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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.[6]
Many vaccine candidates use adjuvants to enhance immunogenicity, as part of the delivery system or as an accompanying immune stimulant.[8][9] 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.[6][10]
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.[11][12] Hundreds of subjects. Sometimes Phase I and II trials are combined.[12]
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.[11][12] 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.[13][14][15]
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.[16][17] Adaptive designs may shorten trial durations and use fewer subjects, possibly expediting decisions, avoiding duplication of research efforts, and enhancing coordination of design changes.[16][18]
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[19][20][21]
Phase III (37,430)[22][23] 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,[24] Mexico,[25] 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.[26] Phase IIb (720): Immunogenicity and Safety of SARS-CoV-2 Recombinant Protein Vaccine With AS03 Adjuvant in Adults 18 Years of Age and Older.[27] Sep 2020 – Apr 2022, United States
Phase III (13,000)[37][38] Adaptive, multicenter, randomized, double-blind, placebo-controlled Jun 2021 – Jul 2022, Vietnam
Phase I–II (620)[39] Phase I (60): Open label, dose escalation. Phase II (560): Randomization, double-blind, multicenter, placebo-controlled. Dec 2020 – Jun 2021, Vietnam
Phase III (30,300) Phase II/III (30,000): Randomized, double-blind, controlled. Phase III (300): Double-blind, randomized, controlled.[51] 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.[52] Jun 2020 – Oct 2021, Australia (phase 1), China (phase 2)
Phase III (54,915)[53][54] 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)[55] Randomized, double-blind, placebo-controlled, parallel-group. Dec 2020 – Aug 2021, Japan
Phase III (40,000)[56] Multicenter, randomized, double-blind, placebo-controlled. Jun 2021 – Feb 2022, Indonesia, Kenya, Malaysia,[57] Mexico, Nepal, the Philippines (5,000)[58]
Phase I–II (5,128)[59][60][61] 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
Phase III (28,000)[71] Multi-center, Randomized, Double-blind, Placebo-controlled May–Nov 2021, China,[72] Colombia, Indonesia, Malaysia, Mexico, Nepal, Pakistan, the Philippines, Turkey
Phase I–II (908) Phase I (168) Phase II (420) Phase I/II (320)[73] Jun 2020 – Oct 2021, China[74]
Phase III (22,500)[75] Global, multi-center, randomized, double-blind, placebo-controlled. Aug 2021–Mar 2023, the Philippines
Phase I (1,060)[76][77] Phase I (180): Single-center, randomized, double-blind and placebo-controlled. Phase II (880): Randomized, double-blind, and placebo-controlled. Feb–May 2021, China
Phase II–III (14,000)[97] 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-controlled Jun 2020 – Jul 2021, Seoul
Phase III (10,300)[100][101] Randomized, stratified, observer-blind, placebo-controlled. Mar–Oct 2021, Italy
Phase I (90)[102] 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
Phase III (7,517) Randomized, placebo-controlled, multi-center.[105] Nov 2020 – Jan 2023, Brazil, Colombia, Mexico, the Philippines, United States[b]
Phase I–II (920) Phase Ia (120): Open-label trial. Phase Ib-IIa (160): Dose-Ranging Trial.[106] Phase II (640): Randomized, double-blinded, placebo-controlled, dose-finding.[107] April 2020 – Feb 2022, China (phase II), South Korea (phase Ib-IIa), United States
Phase II–III (5,028)[110] Randomized, Active-comparator, Observer-blind. Dec 2021 – Jul 2023, Japan
Phase I–II (152)[111] 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
Phase II–III (4,400)[118] 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)[119][120][121] 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) observer-blind study in healthy 18-75 year-olds. Apr 2021 – Oct 2021, India
Phase II (896)[137] Double-Blind, Multi-Center, Randomized, Placebo-Controlled, Dose-Ranging. Oct 2021 – Mar 2022, United States
Phase I (83)[138][139] Phase Ia (35): Double-blind, randomized, placebo-controlled, first-in-Human. Phase Ib (48): Multicenter, randomized, double-blind, placebo-controlled. Sep 2020 – Aug 2021, United States
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