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Covid19Phase 2COVID-19NCT05005156

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

A Phase 2 study testing Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) (Ad5-nCoV) in people with Covid19, run by Fundación Huésped at 4 sites in Argentina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Covid19
What is being tested?
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) (Ad5-nCoV)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
155 participants
Where
4 sitesArgentina
Study dates
24 Jun 2021to 13 Jan 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • Healthy adults, or stable-healthy adults who may have a pre-existing medical condition that does not meet any exclusion criteria. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment.
  • 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.

Who cannot join

  • 1. 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.
  • Note: Disclosure of serostatus post enrolment may accidentally unblind participants to group allocation. Participation in this trial can only be allowed if volunteers are kept blinded to their serology results from local/national serological surveys 3. Planned receipt of any vaccine (licensed or investigational), other than the study intervention, within 14 days before and after study vaccination 4. Prior receipt of an investigational or licensed vaccine likely to impact on the interpretation of the trial data (e.g. Adenovirus vectored vaccines, any coronavirus or SARS vaccines) 5. Administration of immunoglobulins and/or any blood products within the three months prior to the planned administration of the vaccine candidate 6. Any confirmed or suspected immunosuppressive or immunodeficient state (other than living with HIV, on stable treatment, and virologically suppressed for at least 6 months); asplenia; recurrent severe infections and chronic use (more than 14 days) of immunosuppressant medication within the past 6 months. Topical steroids or short-term (course lasting ≤14 days) oral steroids are not an exclusion 7. Active opportunistic infections or other AIDS-defining illness in the last six months.
  • 8. 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.

Trial locations and contacts

4 sites in 1 country.

Argentina4 sites

  • Fundacion Huesped

    CABA, Buenos Aires, C1202ABB

  • Centro de Estudio Infectologicos (CEI)

    Capital Federal, Buenos Aires, 1002

  • Helios Salud

    Capital Federal, Buenos Aires, 1145

  • Hospital Fernandez

    Capital Federal, Buenos Aires, 1425

Other trials in Argentina

About this study

Official title: A Phase IIb Clinical Trial to Evaluate the Efficacy, Safety and Immunogenicity of Two Doses of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in Adults 18 Years of Age and Older, Living With HIV.

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

Read the detailed description

Primary Safety Objectives:

  • Evaluate the incidence of solicited adverse reactions within 7 days after vaccination.
  • Evaluate the incidence of unsolicited adverse events within 28 days after vaccination.
  • Evaluate the HIV viral load 24 and 52 weeks after vaccination
  • Evaluate the incidence of serious adverse events (SAE) and medically attended adverse events (MAE) within 52 weeks after vaccination in all participants.

Primary Immunogenicity Objectives:

  • 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.
  • Evaluate the immunogenicity of two doses of the vaccine.

Secondary Safety Objectives:

  • Evaluate the incidence of a decrease in CD4+ cell count by ≥20% at 24 and 52 weeks after vaccination.
  • Evaluate changes in the CD4/CD8 ratio at 24 and 52 weeks compared to the basal value.
  • To evaluate the efficacy of two doses of Ad5-nCoV in different age groups from 14 and 28 days to 24 and 52 weeks after vaccination. This will be evaluated by weekly participant contact to assess for any signs or symptoms of COVID 19.

Secondary Immunogenicity Objectives:

  • Evaluate the GMT of S-RBD IgG antibody on Day 28, Day 84 and Week 24 and Week 52 after vaccination, measured by ELISA.
  • Evaluate the GMI of S-RBD IgG antibody on Day 28, Day 84 and Week 24 and Week 52 after vaccination, measured by ELISA.
  • Evaluate the seroconversion rate of pseudo-virus neutralizing antibody on Day 28, Day 84 and Week 24 and Week 52 after vaccination.
  • Evaluate the GMT of pseudo-virus neutralizing antibody on Day 28, Day 84 and Week 24 and Week 52 after vaccination.
  • Evaluate the GMI of pseudo-virus neutralizing antibody on Day 28, Day 84 and Week 24 and Week 52 after vaccination.
  • Evaluate the positive rate and level of IFN-γ, TNF, IL-4, IL-5, IL-13 stimulated by peptide pool of S protein on Day 28, Day 84 and Weeks 24 and Week 52 after vaccination, measured by intracellular cytokine staining (ICS) (in a subset of approximately 50 participants).

Exploratory Objectives

  • To evaluate the efficacy of two doses of Ad5-nCoV in preventing virologically confirmed (PCR positive) COVID-19 disease occurring 14 days and 28 days to 52 weeks after vaccination, regardless of severity.
  • To evaluate the efficacy of two doses of Ad5-nCoV in preventing virologically (PCR) or serologically (four-fold increase in SARS-CoV-2 anti-N IgG from pre-immunization to post symptom, defined as Day 21-28 post illness blood test, or pre-symptom to post-symptom blood test) confirmed COVID-19 disease occurring 14 and 28 days to 52 weeks after vaccination, regardless of severity.
  • To evaluate the efficacy of two doses of Ad5-nCoV in preventing severe COVID-19 disease caused by SARS-CoV-2 infection from 14 and 28 days to 24 and 52 weeks after vaccination.

Severe disease is defined as: 1) Clinical signs at rest indicative of severe systemic illness (respiratory rate ≥ 30 per minute, heart rate ≥ 125 per minute, SpO2 ≤ 93% on room air at sea level or PaO2/FiO2 < 300 mm Hg), 2) Respiratory failure (defined as needing high-flow oxygen, non-invasive ventilation, mechanical ventilation or ECMO), 3) Evidence of shock (SBP < 90 mm Hg, DBP < 60 mm Hg, or requiring vasopressors), 4) Significant acute renal, hepatic, or neurologic dysfunction, 5) Admission to an ICU

  • Evaluate the efficacy of Ad5-nCoV in preventing asymptomatic disease of COVID-19 (confirmed by N IgG antibody on week 52 after vaccination).
  • Evaluate the severity of COVID-19 cases among vaccine recipients (based on WHO or FDA criteria) as compared to the control group, to measure antibody-mediated disease enhancement (ADE).
  • Evaluate for any evidence of SARS-CoV-2 virus shedding in COVID-19 cases that occurred 28 days to 52 weeks after vaccination (detection of viral nucleic acid every 2 days after being confirmed).
  • Perform genotyping of SARS-CoV-2 virus isolates of COVID-19 cases that occurred 28 days to 52 weeks after vaccination.
  • Evaluate incidence of suspected but unconfirmed cases of COVID-19 (either because of negative or no tests).
Conditions
Covid19
Being tested
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) (Ad5-nCoV)
Keywords
Adenovirus 5, HIV, COVID19, vaccine
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT05005156
Study groupRoleWhat they receive
Active vaccine Ad5-nCoVExperimentalActive vaccine Ad5-nCoV, 0.5 mL/vial
Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) (Ad5-nCoV)
Placebo for Ad5-nCoVPlacebo comparatorPlacebo for Ad5-nCoV, 0.5 mL/vial
Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) (Ad5-nCoV)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 7 days after vaccine

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

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

    Measured: 28 days after vaccine

  3. Suppression of HIV viral load at 24 and 52 weeks

    Percentage of suppressed HIV viral load

    Measured: 52 weeks after vaccination

  4. 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)

    Measured: 52 weeks after vaccination in all participants.

  5. 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.

    Measured: during 52 weeks after vaccination

  6. Compare antibody response in both group

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

    Measured: during 52 weeks after vaccination

Secondary outcomes (6)

  1. Evaluate impact in CD4* cell

    Evaluate the incidence of a decrease in CD4+ cell count by ≥20%

    Measured: during 52 weeks after vaccination

  2. Evaluate impact in ratio CD4/CD8

    Evaluate changes in the CD4/CD8 ratio at 24 and 52 weeks compared to the basal value.

    Measured: during 52 weeks after vaccination

  3. Geometric mean antibody titers

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

    Measured: during 52 weeks after vaccination

  4. Geometric Mean Increase

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

    Measured: during 52 weeks after vaccination

  5. Evaluate the seroconversion rate of pseudo-virus neutralizing antibody

    Evaluate the GMT and GMI of pseudo-virus neutralizing antibody on Day 28, Day 84 and Week 24 and Week 52 after vaccination.

    Measured: during 52 weeks after vaccination

  6. Evaluate impact in chemokines

    Evaluate the positive rate and level of IFN-γ, TNF, IL-4, IL-5, IL-13 stimulated by peptide pool of S protein measured by intracellular cytokine staining (ICS) (in a subset of approximately 60 participants).

    Measured: during 52 weeks after vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2021
  2. Study start24 Jun 2021
  3. Primary completion13 Jan 2023
  4. Study completion13 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
155 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05005156
Sponsor's protocol ID
FH-58
Acronym
COVID-19
Status last verified
Jun 2025
First submitted
7 Jun 2021
Last updated
25 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 40498774

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) (Ad5-nCoV) in people with Covid19, run by Fundación Huésped at 4 sites in Argentina.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the incidence of solicited adverse reactions at 7 days after vaccination (time frame: 7 days after vaccine). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05005156, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.

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