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Vaccine Reaction clinical trials

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NCT ID: NCT05268185 Completed - COVID-19 Clinical Trials

The BOOSTED (Booster Options Or Switching Tested for Effectiveness and Downsides Study) Trial (COVID-19)

BOOSTED
Start date: January 18, 2022
Phase: N/A
Study type: Interventional

While both heterologous (mixing) and homologous (matching) vaccine regimens are now considered standard of care, post-vaccination complications and long-term effects of the different vaccination regimens have not been thoroughly studied. There is a pressing need to investigate the longitudinal effects of the mixing and matching vaccine-booster approaches. This study proposes to utilize the existing digital infrastructure of the COVID-19 Citizen Science (CCS) study on the Eureka Research Platform to perform a systematic and prospective randomized trial comparing mixing versus matching approaches. Eligible CCS participants will have the opportunity to be randomly assigned to a recommendation of receiving either the Pfizer or Moderna booster vaccine. Long-term effects will be monitored through the participants' completion of their regular weekly CCS follow-up surveys on symptoms and infection. This randomized trial aims to mitigate the effect of confounding variables and provide more conclusive evidence on each regiment to guide booster recommendations.

NCT ID: NCT05237024 Recruiting - Vaccine Reaction Clinical Trials

(VIII): The Eight Study and Immunologic Response Sub-study

Start date: April 15, 2021
Phase:
Study type: Observational

The study's objective is to test the hypothesis that immune system activation and subsequent systemic inflammation can be detected through continuously tracking multiple bio signals including physiologic variables (ECG, skin temperature and their derivatives) and behavioral variables (activity and sleep from accelerometers) collected during routine activities of daily living using wearable biosensors. In the sub-study, the objective is to explore the association between these objectively measured physiologic changes and vaccine-induced humoral and T-cell responses.

NCT ID: NCT05228912 Completed - COVID-19 Clinical Trials

Immunization of 7 Different Vaccines Against SARS-COV-2 Across 4 Countries.

Start date: February 26, 2021
Phase:
Study type: Observational [Patient Registry]

Background: Scarce information exists in relation to the comparison of seroconversion and adverse events following immunization (AEFI) with different SARS-COV2 vaccines. Our aim was to correlate the magnitude of the antibody response to vaccination with previous clinical conditions and AEFI. Methods: A multicentric comparative study where SARS-CoV-2 spike 1-2 IgG antibodies IgG titers are being measured at baseline, 21-28 days after the first and second dose (when applicable), six months and a year of the following vaccines: BNT162b2 mRNA, mRNA-1273, Gam-COVID-Vac, Coronavac, ChAdOx1-S, Ad5-nCoV and Ad26.COV2. Mixed model and Poisson generalized linear models will be performed for the analyses.

NCT ID: NCT05226429 Recruiting - COVID-19 Pandemic Clinical Trials

UNAIR Inactivated COVID-19 Vaccine

Start date: February 8, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This is a randomized, observer blind, controlled phase I/II study to evaluate the Safety, Reactogenicity, and Immunogenicity of UNAIR Inactivated Covid-19 Vaccine in Healthy Populations Aged 18 Years and Above. UNAIR Inactivated Covid-19 Vaccine is an inactivated vaccine developed by Airlangga University (Universitas Airlangga / UNAIR) made of SARS-CoV-2 virus isolated from a patient in Surabaya, Indonesia, composed with aluminium hydroxy gel, tween 80, and L-histidine. This study will be the first in human.

NCT ID: NCT05213455 Active, not recruiting - Vaccine Reaction Clinical Trials

Booster Effect of mRNA Vaccine on Antibody Response for SARS-CoV-2 After Complete Vaccination With Sinos

Start date: January 1, 2022
Phase:
Study type: Observational [Patient Registry]

In most parts of the world, mRNA vaccines were used to provide protection to population against COVID 19. However, in some countries, including Pakistan, traditional viral vaccines named as Sinovac and Sinopharm were used for mass level immunization. Though these vaccines were approved by WHO, their efficacy had been questioned. Now after recommendation of booster doses, we aim to see the effect of mRNA vaccine as a booster dose after Sinovac and Sinopharm in terms of antibody response. (IgG RBD SARS CoV2)

NCT ID: NCT05204602 Recruiting - COVID-19 Clinical Trials

Safety and Immunogenicity of COVID-19 Vaccine Booster in Patients With Liver Diseases

NMCIDCHESS2201
Start date: February 10, 2022
Phase:
Study type: Observational

Previous studies should that patients with chronic liver diseases, cirrhosis, hepatocellular carcinoma and post-liver-trasplant status had lower immunological response to SARS-CoV-2 vaccines than healthy population. Along with the waning of antibody and emerging SARS-CoV-2 variants, a third dose SARS-CoV-2 booster vaccination is now considered as an effective strategy. Previous studies showed good safety and immunogenicity of the SARS-CoV-2 booster vaccination in healthy population. However, the relevant information in patients with liver diseases need further research. This study (NMCID-CHESS 2201) aimed to investigate the safety and immunogenicity of the SARS-CoV-2 booster vaccination in population with chronic liver diseases

NCT ID: NCT05195151 Active, not recruiting - COVID-19 Clinical Trials

Modification of the COVID-19 Vaccine Response by an Intervention on the Intestinal Flora

PIRATES-COV
Start date: November 10, 2022
Phase: N/A
Study type: Interventional

The elderly, who are often in poorer health, have been particularly affected by the COVID-19 pandemic. Recent study results show that while vaccines have been very effective in the short term, protection for the elderly may not be sufficient 6 months after the 2nd dose. Some countries have started to offer a 3rd dose. We are considering acting on the intestinal flora of the elderly (which is often unbalanced) in order to increase the effectiveness of the vaccination. Indeed, it has been demonstrated that probiotics (which can rebalance the intestinal flora) significantly increase the production of antibodies after vaccination against the flu virus. Our hypothesis is that taking probiotics one month before and one month after the 4th dose of COVID vaccine would result in longer lasting vaccine protection in seniors. This study will include 668 seniors, aged 65-89 years, who have not had COVID-19, who have received 3 doses of an mRNA vaccine and who will accept a 4th dose of vaccine. All participants will take 1 capsule/day (probiotics or placebo) for 1 month and in the middle of this period will receive a 4th dose of vaccine. On five occasions (inclusion, vaccination,1 month, 3 months and 6 months post-vaccination), they will prick their fingertip and express the drop of blood on a blotting paper. They will mail this dried blood sample in an envelope for antibody testing in Quebec City. A subgroup of 100 participants willing to travel the Sherbrooke Clinical Research Center for 2 times (inclusion visit and final visit) will be invited to do a blood test. The investigators expect to reduce by 1/3 the number of seniors who are poorly protected by the 4rd dose of vaccine 6 months after the injection thanks to the probiotics. If successful, this approach could quickly be implemented worldwide as probiotics have few side effects and are affordable.

NCT ID: NCT05171946 Not yet recruiting - Safety Clinical Trials

Phase-I Study to Evaluate the Safety and Immunogenicity of a Prophylactic pDNA Vaccine Candidate Against COVID-19 in Healthy Adults

Start date: November 20, 2022
Phase: Phase 1
Study type: Interventional

A pneumonia of unknown cause detected in Wuhan, China, was first reported in December 2019. On 08 January 2020, the pathogen causing this outbreak was identified as a novel coronavirus 2019. The outbreak was declared a Public Health Emergency of International Concern on 30 January 2020. On 12 February 2020, the virus was officially named as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and the WHO officially named the disease caused by SARS-CoV-2 as coronavirus disease 2019 (COVID-19). On 11 March 2020, the WHO upgraded the status of the COVID-19 outbreak from epidemic to pandemic, which is now spreading globally at high speed. There are currently few licensed vaccines to prevent infection with SARS-CoV-2 or COVID-19 and the duration of response is unknown. Given the rapid transmission of COVID-19 and incidence of disease on a worldwide basis, the rapid development of effective vaccines with sufficient protection and duration of response is of utmost importance. IAU has developed a thermally stable plasmid DNA (pDNA)-based vaccine candidate using a platform approach that enables the rapid development of vaccines against emerging viral diseases, including SARS-CoV-2. The pDNA vaccine developed by IAU is a synthetic, codon-optimized, encode either the full-length Spike (S) gene or S1 domain of SARS-CoV-2 as genes of interest. Here, we aim to test a synthetic, codon optimized pDNA encoding S.opt.FL as vaccine candidate against COVID-19. A key advantage of pDNA vaccine is that multiple immunization can be used without the limitations of anti-vector responses. This study is intended to investigate the safety, immunogenicity, and tolerbilty of this prophylactic vaccine against COVID-19 administered as intramuscular immunization (i.m.).

NCT ID: NCT05168709 Completed - COVID-19 Clinical Trials

Investigating COVID-19 Vaccine Immunity in Children in the Melbourne Infant Study of BCG for Allergy and Infection Reduction

COSI BAIR
Start date: January 20, 2022
Phase: Phase 4
Study type: Interventional

The COSI BAIR trial will involve approximately 60 children, aged 5 to 8 years old, comprising a subset of participants from the Melbourne Infant Study BCG for Allergy and Infection Reduction (MIS BAIR) randomised controlled trial. The overall aim of this trial is to investigate the specific and heterologous effects of COVID-19 vaccination on immunity in children. COSI BAIR will aim to recruit its participants from the MIS BAIR Bacillus Calmette-Guérin (BCG)-naïve group. These children will be followed up until 28 days after their final Coronavirus Disease 2019 (COVID-19) vaccination. Venous blood samples will be collected at two study visits, at Murdoch Children's Research Institute (MCRI): 1. Day 0 - baseline (day of COVID-19 vaccination #1), and 2. Day 84 (28 days after COVID-19 vaccination #2).

NCT ID: NCT05154383 Completed - Vaccine Reaction Clinical Trials

Effect of High-Dose Quadrivalent Influenza Vaccine (Efluelda®) Versus Standard-Dose (QIV-SD), in Subjects 65 Years of Age and Older on Innate Immunity, Including Gene Expression

INFLUOMICS
Start date: November 15, 2021
Phase: Phase 4
Study type: Interventional

The purpose of the study is to evaluate innate and adaptive immunity following QIV-HD vaccination compared to QIV-SD vaccination in people 65 years of age and older.