Healthy Adults Research Study

Researchers at Emory University are conducting a study with healthy adults to evaluate the safety and immune response of an experimental inactivated rotavirus vaccine, Inactivated Rotavirus CDC-9. The goal is to determine whether the vaccine effectively stimulates the immune system to produce antibodies and if it offers a safer and potentially more effective alternative to current live oral rotavirus vaccines.

Fast Facts

Generally Healthy

18-45 Years Old

Compensation Provided

Conducted in Atlanta, GA

Study Background

This study aims to evaluate the safety and immune response of an experimental inactivated rotavirus vaccine, Inactivated Rotavirus CDC-9, in adults to potentially improve vaccine effectiveness and prevent severe illness caused by rotavirus infection.

Rotavirus is a contagious virus that primarily affects infants and children, causing symptoms such as severe diarrhea, vomiting, fever, and dehydration. In some cases, the illness can be severe enough to require hospitalization or even result in death. While two FDA-approved vaccines are currently available to protect against rotavirus, both are administered orally and contain live virus. However, these vaccines have shown limited effectiveness in preventing severe illness in certain populations, potentially due to the method of administration. This study, conducted at Emory University, seeks to address this gap by testing an experimental inactivated rotavirus vaccine, which may offer a safer and more effective alternative. By assessing the safety profile and immune response generated by the vaccine over a 9-10 month period, researchers hope to improve preventative measures against rotavirus infection in adults.

Study Background

This study aims to evaluate the safety and immune response of an experimental inactivated rotavirus vaccine, Inactivated Rotavirus CDC-9, in adults to potentially improve vaccine effectiveness and prevent severe illness caused by rotavirus infection.

Rotavirus is a contagious virus that primarily affects infants and children, causing symptoms such as severe diarrhea, vomiting, fever, and dehydration. In some cases, the illness can be severe enough to require hospitalization or even result in death. While two FDA-approved vaccines are currently available to protect against rotavirus, both are administered orally and contain live virus. However, these vaccines have shown limited effectiveness in preventing severe illness in certain populations, potentially due to the method of administration. This study, conducted at Emory University, seeks to address this gap by testing an experimental inactivated rotavirus vaccine, which may offer a safer and more effective alternative. By assessing the safety profile and immune response generated by the vaccine over a 9-10 month period, researchers hope to improve preventative measures against rotavirus infection in adults.

Additional Information

This study is being done to evaluate the safety and effectiveness of an experimental inactivated rotavirus vaccine, Inactivated Rotavirus CDC-9, in healthy adults. Researchers aim to determine whether the vaccine can successfully stimulate the immune system to produce antibodies and offer a safer, more effective alternative to existing live oral vaccines.

 

You may qualify for this study if you meet the following criteria.

Inclusion Criteria:

  • Ages 18-45
  • Generally healthy
  • Healthy weight (BMI between 18.0 – 35.9 kg/m2)
  • Agree to use one acceptable primary form of contraception
  • Able to attend 9 clinic visits

Exclusion Criteria:

  • Previously received a rotavirus vaccine or been diagnosed with rotavirus within the past 10 years
  • Active skin condition (e.g., eczema or other chronic dermatitis) or an open lesion (e.g., laceration, abrasion), scar, tattoo, or rash
  • Clinically significant history of or active/ongoing gastrointestinal disease
  • Currently pregnant or breastfeeding

If you participate in this study, you will attend 13 study visits, including 9 in-person visits at the research clinic and 4 phone calls. During these visits, you will provide medical and medication history, allow blood and possibly urine samples to be collected, undergo a physical exam, receive three doses of the experimental vaccine, and report any side effects in an e-diary. You will also be compensated for your time and effort, with payments made for various visits and completed e-diary entries. If necessary, transportation will be provided through UberHealth. If you do not complete the study, you will still be compensated for the visits you have completed.

As a participant, you can receive up to $940.

There is no cost for you to participate in our research study.