COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05112848

Not reported

cbennett@novavax.com

2021-11-09

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

inclusion criteria: adults 18 to 65 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 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. condoms (male or female) with spermicide (if acceptable in-country) 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. vital signs must be within medically acceptable ranges prior to the first vaccination agree to not participate in any other sars-cov-2 prevention or treatment trials for the duration of the study. for well-controlled plwh plwh with a cluster of differentiation 4 (cd4) + t-cell count of ≥ 350 cells/μl at screening or viral load of ≤ 1,000 copies/ml. plwh being managed on a stable/unchanged antiretroviral therapy (art) regimen for at least 2 months prior to enrollment. no opportunistic infections in the past year. for less-well-controlled plwh plwh with a cd4+ t-cell count of ≥ 200 and < 350 cells/μl at screening or viral load of 1,000 to 10,000 copies/ml. plwh being managed on a stable/unchanged (art) regimen for at least 1 month prior to enrollment.

laboratory-confirmed sars-cov-2 infection (pcr+ within 5 days prior to first study vaccination with results available before randomization) or positive anti-s protein antibody to sars-cov-2 at screening. previous receipt of any investigational or authorized/approved vaccine, prophylactic or therapeutic agent for the prevention or treatment of covid-19. participation in research involving receipt of an investigational product (drug/biologic/device) within 90 days prior to the first study vaccination. received influenza vaccination within 14 days prior to first study vaccination, or any other vaccine 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. chronic administration (defined as > 14 continuous days) of immunosuppressant, systemic glucocorticoids, or other immune-modifying drugs within 90 days prior to first study vaccination. 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 trial 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, contract research organization, and study site personnel involved in the conduct or planning of the study).

5

Novavax

18

65

South Africa

High risk patients

N/A

384

hACE2 receptor binding inhibition assay expressed as GMFR;hACE2 receptor binding inhibition assay expressed as GMFR;hACE2 receptor binding inhibition assay expressed as GMFR;hACE2 receptor binding inhibition assay expressed as GMFR;hACE2 receptor binding inhibition assay expressed as SCR;hACE2 receptor binding inhibition assay expressed as SCR;hACE2 receptor binding inhibition assay expressed as SCR;hACE2 receptor binding inhibition assay expressed as SCR;Human angiotensin-converting enzyme 2 (hACE2) receptor binding inhibition assay expressed as geometric mean titer (GMT);Human angiotensin-converting enzyme 2 (hACE2) receptor binding inhibition assay expressed as geometric mean titer (GMT);Human angiotensin-converting enzyme 2 (hACE2) receptor binding inhibition assay expressed as geometric mean titer (GMT);Human angiotensin-converting enzyme 2 (hACE2) receptor binding inhibition assay expressed as geometric mean titer (GMT);Neutralizing antibody activity expressed as GMFR;Neutralizing antibody activity expressed as GMFR;Neutralizing antibody activity expressed as GMT;Neutralizing antibody activity expressed as GMT;Neutralizing antibody activity expressed as SCR;Neutralizing antibody activity expressed as SCR;Number of HIV-Negative participants with solicited local AEs;Number of HIV-Negative participants with solicited local AEs;Number of HIV-Negative participants with solicited local AEs;Number of HIV-Negative participants with solicited systemic AEs;Number of HIV-Negative participants with solicited systemic AEs;Number of HIV-Negative participants with solicited systemic AEs;Number of HIV-Negative participants with unsolicited AEs;Number of HIV-Negative participants with unsolicited AEs;Number of HIV-Negative participants with unsolicited AEs;Number of PLWH with solicited local AEs;Number of PLWH with solicited local AEs;Number of PLWH with solicited local AEs;Number of PLWH with solicited systemic AEs;Number of PLWH with solicited systemic AEs;Number of PLWH with solicited systemic AEs;Number of PLWH with unsolicited adverse events (AEs);Number of PLWH with unsolicited AEs;Number of PLWH with unsolicited AEs;Serum IgG antibody levels expressed as geometric mean fold rise (GMFR);Serum IgG antibody levels expressed as geometric mean fold rise (GMFR);Serum IgG antibody levels expressed as geometric mean fold rise (GMFR);Serum IgG antibody levels expressed as geometric mean fold rise (GMFR);Serum IgG antibody levels expressed as seroconversion rate (SCR);Serum IgG antibody levels expressed as seroconversion rate (SCR);Serum IgG antibody levels expressed as seroconversion rate (SCR);Serum IgG antibody levels expressed as seroconversion rate (SCR);Serum Immunoglobulin (IgG) antibody levels expressed as geometric mean enzyme-linked immunosorbent assay units (GMEU);Serum Immunoglobulin (IgG) antibody levels expressed as geometric mean enzyme-linked immunosorbent assay units (GMEU);Serum Immunoglobulin (IgG) antibody levels expressed as geometric mean enzyme-linked immunosorbent assay units (GMEU);Serum Immunoglobulin (IgG) antibody levels expressed as geometric mean enzyme-linked immunosorbent assay units (GMEU)

None

Phase 2

[{"arm_notes": "Two doses of 5\u03bcg Day 0 and Day 21; placebo Day 70.", "treatment_id": 918, "treatment_name": "Nvx-cov2373", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Three doses of 5\u03bcg Day 0, Day 21, and Day 70.", "treatment_id": 918, "treatment_name": "Nvx-cov2373", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Two doses of 5\u03bcg Day 0 and Day 70; placebo Day 21.", "treatment_id": 918, "treatment_name": "Nvx-cov2373", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "HIV-Negative Participants; 2 doses of 5\u03bcg ; Day 0 and Day 21 and placebo Day 70.", "treatment_id": 918, "treatment_name": "Nvx-cov2373", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "HIV-Negative Participants; Two doses of 5\u03bcg Day 0 and Day 70 and placebo Day 21.", "treatment_id": 918, "treatment_name": "Nvx-cov2373", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}]