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

NCT05005156 | Completed Phase 2

• 1 other identifier: FH-58
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 4

Brief 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

Conditions

Covid19

Keywords

Adenovirus 5, HIV, COVID19, vaccine

Outcome Measures

Primary Outcomes (6)

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

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

  7 days after vaccine

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

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

  28 days after vaccine

• Suppression of HIV viral load at 24 and 52 weeks

  Percentage of suppressed HIV viral load

  52 weeks after vaccination

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

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

  52 weeks after vaccination in all participants.

• Evaluate the antibody response attended adverse

  ● Evaluate the seroconversion rate of S-RBD IgG antibody on Day 28, Day 84 and Week 24 and Week 52 after vaccination, measured by ELISA.

  during 52 weeks after vaccination

• Compare antibody response in both group

  compare the seroconversion rate of S-RBD IgG antibody of one dose versus two doses of the vacccine

  during 52 weeks after vaccination

Secondary Outcomes (6)

• Evaluate impact in CD4* cell

  during 52 weeks after vaccination

• Evaluate impact in ratio CD4/CD8

  during 52 weeks after vaccination

• Geometric mean antibody titers

  during 52 weeks after vaccination

• Geometric Mean Increase

  during 52 weeks after vaccination

• Evaluate the seroconversion rate of pseudo-virus neutralizing antibody

  during 52 weeks after vaccination

Other Outcomes (5)

• Evaluate impact in preventing CoVID-19 confirmed cases

  from 14 days after vaccination

• Identify variants of interest and concern

  during 52 weeks after vaccination

• Evaluate the incidence of CoVID19 confirmed by IgG antibody disease of COVID-19 confirmed by N IgG antibody

  week 52 after vaccination

Study Arms (2)

Active vaccine Ad5-nCoV

EXPERIMENTAL

Active vaccine Ad5-nCoV, 0.5 mL/vial

Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) (Ad5-nCoV)

Placebo for Ad5-nCoV

PLACEBO COMPARATOR

Placebo for Ad5-nCoV, 0.5 mL/vial

Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) (Ad5-nCoV)

Interventions

Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) (Ad5-nCoV) BIOLOGICAL

All participants will receive two doses vaccine and will be followed to monitor vaccine candidate safety, immunogenicity, and efficacy for a duration of 52 weeks. Fifty four days after the first vaccination, all participants will receive a second injection.

Active vaccine Ad5-nCoV; Placebo for Ad5-nCoV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults of 18 years of age, and older.
• Confirmed HIV infection
• At least two HIV plasma viral load (pVL) below 40 copies in the last 12 months, one within the last 60 days (value obtained at Screening visit can be used for the value within the last 60 days)
• A CD4 count at screening equal or above 300 cells/mL and a CD4 percentage equal or above 15 % within the previous 60 days (value obtained at Screening visit can be used for the value within the last 60 days)
• Participant must be on a stable highly active anti-retroviral treatment (HAART) for 6 months (unless the change is due to tolerability, in which case the regimen can be for only the previous 3 months) and with an estimated adherence of ≥80% within the last 60 days. - A HAART regimen (as defined by the Argentinean ART guidelines), means a combination of 2 NRTIs plus one INSTI or a NNRTI or a boosted PI or a dual combination of dolutegravir and 3TC.
• 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.

You may not qualify if:

• 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.
• \. Participation in any other COVID-19 prophylactic drug trials for the duration of the study.
• Note: Participation in COVID-19 treatment trials is allowed in the event of hospitalization due to COVID-19. The study team should be informed as soon as possible. 2. Participation in SARS-CoV-2 serological surveys where participants are informed of their serostatus for the duration of the study.
• \. History of allergic disease or reactions likely to be exacerbated by any component of Ad5-nCoV 9. Any history of angioedema 10. Any history of anaphylaxis to any vaccine component 11. Pregnancy, lactation or willingness/intention to become pregnant within 90 days after receiving study vaccine 12. Current diagnosis of or treatment for cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ) 13. History of serious psychiatric condition likely to affect participation in the study 14. Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture 15. Suspected or known current alcohol or drug dependency 16. Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness (mild/moderate well-controlled comorbidities are allowed) 17. History of laboratory-confirmed COVID-19 18. Continuous use of anticoagulants, such as coumarins and related anticoagulants (i.e. warfarin) or novel oral anticoagulants (i.e. apixaban, rivaroxaban, dabigatran and edoxaban) 19. Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.

Sponsors & Collaborators

• Fundación Huésped: lead
• Canadian Center for Vaccinology: collaborator
• CanSino Biologics Inc.: collaborator
• Hospital Fernandez: collaborator

Study Sites (4)

Fundacion Huesped

CABA, Buenos Aires, C1202ABB, Argentina

Location

Centro de Estudio Infectologicos (CEI)

Capital Federal, Buenos Aires, 1002, Argentina

Location

Helios Salud

Capital Federal, Buenos Aires, 1145, Argentina

Location

Hospital Fernandez

Capital Federal, Buenos Aires, 1425, Argentina

Location

Related Publications (1)

• Cahn P, Barreto L, Figueroa MI, Fink V, Rolon MJ, Lopardo G, Cassetti I, Ceschel M, Patterson P, Gambardella L, Mernies G, Nava A, Gou J, Wang R, Zhu T, Halperin SA. Immune response induced by the recombinant novel coronavirus vaccine (Adenovirus type 5 vector) (Ad5-nCoV) in persons living with HIV (PLWH). PLoS One. 2025 Jun 11;20(6):e0312893. doi: 10.1371/journal.pone.0312893. eCollection 2025.

  PMID: 40498774 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Pedro Cahn, MD:PhD

  fundacion huesped

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific Director, MD; PhD

Model Details: This Phase IIb study is a clinical trial for 500 participants 18 years of age or older living with HIV. All participants will receive two doses of the study vaccine and will be followed to monitor vaccine candidate safety, immunogenicity, and efficacy during 52 weeks. Fifty five days after the first vaccination, all participants will receive a second injection.

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: August 13, 2021
• Study Start: June 24, 2021
• Primary Completion: January 13, 2023
• Study Completion: January 13, 2023
• Last Updated: June 25, 2025

Record last verified: 2025-06

Locations

AR (4)