Other substances

NVX-CoV2373

A COVID-19 candidate subunit vaccine.

Phase of research

Potential treatment - clinical evidence

How it helps

Vaccine

Drug status

Experimental

Supporting references

Contradictory references

AI-suggested references

Clinical trials

General information

NVX-CoV2373 is a candidate vaccine being developed by Novavax. It is a VLP-recombinant protein nanoparticle vaccine + Matrix-M™ (adjuvant). NVX-CoV2373 uses full-length SARS-CoV-2 Spike protein optimized for baculovirus-insect cell (Sf9) expression system as an immunogen (Guebre-Xabier et al., 2020; Tian et al., 2021) . It is based on the Protein Subunit platform, which is also used for non-COVID-19 candidates such as RSV, CCHF, HPV, VZV, and EBOV. Currently, this COVID-19 candidate vaccine is in Phase 3 of clinical evaluation. On January 28, 2021, Novavax reported that their vaccine demonstrated 89.3% efficacy in Phase 3 trials in the UK. Moreover, it also demonstrated significant clinical efficacy against both the rapidly emerging UK and South Africa variants.

On June 14, 2021, Novavax announced that NVX-CoV2373, its recombinant nanoparticle protein-based COVID-19 vaccine, demonstrated 100% protection against moderate and severe disease, 90.4% efficacy overall, and met the primary endpoint in its PREVENT-19 pivotal Phase 3 trial.

Synonyms

SARS-CoV-2 rS/Matrix-M1 Adjuvant

Supporting references

Link	Tested on	Impact factor	Notes	Publication date
DRAFT landscape of COVID-19 candidate vaccines – 26 March 2020	in vitro			Mar/26/2020
SARS-CoV-2 spike glycoprotein vaccine candidate NVX-CoV2373 immunogenicity in baboons and protection in mice Spike protein ACE2 Biophysical assay Animal model In vitro Mechanism Mixed substance	in vitro biophysical assay; Vero E6 cells; female BALB/c mice; olive baboons; SARS-CoV-2 strain WA1	12.12	The vaccine particles are thermostable and strongly bind to hACE2 receptor in vitro. The vaccine (Matrix-M-adjuvated) elicits potent immune response in mice. Detected were induced anti-S (SARS-CoV-2) IgGs and T cell (CD4+ and CD8+), CD4+ Tfh cell, and GC B cell responses. Induced antibodies neutralized SARS-CoV-2 in vitro. Immunized mice were protected in a viral challenge (reduction of viral loads and lung pathology) and displayed no signs of viral disease enhancement. Potent anti-S and neutralizing antibody responses together with antigen-specific T cell production was also detected in immunized baboons.	Jan/14/2021
Phase 1–2 Trial of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine Randomized controlled single-blind trial Phase II clinical trial Phase I clinical trial	healthy human subjects	74.70	NVX-CoV2373 appeared to be safe, and it elicited immune responses that exceeded levels in Covid-19 convalescent serum. Sample size: 83 (with adjuvant) + 25 (without adjuvant) + 23 placebo. Dosage: 5-μg and 25-μg doses, with or without Matrix-M1 adjuvant; two IM injections, 21 days apart.	Sep/02/2020
NVX-CoV2373 vaccine protects cynomolgus macaque upper and lower airways against SARS-CoV-2 challenge Animal model Mixed substance	Vero E6 cells; Macaca fascicularis; SARS-CoV-2 (WA-1, 2020)	3.14	Administered in combination with Matrix-M™ adjuvant. High titres (compared to human COVID-19 convalescent plasma) of neutralizing antibodies and antibodies inhibiting spike-hACE2 interaction were produced in cell culture and in macaques. The vaccinated macaques had no detectable viral RNA in bronchoalveolar (BAL) fluid or nasal swab at day 4 (even by day 2, except for BAL fluid in the 2.5 μg group) post viral challenge. Sample size: 4 animals in each group. Dosage: 5 or 25 μg NVX-CoV2327 (+50 μg Matrix-M™ adjuvant) or 2.5 μg NVX-CoV2327 (+25 μg Matrix-M™ adjuvant) in two doses 21 days apart.	Oct/23/2020
SARS-CoV-2 variant B.1.1.7 is susceptible to neutralizing antibodies elicited by ancestral spike vaccines Spike protein RNA Protein factor Mixed substance Cohort study	Sera of vaccinated or convalescent adults; HEK293T/17 cells; SARS-CoV-2 Spike pseudovirus	15.92	Although the capacity of sera of vaccinated subjects and convalescent individuals to neutralize SARS-CoV-2 B.1.1.7 variant Spike pseudovirus decreased, the decrease was only modest (2.1-fold and 1.5-fold, respectively); therefore, SARS-CoV-2 variant B.1.1.7 should not be of a major concern for NVX-CoV2373 recipients and convalescent individuals.	Mar/05/2021
Neutralization of SARS-CoV-2 Variants B.1.429 and B.1.351 Spike protein RNA Protein factor Mixed substance Cohort study	Sera of vaccinated individuals; SARS-CoV-2 Spike pseudovirus (B.1.429 and B.1.351)	74.70	Sera from vaccinated individuals displayed only a modest decrease in neutralization capacity against SARS-CoV-2 Spike-psudotyped virus corresponding to the B.1.429 strain (“California”). The magnitude of decrease of neutralization titres against B.1.351 strain, however, was of a greater concern.	Apr/07/2021

AI-suggested references

Link	Publication date
In adults who had not had COVID-19, Novavax vaccine had 90% efficacy at >=7 d after the second dose.	May/03/2022
The Novavax vaccine had 90% efficacy against COVID-19 >=7 d after the second dose.	Nov/02/2021
Different dose regimens of a SARS-CoV-2 recombinant spike protein vaccine (NVX-CoV2373) in younger and older adults: A phase 2 randomized placebo-controlled trial	Jan/18/2022
Safety and immunogenicity of seven COVID-19 vaccines as a third dose (booster) following two doses of ChAdOx1 nCov-19 or BNT162b2 in the UK (COV-BOOST): a blinded, multicentre, randomised, controlled, phase 2 trial	Dec/02/2021
Calibrated comparison of SARS-CoV-2 neutralizing antibody levels in response to protein-, mRNA-, and vector-based COVID-19 vaccines	Sep/02/2020
Editorial: First Approval of the Protein-Based Adjuvanted Nuvaxovid (NVX-CoV2373) Novavax Vaccine for SARS-CoV-2 Could Increase Vaccine Uptake and Provide Immune Protection from Viral Variants	Mar/01/2022
Immunogenicity, safety, and reactogenicity of heterologous COVID-19 primary vaccination incorporating mRNA, viral-vector, and protein-adjuvant vaccines in the UK (Com-COV2): a single-blind, randomised, phase 2, non-inferiority trial.	Jan/01/2022
Fab and Fc contribute to maximal protection against SARS-CoV-2 following NVX-CoV2373 subunit vaccine with Matrix-M vaccination.	Aug/31/2021
Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine	Jun/30/2021
Efficacy of the NVX-CoV2373 Covid-19 Vaccine Against the B.1.351 Variant	May/05/2021
Safety and immunogenicity of NVX-CoV2373 (TAK-019) vaccine in healthy Japanese adults: Interim report of a phase I/II randomized controlled trial	Apr/29/2022
Immunogenicity and safety of a SARS-CoV-2 recombinant spike protein nanoparticle vaccine in people living with and without HIV-1 infection: a randomised, controlled, phase 2A/2B trial	Jan/05/2022
Potential implications of lipid nanoparticles in the pathogenesis of myocarditis associated with the use of mRNA vaccines against SARS-CoV-2.	Dec/17/2021
SARS-CoV-2 vaccination induces immunological T cell memory able to cross-recognize variants from Alpha to Omicron	Mar/30/2021
Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico	Dec/15/2021
Comparison of the immunogenicity & protective efficacy of various SARS-CoV-2 vaccine candidates in non-human primates	Dec/29/2020
Phase 1-2 Trial of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine.	Sep/02/2020
Prediction of long-term kinetics of vaccine-elicited neutralizing antibody and time-varying vaccine-specific efficacy against the SARS-CoV-2 Delta variant by clinical endpoint	Jan/28/2022
Safety, immunogenicity, and efficacy of a COVID-19 vaccine (NVX-CoV2373) co-administered with seasonal influenza vaccines: an exploratory substudy of a randomised, observer-blinded, placebo-controlled, phase 3 trial	Mar/30/2020

Clinical trials

ID	Title	Status	Phase	Start date	Completion date
NCT04611802	A Study to Evaluate the Efficacy, Immune Response, and Safety of a COVID-19 Vaccine in Adults ≥ 18 Years With a Pediatric Expansion in Adolescents (12 to < 18 Years) at Risk for SARS-CoV-2	Active, not recruiting	Phase 3	Dec/27/2020	Jun/30/2023
Alternative id - 2019nCoV-301 Interventions - Biological: SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial Vaccination Period)\|Other: Placebo (Initial Vaccination Period)\|Biological: SARS-CoV-2 rS/Matrix-M1 Adjuvant (Crossover Vaccination period)\|Other: Placebo (Crossover Vaccination period) Study type - Interventional Study results - No Results Available Locations - Alabama Clinical Therapeutics, Llc (Pediatric Site), Birmingham, Alabama, United States\|Accel Research Sites (Adult Site), Birmingham, Alabama, United States\|Central Research Associates, Inc (Pediatric Site), Birmingham, Alabama, United States\|The Pain Center of Arizona (Adult Site), Phoenix, Arizona, United States\|Foothills Research Center-CCT Research (Pediatric Site), Phoenix, Arizona, United States\|Alliance for Multispecialty Research, LLC (Adult Site), Tempe, Arizona, United States\|Lynn Institute of the Ozarks (Adult Site), Little Rock, Arkansas, United States\|Preferred Research Partners, Inc. (Adult Site), Little Rock, Arkansas, United States\|Anaheim Clinical Trials (Adult Site), Anaheim, California, United States\|Advanced Clinical Research - Rancho Paseo (Pediatric & Adult Site), Banning, California, United States\|Coast Clinical Research, LLC (Pediatric Site), Bellflower, California, United States\|eStudy Site (Pediatric & Adult Site), Chula Vista, California, United States\|Premier Health Research Center, Llc (Pediatric Site), Downey, California, United States\|eStudySite - Corporate Offices (Adult Site), La Mesa, California, United States\|Paradigm Clinical Research Centers, Inc (Pediatric Site), La Mesa, California, United States\|WR-PRI, LLC (Adult Site), Los Alamitos, California, United States\|National Research Institute (Pediatric & Adult Site), Los Angeles, California, United States\|Transitional Research Group, Inc. (Pediatric & Adult Site), North Hollywood, California, United States\|Orange County Research Institute (Pediatric Site), Ontario, California, United States\|Empire Clinical Research (Pediatric & Adult Site), Pomona, California, United States\|University of California Davis Health (Pediatric & Adult Site), Sacramento, California, United States\|Benchmark Research (Pediatric & Adult Site), Sacramento, California, United States\|California Research Foundation (Pediatric & Adult Site), San Diego, California, United States\|Synexus Clinical Research US, Inc. (Adult Site), Vista, California, United States\|Dignity Health Medical Foundation - Woodland (Adult Site), Woodland, California, United States\|University of Colorado Hospital CRS (Pediatric & Adult Site), Aurora, Colorado, United States\|Lynn Institute of the Rockies (Adult Site), Colorado Springs, Colorado, United States\|Meridian Clinical Research (Pediatric Site), Washington, District of Columbia, United States\|Howard University Hospital Howard/ University College of Medicine (Adult Site), Washington, District of Columbia, United States\|University Clinical Research-Deland, LLC dba Accel Research Sites (Pediatric & Adult Site), DeLand, Florida, United States\|SIMED Health, LLC / SIMED Research (Adult Site), Gainesville, Florida, United States\|M D Clinical (Adult Site), Hallandale Beach, Florida, United States\|Research Centers of America (Pediatric & Adult Site), Hollywood, Florida, United States\|Jacksonville Center for Clinical Research (Pediatric & Adult Site), Jacksonville, Florida, United States\|Meridien Research/Accel Research (Pediatric & Adult site), Lakeland, Florida, United States\|Miami Veterans Affairs Medical Center (Adult Site), Miami, Florida, United States\|Suncoast Research Associates, LLC (Adult Site), Miami, Florida, United States\|Acevedo Clinical Research Associates (Pediatric Site), Miami, Florida, United States\|Suncoast Research Associates, LLC (Adult Site), Miami, Florida, United States\|Clinical Neuroscience Solutions Inc (Pediatric & Adult Site), Orlando, Florida, United States\|Headlands Research Orlando (Adult Site), Orlando, Florida, United States\|Synexus Clinical Research US, Inc (Adult Site), Pinellas Park, Florida, United States\|Asclepes Research Centers (Adult & Pediatric Site), Spring Hill, Florida, United States\|University of South Florida (Adult Site), Tampa, Florida, United States\|Tampa Heart & Cardiovascular Center (Adult Site), Tampa, Florida, United States\|Synexus Clinical Research US, Inc. (Adult Site), The Villages, Florida, United States\|Comprehensive Clinical Trials, Llc (Pediatric & Adult site), West Palm Beach, Florida, United States\|Emory University Hospital (Adult Site), Atlanta, Georgia, United States\|Atlanta - Morehouse School of Medicine (Adult Site), Atlanta, Georgia, United States\|Synexus Clinical Research US, Inc. (Adult Site), Atlanta, Georgia, United States\|Atlanta Center for Medical Research (Adult Site), Atlanta, Georgia, United States\|Tekton Research, Inc. (Pediatric Site), Chamblee, Georgia, United States\|IACT Health (DBA John B. Amos Cancer Center) (Adult Site), Columbus, Georgia, United States\|Clinical Research Atlanta (Adult Site), Stockbridge, Georgia, United States\|Advanced Clinical Research (Pediatric & Adult Site), Meridian, Idaho, United States\|Synexus (Adult Site), Chicago, Illinois, United States\|Cedar Crosse Research Center (Adult Site), Chicago, Illinois, United States\|Providea Health Partners LLC (Adult Site), Evergreen Park, Illinois, United States\|Synexus USA (Adult Site), Evansville, Indiana, United States\|Buynak Clinical Research, P.C. (Pediatric & Adult Site), Valparaiso, Indiana, United States\|University of Iowa Medical Center (Adult Site), Iowa City, Iowa, United States\|Meridian Clinical Research (Adult Site), Sioux City, Iowa, United States\|Johnson County Clin-Trials, Inc. (Pediatric & Adult Site), Lenexa, Kansas, United States\|Alliance for Multispecialty Research (AMR) (Pediatric Site), Newton, Kansas, United States\|AMR Wichita East (Formerly Heartland Research Associates) (Pediatric SIte), Wichita, Kansas, United States\|Kentucky Pediatric/Adult Research (Pediatric Site), Bardstown, Kentucky, United States\|Brownsboro Park Pediatrics (Pediatric Site), Louisville, Kentucky, United States\|Meridian Clinical Research, LLC (Adult Site), Baton Rouge, Louisiana, United States\|Meridian Clinical Research Baton Rouge (Pediatric Site), Baton Rouge, Louisiana, United States\|Med Pharmics, LLC (Pediatric & Adult Site), Metairie, Louisiana, United States\|Willis-Knighton Physician Network (Adult Site), Shreveport, Louisiana, United States\|c/o The Pediatric Center of Frederick LLC (Adult & Pediatric Site), Baltimore, Maryland, United States\|Beth Israel Deaconess Medical Center (Adult Site), Boston, Massachusetts, United States\|VA Ann Arbor Healthcare System (Adult Site), Ann Arbor, Michigan, United States\|Wayne State University/ Children's Hospital of Michigan (Adult Site), Detroit, Michigan, United States\|University of Minnesota (Adult Site), Minneapolis, Minnesota, United States\|Synexus Clinical Research US, Inc. (Adult Site), Richfield, Minnesota, United States\|MedPharmics, LLC-Biloxi (Pediatric & Adult Site), Gulfport, Mississippi, United States\|The Curators of University of Missouri (Adult Site), Columbia, Missouri, United States\|Sundance Clinical Research, LLC (Pediatric & Adult Site), Saint Louis, Missouri, United States\|Meridian Clinical Research (Adult & Pediatric Site), Norfolk, Nebraska, United States\|Meridian Clinical Research Associates, LLC (Pediatric & Adult Site), Omaha, Nebraska, United States\|University Of Nebraska Medical Center (Pediatric & Adult Site), Omaha, Nebraska, United States\|Synexus Clinical Research US, Inc. (Adult Site), Henderson, Nevada, United States\|Clinical Research Center of Nevada (Pediatric Site), Las Vegas, Nevada, United States\|Clinical Research Consortium (Adult Site), Las Vegas, Nevada, United States\|Meridian Clinical Research (Pediatric Site), Binghamton, New York, United States\|Stony Brook Responder Vaccine Program (Adult Site), Commack, New York, United States\|Weill Cornell Chelsea CRS (Adult Site), New York, New York, United States\|Rochester Clinical Research (Pediatric & Adult Site), Rochester, New York, United States\|University of North Carolina (Pediatric & Adult Site), Chapel Hill, North Carolina, United States\|The Charlotte-Mecklenburg Hospital Authority d/b/a Atrium Health (Pediatric & Adult Site), Charlotte, North Carolina, United States\|M3-Emerging Medical Research, LLC (Pediatric & Adult Site), Durham, North Carolina, United States\|Carolina Institute for Clinical Research (Adult Site), Fayetteville, North Carolina, United States\|Carolina Institute for Clinical Research (Adult Site), Fayetteville, North Carolina, United States\|Womack Army Medical Center (Adult Site), Fort Bragg, North Carolina, United States\|M3 Wake Research, Inc (Adult Site), Raleigh, North Carolina, United States\|PMG Research of Rocky Mount, LLC (Adult Site), Rocky Mount, North Carolina, United States\|Wake Forest Health Network - Pediatrics - Ford, Simpson, Lively & Rice (Pediatric Site), Salem, North Carolina, United States\|PMG Research of Wilmington, LLC (Adult Site), Wilmington, North Carolina, United States\|Synexus Clinical Research, US, Inc. (Adult Site), Akron, Ohio, United States\|Sterling Research Group, Ltd. (Adult Site), Cincinnati, Ohio, United States\|Synexus Clinical Research US, Inc. (Adult Site), Cincinnati, Ohio, United States\|Sterling Research Group, Ltd (Pediatric & Adult Site), Cincinnati, Ohio, United States\|Dr. Shelly David Senders MD Inc. dba Senders Pediatrics (Pediatric Site), Cleveland, Ohio, United States\|Rapid Medical Research, Inc. (Pediatric & Adult Site), Cleveland, Ohio, United States\|Aventiv Research Inc (Pediatric Site), Columbus, Ohio, United States\|Medical Research International (Adult Site), Oklahoma City, Oklahoma, United States\|Lynn Health Science Institute (Pediatric & Adult Site), Oklahoma City, Oklahoma, United States\|CRISOR, LLC - Clinical Research Institute of Southern Oregon, PC (Pediatric & Adult Site), Medford, Oregon, United States\|Preferred Primary Care Physicians, Inc. (Pediatric Site), Pittsburgh, Pennsylvania, United States\|Velocity Clinical Research, Providence (Pediatric & Adult Site), East Greenwich, Rhode Island, United States\|The Miriam Hospital (TMH) (Adult Site), Providence, Rhode Island, United States\|Synexus Clinical Research US, Inc. (Adult Site), Anderson, South Carolina, United States\|Medical University of South Carolina, SCTR Research Nexus (Adult Site), Charleston, South Carolina, United States\|Coastal Carolina Research Center (Pediatric Site), North Charleston, South Carolina, United States\|Spartanburg Medical Research (Pediatric Site), Spartanburg, South Carolina, United States\|Missouri Breaks Industries Research Inc. (Pediatric & Adult Site), Eagle Butte, South Dakota, United States\|PMG Research of Bristol (Pediatric & Adult Site), Bristol, Tennessee, United States\|WR Clinsearch, LLC (Pediatric & Adult Site), Chattanooga, Tennessee, United States\|Holston Medical Group (Pediatric Site), Kingsport, Tennessee, United States\|PMG Research, Inc. d/b/a PMG Research of Knoxville (Adult Site), Knoxville, Tennessee, United States\|Clinical Neurosciecne Solutions, Inc. dba CNS Healthcare (Pediatric & Adult Site), Memphis, Tennessee, United States\|Clinical Research Associates (Pediatric Site), Nashville, Tennessee, United States\|Clinical and Translational Research Center at Meharry Medical College (Adult Site), Nashville, Tennessee, United States\|Benchmark Research (Pediatric & Adult Site), Austin, Texas, United States\|Ventavia Research Group, LLC (Pediatric Site), Fort Worth, Texas, United States\|Benchmark Research (Pediatric & Adult Site), Fort Worth, Texas, United States\|Ventavia Research Group, LLC (Pediatric Site), Houston, Texas, United States\|Baylor College of Medicine (Adult Site), Houston, Texas, United States\|DM Clinical Research - Pediatric Healthcare of NW Houston, P.A. (Pediatric Site), Houston, Texas, United States\|Texas Center for Drug Development, Inc (Pediatric & Adult Site), Houston, Texas, United States\|The University Of Texas Medical Branch (Utmb) (Pediatric Site), League City, Texas, United States\|Centex Studies, Inc (Adult Site), McAllen, Texas, United States\|Research Your Health (Pediatric & Adult site), Plano, Texas, United States\|Synexus, US - San Antonio (Adult Site), San Antonio, Texas, United States\|University of Texas Health Science Center San Antonio (Adult Site), San Antonio, Texas, United States\|Tekton Research, Inc. (Pediatric Site), San Antonio, Texas, United States\|DM Clinical Research (Pediatric & Adult Site), Tomball, Texas, United States\|Wee Care Pediatrics (Pediatric Site), Layton, Utah, United States\|Wee Care Pediatrics (Pediatric Site), Syracuse, Utah, United States\|Advanced Clinical Research (Adult Site), West Jordan, Utah, United States\|Pediatric Research of Charlottesville, LLC (Pediatric Site), Charlottesville, Virginia, United States\|Health Research of Hampton Roads, Inc (Pediatric & Adult Site), Newport News, Virginia, United States\|MultiCare Institute for Research & Innovation (Adult Site), Cheney, Washington, United States\|University of Washington VTEU (Adult Site), Seattle, Washington, United States\|PanAmerican Clinical Research Mexico S.A de C.V (Adult Site), Guadalajara, Jalisco, Mexico\|Instituto Nacional de Salud Publica (INSP) - Cuernavaca - Centro de Investigacion en Salud Poblacional (CISP) (Adult Site), Cuernavaca, Morelos, Mexico\|PanAmerican Clinical Research Mexico (Adult Site), Juriquilla, Queretaro, Mexico\|Unidad de Atencion Medica e Investigacion en Salud (UNAMIS) (Adult Site), Merida, Yucatan, Mexico\|CAIMED Investigacion en Salud S.A de C.V (Adult Site), Mexico City, Mexico\|Caimed Investigacion en Salud S.A. de C.V. (Adult Site), Mexico City, Mexico\|Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (Adult Site), Mexico City, Mexico\|FAICIC S. DE R.L. DE C.V. (Adult Site), Veracruz, Mexico\|Ponce Medical School Foundation Inc. / CAIMED Cneter (Pediatric & Adult Site), Ponce, Puerto Rico\|University of Puerto Rico Medical Sciences Campus Maternal Infant Studies Center (Adult Site), San Juan, Puerto Rico Study designs - Allocation: Randomized\|Intervention Model: Crossover Assignment\|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)\|Primary Purpose: Prevention Enrollment - 33000 Age - 12 Years and older (Child, Adult, Older Adult) Outcome measures - Adult Main Study and Pediatric Expansion: Participants with Symptomatic Mild, Moderate, or Severe Coronavirus Disease 2019 (COVID-19)\|Pediatric Expansion: Reactogenicity Incidence and Severity\|Pediatric Expansion: Incidence and Severity of Medically Attended Adverse Events (MAAEs) Through Day 49\|Pediatric Expansion: Incidence and Severity of Unsolicited Adverse Events (AEs) Through Day 49\|Pediatric Expansion: Incidence and Severity of MAAEs Attributed to Study Vaccine Through Month 12\|Pediatric Expansion: Incidence and Severity of Serious Adverse Events (SAEs) Through Month 12\|Pediatric Expansion: Incidence and Severity of Adverse Events of Special Interest (AESIs) Through Month 12\|Pediatric Expansion: Incidence and Severity of SAEs from Month 12 to Month 24\|Pediatric Expansion: Incidence and Severity of MAAEs Attributed to Study Vaccine from Month 12 to Month 24\|Pediatric Expansion: Incidence and Severity of AESIs from Month 12 to Month 24\|Pediatric Expansion: Antibodies to SARS-CoV-2 Nucleoprotein (NP) at Specific Time Points\|Pediatric Expansion: Deaths Due to Any Cause\|Adult Main Study and Pediatric Expansion: Participants with Symptomatic Moderate or Severe COVID-19\|Adult Main Study and Pediatric Expansion: Participants with Any Symptomatic COVID-19\|Adult Main Study and Pediatric Expansion: Neutralizing Antibody Activity Expressed as Geometric Mean Titers (GMTs)\|Adult Main Study and Pediatric Expansion: Neutralizing Antibody Activity Expressed as Geometric Mean Fold Rises (GMFRs)\|Adult Main Study and Pediatric Expansion: Serum Immunoglobulin G (IgG) Antibody Levels Expressed as GMTs\|Adult Main Study and Pediatric Expansion: Serum IgG Antibody Levels Expressed as GMFRs\|Adult Main Study and Pediatric Expansion: Human Angiotensin-Converting Enzyme 2 (hACE2) Receptor Binding Inhibition Assay Expressed as GMTs\|Adult Main Study and Pediatric Expansion: hACE2 Receptor Binding Inhibition Assay Expressed as GMFRs\|Adult Main Study and Pediatric Expansion: Serum Immunoglobulin G (IgG) Antibody Levels Expressed as GMTs at Later Time Points\|Adult Main Study and Pediatric Expansion: Serum Immunoglobulin G (IgG) Antibody Levels Expressed as GMFRs at Later Time Points\|Adult Main Study and Pediatric Expansion: hACE2 Receptor Binding Inhibition Assay Expressed as GMTs at Later Time Points\|Adult Main Study and Pediatric Expansion: hACE2 Receptor Binding Inhibition Assay Expressed as GMFRs at Later Time Points\|Adult Main Study and Pediatric Expansion: Neutralizing Antibody Activity Expressed as GMTs at Later Time Points\|Adult Main Study and Pediatric Expansion: Neutralizing Antibody Activity Expressed as GMFRs at Later Time Points\|Adult Main Study and Pediatric Expansion: Description of Course, Treatment and Severity of COVID-19\|Adult Main Study: Reactogenicity Incidence and Severity\|Adult Main Study: Incidence and Severity of Medically Attended Adverse Events (MAAEs) Through Day 49\|Adult Main Study: Incidence and Severity of Unsolicited Adverse Events (AEs) Through Day 49\|Adult Main Study: Incidence and Severity of MAAEs Attributed to Study Vaccine Through Month 12\|Adult Main Study: Incidence and Severity of Serious Adverse Events (SAEs) Through Month 12\|Adult Main Study: Incidence and Severity of Adverse Events of Special Interest (AESIs) Through Month 12\|Adult Main Study: Incidence and Severity of SAEs from Month 12 to Month 24\|Adult Main Study: Incidence and Severity of MAAEs Attributed to Study Vaccine from Month 12 to Month 24\|Adult Main Study: Incidence and Severity of AESIs from Month 12 to Month 24\|Adult Main Study and Pediatric Expansion: Antibodies to SARS-CoV-2 Nucleoprotein (NP) at Specific Time Points\|Adult Main Study and Pediatric Expansion: Antibodies to SARS-CoV-2 Nucleoprotein (NP) at Any Time Point\|Adult Main Study: IgG antibodies to SARS-CoV-2 rS at Day 35 After First Crossover Vaccination\|Adult Main Study : Deaths Due to Any Cause\|Adult Main Study and Pediatric Expansion: Participants with 1st episode of positive Polymerase Chain Reaction (PCR) for Coronavirus Disease 2019 (COVID-19) due to a variant not considered as a "variant of concern/interest"
NCT04834869	COVID-19 Vaccines Safety Tracking (CoVaST)	Recruiting		Apr/01/2021	Jan/31/2022
Alternative id - CoVaST Interventions - Biological: BNT162b2\|Biological: mRNA-1273\|Biological: AZD1222\|Biological: CoronaVac\|Biological: Sinopharm\|Biological: Gam-COVID-Vac\|Biological: JNJ-78436735\|Biological: CVnCoV\|Biological: NVX-CoV2373\|Biological: BBV152 Study type - Observational Study results - No Results Available Locations - American College of Physicians, Philadelphia, Pennsylvania, United States\|McMaster University, Hamilton, Ontario, Canada\|University of Split, Split, Croatia\|Masaryk University, Brno, Czechia\|University of Tartu, Tartu, Estonia\|Jimma University, Jimma, Ethiopia\|Justus-Liebig University Giessen, Giessen, Germany\|University of Ghana, Accra, Ghana\|Sinaloa's Pediatric Hospital, Culiacán, Mexico\|Medical University of Silesia, Katowice, Poland\|Nursing School of Coimbra, Coimbra, Portugal\|Irkutsk Scientific Center of Siberian Branch of Russian Academy of Sciences, Irkutsk, Russian Federation\|University of Belgrade, Belgrade, Serbia\|University of Ljubljana, Ljubljana, Slovenia Study designs - Observational Model: Other\|Time Perspective: Prospective Enrollment - 30000 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Local Side Effects\|Systemic Side Effects\|Unrecognized Side Effects
NCT05112848	A Study to Evaluate Safety and Immunogenicity of a COVID-19 Vaccine in People Living With HIV at Risk for SARS-CoV-2 (COVID-19)	Not yet recruiting	Phase 2	Feb/01/2022	Jul/01/2022
Alternative id - 2019nCoV-505 Interventions - Biological: NVX-CoV2373 Study type - Interventional Study results - No Results Available Locations - Study designs - Allocation: Randomized\|Intervention Model: Parallel Assignment\|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)\|Primary Purpose: Prevention Enrollment - 360 Age - 18 Years to 65 Years (Adult, Older Adult) Outcome measures - Number of PLWH with unsolicited adverse events (AEs)\|Number of HIV-Negative participants with unsolicited AEs\|Number of PLWH with unsolicited AEs\|Number of PLWH with solicited systemic AEs\|Number of HIV-Negative participants with solicited systemic AEs\|Number of PLWH with solicited local AEs\|Number of HIV-Negative participants with solicited local AEs\|Serum Immunoglobulin (IgG) antibody levels expressed as geometric mean enzyme-linked immunosorbent assay units (GMEU)\|Serum IgG antibody levels expressed as geometric mean fold rise (GMFR)\|Serum IgG antibody levels expressed as seroconversion rate (SCR)\|Human angiotensin-converting enzyme 2 (hACE2) receptor binding inhibition assay expressed as geometric mean titer (GMT)\|hACE2 receptor binding inhibition assay expressed as GMFR\|hACE2 receptor binding inhibition assay expressed as SCR\|Neutralizing antibody activity expressed as GMT\|Neutralizing antibody activity expressed as SCR\|Neutralizing antibody activity expressed as GMFR\|Serum IgG antibody levels expressed as GMEU\|Serum IgG antibody levels expressed as GMFR\|Serum IgG antibody levels expressed as SCR
NCT05249816	Phase 3 Study to Evaluate a Single Booster of the NVX-CoV2373 COVID19 Vaccine in Adults	Not yet recruiting	Phase 3	Mar/01/2022	Sep/30/2022
Alternative id - G42-HC-2021001 Interventions - Drug: NVX-CoV2373 with Matrix-M adjuvant Injection\|Drug: BBIBP-CorV vaccine Study type - Interventional Study results - No Results Available Locations - Cleveland Clinic Abu Dhabi, Abu Dhabi, United Arab Emirates\|Sheikh Khalifa Medical City (SKMC), Abu Dhabi, United Arab Emirates Study designs - Allocation: Randomized\|Intervention Model: Parallel Assignment\|Masking: Triple (Participant, Care Provider, Investigator)\|Primary Purpose: Prevention Enrollment - 1000 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Utilizing ratio of IgG GMTs and difference in seroconversion rates to compare IgG antibody responses between the vaccines.\|Utilizing Case Report Forms and safety follow up via telephone to measure and assess incidence, duration, and severity of solicited local and systemic adverse events (AEs)\|Utilizing Case Report Forms to measure and assess Incidence, duration, severity, and relationship of unsolicited AEs\|Utilizing Case Report Forms to measure incidence and relationship of medically attended adverse events (MAAEs), adverse events of special interest (AESIs) (predefined list), and serious adverse events (SAEs) throughout the study.\|Utilizing Plaque Reduction Neutralization Tests (PRNT) to compare neutralizing antibody responses
NCT04533399	A Study Looking at the Effectiveness and Safety of a COVID-19 Vaccine in South African Adults	Completed	Phase 2	Aug/17/2020	Jan/19/2022
Alternative id - 2019nCoV-501 Interventions - Biological: SARS-CoV-2 rS/Matrix-M1 Adjuvant\|Other: Placebo Study type - Interventional Study results - No Results Available Locations - ZA018, Bloemfontein, Free State Of South Africa, South Africa\|ZA003, Hillbrow, Gauteng, South Africa\|Site ZA001, Johannesburg, Gauteng, South Africa\|ZA012, Johannesburg, Gauteng, South Africa\|Site ZA015, Pretoria, Gauteng, South Africa\|ZA023, Pretoria, Gauteng, South Africa\|ZA019, Durban, KwaZulu-Natal, South Africa\|ZA020, Durban, KwaZulu-Natal, South Africa\|ZA021, Durban, KwaZulu-Natal, South Africa\|ZA024, Durban, KwaZulu-Natal, South Africa\|ZA007, Thabazimbi, Limpopo, South Africa\|ZA022, Madibeng, North-West, South Africa\|ZA013, Cape Town, Western Cape, South Africa\|ZA014, Worcester, Western Cape, South Africa Study designs - Allocation: Randomized\|Intervention Model: Sequential Assignment\|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)\|Primary Purpose: Prevention Enrollment - 4422 Age - 18 Years to 84 Years (Adult, Older Adult) Outcome measures - Cohort 1: HIV- Participants with Symptomatic Mild, Moderate, or Severe COVID-19\|Cohort 2: HIV + Participants with Symptomatic Mild, Moderate, or Severe COVID-19\|Cohort 1: HIV- Participants with Solicited Adverse Events (AEs)\|Cohort 1: HIV- Participants with Unsolicited AEs\|Cohort 2: HIV+ Participants with Solicited AEs\|Cohort 2: HIV+ Participants with Unsolicited AEs\|Cohort 2: Serum Immunoglobulin G (IgG) Antibody Levels Expressed as Geometric Mean Titers (GMTs)\|Cohort 2: Serum IgG Antibody Levels Expressed as Geometric Mean Fold Rises (GMFRs)\|Cohort 2: Serum IgG Antibody Levels Expressed as Seroconversion Rates (SCRs)\|Healthcare Worker Expansion (Cohort 3): Participants with AESI's\|Healthcare Worker Expansion (Cohort 4): Participants with AESI's\|Cohort 1: HIV- Participants with Individual Strata of Symptomatic Virologically Confirmed, Mild, Moderate, or Severe COVID-19\|Cohort 1: HIV- Participants with COVID-19 Requiring Hospitalization\|Cohort 1: Incidence, Maximum Severity Score, and Symptom Duration of SARS-CoV-2 Infection by Severity Classification\|Cohort 1: Serum IgG Antibody Levels at Multiple Time Points Expressed as GMTs\|Cohort 1: Serum IgG Antibody Levels at Multiple Time Points Expressed as GMFRs\|Cohort 1: Serum IgG Antibody Levels at Multiple Time Points Expressed as SCRs\|Cohort 1: Angiotensin-Converting Enzyme 2 (ACE2) Receptor Binding Inhibition Assay Expressed as GMTs\|Cohort 1: ACE2 Receptor Binding Inhibition Assay Expressed as GMFRs\|Cohort 1: ACE2 Receptor Binding Inhibition Assay Expressed as SCRs\|Cohort 1: ACE2 Receptor Binding Inhibition Assay Expressed as Seroresponse Rates (SRRs)\|Cohort 1: Neutralizing Antibody Activity Expressed as GMTs\|Cohort 1: Neutralizing Antibody Activity Expressed as GMFRs\|Cohort 1: Neutralizing Antibody Activity Expressed as SCRs\|Cohort 1: Neutralizing Antibody Activity Expressed as SRRs\|Cohort 1: HIV- Participants with Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs)\|Cohort 2: Serum IgG Antibody Levels at Multiple Time Points Expressed as GMTs\|Cohort 2: Serum IgG Antibody Levels at Multiple Time Points Expressed as GMFRs\|Cohort 2: Serum IgG Antibody Levels at Multiple Time Points Expressed as SCRs\|Cohort 2: ACE2 Receptor Binding Inhibition Assay Expressed as GMTs\|Cohort 2: ACE2 Receptor Binding Inhibition Assay Expressed as GMFRs\|Cohort 2: ACE2 Receptor Binding Inhibition Assay Expressed as SCRs\|Cohort 2: ACE2 Receptor Binding Inhibition Assay Expressed as SRRs\|Cohort 2: Neutralizing Antibody Activity Expressed as GMTs\|Cohort 2: Neutralizing Antibody Activity Expressed as GMFRs\|Cohort 2: Neutralizing Antibody Activity Expressed as SCRs\|Cohort 2: Neutralizing Antibody Activity Expressed as SRRs\|Cohort 2: HIV+ Participants with MAAEs, AESIs, and SAEs\|Cohort 2: HIV+ Participants with Symptomatic Virologically Confirmed, Mild, Moderate, or Severe COVID-19\|Cohort 2: Incidence, Maximum Severity Score, and Symptom Duration of SARS-CoV-2 Infection by Severity Classification\|Cohort 1: HIV- Participants with Asymptomatic, Symptomatic Mild, Moderate, or Severe COVID-19\|Cohort 2: HIV+ Participants with Asymptomatic, Symptomatic Mild, Moderate, or Severe COVID-19\|Healthcare Worker Expansion (Cohort 3): Serum IgG Antibody Expressed as GMT\|Healthcare Worker Expansion (Cohort 3): Serum IgG Antibody Expressed as GMEU\|Healthcare Worker Expansion (Cohort 3): Serum IgG Antibody Expressed as GMFR\|Healthcare Worker Expansion (Cohort 3): Serum IgG Antibody Expressed as SCR\|Healthcare Worker Expansion (Cohort 4): Serum IgG Antibody Expressed as GMT\|Healthcare Worker Expansion (Cohort 4): Serum IgG Antibody Expressed as GMEU\|Healthcare Worker Expansion (Cohort 4): Serum IgG Antibody Expressed as GMFR\|Healthcare Worker Expansion (Cohort 4): Serum IgG Antibody Expressed as SCR

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