COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05075070

Hanqing He

hanqinghe@cdc.zj.cn

2021-10-12

Recruiting

nonRCT

Non-randomized

Single group assignment

Open label

single-center

Prevention

inclusion criteria: - subjects aged ≥18. - body temperature < 37.3 ° c confirmed by clinical examination before enrollment . - cd4+ count is less than 500/ul and more than 50/ul . - female subjects of reproductive age declare that they are not pregnant, have no birth plan in the first 3 months after enrollment, and have taken effective contraceptive measures in the first 2 weeks before enrollment. - able and willing to complete the entire study plan during the study follow-up period. - have the ability to understand the study procedures, voluntarily sign informed consent, and comply with the requirements of the clinical study protocol. exclusion criteria for the first dose: - being allergic to any component of vaccines (including excipients) . - subjects who have experienced severe allergic reactions to vaccines (e.g. acute anaphylaxis, urticaria, angoneeurotic edema, dyspnea, etc.). - having uncontrolled epilepsy and other progressive neurological disorders and a history of guillain-barre syndrome. - pregnant and lactating women. - the subjects are suffering from an acute illness; or thrombocytopenia patients with platelet count < 20×10^9/l within three days before inoculation, that is, patients at high risk of spontaneous bleeding. - acute hiv infection and opportunistic infection. - subjects with co-opportunistic infections who did not receive antiviral therapy. - subjects with cd4+ count less than 50/ul who have not received antiviral therapy. - hiv-infected subjects undergoing treatment with severe drug interactions and overlapping toxicity (kidney damage, liver damage, hematological problems, etc.). - patients with malignant tumors are undergoing chemotherapy and radiotherapy before and after surgery. - other subjects whose physical conditions, as determined by the investigator, are not suitable for inclusion in clinical studies. exclusion criteria for the second dose: - subjects who had vaccine-related adverse reactions after the first dose. - having high fever (axillary temperature ≥39.0℃) for three days after the first dose of inoculation, or severe allergic reaction. - having any adverse nervous system reaction after the first dose. - during the acute onset of a chronic disease, or the recovery of acute complications less than two weeks. - subjects with severe immunodeficiency (cd4+ count less than 50/ul). - acute hiv infection and opportunistic infection. - subjects with co-opportunistic infections who did not receive antiviral therapy. - hiv-infected subjects undergoing treatment with severe drug interactions and overlapping toxicity (kidney damage, liver damage, hematological problems, etc.). - other reasons for exclusion considered by the investigator.

None

1

China National Biotec Group Company Limited

18

100

China

Healthy volunteers

N/A

400

Baseline neutralizing antibody level;Neutralizing antibody level;Seroconversion rate

None

Phase 4

[{"arm_notes": "HIV patients;2;Days0-21", "treatment_id": 643, "treatment_name": "Inactivated covid-19 vaccine", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]