CompletedPhase 2

Phase IIb Trial of Recombinant Novel Coronavirus Vaccine (Ad5-nCoV) in Adults 18 Years of Age and Older, Living With HIV

Argentina155 participantsStarted 2021-06-24

Plain-language summary

A randomized, double-blind, placebo -controlled, phase IIb clinical trial to evaluate the efficacy, safety and immunogenicity of one or two doses of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in adults 18 years of age and older, living with HIV, on stable treatment, and virologically suppressed for at least 6 months Protocol number: FH-58

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Adults of 18 years of age, and older.
✓. Confirmed HIV infection
✓. Able and willing (in the Investigator's opinion) to comply with all study requirements.
✓. Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner/personal doctor and access all medical records when relevant to study procedures.

Exclusion criteria

✕. For females of childbearing potential only, willingness to practice continuous effective contraception (see glossary) for 30 days prior to enrollment in the study, for 90 days after receiving vaccination during the study, and have a negative pregnancy test on the day(s) of screening/ vaccination (First Injection Visit and Second Injection Visit).
✕. Males participating in this study who are involved in heterosexual sexual activity must agree to practice adequate contraception (see glossary) and refrain from donating sperm for 90 days after receiving the study vaccination.
✕. Agreement to refrain from blood donation during the study.
✕. Provide written informed consent.

What they're measuring

Evaluate the incidence of solicited adverse reactions at 7 days after vaccination

Timeframe: 7 days after vaccine

Evaluate the incidence of unsolicited adverse events at 28 days after vaccination

Timeframe: 28 days after vaccine

Suppression of HIV viral load at 24 and 52 weeks

Timeframe: 52 weeks after vaccination

Evaluate the incidence of serious adverse events (SAE) and medically attended adverse events

Timeframe: 52 weeks after vaccination in all participants.

Evaluate the antibody response attended adverse

Timeframe: during 52 weeks after vaccination

Compare antibody response in both group

Timeframe: during 52 weeks after vaccination

Trial details

NCT IDNCT05005156

SponsorFundación Huésped

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-01-13

View on ClinicalTrials.gov More Covid19 trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Adults of 18 years of age, and older.
✓. Confirmed HIV infection
✓. Able and willing (in the Investigator's opinion) to comply with all study requirements.
✓. Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner/personal doctor and access all medical records when relevant to study procedures.

Exclusion criteria

✕. For females of childbearing potential only, willingness to practice continuous effective contraception (see glossary) for 30 days prior to enrollment in the study, for 90 days after receiving vaccination during the study, and have a negative pregnancy test on the day(s) of screening/ vaccination (First Injection Visit and Second Injection Visit).
✕. Males participating in this study who are involved in heterosexual sexual activity must agree to practice adequate contraception (see glossary) and refrain from donating sperm for 90 days after receiving the study vaccination.
✕. Agreement to refrain from blood donation during the study.
✕. Provide written informed consent.

What they're measuring

Evaluate the incidence of solicited adverse reactions at 7 days after vaccination

Timeframe: 7 days after vaccine

Evaluate the incidence of unsolicited adverse events at 28 days after vaccination

Timeframe: 28 days after vaccine

Suppression of HIV viral load at 24 and 52 weeks

Timeframe: 52 weeks after vaccination

Evaluate the incidence of serious adverse events (SAE) and medically attended adverse events

Timeframe: 52 weeks after vaccination in all participants.

Evaluate the antibody response attended adverse

Timeframe: during 52 weeks after vaccination

Compare antibody response in both group

Timeframe: during 52 weeks after vaccination