Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has caused pandemic since outbreak in 2020. Patients with HIV may be at higher risk than those without HIV for coronavirus disease 2019 (COVID-19). At present, limited data are available on the safety and immunogenicity of coronavirus vaccine for patients with HIV.
This study is a prospective, single-arm, open-label clinical trial. A total of 200 patients with HIV infection were included in this vaccination study. All of the patients will further accept 12 months follow-up study after vaccination. Safety and immunogenicity will be carefully recorded and detected.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Coronavirus vaccine was inoculated on day 0 and day 25±3, respectively
The Fifth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe occurence of adverse effects of COVID-19 vaccine in patients with HIV infection
We design a questionnaire for collecting the side effect, answers to the questionnaire are reported and described in a scale of 0-5, where zero indicates the lack of any side effect. Each patient is asked to complete the questionnaire. The questionnaire will be collected on each visit, and blood is drawn for laboratory test.
Time frame: Within 2 months after the first dose of COVID-19 vaccination
The immunogenicity and persistence after COVID-19 vaccination in patients with HIV infection
The titers of anti-SARS-CoV-2 antibodies will be detected on each follow-up time for evaluating the efficacy and persistence of COVID-19 vaccine in patients with HIV infection.
Time frame: Within 2 months after the first dose of COVID-19 vaccination
The occurence of adverse effects of COVID-19 vaccine in patients with HIV infection
We design a questionnaire for collecting the side effect, answers to the questionnaire are reported and described in a scale of 0-5, where zero indicates the lack of any side effect. Each patient is asked to complete the questionnaire. The questionnaire will be collected on each visit, and blood is drawn for laboratory test.
Time frame: Within 13 months after the first dose of COVID-19 vaccination
The immunogenicity and persistence after COVID-19 vaccination in patients with HIV infection
The titers of anti-SARS-CoV-2 antibodies will be detected on each follow-up time for evaluating the efficacy and persistence of COVID-19 vaccine in patients with HIV infection.
Time frame: Within 13 months after the first dose of COVID-19 vaccination
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.