of the study vaccine;
  8. History of asplenia;
  9.   Use of immunosuppressive therapies six months prior to inclusion in the study or its scheduled use within two years of inclusion. Immunosuppressive therapies will be considered: antineoplastic chemotherapy, radiation therapy, immunosuppressants to induce tolerance to transplants, among others;
  10.   Have received an immunosuppressive dose of corticosteroids in the last three months prior to inclusion in the study or scheduled administration of an immunosuppressive dose of corticosteroids for the three months following inclusion in the study. The dose of corticosteroids considered immunosuppressive is equivalent to prednisone at a dose of 20 mg/day for adults, for more than a week. The continuous use of topical or nasal corticosteroids is not considered immunosuppressive;
  11. Have received blood products (transfusions or immunoglobulins) in the last three months before inclusion in the study, or scheduled administration of blood products or immunoglobulin in the two years following inclusion in the study;
  12.   Suspected or confirmed fever within 2 weeks prior to vaccination or axillary temperature greater than 37.2°C on the day of vaccination (inclusion may be postponed until the participant completes 72 hours without fever);
  13.   Have received vaccine with live attenuated virus in the last 28 days or inactivated vaccine in the last 14 days prior to their inclusion in the study, or have immunization scheduled for the first 28 days after their inclusion in the study;
  14. History of bleeding disorders (for example, deficiency of clotting factors, coagulopathy, platelet dysfunction), or previous history of bleeding or significant bruising after IM injection or venipuncture;
  15. Any other condition that, in the opinion of the principal investigator or his medical representative, could jeopardize the safety or rights of a potential participant or that would prevent him from complying with this protocol.

Interventional

CoronaVac

The vaccine developed by Sinovac Life Sciences Co., Ltd. is a preparation made from the new coronavirus SARS-CoV-2 (strain CZ02) grown in a kidney cell line of an African green monkey (Vero Cell). Following cultivation and harvesting, the viral suspension is inactivated, concentrated, purified and adsorbed by aluminum hydroxide. It contains the SARS-CoV-2 coronavirus, aluminum hydroxide, disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium chloride. Its commercial name is: CoronaVac 0.5 ml/dose containing 600SU of SARS-CoV-2 virus antigen.

None

Randomized

Double Blind

Unspecified

Parallel

This is a double-blind randomization study.

Phase II/III

Utilization Utilization Info
No records found.
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