Phase 3 Study to Evaluate a Single Booster of the NVX-CoV2373 COVID19 Vaccine in Adults

  • STATUS
    Recruiting
  • days left to enroll
    4
  • participants needed
    1000
  • sponsor
    Cogna Technology Solutions LLC
Updated on 10 April 2022
Accepts healthy volunteers

Summary

This is an observer-blinded Phase 3 study to evaluate the safety and immunogenicity of a single booster dose of the Novavax severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) recombinant (r) spike (S) protein nanoparticle vaccine adjuvanted with Matrix-MTM (NVX-CoV2373) in adults previously vaccinated with the BBIBP-CorV vaccine. The study will enroll approximately1,000 participants >18 years of age. All participants will be randomized in a 1:1 ratio to receive a single booster dose of NVX-CoV2373 or the BBIBP-CorV vaccine. All participants will receive the booster dose on Day 0 and remain on study for immunogenicity and safety data collection through Day 180. An interim analysis will be performed of safety and immunogenicity data gathered through Day 28.

Description

Novavax, Inc., is developing recombinant vaccines adjuvanted with the saponin-based Matrix-M for the prevention of disease caused by SARS-CoV-2. Both nonclinical and clinical data to date (Liu 2011; Keech 2020; Formica 2021; Heath 2021) support continued clinical development of SARS-CoV-2 rS vaccines combined with Matrix-M adjuvant as potential vaccines against SARS-CoV-2.

Due to waning immunity following primary vaccination against SARS-CoV-2 as well as the emergence of SARS-CoV-2 variants (eg, Alpha, Beta, Gamma, Delta and Omicron), a number of countries have administered or are planning to administer booster doses of vaccine to either specific subgroups or to their general population. As part of this effort, both homologous boosting (boosting with the same vaccine used for the primary vaccination series) or heterologous boosting (boosting with a vaccine that differs from that used for the primary vaccination series) are being evaluated.

The present study aims to investigate the safety and immunogenicity of a single booster of NVX-CoV2373 administered to participants who have already been immunized with BBIBP-CorV vaccine. The NVX-CoV2373 booster will be administered > 180 days after the second dose of BBIBP-CorV vaccine, and the ability of the vaccine to increase antibody titers against the prototype SARS-CoV-2 strain as well as the ability to induce cross-neutralizing antibodies to variant strains will be evaluated. If favorable immunogenicity and safety profiles are observed following a booster dose of NVX-CoV2373, this option would add flexibility to the global COVID-19 vaccination effort and potentially decrease the need to develop variant-specific vaccines.

Details
Condition Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Treatment NVX-CoV2373 with Matrix-M adjuvant Injection, BBIBP-CorV vaccine
Clinical Study IdentifierNCT05249816
SponsorCogna Technology Solutions LLC
Last Modified on10 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Adults ≥ 18 years of age, inclusive, at screening
Willing and able to give informed consent prior to study enrollment and to comply with study procedures
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 listed below from at least 28 days prior to enrollment and through 3 months after the last vaccination
Condoms (male or female)
Diaphragm with spermicide
Cervical cap with spermicide
Intrauterine device
Oral or patch contraceptives
Norplant®, Depo-Provera®, or other in country regulatory approved contraceptive method that is designed to protect against pregnancy
Abstinence, as a form of contraception, is acceptable if in line with the participant's lifestyle NOTE: Periodic abstinence (eg, calendar, ovulation, symptom-thermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
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 as determined by the investigator prior to
the first vaccination
Agrees to not participate in any other SARS-CoV-2 prevention or treatment trials for the duration of the study
NOTE: For participants who become hospitalized with COVID-19, participation in
investigational treatment studies is permitted
Has previously received a documented complete two dose series of the BBIBP-CorV vaccine with the second dose having been given at least 180 days prior to study vaccination

Exclusion Criteria

If an individual meets any of the following criteria, he or she is ineligible for this
study
Participation in research involving receipt of investigational products
(drug/biologic/device) within 90 days prior to first study vaccination
Received influenza vaccination within 14 days prior to first study vaccination, or any
other vaccine (including COVID-19) within 30 days prior to first study vaccination
Any known allergies to products contained in the investigational product
Any history of anaphylaxis to any prior vaccine
Autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) requiring
ongoing immunomodulatory therapy
NOTE: Stable endocrine disorders (eg, thyroiditis, pancreatitis), including stable
diabetes mellitus with no history of diabetic ketoacidosis are NOT excluded
Chronic administration (defined as > 14 continuous days) of immunosuppressant
systemic glucocorticoids, or other immune-modifying drugs within 90 days prior to
first study vaccination
NOTE: An immunosuppressant dose of glucocorticoid is defined as a systemic dose ≥ 10
mg of prednisone per day or equivalent. The use of topical or intranasal
glucocorticoids is permitted. Topical tacrolimus and ocular cyclosporin are permitted
Use of inhaled glucocorticoids is prohibited
Received immunoglobulin, blood-derived products, or immunosuppressant drugs within 90
days prior to first study vaccination
Active cancer (malignancy) on therapy within 3 years prior to first study vaccination
(with the exception of adequately treated non-melanomatous skin carcinoma or lentigo
maligna and uterine cervical carcinoma in situ without evidence of disease, at the
discretion of the investigator)
Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to
the end of study
Suspected or known history of alcohol abuse or drug addiction within 2 years prior to
the first study vaccine dose that, in the opinion of the investigator, might interfere
with protocol compliance
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 study vaccine
or interpretation of study results (including neurologic or psychiatric conditions
likely to impair the quality of safety reporting)
Study team member or immediate family member of any study team member (inclusive of
Sponsor, CRO, and study site personnel involved in the conduct or planning of the
study)
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