covid-19 vaccine clinical research covid-19 vaccine clinical research covid-19 vaccine clinical research uses clinical research to establish the characteristics of covid-19 vaccines. these characteristics include efficacy, effectiveness and safety. as of november 2022, 40 vaccines are authorized by at least one national regulatory authority for public use: one dna vaccine: zycov-d four rna vaccines: pfizer–biontech, moderna, walvax, and gemcovac twelve inactivated vaccines: chinese academy of medical sciences, coronavac, covaxin, covivac, coviran barekat, fakhravac, minhai-kangtai, qazvac, sinopharm bibp, wibp, turkovac, and vla2001. six viral vector vaccines: sputnik light, sputnik v, oxford–astrazeneca, convidecia, janssen, and incovacc sixteen subunit vaccines: abdala, corbevax, covax-19, epivaccorona, indovac, mvc-cov1901, noora, novavax, razi cov pars, sanofi–gsk, sinopharm cnbg, skycovione, soberana 02, soberana plus, v-01, and zf2001. one virus-like particle vaccine: covlp 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ireland malaysia new zealand russia uk us covid-19 portal as of june 2022, 353 vaccine candidates are in various stages of development, with 135 in clinical research, including 38 in phase i trials, 32 in phase i–ii trials, 39 in phase iii trials, and 9 in phase iv development. formulation a wide variety of technologies are being used to formulate vaccines against covid-19. the development and deployment of mrna vaccines and viral vector vaccines has been outstandingly rapid and can be described as revolutionary. however, global vaccine equity against covid-19 has not been achieved. conventional vaccine manufacturing approaches using whole inactivated virus (wiv), protein-based subunit vaccines, and virus-like particles (vlps) may offer advantages in the development of vaccines for use in low- and middle-income countries (lmics) and in addressing vaccine access gaps. many vaccine candidates use adjuvants to enhance immunogenicity, as part of the delivery system or as an accompanying immune stimulant. vaccine adjuvant formulations using aluminum salts or "alum" may be particularly effective for technologies using inactivated covid-19 virus and for recombinant protein-based or vector-based vaccines. status clinical trials main article: clinical trial the clinical trial process typically consists of three phases, each following the success of the prior phase. trials are doubly blind in that neither the researcher nor the subject know whether they receive the vaccine or a placebo. each phase involves randomly-selected subjects who are randomly assigned to serve either as recipients are controls: phase i trials test primarily for safety and preliminary dosing in healthy subjects. dozens of subjects. phase ii trials evaluate immunogenicity, dose levels (efficacy based on biomarkers) and adverse effects. hundreds of subjects. sometimes phase i and ii trials are combined. phase iii trials typically involve more participants at multiple sites, include a control group, and test effectiveness of the vaccine to prevent the disease (an "interventional" or "pivotal" trial), while monitoring for adverse effects at the selected dose. safety, efficacy, and clinical endpoints may vary, including the definition of side effects, infection or amount of transmission, and whether the vaccine prevents moderate or severe infection. a clinical trial design in progress may adopt an "adaptive design". if accumulating data provide insights about the treatment, the endpoints or other aspects or the trial can be adjusted. adaptive designs may shorten trial durations and use fewer subjects, possibly expediting decisions, avoiding duplication of research efforts, and enhancing coordination of design changes. vaccine candidates in human trials the table below shows various vaccine candidates and the phases which they had completed per the references. current phases are also shown along with other details. covid-19 candidate vaccines in phase i–iii trials covid‑19 vaccine candidates in phase i–iii trials () vaccine candidates,developers, and sponsors country of origin type (technology) current phase (participants)design completed phase (participants)immune response pending authorization sanofi–gsk covid-19 vaccine (vat00008, vidprevtyn)sanofi pasteur, gsk france, united kingdom subunit (sars-cov-2 s adjuvanted recombinant protein) phase iii (37,430)a parallel-group, phase iii, multi-stage, modified double-blind, multi-armed study to assess the efficacy, safety, and immunogenicity of two sars-cov-2 adjuvanted recombinant protein vaccines (monovalent and bivalent) for prevention against covid-19 in adults 18 years of age and older.may 2021 – mar 2023, colombia, dominican republic, ghana, honduras, india (3,000), japan, kenya, mexico, nigeria, pakistan, sri lanka, uganda, united states phase i–ii (1,160)phase i-iia (440): immunogenicity and safety of sars-cov-2 recombinant protein vaccine formulations (with or without adjuvant) in healthy adults 18 years of age and older.phase iib (720): immunogenicity and safety of sars-cov-2 recombinant protein vaccine with as03 adjuvant in adults 18 years of age and older.sep 2020 – apr 2022, united states emergency (5) eu canada usa uk who nanocovaxnanogen pharmaceutical biotechnology jsc vietnam subunit (sars‑cov‑2 recombinant spike protein with aluminum adjuvant) phase iii (13,000)adaptive, multicenter, randomized, double-blind, placebo-controlledjun 2021 – jul 2022, vietnam phase i–ii (620)phase i (60): open label, dose escalation.phase ii (560): randomization, double-blind, multicenter, placebo-controlled.dec 2020 – jun 2021, vietnam emergency (1) vietnam ub-612united biomedical,inc, vaxxinity, dasa brazil, taiwan, united states subunit (multitope peptide based s1-rbd-protein based vaccine) phase iii (18,320)phase iib/iii (7,320): randomized, multicenter, double-blind, placebo controlled, dose-response. phase iii (11,000)jan 2021 – mar 2023, taiwan (phase 2b/3), india (phase 3) phase i–ii (3,910)phase 1 (60): open-label study phase iia (3,850): placebo-controlled, randomized, observer-blind study.sep 2020 – jan 2021, taiwan emergency (1) taiwan scb-2019clover biopharmaceuticals, dynavax technologies, cepi china subunit (spike protein trimeric subunit with combined cpg 1018 and aluminium adjuvant) phase iii (30,300)phase ii/iii (30,000): randomized, double-blind, controlled. phase iii (300): double-blind, randomized, controlled.mar 2021 – oct 2022, belgium, brazil, colombia, dominican republic, germany, nepal, panama, the philippines, poland, south africa, ukraine phase i–ii (950)phase i (150): randomized, double-blind, placebo-controlled, first-in-human. phase ii (800): multi-center, double-blind, randomized, controlled.jun 2020 – oct 2021, australia (phase 1), china (phase 2) emergency (1) who s-268019shionogi japan subunit phase iii (54,915)phase ii/iii: open-label. phase iii: randomized, observer-blind, placebo-controlled cross-over.oct 2021 – dec 2022, japan (3,100), vietnam phase i–ii (300)randomized, double-blind, placebo-controlled, parallel-group.dec 2020 – aug 2021, japan west china hospital covid-19 vaccinejiangsu province centers for disease control and prevention, west china hospital (westvac biopharma), sichuan university china subunit (recombinant with sf9 cell) phase iii (40,000)multicenter, randomized, double-blind, placebo-controlled.jun 2021 – feb 2022, indonesia, kenya, malaysia, mexico, nepal, the philippines (5,000) phase i–ii (5,128)phase i (168): single-center, randomized, placebo-controlled, double-blind. phase iia (960):single-center, randomized, double-blinded, placebo-controlled.phase iib (4,000):single-center, randomized, double-blinded, placebo-controlled.aug 2020 – may 2021, china delns1-2019-ncov-rbd-opt (delns1-ncov-rbd laiv)beijing wantai biological pharmacy, university of hong kong, xiamen university china, hong kong replicating viral vector (flu-based-rbd) phase iii (40,000)multi-center, randomized, double-blind, placebo controlled.oct 2021 – apr 2022, the philippines phase i–ii (895)phase i (60+115=175) phase ii (720)sep 2020 – sep 2022, china (60), hong kong (115) versamune-cov-2fcfarmacore biotechnology, pds biotechnology corporation, faculty of medicine of ribeirão preto brazil, united states subunit phase iii (30,000)double-blind, randomized controlled.aug–dec 2021, brazil phase i–ii (360)double-blind, randomized controlled.mar–aug 2021, brazil walvax covid-19 vaccine (arcov)pla academy of military science, walvax biotech, suzhou abogen biosciences china rna phase iii (28,000)multi-center, randomized, double-blind, placebo-controlledmay–nov 2021, china, colombia, indonesia, malaysia, mexico, nepal, pakistan, the philippines, turkey phase i–ii (908)phase i (168)phase ii (420) phase i/ii (320)jun 2020 – oct 2021, china v-01livzon mabpharm, inc. china subunit (sars-cov-2 recombinant fusion protein) phase iii (22,500)global, multi-center, randomized, double-blind, placebo-controlled.aug 2021–mar 2023, the philippines phase i (1,060)phase i (180): single-center, randomized, double-blind and placebo-controlled. phase ii (880): randomized, double-blind, and placebo-controlled.feb–may 2021, china arct-154 (vbc-cov19-154 in vietnam)arcturus therapeutics, vinbiocare united states, vietnam rna phase iii (20,600)phase iiia (600): randomized, double-blinded, placebo controlled. phase iiib (20,000): randomized, double-blinded, placebo controlled.oct-dec 2021, vietnam phase i–ii (400)phase i (100): randomized, double-blinded, placebo controlled. phase ii (300): randomized, double-blinded, placebo controlled.aug-oct 2021, vietnam recovjiangsu rec-biotechnology co ltd china subunit (recombinant two-component spike and rbd protein (cho cell)) phase ii–iii (20,301)multi-center, randomized, double-blind, placebo-controlled.dec 2021–dec 2022, china, new zealand, the philippines phase i (160)first-in-human, randomized, double-blind, placebo-controlled, dose-finding.jun–dec 2021, new zealand brilife (iibr-100)the israel institute for biological research israel vesicular stomatitis vector (recombinant) phase iii (20,000)randomized, multi-center, placebo-controlled.sept – dec 2021, israel phase i–ii (1,040)randomized, multi-center, placebo-controlled, dose-escalation.oct 2020 – may 2021, israel zhongyianke biotech–liaoning maokangyuan biotech covid-19 vaccinezhongyianke biotech, liaoning maokangyuan biotech, academy of military medical sciences china subunit (recombinant) phase iii (14,600)international multicenter, randomized, double-blind, placebo-controlled.sep 2021–?, china phase i–ii (696)phase i (216): randomized, placebo-controlled, double-blind. phase ii (480): single-center, randomized, double blinded, placebo controlled.oct 2020 – jul 2021, china gx-19 (gx-19n)genexine consortium, international vaccine institute south korea dna phase ii–iii (14,000)randomized, double-blinded, placebo-controlled.oct 2021 – oct 2022, indonesia, seoul phase i–ii (410)phase i-ii (170+210+30): multi-center, some open-labeled, some double-blinded, single arm, randomized, placebo-controlledjun 2020 – jul 2021, seoul grad-cov2reithera, lazzaro spallanzani national institute for infectious diseases italy adenovirus vector (modified gorilla adenovirus vector, grad) phase iii (10,300)randomized, stratified, observer-blind, placebo-controlled.mar–oct 2021, italy phase i (90)subjects (two groups: 18–55 and 65–85 years old) randomly receiving one of three escalating doses of grad-cov2 or a placebo, then monitored over a 24-week period. 93% of subjects who received grad-cov2 developed anti-bodies.aug–dec 2020, rome inovio covid-19 vaccine (ino-4800)inovio, cepi, korea national institute of health, international vaccine institute south korea, united states dna vaccine (plasmid delivered by electroporation) phase iii (7,517)randomized, placebo-controlled, multi-center.nov 2020 – jan 2023, brazil, colombia, mexico, the philippines, united states phase i–ii (920)phase ia (120): open-label trial.phase ib-iia (160): dose-ranging trial.phase ii (640): randomized, double-blinded, placebo-controlled, dose-finding.april 2020 – feb 2022, china (phase ii), south korea (phase ib-iia), united states ds-5670daiichi sankyo japan rna phase ii–iii (5,028)randomized, active-comparator, observer-blind.dec 2021 – jul 2023, japan phase i–ii (152)a phase 1/2 study to assess the safety, immunogenicity and recommended dose of ds-5670a (covid-19 vaccine) in japanese healthy adults and elderly subjects.mar 2021 – jul 2022, japan gbp510sk bioscience co. ltd., gsk south korea, united kingdom subunit (recombinant protein nanoparticle with adjuvanted with as03) phase iii (4,000)randomized, active-controlled, observer-blind, parallel-group, multi-center.aug 2021-mar 2022, south korea phase i–ii (580)phase i-ii (260-320): placebo-controlled, randomized, observer-blinded, dose-finding.jan–aug 2021, south korea hgc019gennova biopharmaceuticals, hdt biotech corporation india, united states rna phase ii–iii (4,400)a prospective, multicentre, randomized, active-controlled (with covishield), observer-blind study to evaluate safety, tolerability and immunogenicity in healthy adults.phase ii (400)phase iii (4,000)sep 2021 – sep 2022, india phase i–ii (620)randomized, phase i/ii, placebo-controlled, dose-ranging, parallel-group, crossover, multi-centre study to evaluate the safety, tolerability and immunogenicity in healthy adult subjects. phase i (120) open-label study in healthy 18-70 year-olds. phase ii (500)