HIV InfectionPhase 1NCT05208125

A Phase I, Randomized, Double-Blind, Placebo-Controlled Safety, Tolerability and Immunogenicity Study of Candidate HIV-1 Vaccines ChAdOx1.HTI and MVA.HTI With Recombinant HIV-1 Envelope Protein ConM SOSIP.v7 gp140 Vaccine, Adjuvanted With MPLA Liposomes in ART-Suppressed HIV-1 Positive Individuals

A Phase 1 study testing ChAdOx1.HTI at week 0, ConM SOSIP.v7 at weeks 4, 12 and 28, and MVA.HTI at week 22 (CSSMS). and Normal saline solution in people with HIV Infection, run by IrsiCaixa at 1 site in Spain.

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

BCN03 is a Single-site, randomized, double-blind, placebo-controlled, phase I study to evaluate the safety, tolerability, immunogenicity, and efficacy of a vaccine regimen that includes a sequence of the T- and B-cell immunogens ChAdOx1.HTI and MVA.HTI and ConM SOSIP.v7 gp140 adjuvanted with MPLA liposomes in 30… Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: HIV Infection
What is being tested?: ChAdOx1.HTI at week 0, ConM SOSIP.v7 at weeks 4, 12 and 28, and MVA.HTI at week 22 (CSSMS). and Normal saline solution
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 1 siteSpain
Study dates: 30 Mar 2022to 18 Dec 2023
Phase: Phase 1
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 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Males and females aged at least 18 years on the day of screening and no greater than 60 years on the day of the first IMP administration.
Confirmed HIV-1 infection.
Optimal virological suppression for at least 2 years prior to the screening visit, defined as maintained pVL <50 cop/ml allowing for isolated blips (non-consecutive 50-200 copies/mL)
Being on the same ART regimen within at least 4 weeks prior to screening visit.
CD4 count ≥ 500 cells/mm3 at the screening visit.
Nadir CD4 count ≥ 350 cells/mm3. Lower counts at the moment of acute HIV-1 infection will be allowed only if appropriate immune recovery was followed after ART initiation and ART was not initiated within first 6 months after estimated time of HIV-1 acquisition.

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Willing and able to be adherent to their ART regimen for the duration of the study.
Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study.
In the opinion of the Principal Investigator or designee, the candidate has understood the information provided and capable of giving written Informed Consent.
If heterosexually active female of childbearing potential(1), using an effective method of contraception (hormonal contraception, intra-uterine device (IUD), or anatomical sterility in self or partner(1) from 14 days prior to the first IMP administration and commit to use it until four months after the last IMP administration or until her pVL is <50 copies/mL in two-consecutive determinations after ART resumption, whichever is later. All female candidates of childbearing potential who are not heterosexually active at screening, must agree to utilise an effective method of contraception if they become heterosexually active during the study.
If heterosexually active male, regardless of reproductive potential, sterilized or agree on the use of an effective method of contraception by his female partner (hormonal contraception, intra-uterine device (IUD), or anatomical sterility(2) from the day of the first IMP administration until four months after the last IMP administration or until his pVL is <50 copies/mL in two-consecutive determinations after ART resumption, whichever is later. All male candidates who are not heterosexually active at screening, must agree to utilise an effective method of contraception if they become heterosexually active during the study.
Il female, willing to undergo urine pregnancy tests at the designated time points.
Willing to accept blood draws and collect stool at time points specified in the Schedule of Events (Appendix VII).
Willing to forgo donating blood, eggs, or sperm from the first IMP administration until four months after last IMP administration or until his or her pVL is <50 copies/mL in two-consecutive determinations after ART resumption, whichever is later.
(1) A woman will be considered of childbearing potential if not permanently sterilized nor postmenopausal. Permanent sterilization methods include tubal ligation, hysterectomy and bilateral oophorectomy. Postmenopausal is defined as 12 months with no menses without an alternative medical cause.
(2) Condom use nor diaphragm are considered as an additional method of contraception only and cannot be the only method of contraception used as not been considered an effective method by the Clinical Trial Facilitation Group (CTFG) guidelines.

Who cannot join

If female, pregnant or planning a pregnancy during the study and until at least four months after the last IMP administration or until her pVL is <50 copies/mL in two-consecutive determinations after ART resumption, whichever is later; or lactating.
ART initiated within 6 months from the estimated time of HIV-1 acquisition documented by immediate ART initation after a) an HIV-1 documented seroconversion (<180 days), b) an HIV-1 diagnose with negative or indeterminate western blot test or positive p24 antigenemia and/or c) presenting with symptoms suggestive of acute retroviral syndrome.
When available, pre-ART genotypic data that demonstrates the presence of clinically significant drug resistance mutations that could prevent the construction of a viable ART regimen post-treatment interruption.
Reported periods of suboptimal adherence to ART or suboptimal ART regimens (dual therapy allowed as switch-regimens if sustained viral uppression pVL<50 copies/ml is documented).
History of past ART interruptions longer than 2 weeks.
Participation in another clinical trial that involves a treatment intervention (active arm) within 12 weeks of study entry (at screening visit).

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Any AIDS-defining disease or progression of HIV-related disease.
History of autoimmune disease.
History or clinical manifestations of any physical or psychiatric disorder which could impair the subject's ability to complete the study.
Receipt of approved vaccines within 3 weeks of study entry(1)
Known hypersensitivity to any component of the IMP formulation, or severe or multiple allergies to drugs or pharmaceutical agents.
Previous immunisation with any experimental immunogens.
Potential participant received or plans to receive:
licensed live attenuated vaccines - within 28 days before or after planned administration of the first or subsequent study vaccinations. For details regarding COVID-19 vaccines, see bullet c and d below.
other licensed (not live) vaccines - within 14 days before or after planned administration of the first or subsequent study vaccinations. For details regarding COVID-19 vaccines, see bullet c and d below.
Recombinant viral vectored COVID-19 vaccines or live attenuated COVID-19 vaccines, either licensed or authorized for emergency use (eg. Emergency Use Authorization [EUA], Emergency Use Listing [EUL] or similar program) - within 28 days before or after planned administration of the first or subsequent study vaccinations.
Other COVID-19 vaccines than the ones specified in bullet c (eg. mRNA vaccines, protein-based vaccines) either licensed or authorized for emergency use (eg. EUA, EUL or similar program) - within 14 days before or after planned administration of the first or subsequent study vaccinations.
Receipt of blood products within 3 months of study entry.
Treatment for cancer or lymphoproliferative disease within 1 year of study entry.
Current or recent use (within last 3 months) of interferon or systemic corticosteroids or other immunosuppressive agents (use on inhaled steroids for asthma or topic steroids for localized skin conditions are permitted).
Any other current or prior therapy which, in the opinion of the investigator, would make the individual unsuitable for the study or influence the results of the study.
Any laboratory abnormalities including:
Hematology
Hemoglobin < 10.0 g/dl
Absolute Neutrophil Count ≤ 1,000 /mm3 (≤ 1 x 109/L)
Absolute Lymphocyte Count ≤ 600 /mm3 (≤ 0.6 x 109/L)
Platelets ≤100,000 /mm3, ≥ 550,000 /mm3 (≤ 100 /L, ≥ 550 /L) Biochemistry
Creatinine > 1.3 x ULN
Aspartate aminotransferase (AST) > 2.5 x ULN
Alanine aminotransferase (ALT) > 2.5 x ULN
Microbiology
Positive for hepatitis B surface antigen,
Positive for hepatitis C antibody, unless confirmed clearance of HCV infection (spontaneous or following treatment)
Positive serology indicating active syphilis requiring treatment(2)
Refusal to an eventual ART interruption within the scope of the study objectives(3).
(1)Efforts will be made to ensure all participants included are updated on their Hepatitis A, Hepatitis B and Pneumococcal vaccinations before enrolment. Seasonal Flu vaccinations or other required vaccinations will be scheduled to avoid the 3 weeks preceding and following IMP administrations and the first 12 weeks of ATI.
(2) Cases in which positive RPR titres are detected but syphilis has been confirmed to have been properly treated will be allowed into the study if treatment has been given >4 weeks prior to study entry/IMP administration.
(3)A questionnaire related to ART interruption will be answered by the candidate during the screening visit to be able to address Expectations and Worries in a timely manner to reduce the risk of participants lost to follow-up during the study.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Germans Trias i Pujol Hospital
Badalona, Barcelona, 08916

Other trials in Spain

About this study

Read the detailed description

Participants will be randomized to receive either the combined regimen with T- and B-cell immunogens (CSSMS) or placebo (PPPPP) in a double-blinded fashion at a ratio of 2:1. Safety and immunogenicity of the combined T- and B-cell regimen will be measured up to week 30 (2 weeks after last ConM SOSIP.v7/placebo administration). At week 30, all participants will undergo an ATI of 24 weeks of duration. At visit week 54 (End-of-ATI visit), or before according to pre-specified criteria, ART will be resumed. Efficacy endpoints will be measured at 12 and 24 weeks of ATI (study visits week 42 and 54). After ART resumption, participants will be followed during an additional safety period of 12 weeks (study visit week 66, End-of-Study visit). Treatment allocation will remain blinded until week 54 (End-of-ATI visit).

Conditions: HIV Infection
Being tested: ChAdOx1.HTI at week 0, ConM SOSIP.v7 at weeks 4, 12 and 28, and MVA.HTI at week 22 (CSSMS)., Normal saline solution
Keywords: Human immunodeficiency, Virus, Vaccine, HIV, Safety, Tolerability
Medical subject headings: HIV Infections, Virus Diseases

What participants receive

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

ChAdOx1.HTI at week 0, ConM SOSIP.v7 at weeks 4, 12 and 28, and MVA.HTI at week 22 (CSSMS).Biological
Intramuscular administration of 1 x ChAdOx1.HTI (5x1010 Vp), 3 x ConM SOSIP.v7 (100μg) adjuvanted with MPLA liposomes (500μg), and 1 x MVA.HTI (2x108pfu)
Normal saline solutionOther
Intramuscular administration of normal saline solution

Study groups in NCT05208125
Study group	Role	What they receive
CSSMS	Experimental	ChAdOx1.HTI at week 0, ConM SOSIP.v7 at weeks 4, 12 and 28, and MVA.HTI at week 22 (CSSMS). Receives: Biological: ChAdOx1.HTI at week 0, ConM SOSIP.v7 at weeks 4, 12 and 28, and MVA.HTI at week 22 (CSSMS).
PPPPP	Placebo comparator	Normal saline solution at weeks 0, 4, 12, 22, and 28 (PPPPP). Receives: Other: Normal saline solution

What is being measured

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

Local IMP-related AEs of Grade 3 and 4
Proportion of participants that develop Grade 3 or 4 local IMP-related AEs, based on the DAIDS scale
Measured: From first administration up to week 30 (i.e., start of ATI, 2 weeks after last administration).
Systemic IMP-related AEs of Grade 3 and 4
Proportion of participants that develop Grade 3 or 4 systemic IMP-related AEs, based on the DAIDS scale
Measured: From first administration up to week 30 (i.e., start of ATI, 2 weeks after last administration).
Descriptive of AEs
Descriptive summary of any local and systemic AEs, including laboratory abnormalities, severity, durability, and relationship to IMP in vaccine recipients.
Measured: From first administration up to week 30 (i.e., start of ATI, 2 weeks after last administration)

Secondary outcomes (18)

De novo T-cell Immunogenicity to HTI
Proportion of participants who develop de-novo T-cell responses to HTI- during the intervention period as determined by IFN (gamma) ELISPOT.
Measured: From week 0 to week 30
Magnitude, focus and breadth of T-cell Immunogenicity to HTI
Magnitude, focus and breadth of HTI-specific T-cell responses during the intervention period as determined by IFN (gamma) ELISPOT
Measured: From week 0 to week 30
B-cell Immunogenicity (serum titers of NAbs)
Serum titers of autologous neutralizing antibodies (NAbs) during the intervention period
Measured: From week 0 to week 30
B-cell Immunogenicity (proportion of NAbs)
Proportion of participants with autologous NAbs during the intervention period
Measured: From week 0 to week 30
B-cell Immunogenicity (magnitude of trimer binding antibodies)
Magnitude of trimer binding antibodies during the intervention period
Measured: From week 0 to week 30
B-cell Immunogenicity (proportion of trimer binding antibodies)
Proportion of participants with a trimer binding antibody response during the intervention period
Measured: From week 0 to week 30
B-cell Immunogenicity (serum titers heterologous neutralising antibodies)
Serum titres of heterologous neutralising antibodies (i.e., against additional [Tier 1a/b, Tier 2] virus strains) during the intervention period
Measured: From week 0 to week 30
B-cell Immunogenicity (proportion of heterologous neutralising antibodies)
Proportion of participants with heterologous neutralising antibodies during the intervention period
Measured: From week 0 to week 30
Viral rebound during ATI (sustained viral remission)
Percentage of participants with sustained viral remission, defined as pVL <50 copies/mL at 12 and 24 weeks after ATI start, respectively
Measured: At 12 and 24 weeks after ATI start
Viral rebound during ATI (time to viral detection)
Time to viral detection, defined as the time from ATI start to the first occurrence of detectable pVL (≥50 copies/mL).
Measured: From ATI start to the first occurrence of detectable pVL pVL (from week 30 to week 54 (ATI period)
Viral rebound during ATI (post-rebound viral control)
Percentage of participants with post-rebound viral control, defined as a pVL <2,000 copies/mL at 12 and 24 weeks after ATI start, respectively
Measured: At 12 and 24 weeks after ATI start
Viral rebound during ATI (percentage of off-ART)
Percentage of participants who remain off-ART at 12 and 24 weeks after ATI start, respectively.
Measured: At 12 and 24 weeks after ATI start
Viral rebound during ATI (time off-ART)
Time off-ART, defined as time from ATI start to ART resumption.
Measured: From ATI start to ART resumption (from week 30 to week 54 (ATI period)
Safety of an ATI period (symptoms compatible with acute retroviral syndrome)
Proportion of participants who develop symptoms compatible with acute retroviral syndrome
Measured: From week 30 to week 54
Safety of an ATI period (stress/anxiety related to ATI)
Proportion of participants with clinically significant changes in the ATI Psychological questionnaire suggestive of stress/anxiety related to ATI.
Measured: From week 30 to week 54
Safety of an ATI period (seeking of psychological support)
Proportion of participants who seek psychological support during and/or after ATI.
Measured: From week 30 to week 54
Safety of post-ATI ART resumption (viral suppression)
Proportion of participants who suppress pVL to <50 copies/mL 12 weeks after ART resumption.
Measured: From week 54 to week 66
Safety of post-ATI ART resumption (new mutations conferring clinically-significant resistance to antiretroviral drugs)
Proportion of participants who develop new mutations not present in the pre-ART viral genotype conferring clinically-significant resistance to antiretroviral drugs. In those participants not reaching viral re-suppression 12 weeks after ART resumption, an ART viral genotype will be analyzed
Measured: From week 54 to week 66

Timeline

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

30 Mar 202218 Dec 2023

First posted26 Jan 2022
Study start30 Mar 2022
Primary completion30 Mar 2022
Study completion18 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HIV InfectionStudies 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Participants will be randomized to receive either the combined regimen with T- and B-cell immunogens (CSSMS) or placebo (PPPPP) in a double-blinded fashion at a ratio of 2:1.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05208125
Sponsor's protocol ID: BCN03
Status last verified: May 2024
First submitted: 3 Nov 2021
Last updated: 7 May 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled Safety, Tolerability and Immunogenicity Study of Candidate HIV-1 Vaccines ChAdOx1.HTI and MVA.HTI With Recombinant HIV-1 Envelope Protein ConM SOSIP.v7 gp140 Vaccine, Adjuvanted With MPLA Liposomes in ART-Suppressed HIV-1 Positive Individuals
ClinicalTrials.gov ID: NCT05208125
Acronym / sponsor ID: BCN03
Conditions: HIV Infection
Keywords: Human immunodeficiency, Virus, Vaccine, HIV, Safety, Tolerability
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: IrsiCaixaUniversity, hospital or other
Collaborators: José Moltó Marhuenda, PhD, MD, Beatriz Mothe Pujadas PhD,MD, Susana Benet Garrabé, PhD,MD, Lucía Bailón Álvarez, MD
Study start: 30 Mar 2022 (actual)
Primary completion: 30 Mar 2022 (actual)
Study completion: 18 Dec 2023 (actual)
First posted: 26 Jan 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: Participants will be randomized to receive either the combined regimen with T- and B-cell immunogens (CSSMS) or placebo (PPPPP) in a double-blinded fashion at a ratio of 2:1.

Arm	Type	Receives
CSSMS	Experimental	Biological: ChAdOx1.HTI at week 0, ConM SOSIP.v7 at weeks 4, 12 and 28, and MVA.HTI at week 22 (CSSMS).ChAdOx1.HTI at week 0, ConM SOSIP.v7 at weeks 4, 12 and 28, and MVA.HTI at week 22 (CSSMS).
PPPPP	Placebo comparator	Other: Normal saline solutionNormal saline solution at weeks 0, 4, 12, 22, and 28 (PPPPP).

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (16 listed)

Males and females aged at least 18 years on the day of screening and no greater than 60 years on the day of the first IMP administration.
Confirmed HIV-1 infection.
Optimal virological suppression for at least 2 years prior to the screening visit, defined as maintained pVL <50 cop/ml allowing for isolated blips (non-consecutive 50-200 copies/mL)
Being on the same ART regimen within at least 4 weeks prior to screening visit.
CD4 count ≥ 500 cells/mm3 at the screening visit.

Key exclusion criteria (38 listed)

If female, pregnant or planning a pregnancy during the study and until at least four months after the last IMP administration or until her pVL is <50 copies/mL in two-consecutive determinations after ART resumption, whichever is later; or lactating.
ART initiated within 6 months from the estimated time of HIV-1 acquisition documented by immediate ART initation after a) an HIV-1 documented seroconversion (<180 days), b) an HIV-1 diagnose with negative or indeterminate western blot test or positive p24 antigenemia and/or c) presenting with symptoms suggestive of acute retroviral syndrome.
When available, pre-ART genotypic data that demonstrates the presence of clinically significant drug resistance mutations that could prevent the construction of a viable ART regimen post-treatment interruption.
Reported periods of suboptimal adherence to ART or suboptimal ART regimens (dual therapy allowed as switch-regimens if sustained viral uppression pVL<50 copies/ml is documented).
History of past ART interruptions longer than 2 weeks.

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
ChAdOx1.HTI at week 0, ConM SOSIP.v7 at weeks 4, 12 and 28, and MVA.HTI at week 22 (CSSMS).Intramuscular administration of 1 x ChAdOx1.HTI (5x1010 Vp), 3 x ConM SOSIP.v7 (100μg) adjuvanted with MPLA liposomes (500μg), and 1 x MVA.HTI (2x108pfu)	Biological	CSSMS
Normal saline solutionIntramuscular administration of normal saline solution	Other	PPPPP

Primary outcome

Local IMP-related AEs of Grade 3 and 4
Time frame: From first administration up to week 30 (i.e., start of ATI, 2 weeks after last administration).
Proportion of participants that develop Grade 3 or 4 local IMP-related AEs, based on the DAIDS scale
Systemic IMP-related AEs of Grade 3 and 4
Time frame: From first administration up to week 30 (i.e., start of ATI, 2 weeks after last administration).
Proportion of participants that develop Grade 3 or 4 systemic IMP-related AEs, based on the DAIDS scale
Descriptive of AEs
Time frame: From first administration up to week 30 (i.e., start of ATI, 2 weeks after last administration)
Descriptive summary of any local and systemic AEs, including laboratory abnormalities, severity, durability, and relationship to IMP in vaccine recipients.

18 secondary outcomes

De novo T-cell Immunogenicity to HTI
Time frame: From week 0 to week 30
Magnitude, focus and breadth of T-cell Immunogenicity to HTI
Time frame: From week 0 to week 30
B-cell Immunogenicity (serum titers of NAbs)
Time frame: From week 0 to week 30
B-cell Immunogenicity (proportion of NAbs)
Time frame: From week 0 to week 30
B-cell Immunogenicity (magnitude of trimer binding antibodies)
Time frame: From week 0 to week 30
B-cell Immunogenicity (proportion of trimer binding antibodies)
Time frame: From week 0 to week 30
B-cell Immunogenicity (serum titers heterologous neutralising antibodies)
Time frame: From week 0 to week 30
B-cell Immunogenicity (proportion of heterologous neutralising antibodies)
Time frame: From week 0 to week 30
Viral rebound during ATI (sustained viral remission)
Time frame: At 12 and 24 weeks after ATI start
Viral rebound during ATI (time to viral detection)
Time frame: From ATI start to the first occurrence of detectable pVL pVL (from week 30 to week 54 (ATI period)
Viral rebound during ATI (post-rebound viral control)
Time frame: At 12 and 24 weeks after ATI start
Viral rebound during ATI (percentage of off-ART)
Time frame: At 12 and 24 weeks after ATI start
Viral rebound during ATI (time off-ART)
Time frame: From ATI start to ART resumption (from week 30 to week 54 (ATI period)
Safety of an ATI period (symptoms compatible with acute retroviral syndrome)
Time frame: From week 30 to week 54
Safety of an ATI period (stress/anxiety related to ATI)
Time frame: From week 30 to week 54
Safety of an ATI period (seeking of psychological support)
Time frame: From week 30 to week 54
Safety of post-ATI ART resumption (viral suppression)
Time frame: From week 54 to week 66
Safety of post-ATI ART resumption (new mutations conferring clinically-significant resistance to antiretroviral drugs)
Time frame: From week 54 to week 66

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 7 May 2024.

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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.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 16 inclusion and 38 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 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Local IMP-related AEs of Grade 3 and 4 (time frame: From first administration up to week 30 (i.e., start of ATI, 2 weeks after last administration).). The study lists 3 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 NCT05208125.

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 7 May 2024.