Clinical Trials


Last updated: 2022 Jan 25
Total hit(s): 64
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The majority of the solicited adverse effects in participants vaccinated with Sputnik Light were mild (66.4% from all vaccines), with only a few being moderate (5.5%). There were no major side effects reported. A) Mild and transient changes were observed in erythrocyte sedimentation rate, alanine and aspartate aminotransferases, lactate dehydrogenase, leukocyte, lymphocyte and neutrophil counts.
B) Both seronegative and seropositive groups were immunogenic to "Sputnik Light" vaccine producing both binding and neutralising antibody responses. It also ellicited cell - mediated immunity along with IFN- secretion.
34746910
(Lancet Reg Health Eur)
PMID
34746910
Date of Publishing: 2021 Dec
Title An open, non-randomised, phase 1/2 trial on the safety, tolerability, and immunogenicity of single-dose vaccine Sputnik Light for prevention of coronavirus infection in healthy adults
Author(s) nameTukhvatulin AI, Dolzhikova IV et al.
Journal Lancet Reg Health Eur
Impact factor
n/a
Citation count: 2
Date of Entry 2022 Jan 25


Both seronegative and seropositive groups were immunogenic to "Sputnik Light" vaccine producing both binding and neutralising antibody responses. It also ellicited cell - mediated immunity along with IFN- secretion. The majority of the solicited adverse events seen in participants vaccinated with "Sputnik Light" were minor and temporary with just 55% of participants having moderate grade adverse effects.
34746910
(Lancet Reg Health Eur)
PMID
34746910
Date of Publishing: 2021 Dec
Title An open, non-randomised, phase 1/2 trial on the safety, tolerability, and immunogenicity of single-dose vaccine Sputnik Light for prevention of coronavirus infection in healthy adults
Author(s) nameTukhvatulin AI, Dolzhikova IV et al.
Journal Lancet Reg Health Eur
Impact factor
n/a
Citation count: 2
Date of Entry 2022 Jan 25


Among the adjuvanted vaccine formulations, the number and severity of local and systemic solicited reactions were higher than expected after the second dose, with the highest frequency in the high-dose plus AS03 groups.On an average, reactions were less frequent and milder in participants aged 50 years than younger adults. The unadjuvanted high-dose formulation produced reactogenicity profiles that were identical to placebo. In AS03-adjuvanted vaccine groups, a non-Th2 cell skewed cytokine response was elicited, with constant IFN- production and robust neutralising and binding antibody responses was observed.
33887209
(Lancet Infect Dis)
PMID
33887209
Date of Publishing: 2021 Apr 19
Title Safety and immunogenicity of SARS-CoV-2 recombinant protein vaccine formulations in healthy adults: interim results of a randomised, placebo-controlled, phase 12, dose-ranging study
Author(s) nameGoepfert PA, Fu B et al.
Journal Lancet Infect Dis
Impact factor
21.77
Citation count: 16
Date of Entry 2022 Jan 25


A higher number of participants exhibited significant reactogenicity after the second dose. The reactogenicity in the 50ug dose cohort after the booster dose was severe that booster dose for 60ug cohort group was dropped. For other doses, there were no significant adverse events or withdrawals due to linked adverse events. This clinical study has several limitations, including a limited sample size and a restriction on people under the age of 55.
32998157
(Nature)
PMID
32998157
Date of Publishing: 2020 Oct
Title COVID-19 vaccine BNT162b1 elicits human antibody and TH1 T cell responses
Author(s) nameSahin U, Muik A et al.
Journal Nature
Impact factor
24.36
Citation count: 422
Date of Entry 2022 Jan 25


The vaccine-induced antibody response was high and dose-dependent. Almost all vaccinated volunteers mounted RBD-specific TH1 cell responses which were not dose-dependent. a) This clinical study has several limitations, including a limited sample size and a restriction on people under the age of 55.
b) The induction of tissue-resident memory CD8+ T cells was not evaluated.
c) Reactogenicity was dose-dependent. Adverse events reported were either temporary or spontaneously resolved.
d) Both the immunogenicity rate and CD8+ T cells response strength of the 60 g cohort were lower than the other cohorts, demonstrating the necessity of booster immunisation.
32998157
(Nature)
PMID
32998157
Date of Publishing: 2020 Oct
Title COVID-19 vaccine BNT162b1 elicits human antibody and TH1 T cell responses
Author(s) nameSahin U, Muik A et al.
Journal Nature
Impact factor
24.36
Citation count: 422
Date of Entry 2022 Jan 25


A single dose of an adenoviral vaccine GRAd-CoV2 could be an effective tool for priming a balanced immune response that can then be enhanced to high levels by a single dose of a different vaccine platform. Volunteer F is the lone exception, having received the first BNT162b2 only three days before the week-24 visit, resulting in an excellent internal "no-boost" control.
34737309
()
PMID
34737309
Title Strong immunogenicity of heterologous prime-boost immunizations with the experimental vaccine GRAd-CoV2 and BNT162b2 or ChAdOx1-nCOV19
Impact factor
N/A
Date of Entry 2022 Jan 25


In the combined phase 1 and phase 2 trial, the KCONVAC vaccine was found to be safe and did not elicit major adverse events. The 5ug dose of vaccine was selected for phase 3 trials. In the combined phase 1 and phase 2 trial, the KCONOVOC vaccine elicited a strong immune response. The vaccine induced good antibody response and a moderately good T-cell response.
33928916
(Chin Med J (Engl))
PMID
33928916
Date of Publishing: 2021 Apr 28
Title Immunogenicity and safety of a severe acute respiratory syndrome coronavirus 2 inactivated vaccine in healthy adults: randomized, double-blind, and placebo-controlled phase 1 and phase 2 clinical trials
Author(s) namePan HX, Liu JK et al.
Journal Chin Med J (Engl)
Impact factor
1.053
Citation count: 5
Date of Entry 2021 Dec 15


In the combined phase 1 and phase 2 trial, the KCONOVOC vaccine elicited a strong immune response. The vaccine induced good antibody response and a moderately good T-cell response. Based on the results, KCONOVOC vaccine at a dose of 5ug in 0/28 regimen was selected for phase 3 clinical trial
33928916
(Chin Med J (Engl))
PMID
33928916
Date of Publishing: 2021 Apr 28
Title Immunogenicity and safety of a severe acute respiratory syndrome coronavirus 2 inactivated vaccine in healthy adults: randomized, double-blind, and placebo-controlled phase 1 and phase 2 clinical trials
Author(s) namePan HX, Liu JK et al.
Journal Chin Med J (Engl)
Impact factor
1.053
Citation count: 5
Date of Entry 2021 Dec 15


Nonhuman primates vaccinated with mRNA-1273 developed a strong immune response. Exposure of vaccinated animals to the SARS-CoV-2 virus protected the animals from infection. There was a significant decrease in the levels of viral RNA in the nasal passage and lungs of vaccinated animals when compared to the control.
32722908
(N Engl J Med)
PMID
32722908
Date of Publishing: 2020 Oct 15
Title Evaluation of the mRNA-1273 Vaccine against SARS-CoV-2 in Nonhuman Primates
Author(s) nameCorbett KS, Flynn B et al.
Journal N Engl J Med
Impact factor
37.91
Citation count: 368
Date of Entry 2021 Oct 31


In a phase I clinical trial, the DNA vaccine ZyCoV-D was found to be safe and immunogenic. When ZyCoV-D was administered intradermally, it induced good antibody and cellular immune responses. In comparison to the 1 mg vaccination dose, the 2 mg vaccine dose had a greater seroconversion rate, regardless of delivery method. 1) Vaccination with 2mg dose via NFIS was found to elicit significant SARS-CoV-2 specific IgG, neutralising antibody (NAB) titres and decrease in viral load was observed in animals post challenge. 2) No vaccine related severe or solicited adverse events were reported. The adverse events reported were mild to moderate and common.
34308319
(EClinicalMedicine)
PMID
34308319
Date of Publishing: 2021 Aug
Title Safety and Immunogenicity of a DNA SARS-CoV-2 vaccine (ZyCoV-D): Results of an open-label, non-randomized phase I part of phase I/II clinical study by intradermal route in healthy subjects in India
Author(s) nameMomin T, Kansagra K et al.
Journal EClinicalMedicine
Impact factor
6.68
Citation count: 13
Date of Entry 2021 Oct 30


In a phase I clinical trial, DNA vaccine ZyCoV-D was found to be safe, well-tolerated, and immunogenic in healthy individuals with no vaccine-related severe or solicited adverse events. The adverse events reported were mild to moderate in severity. 1) Interesting to note that all the study participants were males. 2)Solicited local and systemic adverse symptoms were reported for 7 days post each vaccine dose and any other unsolicited adverse events were reported within 28 days post each dose. 3)No subject was discontinued from the study due to a solicited adverse event. 4) One subject withdrew from the study because of asymptomatic positive COVID-19 test, 27 days after receiving the first dose of the vaccine. 5)ZyCoV-D when administered intradermally induced good humoral and cellular immune responses.
34308319
(EClinicalMedicine)
PMID
34308319
Date of Publishing: 2021 Aug
Title Safety and Immunogenicity of a DNA SARS-CoV-2 vaccine (ZyCoV-D): Results of an open-label, non-randomized phase I part of phase I/II clinical study by intradermal route in healthy subjects in India
Author(s) nameMomin T, Kansagra K et al.
Journal EClinicalMedicine
Impact factor
6.68
Citation count: 13
Date of Entry 2021 Oct 30


In a phase 2 placebo-controlled clinical trial, the mRNA-1273 vaccine induced good immune responses in young adults aged 18 and older. Anti-SARS-CoV-2 spike binding and neutralising antibodies were induced by both doses of the vaccine within 28 days of the first injection and increased to peak titers by 14 days after the second dose. The neutralising antibody levels were higher than levels found in convalescent sera. The mRNA-1273 vaccine was found to be safe and did not induce major adverse events. Longer the interval between the 2 doses, better the induction of antibodies.
33707061
(Vaccine)
PMID
33707061
Date of Publishing: 2021 May 12
Title A preliminary report of a randomized controlled phase 2 trial of the safety and immunogenicity of mRNA-1273 SARS-CoV-2 vaccine
Author(s) nameChu L, McPhee R et al.
Journal Vaccine
Impact factor
3.31
Citation count: 24
Date of Entry 2021 Oct 30


In a phase 2 placebo-controlled clinical trial, the mRNA-1273 vaccine was found to be safe at 50 and 100 g doses given as a 2 dose-regimen. The mRNA-1273 vaccine was found to be safe and immunogenic at both the 50 and 100ug doses. The vaccine induced good titers of neutralsing antibodies.
33707061
(Vaccine)
PMID
33707061
Date of Publishing: 2021 May 12
Title A preliminary report of a randomized controlled phase 2 trial of the safety and immunogenicity of mRNA-1273 SARS-CoV-2 vaccine
Author(s) nameChu L, McPhee R et al.
Journal Vaccine
Impact factor
3.31
Citation count: 24
Date of Entry 2021 Oct 30


In the four randomised trials, the ChAdOx1 nCoV-19 (AZD1222) vaccine was found to be safe with low incidence of adverse events. In the participants who received two standard doses, the efficacy after the second dose was higher in those who received the booster dose after 12 weeks when compared to those who received the second dose after 6 weeks.
33617777
(Lancet)
PMID
33617777
Date of Publishing: 2021 Feb 19
Title Single-dose administration and the influence of the timing of the booster dose on immunogenicity and efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine: a pooled analysis of four randomised trials
Author(s) nameVoysey M, Costa Clemens SA et al.
Journal Lancet
Impact factor
43.38
Citation count: 285
Date of Entry 2021 Oct 30


In the four randomised trials, the ChAdOx1 nCoV-19 (AZD1222) vaccine showed good antibody responses. The antibody responses were more than two-fold higher in participants who received the booster dose after an interval of 12 or more weeks compared with an interval of less than 6 weeks.
33617777
(Lancet)
PMID
33617777
Date of Publishing: 2021 Feb 19
Title Single-dose administration and the influence of the timing of the booster dose on immunogenicity and efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine: a pooled analysis of four randomised trials
Author(s) nameVoysey M, Costa Clemens SA et al.
Journal Lancet
Impact factor
43.38
Citation count: 285
Date of Entry 2021 Oct 30


In a placebo-controlled, phase 1/2 clinical trial, two doses of inactivated virus vaccine CoronaVac was found to be safe with lower adverse effects in healthy adults aged 1859 years. The vaccine was found to be safe and induced good humoral immune response.
33217362
(Lancet Infect Dis)
PMID
33217362
Date of Publishing: 2020 Nov 17
Title Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18-59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial
Author(s) nameZhang Y, Zeng G et al.
Journal Lancet Infect Dis
Impact factor
21.77
Citation count: 334
Date of Entry 2021 Oct 30


In a placebo-controlled, phase 1/2 clinical trial of two doses of inactivated virus vaccine CoronaVac was found to induce good antibody response in healthy adults aged 1859 years. The vaccine was found to be safe and did not induce any serious adverse events.
33217362
(Lancet Infect Dis)
PMID
33217362
Date of Publishing: 2020 Nov 17
Title Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18-59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial
Author(s) nameZhang Y, Zeng G et al.
Journal Lancet Infect Dis
Impact factor
21.77
Citation count: 334
Date of Entry 2021 Oct 30


Following two doses of AZD1222, spike-specific CD4+ T cell helper type 1 (Th1) and CD8+ T-cell responses were significantly increased in AZD1222-vaccinated persons of all ages.
34189538
()
PMID
34189538
Title T-cell mediated immunity after AZD1222 vaccination: A polyfunctional spike-specific Th1 response with a diverse TCR repertoire
Impact factor
N/A
Date of Entry 2021 Oct 30


The safety, efficacy, and immunogenicity of the BBV152 vaccine were assessed in a multicenter, phase 3 clinical trial. In adults, the BBV152 was immunogenic and efficacious against symptomatic and asymptomatic COVID-19 variant associated disease. The vaccine was well tolerated. with the overall occurance of adverse events being less than that observed in other COVID-19 vaccines
Pre-print ( medRXiv )
Title Efficacy, safety, and lot to lot immunogenicity of an inactivated SARS-CoV-2 vaccine (BBV152): a, double-blind, randomised, controlled phase 3 trial
Impact factor
N/A
Date of Entry 2021 Oct 30


In a multicentre, phase 3 clinical trial, the BBV152 vaccine was found to be safe and immunogenic. The overall efficacy of the vaccine was 77.8%. The overall rate of adverse reactions was lower than that seen with other vaccinations. 15 deaths were reported, of which 6 deaths were related to COVID-19. The cause of death was not related to the vaccine, no analphylatic events were reported.
Pre-print ( medRXiv )
Title Efficacy, safety, and lot to lot immunogenicity of an inactivated SARS-CoV-2 vaccine (BBV152): a, double-blind, randomised, controlled phase 3 trial
Impact factor
N/A
Date of Entry 2021 Oct 30


In a phase IV clinical study, the BNT162b2 mRNA Covid-19 vaccine conferred high neutralising antibody levels (41.18-folds) after the timely administration of the second dose in a population above 85 years of age. Comorbidities in the vaccinated individuals had no significant effect on the antibody response. In the case of chronic comorbidities and cardiovascular diseases, no relation between Type 2 diabetes or High Blood Pressure was associated with vaccine effectiveness. Recipients having a history of heart disease showed low levels of antibody titers after the first dose of the vaccine. No significant difference between genders was observed.
34633648
(Aging Clin Exp Res)
PMID
34633648
Date of Publishing: 2021 Oct 11
Title Immunogenicity of the BNT162b2 mRNA COVID-19 Vaccine in Elderly People Over 85 Years of Age in Greece
Author(s) nameKontopoulou K, Nakas CT et al.
Journal Aging Clin Exp Res
Impact factor
2.37
Citation count: 1
Date of Entry 2021 Sep 27


In a randomized, double-blind placebo-controlled phase 3 trial, a single-dose of the Ad26.COV2.S vaccine was safe and efficacious against severe critical Covid 19 disease. The vaccine was found to be more efficacious against critical severe COVID-19 disease than moderate to severe COVID-19 disease. The vaccine showed good efficacy against different variants. The trial showed safety and efficacy of the single dose vaccine for ethinically and geographically diverse population.
33882225
(N Engl J Med)
PMID
33882225
Date of Publishing: 2021 Apr 21
Title Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19
Author(s) nameSadoff J, Gray G et al.
Journal N Engl J Med
Impact factor
37.91
Citation count: 339
Date of Entry 2021 Sep 27


In a phase 1 trial, the adjuvanted sclamp subunit vaccine was found to be safe and free from severe solicited adverse reactions. Similar frequency of adverse events were observed in the placebo and the vaccine group, irrespective of the vaccine dosage. The data are reported are up unitl day 57. The MF59-adjuvanted vaccine was found to be safe and elicited a good antigen-specific immune response.
33887208
(Lancet Infect Dis)
PMID
33887208
Date of Publishing: 2021 Apr 19
Title Safety and immunogenicity of an MF59-adjuvanted spike glycoprotein-clamp vaccine for SARS-CoV-2: a randomised, double-blind, placebo-controlled, phase 1 trial
Author(s) nameChappell KJ, Mordant FL et al.
Journal Lancet Infect Dis
Impact factor
21.77
Citation count: 15
Date of Entry 2021 Sep 27


In phase 1 trial, two doses of SARS-CoV-2 sclamp vaccine, at all doses (5, 15 and 45ug) induced a robust neutralising immune response and a spike glycoprotein-specific T-cell response, which indicates protection against SARS-CoV-2 infection. The presence of the glycoprotein 41 peptide in the clamp caused HIV diagnostic assay interference, posing a potential obstacle to successful implementation and highlighting the need of non-spike directed immunogenicity during vaccine development. Alternative molecular clamp trimerisation domains are being studied to improve this response.
33887208
(Lancet Infect Dis)
PMID
33887208
Date of Publishing: 2021 Apr 19
Title Safety and immunogenicity of an MF59-adjuvanted spike glycoprotein-clamp vaccine for SARS-CoV-2: a randomised, double-blind, placebo-controlled, phase 1 trial
Author(s) nameChappell KJ, Mordant FL et al.
Journal Lancet Infect Dis
Impact factor
21.77
Citation count: 15
Date of Entry 2021 Sep 27


In two randomised, placebo-controlled, phase1/ 2 trials, RBD dimer-protein subunit vaccine ZF200 was found to be safe and well tolerated. 25g of the vaccine as a 3-dose regimen was selected for phase-3 trials. The two or three dose schedule of ZF2001 vaccine was well tolerated in both phase 1 and phase 2 trials. The adverse events reported were anticipated for alum adjuvanted protein subunit vaccines and were short-lived (resolved within 3 to 4 days after vaccination). The occurence of pain at injected site, fatigue, headache, nausea were lower with ZF2001 when compared with NVX-CoV2373 (where Matrix M1 was used as an adjuvant).
33773111
(Lancet Infect Dis)
PMID
33773111
Date of Publishing: 2021 Mar 24
Title Safety and immunogenicity of a recombinant tandem - repeat dimeric RBD - based protein subunit vaccine (ZF2001) against COVID-19 in adults : two randomised, double - blind, placebo - controlled, phase 1 and 2 trials
Author(s) nameYang S, Li Y et al.
Journal Lancet Infect Dis
Impact factor
21.77
Citation count: 72
Date of Entry 2021 Sep 27