COVID-19 VaccinePhase 2FH-63NCT05293223
Phase IIB Study of Recombinant Novel Coronavirus Vaccine
A Phase 2 study testing Ad5-nCov in people with COVID-19 Vaccine, run by Fundación Huésped at 3 sites in Argentina.
Trial summary
This is an open-label and non-randomized study to demonstrate the immunogenicity and safety profile in adults that received the Ad5-nCoV vaccine at least 21 days but no later than 90 days after the first dose of Sputnik V. The non-inferiority hypothesis is used for the evaluation of the exploratory objective. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Vaccine
- What is being tested?
- Ad5-nCov
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 3 sitesArgentina
- Study dates
- 1 Oct 2021to 15 Dec 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
- Participants aged 18 years and above at the time of randomization.
- Provide written informed consent.
- Axillary temperature ≤ 37℃.
- Never received any investigational or licensed COVID-19 vaccine other than the 1st dose of Sputnik V with an interval of 21-90 days before the study.
- Subjects are eligible for immunization of this product as evaluated by investigators after medical history examination, physical examination and clinical judgment of health.
Who cannot join
- Have a history of seizures, epilepsy, encephalopathy, psychosis.
- History of anaphylaxis to any vaccine component.
- Positive urine pregnancy test result, pregnant, lactation women, or intend to become pregnant within the next 6 months.
- Congenital or acquired angioedema/neuroedema.
- Medical history of Guillain-Barré syndrome.
- Asplenia or functional absence of spleen.
Show all 15Show fewer
- Bleeding disorder (e.g. protein S or factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture.
- Any confirmed or suspected immunosuppressive or immunodeficient state; received immunosuppressive therapy, cytotoxic therapy, or chronic corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis and surface corticosteroid therapy for acute non-complicated dermatitis) within the past 6 months,
- History of chronic systematic infection.
- Administration of immunoglobulins and/or any blood products within three months prior to the planned administration of the vaccine candidate.
- Receiving anti-tuberculosis or cancer treatment.
- History of laboratory-confirmed COVID-19, or has a positive result at the examination of SARS-CoV-2 antigen before vaccination.
- Planned to receive any vaccine (licensed or investigational), other than the study intervention, within 14 days before and after study vaccination.
- Continuous use of anticoagulants, such as coumarins and related anticoagulants (i.e. warfarin) or novel oral anticoagulants (i.e. apixaban, rivaroxaban, dabigatran and edoxaban).
- Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, and affect the ability of the volunteer to participate in the study or impair interpretation of the study data.
Trial locations and contacts
3 sites in 1 country.
Argentina3 sites
Centro de Investigación y Prevención Cardiovascular CIPREC
Buenos Aires, 1119
Centro de vacunación PREVIVAX
Ciudad Autonoma de Buenos Aire, Ciudad Autónoam de Buenos Aires, 1414
Fundación Huésped
Ciudad Autónoma de Buenos Aires, Buenos Aires, 1202
About this study
Official title: An Open-label Clinical Trial Phase IIB to Evaluate the Immunogenicity and Safety of Recombinant Novel Coronavirus Vaccine in Participants Aged 18 Years and Above That Previously Received One Dose of Sputnik V
This is an open-label and non-randomized study to demonstrate the immunogenicity and safety profile in adults that received the Ad5-nCoV vaccine at least 21 days but no later than 90 days after the first dose of Sputnik V.
The non-inferiority hypothesis is used for the evaluation of the exploratory objective. The ratio of Geometric mean titers (GMTs) of SARS-CoV-2 neutralizing antibody in participants on Day 21 post-vaccination of Ad5-nCoV (previously received a 1st dose of Sputnik V) (Group A) and two doses of Sputnik V (Group B) is used for the evaluation of this hypothesis.
Read more
It is assumed to enroll about 100 subjects for each group. Additionally, 45 participants will be selected from Group A (to enter the immunogenicity subgroup for cellular immune response analysis. According to the above, considering extra subjects for compensating about 10% dropouts, the sample size of Group A is designed to be 450, for Group B is 200. Participants enrolled in Group A (1st dose of Sputnik V plus 1 dose of Ad5-nCoV) must have only received the 1st dose of Sputnik V and the interval between the previous injection (1st dose of Sputnik V) and the day of vaccination with Ad5-nCoV should be between 21 and 90 days. The comparator (Group B) will be the samples stored at the immunology lab of the Buenos Aires University Medical School, corresponding to individuals vaccinated with 2 doses of Sputnik V.
UPDATE : It's worth noting that enrollment number during the study was lower than the originallyplanned. According to the Protocol Group A sample size was designed to be 450. A low enrollment rate due to a fast vaccination rate (second dose) through the national COVID vaccination campaign for the entire population of Argentina resulted in difficulties in reaching the sample size planned. (the final number of participants enrolled and vaccinated in the study was 86 in arm A ).The enrollment period was affected due to the fast expansion of the National Vaccination Plan and the opportunity for potential participants to access it. Therefore, it was not possible to achieve the number of enrolled participants that was planned at the beginning of the study (450).
Read the detailed description
There are 4 planned site visits in total: V1 (day0), V2 (day21), V3 (month 3), V4 (month 6) Healthy adults aged 18 years and above in Argentina will be informed by a procedure approved by the ethical review committee before consent is sought to be a volunteer. After passing the physical examination and screening according to the inclusion and exclusion criteria, they will be eligible to participate in this study.
Group B is a comparator group, in which samples stored corresponding to individuals who have already received 2 doses of Sputnik V will be used for the immunogenicity evaluation.
Study Procedures
- Informed consent
- Check inclusion and exclusion criteria All inclusion and exclusion criteria will be checked at the screening in-person visit and be reviewed at each in-person visit.
- Collect demographic data and contact information
- Medical history Obtain the participant's medical history by interview and/or review of the participant's medical records and record any pre-existing conditions or signs and/or symptoms present prior to injection in the EDC. This will include reviewing of any health condition that may prevent the participant from enrolling in the study, such as an unstable health condition or known positive HIV status (with less than 200 CD4 cells/mL).
- Check contraindications, warnings and precautions to injection Contraindications, warnings and precautions to injection must be checked before vaccination.
- Urine Pregnancy Test/Birth Control Women of child-bearing age will be asked to perform a urine pregnancy test at the day of enrollment. The result of the urine pregnancy test must be negative. In addition, participants who are able to become pregnant or could impregnate a partner are required to have used approved contraception at least 30 days prior to the study vaccination and for 90 days' post-vaccination.
- Physical examination Screening conclusion Participants will be deemed eligible to participate upon reviewing medical history and inclusion and exclusion criteria. This will occur prior to vaccination.
- Study group and treatment number allocation The eligible participants will be enrolled into Group A. Each participant will be assigned a treatment identification number (Subject ID).
- Check and record prior medications and concomitant medication/injection
- Check and record intercurrent medical conditions
- Pre-vaccination serology Approximately 10 mL of whole blood will be collected from each participant in Group A at Day 0 and separated for serum.
- Injection of study vaccine After completing all prerequisite procedures prior to injection, one dose of the assigned vaccine will be administered IM in the deltoid muscle of the upper arm for participants in Group A.
- Safety participant contacts Participants in group A need to record any AEs they may experience within 21 days post-vaccination. There is an on-site visit on the 21st day post-vaccination and the subjects need to submit their diary card.
Following up serology All participants in group A will have an in-person visit at Day 21, Month 3, and Month 6 post-vaccination of either Ad5-nCoV. Approximately 10 mL of whole blood will be collected from each participant and separated for serum.
- Conditions
- COVID-19 Vaccine
- Being tested
- Ad5-nCov
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ad5-nCovBiological
Participants enrolled in Group A with only the 1st dose of Sputnik V will receive Ad5-nCoV vaccine at least 21 days but no more than 180 days after the first dose. They will be followed to evaluate the immunogenicity and safety of Ad5-nCoV vaccine during 6 months
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | One dose Sputnik V + one dose Ad5-nCoV Receives: Biological: Ad5-nCov |
| Group B | No intervention | Samples stored at the immunology lab of the Buenos Aires University Medical School, corresponding to individuals vaccinated with 2 doses of Sputnik V. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Geometric mean titers (GMTs) of SARS-CoV-2 neutralizing antibody
The Geometric mean titers (GMTs) of SARS-CoV-2 neutralizing antibody on Day 21 post-vaccination of Ad5-nCoV.
Measured: 21 days from baseline
Secondary outcomes (6)
The Geometric mean titers (GMTs) of SARS-CoV-2 neutralizing antibody
The GMT of SARS-CoV-2 neutralizing antibody on Month 3 and Month 6 post-vaccination of Ad5-nCoV or the 2nd dose of Sputnik V.
Measured: Month 3 and Month 6 from baseline
solicited adverse events
The incidence of solicited adverse reactions (ARs) within 7 days post-vaccination of Ad5-nCoV.
Measured: from baseline to 7 days post-vaccination
SARS-CoV-2 specific T-cell response
The SARS-CoV-2 specific T-cell response is studied using flow cytometry, evaluating the expression of activation markers in T CD4+ and CD8+ cells. Expression of CD40L (CD154), and the production of interferon γ (IFN-γ), interleukin-2 (IL-2) and tumoral necrosis factor (TNF-α) will be studied.
Measured: Day 21 post-vaccination of Ad5-nCoV
The GMT of S-protein receptor binding domain (S-RBD) antibody
The GMT of S-protein receptor binding domain (S-RBD) antibody on Day 21, Month 3, and Month 6 post-vaccination of Ad5-nCoV or the 2nd dose of Sputnik V.
Measured: Day 21, Month 3, and Month 6
unsolicited adverse events (AEs)
To evaluate the incidence of unsolicited adverse events (AEs) within 21 days post-vaccination of Ad5-nCoV.
Measured: from baseline to 21 days post-vaccination
serious adverse events (SAEs)
The incidence of serious adverse events (SAEs) within 6 months post-vaccination of Ad5-nCoV.
Measured: from baseline to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start1 Oct 2021
- Primary completion15 Nov 2022
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 VaccineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The ratio of Geometric mean titers (GMTs) of SARS-CoV-2 neutralizing antibody in participants on Day 21 post-vaccination of Ad5-nCoV (previously received a 1st dose of Sputnik V) (Group A) and two doses of Sputnik V (Group B) is used for the evaluation of this hypothesis.
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Huésped
- Sponsor type
- University, hospital or other
- Collaborators
- Dalhousie University, CanSino Biologics Inc.
- Responsible party
- Principal investigator, Pedro Cahn, Fundación Huésped
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05293223
- Sponsor's protocol ID
- FH-63 (CS-nCoV-SeqAD26)
- Acronym
- FH-63
- Status last verified
- Jun 2025
- First submitted
- 24 Nov 2021
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Clinical Trial Phase IIB to Evaluate the Immunogenicity and Safety of Recombinant Novel Coronavirus Vaccine in Participants Aged 18 Years and Above That Previously Received One Dose of Sputnik V
- ClinicalTrials.gov ID
- NCT05293223
- Acronym / sponsor ID
- FH-63 / FH-63 (CS-nCoV-SeqAD26)
- Conditions
- COVID-19 Vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Fundación HuéspedUniversity, hospital or other
- Collaborators
- Dalhousie University, CanSino Biologics Inc.
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 24 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label and non-randomized study to demonstrate the immunogenicity and safety profile in adults that received the Ad5-nCoV vaccine at least 21 days but no later than 90 days after the first dose of Sputnik V.
The non-inferiority hypothesis is used for the evaluation of the exploratory objective. The ratio of Geometric mean titers (GMTs) of SARS-CoV-2 neutralizing antibody in participants on Day 21 post-vaccination of Ad5-nCoV (previously received a 1st dose of Sputnik V) (Group A) and two doses of Sputnik V (Group B) is used for the evaluation of this hypothesis.
It is assumed to enroll about 100 subjects for each group. Additionally, 45 participants will be selected from Group A (to enter the immunogenicity subgroup for cellular immune response analysis. According to the above, considering extra subjects for compensating about 10% dropouts, the sample size of Group A is designed to be 450, for Group B is 200. Participants enrolled in Group A (1st dose of Sputnik V plus 1 dose of Ad5-nCoV) must have only received the 1st dose of Sputnik V and the interval between the previous injection (1st dose of Sputnik V) and the day of vaccination with Ad5-nCoV should be between 21 and 90 days. The comparator (Group B) will be the samples stored at the immunology lab of the Buenos Aires University Medical School, corresponding to individuals vaccinated with 2 doses of Sputnik V.
UPDATE : It's worth noting that enrollment number during the study was lower than the originallyplanned. According to the Protocol Group A sample size was designed to be 450. A low enrollment rate due to a fast vaccination rate (second dose) through the national COVID vaccination campaign for the entire population of Argentina resulted in difficulties in reaching the sample size planned. (the final number of participants enrolled and vaccinated in the study was 86 in arm A ).The enrollment period was affected due to the fast expansion of the National Vaccination Plan and the opportunity for potential participants to access it. Therefore, it was not possible to achieve the number of enrolled participants that was planned at the beginning of the study (450).
Detailed description
There are 4 planned site visits in total: V1 (day0), V2 (day21), V3 (month 3), V4 (month 6) Healthy adults aged 18 years and above in Argentina will be informed by a procedure approved by the ethical review committee before consent is sought to be a volunteer. After passing the physical examination and screening according to the inclusion and exclusion criteria, they will be eligible to participate in this study.
Group B is a comparator group, in which samples stored corresponding to individuals who have already received 2 doses of Sputnik V will be used for the immunogenicity evaluation.
Study Procedures
- Informed consent
- Check inclusion and exclusion criteria All inclusion and exclusion criteria will be checked at the screening in-person visit and be reviewed at each in-person visit.
- Collect demographic data and contact information
- Medical history Obtain the participant's medical history by interview and/or review of the participant's medical records and record any pre-existing conditions or signs and/or symptoms present prior to injection in the EDC. This will include reviewing of any health condition that may prevent the participant from enrolling in the study, such as an unstable health condition or known positive HIV status (with less than 200 CD4 cells/mL).
- Check contraindications, warnings and precautions to injection Contraindications, warnings and precautions to injection must be checked before vaccination.
- Urine Pregnancy Test/Birth Control Women of child-bearing age will be asked to perform a urine pregnancy test at the day of enrollment. The result of the urine pregnancy test must be negative. In addition, participants who are able to become pregnant or could impregnate a partner are required to have used approved contraception at least 30 days prior to the study vaccination and for 90 days' post-vaccination.
- Physical examination Screening conclusion Participants will be deemed eligible to participate upon reviewing medical history and inclusion and exclusion criteria. This will occur prior to vaccination.
- Study group and treatment number allocation The eligible participants will be enrolled into Group A. Each participant will be assigned a treatment identification number (Subject ID).
- Check and record prior medications and concomitant medication/injection
- Check and record intercurrent medical conditions
- Pre-vaccination serology Approximately 10 mL of whole blood will be collected from each participant in Group A at Day 0 and separated for serum.
- Injection of study vaccine After completing all prerequisite procedures prior to injection, one dose of the assigned vaccine will be administered IM in the deltoid muscle of the upper arm for participants in Group A.
- Safety participant contacts Participants in group A need to record any AEs they may experience within 21 days post-vaccination. There is an on-site visit on the 21st day post-vaccination and the subjects need to submit their diary card.
Following up serology All participants in group A will have an in-person visit at Day 21, Month 3, and Month 6 post-vaccination of either Ad5-nCoV. Approximately 10 mL of whole blood will be collected from each participant and separated for serum.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The ratio of Geometric mean titers (GMTs) of SARS-CoV-2 neutralizing antibody in participants on Day 21 post-vaccination of Ad5-nCoV (previously received a 1st dose of Sputnik V) (Group A) and two doses of Sputnik V (Group B) is used for the evaluation of this hypothesis.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: Ad5-nCovOne dose Sputnik V + one dose Ad5-nCoV |
| Group B | No intervention | –Samples stored at the immunology lab of the Buenos Aires University Medical School, corresponding to individuals vaccinated with 2 doses of Sputnik V. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants aged 18 years and above at the time of randomization.
- Provide written informed consent.
- Axillary temperature ≤ 37℃.
- Never received any investigational or licensed COVID-19 vaccine other than the 1st dose of Sputnik V with an interval of 21-90 days before the study.
- Subjects are eligible for immunization of this product as evaluated by investigators after medical history examination, physical examination and clinical judgment of health.
Key exclusion criteria (15 listed)
- Have a history of seizures, epilepsy, encephalopathy, psychosis.
- History of anaphylaxis to any vaccine component.
- Positive urine pregnancy test result, pregnant, lactation women, or intend to become pregnant within the next 6 months.
- Congenital or acquired angioedema/neuroedema.
- Medical history of Guillain-Barré syndrome.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ad5-nCovParticipants enrolled in Group A with only the 1st dose of Sputnik V will receive Ad5-nCoV vaccine at least 21 days but no more than 180 days after the first dose. They will be followed to evaluate the immunogenicity and safety of Ad5-nCoV vaccine during 6 months | Biological | Group A |
Primary outcome
The Geometric mean titers (GMTs) of SARS-CoV-2 neutralizing antibody
Time frame: 21 days from baseline
The Geometric mean titers (GMTs) of SARS-CoV-2 neutralizing antibody on Day 21 post-vaccination of Ad5-nCoV.
6 secondary outcomes
The Geometric mean titers (GMTs) of SARS-CoV-2 neutralizing antibody
Time frame: Month 3 and Month 6 from baseline
solicited adverse events
Time frame: from baseline to 7 days post-vaccination
SARS-CoV-2 specific T-cell response
Time frame: Day 21 post-vaccination of Ad5-nCoV
The GMT of S-protein receptor binding domain (S-RBD) antibody
Time frame: Day 21, Month 3, and Month 6
unsolicited adverse events (AEs)
Time frame: from baseline to 21 days post-vaccination
serious adverse events (SAEs)
Time frame: from baseline to week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ad5-nCov in people with COVID-19 Vaccine, run by Fundación Huésped at 3 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 5 inclusion and 15 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 3 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. 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?
The Geometric mean titers (GMTs) of SARS-CoV-2 neutralizing antibody (time frame: 21 days from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.