A Study to Evaluate Safety and Immunogenicity of APV006 in Healthy Adults

Launched by LG CHEM · Jul 11, 2023

Keywords

ClinConnect Summary

The clinical trial titled "A Study to Evaluate Safety and Immunogenicity of APV006 in Healthy Adults" is looking at a new vaccine called APV006 to see how safe it is and how well it helps the body build protection against several infections, including diphtheria, tetanus, pertussis (whooping cough), poliomyelitis (polio), hepatitis B, and infections caused by Haemophilus influenzae type b. This study will be conducted with healthy adults at a single location, and participants will receive either the new vaccine or another vaccine for comparison, without knowing which one they got.

To join this study, participants need to be healthy adults aged 19 to 55 years, with a body mass index (BMI) between 18.5 and 30, and must not have any significant health issues. They should not have received certain vaccines recently or participated in other studies involving investigational products in the past six months. If eligible, participants will receive a single dose of the vaccine and will be monitored for any side effects and how well their immune system responds. It's important to know that this trial is not yet recruiting participants, so if you're interested, keep an eye out for updates!

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Healthy male and female adults aged 19 - 55 on Visit 1
• • Those without clinically significant abnormalities on the screening test on Visit 1
• • Those with a confirmed BMI of 18.5 kg/m2 to less than 30 kg/m2 on Visit 1
• • Those who have heard a detailed explanation of the study and whose written consent to participate in the study was given voluntarily by themselves or their legal representatives
• Exclusion Criteria:
• • Those who participated in other studies and took investigational products/ investigational vaccines within 6 months from Visit 1
• • Those who took tetanus toxoid (TT), tetanus-diphtheria (Td), tetanus-reduced diphtheria-acellular pertussis (Tdap) vaccine for adults, or other vaccines containing tetanus-diphtheria for adults within 5 years from Visit 1
• • Those who were vaccinated within 4 weeks from Visit 1 or who plan to receive vaccines other than the investigational vaccine from the participation in this study to Visit 5
• • Have had diphtheria, tetanus, pertussis, hepatitis B, polio, or invasive diseases caused by Haemophilus influenzae type b