Monthly Update

Monthly Update: April 1, 2023 to April 28, 2023.

New Studies with results available

3 new vaccine RCTs with results are available on our website: see here

Branche A, medRxiv, 2023 Immunogenicity of the BA.1 and BA.4/5 Bivalent Boosts: A Brief Report of Preliminary Results from the COVAIL Randomized Clinical Trial
Lee I, medRxiv, 2023a A Randomized Trial Comparing Omicron-Containing Boosters with the Original Covid-19 Vaccine mRNA-1273
Rao CC, medRxiv, 2022 Heterologous boosting of neutralizing activity against Delta and Omicron SARS-CoV-2 variants in CoronaVac-primed adults; a randomized study with SCB-2019 vaccine

Studies pending data extraction

18 new vaccine RCTs under extraction:

Akahata W, SSRN, 2023 Safety and Immunogenicity of SARS-CoV-2 Self-Amplifying RNA Vaccine Expressing Anchored RBD: A Randomised, Observer-Blind, Phase 1 Study
Al Kaabi N, Vaccines, 2023 Efficacy and Safety of a Booster Vaccination with Two Inactivated SARS-CoV-2 Vaccines on Symptomatic COVID-19 Infection in Adults: Results of a Double-Blind, Randomized, Placebo-Controlled, Phase 3 Trial in Abu Dhabi
Barda N, Clin Microbiol Infect, 2023 Immunogenicity of Omicron BA.1-adapted BNT162b2 vaccines; randomized trial, 3 months follow-up.
Estephan L,Vaccine Safety and immunogenicity of homologous versus heterologous booster dose with AZD1222, mRNA-1273, or MVC-COV1901 SARS-CoV-2 vaccines in adults: An observer-blinded, multi-center, phase 2 randomized trial
Griessbach A, Open Forum Infect Dis, 2023 Antibody Response After Third Vaccination With mRNA-1273 or BNT162b2: Extension of a Randomized Controlled SARS-CoV-2 Noninferiority Vaccine Trial in Patients With Different Levels of Immunosuppression (COVERALL-2).
Hannawi S, J Infect, 2022 Safety and Immunogenicity of a Bivalent SARS-CoV-2 Protein Booster Vaccine, SCTV01C in Adults Previously Vaccinated with Inactivated Vaccine: a Randomized, Double-blind, Placebo-controlled Phase 1/2 Clinical Trial
Kulkarni P, ResearchSquare, 2023 A randomized, controlled study to evaluate the safety and immunogenicity of a heterologous booster dose of an adjuvanted SARS CoV-2 recombinant spike protein vaccine in adults
Li JX, SSRN, 2023 Safety, Immunogenicity and Efficacy of Heterologous Boost with an Aerosolized Ad5-nCoV after Two-Dose Priming with Inactivated COVID-19 Vaccines in Adults: A Multicenter, Open-Label Trial
Natori, transplant international, 2023 A Pilot Single-Blinded, Randomized, Controlled Trial Comparing BNT162b2 vs. JNJ-78436735 Vaccine as the Third Dose After Two Doses of BNT162b2 Vaccine in Solid Organ Transplant Recipients
Niyomnaitham S, Hum Vaccin Immunother, 2022 Immunogenicity and reactogenicity against the SARS-CoV-2 variants following heterologous primary series involving CoronaVac, ChAdox1 nCov-19 and BNT162b2 plus BNT162b2 booster vaccination: An open-label randomized study in healthy Thai adul
Omma A, Hum Vaccin Immunother, 2022 Safety and immunogenicity of inactive vaccines as booster doses for COVID-19 in Türkiye: A randomized trial
Tan NH, Lancet inf dis, 2023 Immunogenicity of bivalent omicron (BA.1) booster vaccination after different priming regimens in health-care workers in the Netherlands (SWITCH ON): results from the direct boost group of an open-label, multicentre, randomised controlled t
Tawinprai K, Expert Rev Vaccines, 2022 Reactogenicity, immunogenicity, and humoral immune response dynamics after the third dose of heterologous COVID-19 vaccines in participants fully vaccinated with inactivated vaccine.
Thuluva S, medRxiv, 2023 "Immunogenicity and safety of Biological Es CORBEVAX vaccine as a heterologous booster dose in adult volunteers previously vaccinated with two doses of either COVISHIELD or COVAXIN: a Prospective double-blind randomised phase III clinical s
Toback S, medrxiv, 2023 Safety and Immunogenicity of the NVX-CoV2373 Vaccine as a Booster in Adults Previously Vaccinated with the BBIBP-CorV Vaccine: an Interim Analysis
Wang L, SSRN, 2022 Safety and Cross-Reactive Immune Response Against the Omicron Variant of a Third Dose of CoronaVac, and Immune Persistence of Primary Immunization in Healthy Children and Adolescents: Interim Results from a Double-Blind, Randomised, Placebo
Winokur P, N Engl J Med, 2023 Bivalent Omicron BA.1-Adapted BNT162b2 Booster in Adults Older than 55 Years
Xia N, Research sqaure, 2023 The efficacy and safety of an intranasal spray COVID-19 vaccine in a randomized double-blind placebo-controlled phase Ⅲ trial during Omicron period

As of December 14, 2022, the COVID-NMA revised its protocol and stopped including prime vaccination trials.

6 prime vaccination RCTs identified but not extracted:

Anez G, medrxiv, 2022 Safety, Immunogenicity and Efficacy of NVX-CoV2373 in Adolescents in PREVENT-19: a Randomized, Phase 3 Trial
Charland N, NPJ Vaccines, 2022a Safety and immunogenicity of an AS03-adjuvanted plant-based SARS-CoV-2 vaccine in Adults with and without Comorbidities.
Huang LM, Research Square, 2022 Safety and immunogenicity of SARS-CoV-2 vaccine MVC-COV1901 in Taiwanese adolescents: A double-blind, randomized, placebo-controlled phase 2 trial
Kulkarni PS, SSRN, 2022 Safety and Immunogenicity of SII-NVX-CoV2373 (COVID-19 Vaccine) In Adults in a Phase 2/3, Observer-Blind, Randomised, Controlled Study
Kundro MA, Public Health Pract (Oxf), 2022 Safety and immunogenicity of heterologous COVID-19 vaccine regimens to deal with product shortage: a randomised clinical trial in an elderly population
Li G, Lancet, 2022 b Safety and immunogenicity of the ChAdOx1 nCoV-19 (AZD1222) vaccine in children aged 6-17 years: a preliminary report of COV006, a phase 2 single-blind, randomised, controlled trial.

42 early phase vaccine trials where the vaccine dose and schedule have not yet been determined:

Abarca K, Vaccines, 2022 Safety and efficacy of two immunization schedules with an inactivated SARS-CoV-2 vaccine in adults. A randomized non-inferiority clinical trial.
Alcamí Pertejo J, SSRN, 2022 Immunogenic Dynamics and SARS-CoV-2 Variants Neutralization of the Heterologous ChAdOx1-S/BNT162b2 Vaccination: Secondary Analysis of the CombiVacS Study
Angkasekwinai N, Vaccine, 2021 Comparison of safety and immunogenicity of CoronaVac and ChAdOx1 against the SARS-CoV-2 circulating variants of concern (Alpha, Delta, Beta) in Thai healthcare workers
Baden L, N Engl J Med, 2021 Phase 3 Trial of mRNA-1273 during the Delta-Variant Surge
Butta N, SSRN, 2022 Effect of a COVID-19-Heterologous Vaccination Schedule on Haemostasis: A Subanalysis of the Phase 2, Multicentre, Randomised, Controlled CombiVacS Study
Cao Y, Sci China Life Sci, 2022 A third high dose of inactivated COVID-19 vaccine induces higher neutralizing antibodies in humans against the Delta and Omicron variants: a Randomized, Double-Blinded Clinical Trial.
Capone S, medrxiv, 2022 GRAd-COV2 vaccine provides potent and durable immunity in a randomised placebo-controlled phase 2 trial (COVITAR)
Chen GL, Lancet microbe, 2022 Safety and immunogenicity of the SARS-CoV-2 ARCoV mRNA vaccine in Chinese adults: a randomised, double-blind, placebo-controlled, phase 1 trial
Chen J, 2021 [A randomized controlled trial study of immunogenicity and safety of an inactivated SARS-CoV-2 vaccine in different immunization schedules].
Chiuppesi F, Lancet Microbe, 2022 Safety and immunogenicity of a synthetic multiantigen modified vaccinia virus Ankara-based COVID-19 vaccine (COH04S1): an open-label and randomised, phase 1 trial.
Duc Dang A, Vaccine, 2022 Safety and immunogenicity of an egg-based inactivated Newcastle disease virus vaccine expressing SARS-CoV-2 spike: Interim results of a randomized, placebo-controlled, phase 1/2 trial in Vietnam.
Follmann D, Ann Intern Med, 2022 Antinucleocapsid Antibodies After SARS-CoV-2 Infection in the Blinded Phase of the Randomized, Placebo-Controlled mRNA-1273 COVID-19 Vaccine Efficacy Clinical Trial.
Garcia-Perez J, eClinicalMedicine, 2022 Immunogenic dynamics and SARS-CoV-2 variant neutralisation of the heterologous ChAdOx1-S/BNT162b2 vaccination: Secondary analysis of the randomised CombiVacS study.
Han BH, , Zhonghua yu fang yi xue za zhi [Chinese journal of preventive medicine], 2022 Safety of an inactivated 2019-nCoV vaccine (Vero) in adults aged 60 years and older
Iwata S, Vaccine, 2022 Phase 1/2 Clinical Trial of COVID-19 Vaccine in Japanese Participants: A Report of Interim Findings
Jin P, PLoS med, 2022 Safety and immunogenicity of heterologous boost immunization with an adenovirus type-5-vectored and protein-subunit-based COVID-19 vaccine (Convidecia/ZF2001): A randomized, observer-blinded, placebo-controlled trial.
Leal L, medrxiv, 2022 Safety and Immunogenicity of a Recombinant Protein RBD Fusion Heterodimer Vaccine against SARS-CoV-2: preliminary results of a phase 1-2a dose-escalating, randomized, double-blind clinical trial
Li J, Adv Therap, 2022 Immune Persistence and Safety After SARS-CoV-2 BNT162b1 mRNA Vaccination in Chinese Adults: A Randomized, Placebo-Controlled, Double-Blind Phase 1 Trial.
Lin KY, J Formos Med Assoc, 2022 Serological response after COVID-19 mRNA-1273 booster dose in immunocompromised patients, Taiwan, July to August 2021.
Luo D, Clin Transl Med, 2022 A randomized, double-blind, placebo-controlled phase 1 and phase 2 clinical trial to evaluate efficacy and safety of a SARS-CoV-2 vaccine SCoK in adults.
Marchevsky NG, eBioMedicine, 2022 An exploratory analysis of the response to ChAdOx1 nCoV-19 (AZD1222) vaccine in males and females.
Mohraz M, BMJ Open, 2022 Safety and immunogenicity of an inactivated virus particle vaccine for SARS-CoV-2, BIV1-CovIran: findings from double-blind, randomised, placebo-controlled, phase I and II clinical trials among healthy adults.
NCT04569786 Dose Ranging Trial to Assess Safety and Immunogenicity of V590 in Healthy Adults (V590-001)
Orozco MN, medrxiv, 2022 Phase I study of a SARS-CoV-2 mRNA vaccine PTX-COVID19-B
Ozdarendeli A, SSRN, 2022 Safety and Immunogenicity of an Inactivated Whole Virion SARS-CoV-2 Vaccine, TURKOVAC, in Healthy Adults: Interim Results from Randomised, Double-Blind, Placebo-Controlled Phase 1 and 2 Trials
Pajon R, Nat Med, 2022 Initial analysis of viral dynamics and circulating viral variants during the mRNA-1273 Phase 3 COVE trial.
Pitisuttithum P, EClinicalMedicine, 2022 Safety and immunogenicity of an inactivated recombinant Newcastle disease virus vaccine expressing SARS-CoV-2 spike: Interim results of a randomised, placebo-controlled, phase 1 trial.
Pollock KM, eclinicalmedicine, 2022 Safety and immunogenicity of a self-amplifying RNA vaccine against COVID-19: COVAC1, a phase I, dose-ranging trial
Puthanakit T, vaccines, 2022 Immunogenicity of a Fractional Dose of mRNA BNT162b2 COVID-19 Vaccine for Primary Series and Booster Vaccination among Healthy Adolescents.
Robbins JA, eBioMedicine, 2022 Safety and immunogenicity of intramuscular, single-dose V590 (rVSV-SARS-CoV-2 Vaccine) in healthy adults: Results from a phase 1 randomised, double-blind, placebo-controlled, dose-ranging trial.
Saez-Llorens X , SSRN, 2021 Safety and Immunogenicity of mRNA-LNP COVID-19 Vaccine CVnCoV in Latin American Adults; A Phase 2 Randomized Study
Song JY, EClinicalMedicine, 2022 Safety and immunogenicity of a SARS-CoV-2 recombinant protein nanoparticle vaccine (GBP510) adjuvanted with AS03: A randomised, placebo-controlled, observer-blinded phase 1/2 trial.
Tanishima M, medRxiv, 2022 Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, KD-414, in healthy adult and elderly subjects: a randomized, double-blind, placebo-controlled, phase 1/2 clinical study in Japan
Thuluva S, EBioMedicine, 2022 Evaluation of safety and immunogenicity of receptor-binding domain-based COVID-19 vaccine (Corbevax) to select the optimum formulation in open-label, multicentre, and randomised phase-1/2 and phase-2 clinical trials
Thuluva S, medRxiv, 2022 Selection of optimum formulation of RBD-based protein sub-unit covid19 vaccine (Corbevax) based on safety and immunogenicity in an open-label, randomized Phase-1 and 2 clinical studies
Vanhoutte F, EBioMedicine, 2022 Safety and immunogenicity of the measles vector-based SARS-CoV-2 vaccine candidate, V591, in adults: results from a phase 1/2 randomised, double-blind, placebo-controlled, dose-ranging trial
Waits A, Int J Infect Dis, 2022 Safety and Immunogenicity of MVC-COV1901 Vaccine in Older Adults: phase 2 Randomized Dose-Comparison Trial
Wang CY, J Clin Invest, 2022 A multitope SARS-COV-2 vaccine provides long-lasting B cell and T cell immunity against Delta and Omicron variants.
Wynne C, medRxiv, 2022 The preliminary safety and immunogenicity results of a randomized, double-blind, placebo-controlled Phase I trial for a recombinant two-component subunit SARS-CoV-2 vaccine ReCOV
Xia S, Front Immunol, 2022 Safety and Immunogenicity of an Inactivated COVID-19 Vaccine, WIBP-CorV, in Healthy Children: Interim Analysis of a Randomized, Double-Blind, Controlled, Phase 1/2 Trial.
Yassini P, medrxiv, 2022 Interim Analysis of a Phase I Randomized Clinical Trial on the Safety and Immunogenicity of the mRNA-1283 SARS-CoV-2 Vaccine in Adults
Zhu, Lancet Respir Med., 2022 Safety and immunogenicity of a live-attenuated influenza virus vector-based intranasal SARS-CoV-2 vaccine in adults: randomised, double-blind, placebo-controlled, phase 1 and 2 trials

As of December 14, 2022, the COVID-NMA revised its protocol and stopped including pharmacological interventions trials. List of studies included but not extracted here.

We also stopped the living review for vaccine observational studies. Last search date Nov 03,2021. No more studies will be included after this date.