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URMC / Infectious Diseases Research Clinic / Clinical Studies

 

Clinical Studies

TESTING SITE: Licensed practical nurse Linda Anderson (left) works with clinical research coordinator Doreen Francis to prepare Eron Damercy of Rochester for a COVID-19 vaccine trial at the Medical Center. (Photograph by J. Adam Fenster)We are regularly looking for volunteers and participants for various studies relating to vaccine research. Please check here periodically for current and upcoming studies.

COVID-19

Participate in a COVID-19 Study

The purpose of this research is to test additional vaccine booster shots that use different vaccine types and/or variant spikes to see if these new combinations are safe and to evaluate the immune system responses. Vaccines tell your germ-fighting cells to make antibodies and other substances to fight infections. All the study vaccines are intended to train the immune system so that if the person is then infected with the SARS-CoV-2 virus, they have a “head start” and the infection can be stopped or made less severe. Using a booster vaccine that has one or more different variant spikes, or the original spike in combination with variant spikes, may improve protection against variant strains.

This study uses vaccines that have received FDA approval or EUA and also experimental vaccines that are still under investigation. The vaccines used in this study include different vaccine types, the variant spikes, or both together as experimental vaccine approaches

Experimental means the study vaccine is not approved for routine use by the FDA; however, the FDA is allowing experimental variant vaccines to be used that have been developed in the same manner as approved vaccines. Some of the vaccines used in this study may include:

  • A low dose Moderna vaccine, mRNA-1273, 50 mcg, granted FDA EUA as a booster
  • Moderna mRNA study vaccines updated with three new variants: B.1.351 (Beta variant), B.1.617.2 (Delta variant) and B.1.1.519 (Omicron variant)
  • Moderna mRNA study vaccines containing a combination of 2 or more variants
  • Variant study vaccines using different technologies to deliver spike protein

Groups of participants who have already received the Moderna primary series (2 doses) and booster, the Pfizer primary series (2 doses) and booster, or Janssen vaccine (1 dose) and booster as recommended by the CDC will be enrolled. Immune responses to additional booster doses may also differ based on age and whether or not someone has been infected and recovered from SARS-CoV-2. We have therefore designed the study to have at least 45% of adults aged 65 years or older and 35% of participants who are fully vaccinated and have recovered from COVID-19.

Full clinical trial description ClinicalTrials.gov

The primary purpose of the KidCOVE Study is to test the safety and effectiveness of the study vaccine, called mRNA-1273, that may protect children between the ages of 6 months to < 12 years from getting sick if they come into contact with SARS-CoV-2, which causes COVID-19.

Moderna plans to enroll this study in two parts, staggering the recruitment of three different age groups. The first age group will start in children between the ages of 6 years to less than 12 years old. The second age group, recruiting later on, will be for children between the ages of 2 years to less than 6 years old. Finally, the third, and last group to start, will be for children ages 6 months to less than 2 years old. Please be aware that it may be several months before your child’s age group and/or a site near you opens.

Please visit KidCoveStudy for additional information, such as study overview, participation criteria, and site locations along with contact numbers for each location for the study.

Full clinical trial description ClinicalTrials.gov

This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of a delayed (>/=12 weeks) vaccine boost on a range of Emergency Use Authorization (EUA)-dosed COVID-19 vaccines. This is an adaptive design and may add arms (and increase sample size) as vaccines are awarded EUA and/or variant lineage spike vaccines are manufactured or become available. Enrollment will occur at up to twelve domestic clinical research sites.

Participants must be 18 years of age or older, in good health, and have been fully vaccinated against COVID-19 for at least 12 weeks prior to enrollment.

Full clinical trial description at ClinicalTrials.gov

This is an observational, non-interventional, prospective cohort study designed to collect clinical information and specimens to evaluate the immune responses from pregnant individuals and postpartum individuals and their infants following maternal receipt of licensed or Emergency Use Authorization (EUA) severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines.

Both pregnant and postpregnant participants are needed 18 years of age or older. Participants must have received or be scheduled to receive a COVID-19 vaccine during pregnancy or within the first 2 months postpartum.

Full clinical trial description at ClinicalTrials.gov

This Phase 1 trial is an open-label trial to evaluate the safety, reactogenicity and immunogenicity of two dosages of intranasal CVXGA1 administered as a single dose in two age groups, 18-55 and 56-75.

Participants must be healthy males or non-pregnant females, aged 18 – 75 years old, in good health and must adhere to pandemic public health guidance on preventing SARS-CoV-2 infection (e.g. wearing a mask, keeping physically distant, sheltering-in) throughout trial duration.

Full trial description at ClinicalTrials.gov

Flu

Participate in a Flu study

The primary purpose of this study is to evaluate the safety, tolerability, and immunogenicity of a modified RNA vaccine against influenza.

Participants must be healthy and 65 - 85 years of age.

Full clinical trial description at ClinicalTrials.gov

Other Studies

Contact the IDRC to Join

This study will recruit and enroll volunteers who are hospitalized with an acute respiratory illness.

This randomized, double-blinded, placebo-controlled Phase 3 study is designed to assess the safety, immunogenicity, and efficacy of RSVpreF in the prevention of moderate to severe LRTI-RSV in adults.

Participants must be healthy adults 60 years of age or older.

Full clinical trial description at ClinicalTrials.gov