Clinical Trials

Last updated: 2022 Aug 26
Total hit(s): 79
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Original Article
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20 days after the first dose, the estimated vaccination effectiveness against verified SARS-CoV-2 infection was 62% (95 percent confidence range, 59% to 65%), and 60 days after the second dose, the estimated efficiency was 93% (92% to 94%). Insensitivity analysis revealed that informed filtering had no impact on the outcomes. Teenagers who were unvaccinated had SARS-CoV-2 testing more frequently than those who had received vaccinations during follow-up (1114 v 874 tests per 1000 individuals per month).
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 		35410884
(BMJ)
PMID
35410884
Date of Publishing: 2022 Apr 11
Title Risk of adverse events after covid-19 in Danish children and adolescents and effectiveness of BNT162b2 in adolescents: cohort study
Author(s) nameKildegaard H, Lund LC et al.
Journal BMJ
Impact factor
30.22
Citation count: 1
Date of Entry 2022 Aug 26

Fingolimod and anti-CD20 monoclonal antibodies were linked with reduced seroconversion after the SARS-CoV-2 vaccine when compared to no disease modifying medication. Other medications did not significantly vary from the untreated cohort. The duration of treatment and the period since the last anti-CD20 medication were both strongly correlated with the vaccination response. However, in people on anti-CD20 drugs, the vaccine type did not substantially predict seroconversion. According to preliminary findings on cellular T-cell immunity, detectable anti-SARS-CoV-2 T cell responses were seen in 40% of seronegative patients.
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 		34687063
(Ann Neurol)
PMID
34687063
Date of Publishing: 2021 Oct 22
Title COVID-19 Vaccine Response in People with Multiple Sclerosis
Author(s) nameTallantyre EC, Vickaryous N et al.
Journal Ann Neurol
Impact factor
9.55
Citation count: 24
Date of Entry 2022 Aug 26

The median anti-S1 antibody level in the patients (median age 68 years; interquartile range (IQR), 53-76 years; 65 percent men) was 284 [IQR, 83-1190] AU/mL after the second dose and 7,554 [IQR, 2,268-11,736] AU/mL after the third dose. After receiving the second dose of the vaccine, three patients were nonresponders (anti-S1 antibody level 0.8 AU/mL) and 12 had weak responders (anti-S1 antibody level 0.8-50 AU/mL). One of the three original nonresponders produced anti-spike antibody after the third treatment, while all 12 initial weak responders had an increase in antibody levels. Antibody levels were lower after the second dosage and there was more time between the second and third doses in patients who experienced a higher increase in anti-S1 antibody levels after the third dose.
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 		34508833
(Am J Kidney Dis)
PMID
34508833
Date of Publishing: 2021 Sep 8
Title SARS-CoV-2 Antibody Response After a Third Dose of the BNT162b2 Vaccine in Patients Receiving Maintenance Hemodialysis or Peritoneal Dialysis
Author(s) nameBensouna I, Caudwell V et al.
Journal Am J Kidney Dis
Impact factor
5.59
Citation count: 25
Date of Entry 2022 Aug 26

On day 28 following the second vaccination, the neutralising antibody GMT against the SARS-CoV-2 virus ranged from 105.3 to 180.2 in the 3-5 years cohort, 84.1 to 168.6 in the 6-12 years cohort, and 88.0 to 155.7 in the 13-17 years cohort. On day 28 following the third vaccination, it ranged from 143.5 to 224.4 in the 3-5 years cohort, 127.9 to 184.8 in the 6-12 years The inactivated COVID-19 vaccine BBIBP-CorV is safe and well tolerated in participants ages 3 to 17 at all tested dose levels. Following two doses, BBIBP-CorV also induced potent humoral defences against SARS-CoV-2 infection.
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 		34536349
(Lancet Infect Dis)
PMID
34536349
Date of Publishing: 2021 Sep 15
Title Safety and immunogenicity of an inactivated COVID-19 vaccine, BBIBP-CorV, in people younger than 18 years: a randomised, double-blind, controlled, phase 1/2 trial
Author(s) nameXia S, Zhang Y et al.
Journal Lancet Infect Dis
Impact factor
21.77
Citation count: 25
Date of Entry 2022 Aug 26

The third dose BNT162b2 Vaccine helped in 50% serum neutralization titers against wild-type (USA-WA1/2020) severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) and a recombinant beta variant strain. A third dose may extend protection and broaden it even more, according to the safety and immunogenicity of a booster dose of BNT162b2 given 7 to 9 months after the initial two-dose series.
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 		34525276
(N Engl J Med)
PMID
34525276
Date of Publishing: 2021 Sep 15
Title SARS-CoV-2 Neutralization with BNT162b2 Vaccine Dose 3
Author(s) nameFalsey AR, Frenck RW Jr et al.
Journal N Engl J Med
Impact factor
37.91
Citation count: 81
Date of Entry 2022 Aug 26

After the first vaccine, four people experienced side effects, while 16 people experienced side effects after the second. The facility received 19 patients in total. After an average of 2 days, everyone was released. Neither readmissions nor fatalities occurred. After developing myocarditis, two individuals received a second immunisation; neither had worsening of their symptoms. Thirteen individuals had their symptoms resolved and seven were making progress at the most recent follow-up following symptom onset.
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 		34347001
(JAMA)
PMID
34347001
Date of Publishing: 2021 Aug 4
Title Myocarditis and Pericarditis After Vaccination for COVID-19
Author(s) nameDiaz GA, Parsons GT et al.
Journal JAMA
Impact factor
14.78
Citation count: 88
Date of Entry 2022 Aug 26

A lipid nanoparticle-encapsulated and nucleoside-unmodified mRNA (mRNA-LNP) vaccine encoding the trimerized RBD (RBD trimer), elicits strong plasma B cell response. The RBD trimer mRNA vaccine modulates the antibody response toward more conserved regions on the RBD, hence overcoming the escape mutations that attenuate the efficacy of vaccines in mouse models. The vaccine protects K18-hACE2 mice from death after infection with live SARS-CoV-2 WT D614, B.1.351, and B.1.617.2 variants. B.1.351- and B.1.617.2-infected control animals demonstrated significantly higher levels of viral load than the RBD-trimer-vaccinated animals. The protectivity of the vaccine was correlated with RBD-specific B cell responses especially the long-lived plasma B cells in bone marrow, strong ability in triggering BCR clustering, and downstream signaling. Monoclonal antibodies isolated from vaccinated animals demonstrated broad and potent neutralizing activity against VOCs tested. The results suggest the existence of highly conserved and vulnerable regions within the RBD that could be precisely targeted for the development of next-generation vaccines capable of inducing broad and protective immunity against SARS-CoV-2 variants.
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 		35291264
(iScience)
PMID
35291264
Date of Publishing: 2022 Apr 15
Title RBD trimer mRNA vaccine elicits broad and protective immune responses against SARS-CoV-2 variants
Author(s) nameLiang Q, Wang Y et al.
Journal iScience
Impact factor
4.447
Citation count: 1
Date of Entry 2022 Jul 13

Vaccine efficacy against Covid-19 was 91.3% (95% confidence interval [CI], 89.0 to 93.2) after 6 months of follow-up among subjects who had no indication of prior SARS-CoV-2 infection. Vaccine efficacy began to deteriorate gradually. Vaccine efficacy of 86 to 100 percent was observed across nations and in people with a wide range of ages, sexes, race or ethnic groupings, and risk factors for Covid-19 among participants who had no prior infection with SARS-CoV-2. The vaccine was 96.7% effective against severe illness (95% CI, 80.3 to 99.9). In South Africa, where the SARS-CoV-2 variant of concern B.1.351 (or beta) was prevalent, vaccine effectiveness was reported to be 100% (95% confidence interval, 53.5 to 100).
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 		34525277
(N Engl J Med)
PMID
34525277
Date of Publishing: 2021 Sep 15
Title Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months
Author(s) nameThomas SJ, Moreira ED Jr et al.
Journal N Engl J Med
Impact factor
37.91
Citation count: 224
Date of Entry 2022 Jun 20

The vaccine was found effective against B1.1.7 variant of COVID-19 and was found to prevent both symptomatic and asymptomatic infection in working-age adults. However the vaccine does not prevent all cases of infection. This cohort was vaccinated when the dominant variant in circulation was B1.1.7 and shows effectiveness against this variant.
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 		33901423
(Lancet)
PMID
33901423
Date of Publishing: 2021 May 8
Title COVID-19 vaccine coverage in healthcare workers in England and effectiveness of BNT162b2 mRNA vaccine against infection (SIREN) : a prospective, multicentre and cohort study
Author(s) nameHall VJ, Foulkes S et al.
Journal Lancet
Impact factor
43.38
Citation count: 301
Date of Entry 2022 Jun 20

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.
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 		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: 396
Date of Entry 2022 Jun 20

In the following study, majority of the participants showed mild to moderate side affects. It was found that side effects were observed in patients that showed vaccine immune response. Older participants showed fewer or even no side effects.
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 		Pre-print ( papers.ssrn.com )
Title Declined antibody responses to COVID-19 mRNA vaccine within first three months
Impact factor
N/A
Date of Entry 2022 Jun 20

Majority of participants who received BNT162b2 had higher local and systemic adverse events than those who received placebo. The adverse events reported were mild to moderate and transient. In 5 to 11-year old children, two doses of 10 g of BNT162b2 vaccination given 21 days apart were found to be safe, immunogenic, and 90.7% effective against Covid-19. It was chosen as the dose level to be tested in phase 2-3 studies. a) It was found that slightly more BNT162b2 recipients (3.0%) than placebo recipients (2.1%) reported adverse events that were thought to be due to the vaccine or placebo.
b) In 0.1% of BNT162b2 recipients and 0.1% of placebo recipients, severe adverse events were reported.
c) The geometric mean ratio of SARS-CoV-2 neutralising titers in 5-to-11-year-olds to those in 16-to-25-year-olds was 1.04 one month after the second injection.
d) The absence of longer-term follow-up to examine the duration of immune responses, efficacy, and safety is one of the study's limitations.
e) Concomitant administration of BNT162b2 with other vaccines was not evaluated, and cell-mediated responses to immunisation are not yet available.
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 		34752019
(N Engl J Med)
PMID
34752019
Date of Publishing: 2021 Nov 9
Title Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age
Author(s) nameWalter EB, Talaat KR et al.
Journal N Engl J Med
Impact factor
37.91
Citation count: 58
Date of Entry 2022 Apr 29

In 5 to 11-year old children, two doses of 10 g of BNT162b2 vaccination given 21 days apart were found to be safe, immunogenic, and 90.7% effective against Covid-19. These doses were chosen as the dose level to be tested in phase 2-3 studies.The geometric mean ratio of SARS-CoV-2 neutralising titers in 5-to-11-year-olds to those in 16-to-25-year-olds was 1.04 one month after the second injection. a)The neutralising GMTs reported in phase 1 were from serum samples taken 7 days after the second dose, while the GMTs reported in phases 23 were from serum samples taken one month after the second dose.
b) Majority of participants who received BNT162b2 had higher local and systemic adverse events than those who received placebo.
c) In phase-2, adverse events were reported by 10.9% of BNT162b2 recipients and 9.2% of placebo recipients from the first dose to one month after the second dose.
d) The absence of longer-term follow-up to examine the duration of immune responses, efficacy, and safety is one of the study's limitations.
e) Concomitant administration of BNT162b2 with other vaccines was not evaluated, and cell-mediated responses to immunisation are not yet available.
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 		34752019
(N Engl J Med)
PMID
34752019
Date of Publishing: 2021 Nov 9
Title Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age
Author(s) nameWalter EB, Talaat KR et al.
Journal N Engl J Med
Impact factor
37.91
Citation count: 58
Date of Entry 2022 Apr 29

Two doses of ChAdOx1 nCoV-19 vaccine given 21 to 35 days apart were found to be safe and immunogenic. Due to the B.1.351 strain, a two-dose strategy of the ChAdOx1 nCoV-19 vaccination did not provide protection against mild-to-moderate Covid-19. a) Serious adverse events reported were equally distributed between the vaccine and placebo groups. Majority of the participants had fever which disappeared within 24 hrs after the 1st dose of ChAdOx1 nCoV-19 (AZD1222) , while no reactogenicity was observed after the second dose.
b) The neutralising antibody responses to the original SARS-CoV-2 virus in recipients of the ChAdOx1 nCoV-19 vaccine were identical to those in vaccinated recipients in studies done in the United Kingdom and Brazil.
c) It's unclear if a better antibody response from a longer gap between the first and second doses of the ChAdOx1 nCov-19 vaccine, would result in better residual neutralising activity against the B.1.351 variant.
d) T-cell responses may contribute to protection from Covid-19 even in the presence of lower neutralising antibody titers, despite the significant association between antibody response and vaccine efficacy, implying that the neutralising antibody response is important.
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 		33725432
(N Engl J Med)
PMID
33725432
Date of Publishing: 2021 Mar 16
Title Efficacy of the ChAdOx1 nCoV-19 Covid-19 Vaccine against the B.1.351 Variant
Author(s) nameMadhi SA, Baillie V et al.
Journal N Engl J Med
Impact factor
37.91
Citation count: 488
Date of Entry 2022 Apr 29

Serious adverse events reported were equally distributed between the vaccine and placebo groups. Most of the participants had fever which disappeared within 24 hrs after the 1st dose of ChAdOx1 nCoV-19 (AZD1222). There was no reactogenicity observed after the second dose. a) Two doses of ChAdOx1 nCoV-19 vaccine given 21 to 35 days apart were found to be safe and immunogenic.
b) Due to the B.1.351 strain, a two-dose strategy of the ChAdOx1 nCoV-19 vaccination did not provide protection against mild-to-moderate Covid-19.
c) In the United Kingdom, the ChAdOx1 nCoV-19 vaccine was 74.6% effective against the B.1.1.7 strain (95% CI, 41.6 to 88.9).
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 		33725432
(N Engl J Med)
PMID
33725432
Date of Publishing: 2021 Mar 16
Title Efficacy of the ChAdOx1 nCoV-19 Covid-19 Vaccine against the B.1.351 Variant
Author(s) nameMadhi SA, Baillie V et al.
Journal N Engl J Med
Impact factor
37.91
Citation count: 488
Date of Entry 2022 Apr 29

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.
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 		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: 6
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.
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 		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: 6
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.
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 		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: 37
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.
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 		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: 621
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.
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 		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: 621
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.
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 		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.
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 		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: 22
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
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 		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: 22
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.
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 		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: 460
Date of Entry 2021 Oct 31

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.
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 		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: 32
Date of Entry 2021 Oct 30