Summary

Eligibility
for people ages 12 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UC Davis
Dates
study started
estimated completion
Principal Investigator
by Stuart H Cohen (ucdavis)

Description

Summary

This is a study to evaluate the effectiveness, immune response, and safety of a coronavirus disease 2019 (COVID-19) vaccine called SARS-CoV-2 rS with Matrix-M1 adjuvant in adults 18 years of age and older with a pediatric expansion in adolescents (12 to 17 years) in the United States and Mexico. A vaccine causes the body to have an immune response that may help prevent the infection or reduce the severity of symptoms. An adjuvant is something that can make a vaccine work better. This study will look at the protective effect, body's immune response, and safety of SARS-CoV-2 rS with Matrix-M1 adjuvant in the study population. Participants in the study will randomly be assigned to receive SARS-CoV-2 rS with Matrix-M1 adjuvant or placebo. Each participant in the study will receive a total of 2 intramuscular injections of either ARS-CoV-2 rS with Matrix-M1 adjuvant or placebo in the Initial Vaccination Period. Up to 33,000 participants will take part in the study. Following the recommendation of COVID-19 vaccination for all adults 18 years of age and older, adult participants will be scheduled for the administration of 2 injections of the alternate study material 21 days apart ("blinded crossover"). That is, initial recipients of placebo will receive SARS-CoV-2 rS with Matrix-M1 adjuvant and initial recipients of SARS-CoV-2 rS with Matrix-M1 adjuvant will receive placebo. A blinded crossover will be implemented for adolescents 12-17 years of age approximately 6 months after the initial vaccination.

Official Title

A Phase 3, Randomized, Observer-Blinded, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) With Matrix-M1™ Adjuvant in Adult Participants ≥ 18 Years With a Pediatric Expansion in Adolescents (12 to 17 Years)

Keywords

SARS-CoV Infection Covid19 Coronavirus Prevent-19 Severe Acute Respiratory Syndrome Vaccines SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial Vaccination Period) SARS-CoV-2 rS/Matrix-M1 Adjuvant (Crossover Vaccination period) SARS-CoV-2 rS/Matrix-M1 Adjuvant

Eligibility

You can join if…

Open to people ages 12 years and up

Adult Main Study:

  1. Adults ≥ 18 years of age at screening who, by virtue of age, race, ethnicity or life circumstances, are considered at substantial risk of exposure to and infection with SARS-CoV-2.
  2. Willing and able to give informed consent prior to study enrollment and to comply with study procedures.
  3. Participants of childbearing potential (defined as any participant who has experienced menarche and who is NOT surgically sterile [ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months]) must agree to be heterosexually inactive from at least 28 days prior to enrollment and through 3 months after the last vaccination OR agree to consistently use a medically acceptable method of contraception from at least 28 days prior to enrollment and through 3 months after the last vaccination.
  4. Is medically stable, as determined by the investigator (based on review of health status, vital signs [to include body temperature], medical history, and targeted physical examination [to include body weight]). Vital signs must be within medically acceptable ranges prior to the first vaccination.
  5. Agree to not participate in any other SARS-CoV-2 prevention trial during the study follow-up.

Pediatric Expansion:

  1. Pediatric participants 12 to 17 years of age at screening, determined to be healthy or medically stable by the investigator (based on review of health status, vital signs [to include body temperature], medical history, and targeted physical examination [to include body weight]). Vital signs must be within medically acceptable ranges prior to the first vaccination.
  2. Participant and parent(s)/caregiver(s) or legally acceptable representative willing and able to give informed consent and assent, as required, prior to study enrollment and to comply with study procedures.
  3. Participants of childbearing potential (defined as any participant who has experienced menarche and who is NOT surgically sterile [ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] must agree to be heterosexually inactive from at least 28 days prior to enrollment and through 3 months after the last vaccination OR agree to consistently use a medically acceptable method of contraception from at least 28 days prior to enrollment and through 3 months after the last vaccination.
  4. Agree to not participate in another SARS-CoV-2 prevention trial during the study follow-up

You CAN'T join if...

Adult and pediatric participants meeting any of the following criteria will be excluded from the study:

  1. Unstable acute or chronic illness. Criteria for unstable medical conditions include:
  2. Substantive changes in chronic prescribed medication (change in class or significant change in dose) in the past 2 months.
  3. Currently undergoing workup of undiagnosed illness that could lead to diagnosis of a new condition.
  4. Participation in research involving an investigational product (drug/biologic/device) within 45 days prior to first study vaccination.
  5. History of a previous laboratory-confirmed diagnosis of SARS-CoV-2 infection or COVID-19.
  6. Received influenza vaccination or any other adult vaccine within 4 days prior to or within 7 days after either study vaccination.Received any vaccine within 4 days prior to first study vaccination or planned receipt of any vaccine before Day 49 (ie, 28 days after second vaccination).
  7. Autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) requiring ongoing immunomodulatory therapy.
  8. Chronic administration (defined as > 14 continuous days) of immunosuppressant, systemic glucocorticoids, or other immune-modifying drugs within 90 days prior to first study vaccination.
  9. Received immunoglobulin, blood-derived products, or immunosuppressant drugs within 90 days prior to first study vaccination.
  10. Active cancer (malignancy) on therapy within 1 year prior to first study vaccination (with the exception of malignancy cured via excision, at the discretion of the investigator).
  11. Any known allergies to products contained in the investigational product.
  12. . Participants who are breastfeeding, pregnant or who plan to become pregnant within 3 months following last study vaccination.
  13. . Any other condition that, in the opinion of the investigator, would pose a health risk to the participant if enrolled or could interfere with evaluation of the trial vaccine or interpretation of study results.
  14. . Study team member or first-degree relative of any study team member (inclusive of Sponsor, and study site personnel involved in the study).
  15. . Current participation in any other COVID-19 prevention clinical trial.

Locations

  • University of California Davis Health (Pediatric & Adult Site) accepting new patients
    Sacramento California 95817-2201 United States
  • Paradigm Clinical Research Centers, Inc (Pediatric Site) accepting new patients
    La Mesa California 92117 United States
  • California Research Foundation (Pediatric & Adult Site) accepting new patients
    San Diego California 92123 United States
  • Transitional Research Group, Inc. (Pediatric & Adult Site) accepting new patients
    North Hollywood California 91606 United States
  • National Research Institute (Pediatric & Adult Site) accepting new patients
    Los Angeles California 90057 United States
  • Dignity Health Medical Foundation - Woodland (Adult Site) accepting new patients
    Woodland California 95695 United States

Lead Scientist at University of California Health

  • Stuart H Cohen (ucdavis)
    Professor, Infectious Diseases. Authored (or co-authored) 103 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novavax
ID
NCT04611802
Phase
Phase 3
Study Type
Interventional
Last Updated