​​​​JEFFREY ADELGLASS, M.D., F.A.C.S.
​mICHELE rEYNOLDS, m.D., CPI
​CLINICAL RESEARCH STUDIES
​Dallas | ft. worth TEXAS

​​​ currently enrolling subjects for
​PAID CLINICAL RESEARCH participation

A clinical trial follows a protocol that has been approved by regulatory agencies to ensure patients’ and trial participants’ safety. The protocol outlines the types of trial participants to include, the schedule of visits and procedures, safety precautions, and what and how data will be analysed.


What are the phases of clinical trials?
Clinical trials are conducted in phases. Each phase of the trial has a different purpose and helps scientists answer different questions:

  • In Phase 1 trials, researchers test a new vaccine, drug, or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
  • In Phase 2 trials, the investigational vaccine, drug, or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
  • In Phase 3 trials, the investigational vaccine, drug, or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
  • In Phase 4 trials, post-marketing studies delineate additional information including the drug’s risks, benefits, and optimal use.


Reference: https://www.ciscrp.org/education-center/important-information/#faq

Why is diversity important in clinical trials?
Clinical trials and trial volunteers are vital to advancing research of an investigational vaccine that may potentially protect people of all ages and from all backgrounds.
 
Given that different populations and ages can respond differently to medical therapies, it is extremely important that this clinical trial include people of all ages, sexes, races, and ethnicities to ensure the investigational vaccine is safe and effective for everyone to use.

Will compensation for time be available as part of this clinical trial?
Qualified participants will receive payment for their trial-related time and travel.

Does the mRNA-1283.815 investigational vaccine contain a live virus?
The investigational vaccine being evaluated in this clinical trial is called mRNA-1283.815. Unlike vaccines that are made from weakened or killed viruses, mRNA-1283.815 is made from messenger RNA (mRNA), an instructional molecule that naturally occurs in the body and tells cells how to make specific protein. The goal of this vaccine is that the protein will trigger the body’s immune system to create the antibodies it needs to fight the real SARS-CoV-2, the virus that causes COVID-19. You cannot get COVID-19 from the mRNA-1283.815 investigational vaccine.

How can I check to see if I am eligible for this trial?
You can check if you are potentially eligible for this trial by answering a set of screening questions. Call 972-746-2222 to be screened for this study.

Can I remove myself from the trial at any time?
Participation is voluntary. You have the right to end your participation in the clinical trial at any time for any reason, or no reason at all. The clinical trial doctor or sponsor also has the right to discontinue a participant at any time for that person’s safety or if the participant no longer meets the trial requirements. 

​​Viewing on your phone? Complete interest form at bottom of page to be contacted for this study


About the NextCOVE Study (Part B)

A clinical trial of an investigational COVID-19 vaccine for adults and teens over 12. The NextCOVE Study is a Phase 3 clinical trial conducted by Moderna to evaluate an investigational vaccine that may protect people from getting sick if they come into contact with the virus that causes COVID-19, including the XBB.1.5 variant.

Trial Details
The NextCOVE Study is evaluating mRNA-1283.815, one of Moderna’s  investigational vaccines that may protect people from getting sick if they come into contact with the virus that causes COVID-19.  Moderna will be studying this new investigational vaccine in children and adults to learn more about how it works in the body.

You or your child, along with up to 33,574 other individuals, will be helping researchers learn more about Moderna’s latest investigational vaccine that may help protect people from getting sick if they come into contact with the virus.

Estimated Enrolment: Up to 33,574 participants
Phase 3

Eligibility Criteria
Participants must:

  • Be at least 12 years old
  • Be willing and able to comply with trial requirements


Participants must not:

  • Have had a positive COVID-19 test within 3 months prior to the screening visit
  • Have been exposed to someone with SARS-CoV-2 infection or COVID-19 within 2 weeks prior to receiving the first vaccination
  • Have received a COVID-19 vaccine within 3 months prior to the screening visit


Check Your Eligibility

  • We’ll check to see if you may qualify for this clinical trial by asking you some questions.
  • Get Started


 What to Expect

  • Participation in the NextCOVE Study will last approximately 13 months and includes up to 7 visits to a trial site and 3 safety phone calls.

  • You or your child will be chosen at random to receive either mRNA-1273.815 or the investigational dose of mRNA-1283.815. By comparing the vaccines, medical researchers can better understand how well the investigational vaccine works.

  • All trial participants will receive the same level of quality care regardless of which vaccine they receive.


  • You or your child will also be asked to complete electronic diary (eDiary) entries for the duration of the trial to report any COVID-19 symptoms that may occur.


  • Insurance is not needed to participate, and qualified participants will receive payment for their trial-related time and travel.

  • Participants will need to go to one of the clinics taking part in this clinical trial. Participating clinic:


               Research Your Health

               6020 W. Parker Rd., Suite 430

               Plano, TX 75093

 Frequently Asked Questions (FAQ)

What is COVID-19?

COVID-19 is a respiratory illness caused by the SARS-CoV-2 virus. Common symptoms are similar to the flu and include fever, cough, and tiredness. More serious symptoms include difficulty breathing and, in rare cases, death. The World Health Organisation declared COVID-19 a pandemic in March 2020. Since that time, there have been more than 500 million cases and 6.2 million deaths worldwide.


What is a clinical trial?
Clinical trials are carefully controlled scientific studies that evaluate how well investigational or modified medicines may treat or prevent diseases in people. Clinical trials are conducted to answer questions such as:

  • Is the investigational treatment or vaccine safe enough to outweigh the risks?
  • What is the best dose needed for the investigational treatment or vaccine to work?
  • How often should the investigational treatment or vaccine be given?
  • How effective is the investigational treatment or vaccine at treating or preventing symptoms or the condition?
Never received a Covid vaccine? We're looking for Covid-19 vaccine-naive participants (ages 12 and up) for the NextCOVE study!