Antibody response and safety through 12 months after booster vaccination with an investigational Lyme disease vaccine in adults: a plain language summary

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Plain Language Summary What is this summary about? This is a summary of an article describing a clinical study that was originally published in The Lancet Infectious Diseases. The study looked at whether a booster dose of VLA15, a vaccine being developed to provide protection against Lyme disease, could be a safe strategy for raising antibody levels before the next tick season. Adult participants first received intramuscular (into a muscle) injections of 135 or 180 micrograms VLA15 or placebo at Months 0, 2, and 6. Based on the results following these vaccinations, participants who received 180 micrograms VLA15 then received a booster dose of either VLA15 or placebo at Month 18. Safety and antibody responses were evaluated through Month 30. This study was blinded throughout, meaning that study researchers, staff, and participants did not know which treatment each participant received. What were the results? Initial results showed that a 180-microgram dose level of VLA15 given at Months 0, 2, and 6 was safe, well tolerated, and led to the highest antibody levels compared with the 135-microgram dose in this study or other combinations of dose levels and vaccination schedules tested in another study. Peak antibody levels increased during the first 3 doses and were highest after the Month 18 booster dose. Participants had similar side effects after each dose, and vaccination did not raise any safety concerns. What do the results mean? A Month 18 booster dose of 180 micrograms VLA15 after a 3-dose schedule at Months 0, 2, and 6 results in high antibody levels without raising any safety concerns up to the 1-year mark at Month 30. How to say (download PDF and double click sound icon to play sound)… Antibody: AN-tee-bod-ee Borrelia : baw-REH-lee-uh Lyme borreliosis: LYME baw-REH-lee-OH-sis Placebo: pluh-SEE-boh Boosting/booster dose: Giving an additional vaccine dose, called a booster dose, after one or more earlier doses to help the body produce more antibodies. VLA15: The vaccine being developed to provide protection against Lyme disease that was tested in this study. Vaccine: A medicine designed to help the body make antibodies against specific bacteria, viruses or anything else that might cause an infection. Antibody: A substance the body produces to fight off an infection. Placebo: Something that looks like the vaccine being studied but doesn’t contain any medicine. Antibody response: The amount of antibodies the body produces after vaccination. Blinded/blinding: A clinical study method in which study researchers, staff, and participants do not know which treatment each participant received. Side effect: A change in the participant’s body or health after vaccination. Side effects can be: local, occurring at or near the site of vaccination (for example, pain where the vaccine was given), or, systemic, affecting other parts of the body (for example, fever). This is an abstract of the Plain Language Summary of Publication article. View the full Plain Language Summary PDF of this article to read the full-text Link to original article here

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