Evaluation of the Safety and Immunogenicity of SII Vaccine Constructs Based on the SARS-CoV-2 (COVID-19) Variant in Adults

NCT ID: NCT05029856

Last Updated: 2022-05-31

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-04
• Study Completion Date: 2022-08-31

Brief Summary

This is a randomized, observer-blinded, Phase 1/2 study with an open-label group to evaluate the safety and immunogenicity of 3 novel SARS-CoV-2 variant vaccine constructs adjuvanted with Matrix-M1 adjuvant. Investigational products will include a monovalent SII SARS-CoV-2 B.1.351 (Beta) variant vaccine (SII B.1.351), a bivalent SII vaccine containing antigen for both the ancestral strain and B.1.351 (Beta) variant of SARS-CoV-2 (SII Bivalent), and a monovalent SII SARS-CoV-2 B.1.617.2 (Delta) variant vaccine (SII B.1.617.2).

Conditions

Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Group A- SII B.1.351 Vaccine / Matrix-M1 Adjuvant

2 doses of 3 μg SII B.1.351 Vaccine+ 50 μg Matrix-M1 adjuvant (co-formulated) . 1 dose each on Days 0 and Day 21.

Group Type: EXPERIMENTAL

SII B.1.351

Intervention Type: BIOLOGICAL

Intramuscular (deltoid) injections of 3 μg SII B.1.351 and 50 μg Matrix-M1 Adjuvant,

1 or 2 doses:1 on Day 0 and ± 1 on Day 21.

Group B- SII B.1.351 Vaccine / Matrix-M1 Adjuvant

2 doses of 5 μg SII B.1.351 Vaccine+ 50 μg Matrix-M1 adjuvant (co-formulated) . 1 dose each on Days 0 and Day 21.

Group Type: EXPERIMENTAL

SII B.1.351

Intervention Type: BIOLOGICAL

Intramuscular (deltoid) injections of 5 μg SII B.1.351 and 50 μg Matrix-M1 Adjuvant,

1 or 2 doses:1 on Day 0 and ± 1 on Day 21.

Group C- SII B.1.351 Vaccine / Matrix-M1 Adjuvant

1 dose of 3 μg SII B.1.351 Vaccine+ 50 μg Matrix-M1 adjuvant (co-formulated) .1 dose on Day 0.

Group Type: EXPERIMENTAL

SII B.1.351

Intervention Type: BIOLOGICAL

Intramuscular (deltoid) injections of 3 μg SII B.1.351 and 50 μg Matrix-M1 Adjuvant,

1 or 2 doses:1 on Day 0 and ± 1 on Day 21.

Group D - SII B.1.351 Vaccine / Matrix-M1 Adjuvant

1 dose of 5 μg SII B.1.351 Vaccine + 50 μg Matrix-M1 adjuvant (co-formulated) .1 dose on Day 0.

Group Type: EXPERIMENTAL

SII B.1.351

Intervention Type: BIOLOGICAL

Intramuscular (deltoid) injections of 5 μg SII B.1.351 and 50 μg Matrix-M1 Adjuvant,

1 or 2 doses:1 on Day 0 and ± 1 on Day 21.

Group E -SII Bivalent Vaccine / Matrix-M1 Adjuvant

2 doses of 6 μg SII Bivalent Vaccine+ 50 μg Matrix-M1 adjuvant (co-formulated) . 1 dose each on Days 0 and Day 21.

Group Type: EXPERIMENTAL

SII Bivalent

Intervention Type: BIOLOGICAL

Intramuscular (deltoid) injections of 6 μg SII Bivalent and 50 μg Matrix-M1 Adjuvant, 2 doses: 1 on Day 0 and 1 on Day 21.

Group F- SII Bivalent Vaccine / Matrix-M1 Adjuvant

2 doses of 10 μg SII Bivalent Vaccine+ 50 μg Matrix-M1 adjuvant (co-formulated) . 1 dose each on Days 0 and Day 21.

Group Type: EXPERIMENTAL

SII Bivalent

Intervention Type: BIOLOGICAL

Intramuscular (deltoid) injections of 10 μg SII Bivalent and 50 μg Matrix-M1 Adjuvant, 2 doses: 1 on Day 0 and 1 on Day 21.

Group G- SII B.1.617.2 Vaccine / Matrix-M1 Adjuvant

2 doses of 5 μg SII B.1.617.2 Vaccine+ 50 μg Matrix-M1 adjuvant (co-formulated) . 1 dose each on Days 0 and Day 21.

Group Type: EXPERIMENTAL

SII B.1.617.2

Intervention Type: BIOLOGICAL

Intramuscular (deltoid) injections of 5 μg SII B.1.617.2 and 50 μg Matrix-M1 Adjuvant,

1 or 2 doses:1 on Day 0 and ± 1 on Day 21.

Group H- SII B.1.617.2 Vaccine / Matrix-M1 Adjuvant

1 doses of 5 μg SII B.1.617.2 Vaccine+ 50 μg Matrix-M1 adjuvant (co-formulated) . 1 dose on Days 0.

Group Type: EXPERIMENTAL

SII B.1.617.2

Intervention Type: BIOLOGICAL

Intramuscular (deltoid) injections of 5 μg SII B.1.617.2 and 50 μg Matrix-M1 Adjuvant,

1 or 2 doses:1 on Day 0 and ± 1 on Day 21.

Interventions

SII B.1.351

Intramuscular (deltoid) injections of 3 μg SII B.1.351 and 50 μg Matrix-M1 Adjuvant,

1 or 2 doses:1 on Day 0 and ± 1 on Day 21.

Intervention Type: BIOLOGICAL

SII B.1.351

Intramuscular (deltoid) injections of 5 μg SII B.1.351 and 50 μg Matrix-M1 Adjuvant,

1 or 2 doses:1 on Day 0 and ± 1 on Day 21.

Intervention Type: BIOLOGICAL

SII Bivalent

Intramuscular (deltoid) injections of 6 μg SII Bivalent and 50 μg Matrix-M1 Adjuvant, 2 doses: 1 on Day 0 and 1 on Day 21.

Intervention Type: BIOLOGICAL

SII Bivalent

Intramuscular (deltoid) injections of 10 μg SII Bivalent and 50 μg Matrix-M1 Adjuvant, 2 doses: 1 on Day 0 and 1 on Day 21.

Intervention Type: BIOLOGICAL

SII B.1.617.2

Intramuscular (deltoid) injections of 5 μg SII B.1.617.2 and 50 μg Matrix-M1 Adjuvant,

1 or 2 doses:1 on Day 0 and ± 1 on Day 21.

Intervention Type: BIOLOGICAL

Other Intervention Names

(Monovalent B.1.351 [Beta] variant strain vaccine); (Monovalent B.1.351 [Beta] variant strain vaccine); (Bivalent ancestral and B.1.351 [Beta] variant strain vaccine); (Bivalent ancestral and B.1.351 [Beta] variant strain vaccine); (Monovalent B.1.617.2 [Delta] variant strain vaccine)

Eligibility Criteria

Inclusion Criteria

1. Adults 18 to 64 years of age, inclusive, at screening.

2. Willing and able to give informed consent prior to study enrollment and to comply with study procedures.

3. Female 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 the end of the study OR agree to consistently use a medically acceptable method of contraception listed below from at least 28 days prior to enrollment and through the end of the study.

1. Condoms (male or female) with spermicide (if acceptable in country)

2. Diaphragm with spermicide

3. Cervical cap with spermicide

4. Intrauterine device

5. Oral or patch contraceptives

6. Norplant®, Depo-Provera®, or other in-country regulatory approved contraceptive method that is designed to protect against pregnancy

7. Abstinence, as a form of contraception, is acceptable if in line with the participant's lifestyle

4. Is medically stable, as determined by the investigator (based on a 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. Agrees to not participate in any other SARS-CoV-2 prevention or treatment trials for the duration of the study.

For previously vaccinated Participants (Groups C, D and H):

6. Documented receipt of 2 doses of the investigational Novavax vaccine with Matrix-M1 adjuvant (NVX-CoV2373) administered approximately 21 days apart or 2 doses of a TGA-authorized/approved COVID-19 vaccine administered at least 60 days prior to first study vaccination.

Exclusion Criteria

If an individual meets any of the following criteria, he or she is ineligible for this study:

1. History of laboratory-confirmed (by PCR or serology to SARS-CoV-2) COVID-19 infection at any time prior to randomization/enrollment.

2. Previous receipt of any investigational or authorized/approved vaccine, prophylactic or therapeutic agent for the prevention or treatment of SARS-CoV-2 infection, except for previously vaccinated participants.

3. Participation in research involving receipt of investigational products (drug/biologic/device) within 90 days prior to first study vaccination.

4. Received influenza vaccination within 14 days prior to first study vaccination, or any other vaccine within 30 days prior to the first study vaccination.

5. Any known allergies to products contained in the investigational product.

6. Any history of anaphylaxis to any prior vaccine.

7. Autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) requiring ongoing immunomodulatory therapy.

8. Chronic administration (defined as > 14 continuous days) of immunosuppressants, 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 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).

11. Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the end of study.

12. 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.

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 study vaccine or interpretation of study results (including neurologic or psychiatric conditions likely to impair the quality of safety reporting).

14. 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novavax

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Development

Role: STUDY_DIRECTOR

Novavax

Locations

Australian Clinical Research Network (ACRN)

Maroubra, New South Wales, Australia

Holdsworth House Medical Practice - Sydney

Sydney, New South Wales, Australia

University Hospital Geelong-Barwon Health

Geelong, Victoria, Australia

Emeritus Research

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

2019nCoV-102

Identifier Type: -

Identifier Source: org_study_id